NOAEL Studies
UV Filter / Sunscreen
Diethylamino Hydroxybenzoyl Hexyl Benzoate NOAEL Studies
INCI: DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE
CAS: 302776-68-7
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 1000 | mg/kg bw/day | rat | oral | 6-19 Gestation day | Developmental | SCCP; Schilling K., H et al. (4-Diethylamino-2-hydroxybenzoyl)-benzoesaurehexylester- Prenatal Developmental Toxicity Study in Wistar Rats, Oral Administration Gavage).Project 30R0408/99112. BASF AG Product Safety Regulations Tox and Ecology |
| COSMOS_DB | NOAEL | 200 | mg/kg bw/day | rat | oral | 6-19 Gestation day | Developmental | SCCP; Schilling K., H et al. (4-Diethylamino-2-hydroxybenzoyl)-benzoesaurehexylester- Prenatal Developmental Toxicity Study in Wistar Rats, Oral Administration Gavage).Project 30R0408/99112. BASF AG Product Safety Regulations Tox and Ecology |
SCCNFP_vision_codex 36 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =15000 | ppm | rabbit | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 11 2","dose":"__________________________________________________________________ 6 All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.","effect":"__________________________________________________________________ 6 All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Ref. : 11 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Method : According to OECD n° 404 (1992); EU n° B.5 (1992); US EPA, Health Effects Test Guidelines OPPTS 870.2400 \"Acute Eye Irritation\" (1998) Test animals : 3 White New Zealand Rabbits Test substan","page":6,"pdf":"out223_en.pdf","row_type":"noael_study","study_id":"out223_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =200 | mg/kg bw/day | - | oral | prenatal | developmental toxicity | {"citation":"Ref. : 12 2","dose":"No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/day.","effect":"icity, by transient salivation, reduced food consumption on days 6 - 13 p.c. and slight impairments in absolute and corrected body weight gain was noted. No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/day. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day). The no observed adverse effect level (NOAEL) for maternal toxicity is 200-1000 mg/kg bw/day, while it is > 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. The slight difference, compared with the NOAEL derived from the 90-day study may be due to the kind of administration (diet versus gavage of an oily suspension as bolus and consequently reaching actual higher systemic levels). Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Test substance : 10 % a.i. in a cosmetic formulation (o/w","page":8,"pdf":"out223_en.pdf","row_type":"noael_study","study_id":"out223_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | >1000 | mg/kg bw/day | pig | oral | prenatal | developmental toxicity | {"citation":"Ref. : 12 2","dose":"els of 40 or 200 mg/kg bw/day.","effect":"els of 40 or 200 mg/kg bw/day. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day). The no observed adverse effect level (NOAEL) for maternal toxicity is 200-1000 mg/kg bw/day, while it is > 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. The slight difference, compared with the NOAEL derived from the 90-day study may be due to the kind of administration (diet versus gavage of an oily suspension as bolus and consequently reaching actual higher systemic levels). Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Test substance : 10 % a.i. in a cosmetic formulation (o/w emulsion, no composition stated). Solubility in receptor fluid is 1.28 mg/ml. Batch n° : R323/681 Purity : 99.35 % Dosage : 2 mg/cm² and 10 mg/cm² Skin preparation : full-thickness pig skin. The","page":8,"pdf":"out223_en.pdf","row_type":"noael_study","study_id":"out223_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =1350 | mg/kg bw | rat | oral | 90-day | NOAEL study | {"citation":"Ref. : 9 2","dose":"Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat.","effect":"of 1.05. This, however, is not biologically relevant in this case. No phototoxic potential can be predicted. Conclusion In the study described and under the experimental conditions reported no phototoxic potential was observed after treatment of Balb/c3T3 cells in the absence and in the presence of artificial sunlight. Ref. : 9 2.11. Safety evaluation NOT APPLICABLE 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while > 1000 mg/kg bw can be regarded as NOEL for pre-natal development. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin and mucous membranes in rabbits. It is not a dermal sensitiser. The percutaneous","page":14,"pdf":"out223_en.pdf","row_type":"noael_study","study_id":"out223_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | >1000 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"citation":"Ref. : 9 2","dose":"Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat.","effect":"ght. Ref. : 9 2.11. Safety evaluation NOT APPLICABLE 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while > 1000 mg/kg bw can be regarded as NOEL for pre-natal development. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin and mucous membranes in rabbits. It is not a dermal sensitiser. The percutaneous absorption study is inadequate. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is neither phototoxic nor photosensitising. It is not mutagenic/photo-mutagenic in vitro. As to a safety assessment of an use of UV-filters by children over the age of 1 year, the SCCNFP issued a position statement (SCC","page":14,"pdf":"out223_en.pdf","row_type":"noael_study","study_id":"out223_en_noael_007"} |
| SCCNFP_vision_codex | NOAEL | =3000 | ppm | rabbit | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 11 2","dose":"hey were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.","effect":"hey were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Under conservative judgement, the NOEL was set at 3000 ppm (250 mg/kg bw). Ref. : 11 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Method : According to OECD n° 404 (1992); EU n° B.5 (1992); US EPA, Health Effects Test Guidelines OPPTS 870.2400 \"Acute Eye Irritation\" (1998) Test animals : 3 White New Zealand Rabbits Test substance : Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester Batch no :","page":6,"pdf":"out241_en.pdf","row_type":"noael_study","study_id":"out241_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =2000 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"xybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 (Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) Maximum absorption through the skin A (µg/cm²) = 0.1 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Der...","effect":"xybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 (Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) Maximum absorption through the skin A (µg/cm²) = 0.1 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.001 = 1.800 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0. 03 mg/kg No observed effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral) Margin of Safety NOAEL / SED = 6667 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while","page":15,"pdf":"out241_en.pdf","row_type":"noael_study","study_id":"out241_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =0.1 | µg/cm | rat | oral | 90-day | dermal absorption | {"dose":"Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat.","effect":"y oral) Margin of Safety NOAEL / SED = 6667 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while > 1000 mg/kg bw can be regarded as NOEL for pre-natal development. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin and mucous membranes in rabbits. It is not a dermal sensitiser. The percutaneous absorption was set at 0.1 µg/cm². Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is neither phototoxic nor photosensitising. It is not mutagenic/photo-mutagenic in vitro. As to a safety assessment for use of UV-filters by children over the age of 1 year, the SCCNFP issued a position statement","page":15,"pdf":"out241_en.pdf","row_type":"noael_study","study_id":"out241_en_noael_011"} |
| SCCNFP_vision_codex | NOAEL | =200 | mg/kg | rat | oral | - | NOAEL study | {"dose":"No observed effect level (mg/kg) (rat, teratogenicity oral) | NOAEL | = | 200 mg/kg","effect":"CALCULATION OF THE MARGIN OF SAFETY: No observed effect level (mg/kg) (rat, teratogenicity oral) | NOAEL | = | 200 mg/kg","page":15,"pdf":"out241_en.pdf","row_type":"noael_study","study_id":"out241_en_noael_012"} |
| SCCNFP_vision_codex | NOAEL | =15000 | ppm | rabbit | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 11 2","dose":"__________________________________________________________________ 6 All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.","effect":"__________________________________________________________________ 6 All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Ref. : 11 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Method : According to OECD n° 404 (1992); EU n° B.5 (1992); US EPA, Health Effects Test Guidelines OPPTS 870.2400 \"Acute Eye Irritation\" (1998) Test animals : 3 White New Zealand Rabbits Test substan","page":6,"pdf":"out223_en.pdf","row_type":"noael_study","study_id":"out223_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =200 | mg/kg bw/day | - | oral | prenatal | developmental toxicity | {"citation":"Ref. : 12 2","dose":"No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/day.","effect":"icity, by transient salivation, reduced food consumption on days 6 - 13 p.c. and slight impairments in absolute and corrected body weight gain was noted. No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/day. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day). The no observed adverse effect level (NOAEL) for maternal toxicity is 200-1000 mg/kg bw/day, while it is > 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. The slight difference, compared with the NOAEL derived from the 90-day study may be due to the kind of administration (diet versus gavage of an oily suspension as bolus and consequently reaching actual higher systemic levels). Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Test substance : 10 % a.i. in a cosmetic formulation (o/w","page":8,"pdf":"out223_en.pdf","row_type":"noael_study","study_id":"out223_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | >1000 | mg/kg bw/day | pig | oral | prenatal | developmental toxicity | {"citation":"Ref. : 12 2","dose":"els of 40 or 200 mg/kg bw/day.","effect":"els of 40 or 200 mg/kg bw/day. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day). The no observed adverse effect level (NOAEL) for maternal toxicity is 200-1000 mg/kg bw/day, while it is > 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. The slight difference, compared with the NOAEL derived from the 90-day study may be due to the kind of administration (diet versus gavage of an oily suspension as bolus and consequently reaching actual higher systemic levels). Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Test substance : 10 % a.i. in a cosmetic formulation (o/w emulsion, no composition stated). Solubility in receptor fluid is 1.28 mg/ml. Batch n° : R323/681 Purity : 99.35 % Dosage : 2 mg/cm² and 10 mg/cm² Skin preparation : full-thickness pig skin. The","page":8,"pdf":"out223_en.pdf","row_type":"noael_study","study_id":"out223_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =1350 | mg/kg bw | rat | oral | 90-day | NOAEL study | {"citation":"Ref. : 9 2","dose":"Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat.","effect":"of 1.05. This, however, is not biologically relevant in this case. No phototoxic potential can be predicted. Conclusion In the study described and under the experimental conditions reported no phototoxic potential was observed after treatment of Balb/c3T3 cells in the absence and in the presence of artificial sunlight. Ref. : 9 2.11. Safety evaluation NOT APPLICABLE 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while > 1000 mg/kg bw can be regarded as NOEL for pre-natal development. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin and mucous membranes in rabbits. It is not a dermal sensitiser. The percutaneous","page":14,"pdf":"out223_en.pdf","row_type":"noael_study","study_id":"out223_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | >1000 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"citation":"Ref. : 9 2","dose":"Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat.","effect":"ght. Ref. : 9 2.11. Safety evaluation NOT APPLICABLE 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while > 1000 mg/kg bw can be regarded as NOEL for pre-natal development. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin and mucous membranes in rabbits. It is not a dermal sensitiser. The percutaneous absorption study is inadequate. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is neither phototoxic nor photosensitising. It is not mutagenic/photo-mutagenic in vitro. As to a safety assessment of an use of UV-filters by children over the age of 1 year, the SCCNFP issued a position statement (SCC","page":14,"pdf":"out223_en.pdf","row_type":"noael_study","study_id":"out223_en_noael_007"} |
| SCCNFP_vision_codex | NOAEL | =3000 | ppm | rabbit | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 11 2","dose":"hey were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.","effect":"hey were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Under conservative judgement, the NOEL was set at 3000 ppm (250 mg/kg bw). Ref. : 11 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Method : According to OECD n° 404 (1992); EU n° B.5 (1992); US EPA, Health Effects Test Guidelines OPPTS 870.2400 \"Acute Eye Irritation\" (1998) Test animals : 3 White New Zealand Rabbits Test substance : Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester Batch no :","page":6,"pdf":"out241_en.pdf","row_type":"noael_study","study_id":"out241_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =2000 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"xybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 (Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) Maximum absorption through the skin A (µg/cm²) = 0.1 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Der...","effect":"xybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 (Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) Maximum absorption through the skin A (µg/cm²) = 0.1 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.001 = 1.800 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0. 03 mg/kg No observed effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral) Margin of Safety NOAEL / SED = 6667 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while","page":15,"pdf":"out241_en.pdf","row_type":"noael_study","study_id":"out241_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =0.1 | µg/cm | rat | oral | 90-day | dermal absorption | {"dose":"Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat.","effect":"y oral) Margin of Safety NOAEL / SED = 6667 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while > 1000 mg/kg bw can be regarded as NOEL for pre-natal development. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin and mucous membranes in rabbits. It is not a dermal sensitiser. The percutaneous absorption was set at 0.1 µg/cm². Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is neither phototoxic nor photosensitising. It is not mutagenic/photo-mutagenic in vitro. As to a safety assessment for use of UV-filters by children over the age of 1 year, the SCCNFP issued a position statement","page":15,"pdf":"out241_en.pdf","row_type":"noael_study","study_id":"out241_en_noael_011"} |
| SCCNFP_vision_codex | NOAEL | =200 | mg/kg | rat | oral | - | NOAEL study | {"dose":"No observed effect level (mg/kg) (rat, teratogenicity oral) | NOAEL | = | 200 mg/kg","effect":"CALCULATION OF THE MARGIN OF SAFETY: No observed effect level (mg/kg) (rat, teratogenicity oral) | NOAEL | = | 200 mg/kg","page":15,"pdf":"out241_en.pdf","row_type":"noael_study","study_id":"out241_en_noael_012"} |
| SCCNFP_vision_codex | NOAEL | =15000 | ppm | rabbit | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 11 2","dose":"__________________________________________________________________ 6 All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.","effect":"__________________________________________________________________ 6 All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Ref. : 11 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Method : According to OECD n° 404 (1992); EU n° B.5 (1992); US EPA, Health Effects Test Guidelines OPPTS 870.2400 \"Acute Eye Irritation\" (1998) Test animals : 3 White New Zealand Rabbits Test substan","page":6,"pdf":"out223_en.pdf","row_type":"noael_study","study_id":"out223_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =200 | mg/kg bw/day | - | oral | prenatal | developmental toxicity | {"citation":"Ref. : 12 2","dose":"No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/day.","effect":"icity, by transient salivation, reduced food consumption on days 6 - 13 p.c. and slight impairments in absolute and corrected body weight gain was noted. No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/day. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day). The no observed adverse effect level (NOAEL) for maternal toxicity is 200-1000 mg/kg bw/day, while it is > 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. The slight difference, compared with the NOAEL derived from the 90-day study may be due to the kind of administration (diet versus gavage of an oily suspension as bolus and consequently reaching actual higher systemic levels). Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Test substance : 10 % a.i. in a cosmetic formulation (o/w","page":8,"pdf":"out223_en.pdf","row_type":"noael_study","study_id":"out223_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | >1000 | mg/kg bw/day | pig | oral | prenatal | developmental toxicity | {"citation":"Ref. : 12 2","dose":"els of 40 or 200 mg/kg bw/day.","effect":"els of 40 or 200 mg/kg bw/day. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day). The no observed adverse effect level (NOAEL) for maternal toxicity is 200-1000 mg/kg bw/day, while it is > 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. The slight difference, compared with the NOAEL derived from the 90-day study may be due to the kind of administration (diet versus gavage of an oily suspension as bolus and consequently reaching actual higher systemic levels). Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Test substance : 10 % a.i. in a cosmetic formulation (o/w emulsion, no composition stated). Solubility in receptor fluid is 1.28 mg/ml. Batch n° : R323/681 Purity : 99.35 % Dosage : 2 mg/cm² and 10 mg/cm² Skin preparation : full-thickness pig skin. The","page":8,"pdf":"out223_en.pdf","row_type":"noael_study","study_id":"out223_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =1350 | mg/kg bw | rat | oral | 90-day | NOAEL study | {"citation":"Ref. : 9 2","dose":"Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat.","effect":"of 1.05. This, however, is not biologically relevant in this case. No phototoxic potential can be predicted. Conclusion In the study described and under the experimental conditions reported no phototoxic potential was observed after treatment of Balb/c3T3 cells in the absence and in the presence of artificial sunlight. Ref. : 9 2.11. Safety evaluation NOT APPLICABLE 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while > 1000 mg/kg bw can be regarded as NOEL for pre-natal development. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin and mucous membranes in rabbits. It is not a dermal sensitiser. The percutaneous","page":14,"pdf":"out223_en.pdf","row_type":"noael_study","study_id":"out223_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | >1000 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"citation":"Ref. : 9 2","dose":"Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat.","effect":"ght. Ref. : 9 2.11. Safety evaluation NOT APPLICABLE 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while > 1000 mg/kg bw can be regarded as NOEL for pre-natal development. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin and mucous membranes in rabbits. It is not a dermal sensitiser. The percutaneous absorption study is inadequate. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is neither phototoxic nor photosensitising. It is not mutagenic/photo-mutagenic in vitro. As to a safety assessment of an use of UV-filters by children over the age of 1 year, the SCCNFP issued a position statement (SCC","page":14,"pdf":"out223_en.pdf","row_type":"noael_study","study_id":"out223_en_noael_007"} |
| SCCNFP_vision_codex | NOAEL | =3000 | ppm | rabbit | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 11 2","dose":"hey were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.","effect":"hey were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Under conservative judgement, the NOEL was set at 3000 ppm (250 mg/kg bw). Ref. : 11 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Method : According to OECD n° 404 (1992); EU n° B.5 (1992); US EPA, Health Effects Test Guidelines OPPTS 870.2400 \"Acute Eye Irritation\" (1998) Test animals : 3 White New Zealand Rabbits Test substance : Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester Batch no :","page":6,"pdf":"out241_en.pdf","row_type":"noael_study","study_id":"out241_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =2000 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"xybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 (Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) Maximum absorption through the skin A (µg/cm²) = 0.1 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Der...","effect":"xybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 (Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) Maximum absorption through the skin A (µg/cm²) = 0.1 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.001 = 1.800 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0. 03 mg/kg No observed effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral) Margin of Safety NOAEL / SED = 6667 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while","page":15,"pdf":"out241_en.pdf","row_type":"noael_study","study_id":"out241_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =0.1 | µg/cm | rat | oral | 90-day | dermal absorption | {"dose":"Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat.","effect":"y oral) Margin of Safety NOAEL / SED = 6667 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while > 1000 mg/kg bw can be regarded as NOEL for pre-natal development. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin and mucous membranes in rabbits. It is not a dermal sensitiser. The percutaneous absorption was set at 0.1 µg/cm². Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is neither phototoxic nor photosensitising. It is not mutagenic/photo-mutagenic in vitro. As to a safety assessment for use of UV-filters by children over the age of 1 year, the SCCNFP issued a position statement","page":15,"pdf":"out241_en.pdf","row_type":"noael_study","study_id":"out241_en_noael_011"} |
| SCCNFP_vision_codex | NOAEL | =200 | mg/kg | rat | oral | - | NOAEL study | {"dose":"No observed effect level (mg/kg) (rat, teratogenicity oral) | NOAEL | = | 200 mg/kg","effect":"CALCULATION OF THE MARGIN OF SAFETY: No observed effect level (mg/kg) (rat, teratogenicity oral) | NOAEL | = | 200 mg/kg","page":15,"pdf":"out241_en.pdf","row_type":"noael_study","study_id":"out241_en_noael_012"} |
| SCCNFP_vision_codex | NOAEL | =15000 | ppm | rabbit | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 11 2","dose":"__________________________________________________________________ 6 All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.","effect":"__________________________________________________________________ 6 All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Ref. : 11 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Method : According to OECD n° 404 (1992); EU n° B.5 (1992); US EPA, Health Effects Test Guidelines OPPTS 870.2400 \"Acute Eye Irritation\" (1998) Test animals : 3 White New Zealand Rabbits Test substan","page":6,"pdf":"out223_en.pdf","row_type":"noael_study","study_id":"out223_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =200 | mg/kg bw/day | - | oral | prenatal | developmental toxicity | {"citation":"Ref. : 12 2","dose":"No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/day.","effect":"icity, by transient salivation, reduced food consumption on days 6 - 13 p.c. and slight impairments in absolute and corrected body weight gain was noted. No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/day. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day). The no observed adverse effect level (NOAEL) for maternal toxicity is 200-1000 mg/kg bw/day, while it is > 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. The slight difference, compared with the NOAEL derived from the 90-day study may be due to the kind of administration (diet versus gavage of an oily suspension as bolus and consequently reaching actual higher systemic levels). Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Test substance : 10 % a.i. in a cosmetic formulation (o/w","page":8,"pdf":"out223_en.pdf","row_type":"noael_study","study_id":"out223_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | >1000 | mg/kg bw/day | pig | oral | prenatal | developmental toxicity | {"citation":"Ref. : 12 2","dose":"els of 40 or 200 mg/kg bw/day.","effect":"els of 40 or 200 mg/kg bw/day. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day). The no observed adverse effect level (NOAEL) for maternal toxicity is 200-1000 mg/kg bw/day, while it is > 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. The slight difference, compared with the NOAEL derived from the 90-day study may be due to the kind of administration (diet versus gavage of an oily suspension as bolus and consequently reaching actual higher systemic levels). Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Test substance : 10 % a.i. in a cosmetic formulation (o/w emulsion, no composition stated). Solubility in receptor fluid is 1.28 mg/ml. Batch n° : R323/681 Purity : 99.35 % Dosage : 2 mg/cm² and 10 mg/cm² Skin preparation : full-thickness pig skin. The","page":8,"pdf":"out223_en.pdf","row_type":"noael_study","study_id":"out223_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =1350 | mg/kg bw | rat | oral | 90-day | NOAEL study | {"citation":"Ref. : 9 2","dose":"Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat.","effect":"of 1.05. This, however, is not biologically relevant in this case. No phototoxic potential can be predicted. Conclusion In the study described and under the experimental conditions reported no phototoxic potential was observed after treatment of Balb/c3T3 cells in the absence and in the presence of artificial sunlight. Ref. : 9 2.11. Safety evaluation NOT APPLICABLE 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while > 1000 mg/kg bw can be regarded as NOEL for pre-natal development. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin and mucous membranes in rabbits. It is not a dermal sensitiser. The percutaneous","page":14,"pdf":"out223_en.pdf","row_type":"noael_study","study_id":"out223_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | >1000 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"citation":"Ref. : 9 2","dose":"Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat.","effect":"ght. Ref. : 9 2.11. Safety evaluation NOT APPLICABLE 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while > 1000 mg/kg bw can be regarded as NOEL for pre-natal development. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin and mucous membranes in rabbits. It is not a dermal sensitiser. The percutaneous absorption study is inadequate. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is neither phototoxic nor photosensitising. It is not mutagenic/photo-mutagenic in vitro. As to a safety assessment of an use of UV-filters by children over the age of 1 year, the SCCNFP issued a position statement (SCC","page":14,"pdf":"out223_en.pdf","row_type":"noael_study","study_id":"out223_en_noael_007"} |
| SCCNFP_vision_codex | NOAEL | =3000 | ppm | rabbit | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 11 2","dose":"hey were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.","effect":"hey were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Under conservative judgement, the NOEL was set at 3000 ppm (250 mg/kg bw). Ref. : 11 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Method : According to OECD n° 404 (1992); EU n° B.5 (1992); US EPA, Health Effects Test Guidelines OPPTS 870.2400 \"Acute Eye Irritation\" (1998) Test animals : 3 White New Zealand Rabbits Test substance : Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester Batch no :","page":6,"pdf":"out241_en.pdf","row_type":"noael_study","study_id":"out241_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =2000 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"xybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 (Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) Maximum absorption through the skin A (µg/cm²) = 0.1 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Der...","effect":"xybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 (Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) Maximum absorption through the skin A (µg/cm²) = 0.1 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.001 = 1.800 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0. 03 mg/kg No observed effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral) Margin of Safety NOAEL / SED = 6667 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while","page":15,"pdf":"out241_en.pdf","row_type":"noael_study","study_id":"out241_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =0.1 | µg/cm | rat | oral | 90-day | dermal absorption | {"dose":"Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat.","effect":"y oral) Margin of Safety NOAEL / SED = 6667 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while > 1000 mg/kg bw can be regarded as NOEL for pre-natal development. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin and mucous membranes in rabbits. It is not a dermal sensitiser. The percutaneous absorption was set at 0.1 µg/cm². Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is neither phototoxic nor photosensitising. It is not mutagenic/photo-mutagenic in vitro. As to a safety assessment for use of UV-filters by children over the age of 1 year, the SCCNFP issued a position statement","page":15,"pdf":"out241_en.pdf","row_type":"noael_study","study_id":"out241_en_noael_011"} |
| SCCNFP_vision_codex | NOAEL | =200 | mg/kg | rat | oral | - | NOAEL study | {"dose":"No observed effect level (mg/kg) (rat, teratogenicity oral) | NOAEL | = | 200 mg/kg","effect":"CALCULATION OF THE MARGIN OF SAFETY: No observed effect level (mg/kg) (rat, teratogenicity oral) | NOAEL | = | 200 mg/kg","page":15,"pdf":"out241_en.pdf","row_type":"noael_study","study_id":"out241_en_noael_012"} |
SCCS_vision_codex 88 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =15000 | ppm | rat | - | Chronic | reproductive toxicity | {"citation":"Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248","dose":"All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.","effect":"egard this as treatment related. All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/d in females). Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3,000 ppm (250 mg/kg bw/d). 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strains: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Esche","page":12,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_001"} |
| SCCS_vision_codex | NOAEL | =3000 | ppm | rat | - | Chronic | reproductive toxicity | {"citation":"Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248","dose":"in control and high dose males and/or females.","effect":"in control and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/d in females). Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3,000 ppm (250 mg/kg bw/d). 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strains: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2 uvrA Test substance: Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester Batch: R323/681 Purity: 99.35% Replicates: 3 plates per test Concentrations: Standard plate test: 20 µg","page":12,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_003"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/d | - | oral | prenatal | developmental toxicity | {"citation":"Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental tox","dose":"SCCP/0996/06 Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance in...","effect":"SCCP/0996/06 Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Cytotoxicity Assay in vitro: Neutral Red (NR) Assay at simultaneous Irradiat","page":15,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_004"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw/d | - | oral | prenatal | developmental toxicity | {"citation":"Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental tox","dose":"SCCP/0996/06 Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance in...","effect":"SCCP/0996/06 Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Cytotoxicity Assay in vitro: Neutral Red (NR) Assay at simultaneous Irradiation wit","page":15,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.093 | mg/kg | rat | oral | 90-day | developmental toxicity | {"dose":"Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No obs...","effect":"CALCULATION OF THE MARGIN OF SAFETY Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/d. In a prenatal development","page":20,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_008"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg | rat | oral | 90-day | developmental toxicity | {"dose":"Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No obs...","effect":"oic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/d. In a prenatal development toxicity stud","page":20,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_009"} |
| SCCS_vision_codex | NOAEL | =2000 | mg/kg bw | rat | oral | 90-day | developmental toxicity | {"dose":"mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14.","effect":"mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/d. In a prenatal development toxicity study, the NOAEL for maternal toxicity was 200 mg/kg bw/d and 1000 mg/kg bw for prenatal developmental toxicity. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin of guinea pigs for treatments up to 14 days. It caused transient irritation to the rabbit eye. A study of skin sensitisation in guinea pigs cannot be evaluated. The percutaneous absorption was 0.100 ± 0.11","page":20,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_011"} |
| SCCS_vision_codex | NOAEL | =15000 | ppm | rat | - | - | reproductive toxicity | {"citation":"Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day)","dose":"All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.","effect":"ated. All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Conclusion The study authors considered that the NOAEL was equal to the highest dose used. That is 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day).","page":14,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_001"} |
| SCCS_vision_codex | NOAEL | =3000 | ppm | rat | - | - | reproductive toxicity | {"citation":"Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day)","dose":"l and high dose males and/or females.","effect":"l and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Conclusion The study authors considered that the NOAEL was equal to the highest dose used. That is 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day).","page":14,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_002"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/d | - | oral | prenatal | developmental toxicity | {"citation":"Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental t","dose":"ced food consumption on day 6 - 13 p.c. and slight alterations in absolute and corrected body weight gain were noted at 1,000 mg/kg bw/day.","effect":"ced food consumption on day 6 - 13 p.c. and slight alterations in absolute and corrected body weight gain were noted at 1,000 mg/kg bw/day. No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/d. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted","page":18,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_003"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw/day | - | oral | prenatal | developmental toxicity | {"citation":"Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental t","dose":"p.c. and slight alterations in absolute and corrected body weight gain were noted at 1,000 mg/kg bw/day.","effect":"p.c. and slight alterations in absolute and corrected body weight gain were noted at 1,000 mg/kg bw/day. No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/d. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted","page":18,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.09 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No obser...","effect":"realistic value. Thus, for the calculation of MoS it is assumed that (17.79 + 18.0 ~ 36) 36 g cosmetics per day containing 10% diethylamino hydroxybenzoyl hexyl benzoate is used. Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2222 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered (It has been proposed that Uvinul A Plus should be labelled R53: May cause long-term adverse effects in the aquatic environment [draft 31st adaptation to technical progress of directive 67/584/EEC on dangerous substances]. Diethy","page":23,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_007"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw | rat | oral | - | dermal absorption | {"dose":"Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No obser...","effect":"n of MoS it is assumed that (17.79 + 18.0 ~ 36) 36 g cosmetics per day containing 10% diethylamino hydroxybenzoyl hexyl benzoate is used. Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2222 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered (It has been proposed that Uvinul A Plus should be labelled R53: May cause long-term adverse effects in the aquatic environment [draft 31st adaptation to technical progress of directive 67/584/EEC on dangerous substances]. Diethylamino hydroxy","page":23,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_008"} |
| SCCS_vision_codex | NOAEL | =2000 | mg/kg bw | rat | oral | 90-day | developmental toxicity | {"dose":"Diethylamino hydroxybenzoyl hexyl benzoate has low acute oral toxicity; more than 2000 mg/kg bw in the rat.","effect":"D = 2222 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered (It has been proposed that Uvinul A Plus should be labelled R53: May cause long-term adverse effects in the aquatic environment [draft 31st adaptation to technical progress of directive 67/584/EEC on dangerous substances]. Diethylamino hydroxybenzoyl hexyl benzoate has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/day. In a prenatal development toxicity study, the NOAEL for maternal toxicity was 200 mg/kg bw/day and 1000 mg/kg bw for prenatal developmental toxicity. Diethylamino hydroxybenzoyl hexyl benzoate is not irritating to the skin of guinea pigs for treatments up to 14 days. It caused transient irritation to the rabbit eye. A study of skin sensitisation in guinea pigs cannot be evaluated. The percutaneous absorption was 0.10 ± 0.12 µg/cm² or 0.04 ± 0","page":23,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_010"} |
| SCCS_vision_codex | NOAEL | =5 | mg/kg bw/d | rat | oral | Prenatal | reproductive toxicity | {"dose":"Of the 19 studies, the publication by Saillenfait (2013) was considered to be the most robust, reporting a NOAEL of 5 mg/kg bw/d.","effect":"of the CLP regulation regarding its endocrine active properties: https://echa.europa.eu/fr/registry-of-clh-intentions-until- outcome/-/dislist/details/0b0236e1892b821d As part of a risk assessment, Pirow et al. (2024, supplemental information) conducted a literature search on in vivo animal studies with at least three doses of DnHexP addressing the reproductive hazard of DnHexP in order to identify a PoD. Of the 19 studies, the publication by Saillenfait (2013) was considered to be the most robust, reporting a NOAEL of 5 mg/kg bw/d. The studies were also examined by the SCCS and are summarised below. 1. Prenatal developmental toxicity study in rats The study evaluated the dose–response relationship for the effects of DnHexP on the synthesis and production of testosterone in the fetal rat testis. Pregnant Sprague–Dawley rats were administered the vehicle (olive oil) and either DnHexP (5 to 625 mg kg–1 per day) or diethylhexyl phthalate (DEHP) (50 or 625 mg kg–1 per day), by gavage, from gestation day (GD) 12 to 19. Fetal te","page":13,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_001"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/d | rat | oral | 35-day | reproductive toxicity | {"citation":"Ref: Saillenfait 2009) 3","dose":"d DCHP induced a significant and dose-related decrease in the anogenital distance of male fetuses at all doses, and there was a significant increase in the incidence of male fetuses with undescended testis at 500 and 750 mg kg-1 per day of DnHP.","effect":"d DCHP induced a significant and dose-related decrease in the anogenital distance of male fetuses at all doses, and there was a significant increase in the incidence of male fetuses with undescended testis at 500 and 750 mg kg-1 per day of DnHP. In conclusion, DnHP showed clear embryo lethality and teratogenicity, but not DCHP. There was evidence that both phthalates could alter the development of the male reproductive system after in utero exposure, DnHP being much more potent than DCHP. The authors stated that a NOAEL could not be derived from this study, while the lowest observable adverse effect was judged to be 250 mg/kg bw/d. (Ref: Saillenfait 2009) 3. Study on Leydig cell hyperplasia DnHexP (in the publication abbreviated as DNHP) in doses of 0, 10, 100, and 1000 mg/kg was administered via gavage to 35-day-old male Sprague-Dawley rats for 21 days. Serum levels of testosterone, luteinizing hormone, follicle-stimulating hormone, Leydig cell number, the expression of Leydig and Sertoli cell genes and proteins were investig","page":14,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_004"} |
| SCCS_vision_codex | NOAEL | =18 | - | rat | - | - | reproductive toxicity | {"citation":"Ref: Furr 2014)","dose":"Dose-response studies also were conducted to determine their relative potencies.","effect":"ction (T Prod) was measured on GD 18. Dose-response studies also were conducted to determine their relative potencies. CD-1 mice were also exposed to varying dose levels of Dipentylphthalate (DPeP) from GD 13 to 17 to determine if DPeP reduced T Prod in this species since there is a discrepancy among the results of in utero studies of PEs in mice. Compared to the known male reproductive effects of the PEs in rats the FPS correctly identified all known “positives” and “negatives” tested. The study does not report a NOAEL, but from one of the graphic presentations showing an effect on testis testosterone production, a NOAEL of 10 mg kg bw/d could be deduced. (Ref: Furr 2014)","page":14,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_005"} |
| SCCS_vision_codex | NOAEL | =-1 | - | rat | - | - | reproductive toxicity | {"citation":"Ref: Furr 2014)","dose":"CD-1 mice were also exposed to varying dose levels of Dipentylphthalate (DPeP) from GD 13 to 17 to determine if DPeP reduced T Prod in this species since there is a discrepancy among the results of in utero studies of PEs in mice.","effect":"ive potencies. CD-1 mice were also exposed to varying dose levels of Dipentylphthalate (DPeP) from GD 13 to 17 to determine if DPeP reduced T Prod in this species since there is a discrepancy among the results of in utero studies of PEs in mice. Compared to the known male reproductive effects of the PEs in rats the FPS correctly identified all known “positives” and “negatives” tested. The study does not report a NOAEL, but from one of the graphic presentations showing an effect on testis testosterone production, a NOAEL of 10 mg kg bw/d could be deduced. (Ref: Furr 2014)","page":14,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_006"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/day | - | - | - | repeated dose toxicity | {"dose":"All experiments used the same doses of 0, 20, 100, and 500 mg/kg bw/day on gestational day 6 - 19.","effect":"of DnHexP on various fertility/reproductive toxicity parameters were investigated. All experiments used the same doses of 0, 20, 100, and 500 mg/kg bw/day on gestational day 6 - 19. Besides clinical serum and hematological parameters, decreased anogenital distance (AGD), decreased weight of the male reproductive organs and histopathological findings in the testes, prostate, epididymis and an increased number of abnormal sperm in the male offspring were observed. While a LOAEL of 20 mg/kg bw/day could be derived, a NOAEL was not established. In a recent publication with literature review (Pirow, 2024, Supplement) reservations were expressed regarding the reliability of the studies from this research group. 3.4.1 Repeated dose toxicity See section 3.4 above 3.4.2 Reproductive toxicity See section 3.4 above 3.4.3 Mutagenicity / genotoxicity No mutagenicity/genotoxicity studies are available. DnHexP shares the same mechanism of action with DEHP. EFSA (2019) considered DEHP along with Benzylbutylphthalate (BBB) and Di-n-Butylph","page":15,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_007"} |
| SCCS_vision_codex | NOAEL | =2.5 | mg/kg bw/d | - | oral | 1 year | NOAEL study | {"dose":"302776- 68-7/443-860-6) from cosmetic products ___________________________________________________________________________________________ ___________________________________________________________________________________________ 17 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) Back-calculations for dermal exposure of the maximum saf...","effect":"cument Scientific advice on the safety of Diethylamino Hydroxybenzoyl Hexyl Benzoate -DHHB – S83 (CAS/EC No. 302776- 68-7/443-860-6) from cosmetic products ___________________________________________________________________________________________ ___________________________________________________________________________________________ 17 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) Back-calculations for dermal exposure of the maximum safe levels of DnHexP from the SED derived from the (adjusted) NOAEL* = 2.5 mg/kg bw/d *) adjusted for 50% oral absorption (EFSA 2019) For childrens’ body weights, the SCCS used the conservative median (P50) values from EFSA (2012), which are 8.7 kg, 11.6 kg and 21.7 kg for the 0.5-1 year, 1-3 years and 6-10 years age groups, respectively. The SCCS recommends applying the more conservative EFSA P5 value of 14.0 kg (for children 3-10 years) for the 3-6 years age group. For the 10 – 14 years age group, a body weight of 43.4 kg was used. Corresponding estimates of children's body sur","page":17,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_008"} |
| SCCS_vision_codex | NOAEL | =50 | % | - | oral | - | NOAEL study | {"dose":"In Table 1 the SCCS has, for the respective age categories, back-calculated the fractions of DnHexP that can be considered safe, based on a SED of 0.025 mg/kg bw/d for DnHexP.","effect":"refinement for specific age categories was performed based on the skin surface areas and bodyweights as explained above (SSA/BW scaling approach). In Table 1 the SCCS has, for the respective age categories, back-calculated the fractions of DnHexP that can be considered safe, based on a SED of 0.025 mg/kg bw/d for DnHexP. In the absence of data that are specific for DnHexP and in view of EFSA’s considerations regarding the oral availability of phthalates (EFSA, 2019), the SCCS has applied a 50% adjustment to the NOAEL. Thus, the maximum SED that can be considered safe is derived from a MoS = 100, i.e. 0.01 X NOAEL(adj) = 0.025 mg/kg bw/d. This safe SED = Amount applied on skin in mg/d X %DHHB X %DnHexP in DHHB X %DermAbs)/Bodyweight Following this, the maximum safe fraction of DnHexP in DHHB is: 0.025 mg/kg bw/d divided by [product amount applied in mg/kg bw/d x fraction DHHB allowed in product x fraction DermAbs] For the product amount, the SCCS has used a (conservative) deterministic approach.","page":17,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_009"} |
| SCCS_vision_codex | NOAEL | =0.025 | mg/kg bw/d | - | oral | - | NOAEL study | {"dose":"In Table 1 the SCCS has, for the respective age categories, back-calculated the fractions of DnHexP that can be considered safe, based on a SED of 0.025 mg/kg bw/d for DnHexP.","effect":"ts as explained above (SSA/BW scaling approach). In Table 1 the SCCS has, for the respective age categories, back-calculated the fractions of DnHexP that can be considered safe, based on a SED of 0.025 mg/kg bw/d for DnHexP. In the absence of data that are specific for DnHexP and in view of EFSA’s considerations regarding the oral availability of phthalates (EFSA, 2019), the SCCS has applied a 50% adjustment to the NOAEL. Thus, the maximum SED that can be considered safe is derived from a MoS = 100, i.e. 0.01 X NOAEL(adj) = 0.025 mg/kg bw/d. This safe SED = Amount applied on skin in mg/d X %DHHB X %DnHexP in DHHB X %DermAbs)/Bodyweight Following this, the maximum safe fraction of DnHexP in DHHB is: 0.025 mg/kg bw/d divided by [product amount applied in mg/kg bw/d x fraction DHHB allowed in product x fraction DermAbs] For the product amount, the SCCS has used a (conservative) deterministic approach.","page":17,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_010"} |
| SCCS_vision_codex | NOAEL | =15000 | ppm | rat | - | Chronic | reproductive toxicity | {"citation":"Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248","dose":"All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.","effect":"egard this as treatment related. All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/d in females). Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3,000 ppm (250 mg/kg bw/d). 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strains: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Esche","page":12,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_001"} |
| SCCS_vision_codex | NOAEL | =3000 | ppm | rat | - | Chronic | reproductive toxicity | {"citation":"Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248","dose":"in control and high dose males and/or females.","effect":"in control and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/d in females). Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3,000 ppm (250 mg/kg bw/d). 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strains: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2 uvrA Test substance: Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester Batch: R323/681 Purity: 99.35% Replicates: 3 plates per test Concentrations: Standard plate test: 20 µg","page":12,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_003"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/d | - | oral | prenatal | developmental toxicity | {"citation":"Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental tox","dose":"SCCP/0996/06 Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance in...","effect":"SCCP/0996/06 Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Cytotoxicity Assay in vitro: Neutral Red (NR) Assay at simultaneous Irradiat","page":15,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_004"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw/d | - | oral | prenatal | developmental toxicity | {"citation":"Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental tox","dose":"SCCP/0996/06 Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance in...","effect":"SCCP/0996/06 Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Cytotoxicity Assay in vitro: Neutral Red (NR) Assay at simultaneous Irradiation wit","page":15,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.093 | mg/kg | rat | oral | 90-day | developmental toxicity | {"dose":"Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No obs...","effect":"CALCULATION OF THE MARGIN OF SAFETY Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/d. In a prenatal development","page":20,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_008"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg | rat | oral | 90-day | developmental toxicity | {"dose":"Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No obs...","effect":"oic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/d. In a prenatal development toxicity stud","page":20,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_009"} |
| SCCS_vision_codex | NOAEL | =2000 | mg/kg bw | rat | oral | 90-day | developmental toxicity | {"dose":"mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14.","effect":"mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/d. In a prenatal development toxicity study, the NOAEL for maternal toxicity was 200 mg/kg bw/d and 1000 mg/kg bw for prenatal developmental toxicity. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin of guinea pigs for treatments up to 14 days. It caused transient irritation to the rabbit eye. A study of skin sensitisation in guinea pigs cannot be evaluated. The percutaneous absorption was 0.100 ± 0.11","page":20,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_011"} |
| SCCS_vision_codex | NOAEL | =15000 | ppm | rat | - | Chronic | reproductive toxicity | {"citation":"Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248","dose":"All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.","effect":"egard this as treatment related. All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/d in females). Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3,000 ppm (250 mg/kg bw/d). 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strains: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Esche","page":12,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_001"} |
| SCCS_vision_codex | NOAEL | =3000 | ppm | rat | - | Chronic | reproductive toxicity | {"citation":"Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248","dose":"in control and high dose males and/or females.","effect":"in control and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/d in females). Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3,000 ppm (250 mg/kg bw/d). 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strains: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2 uvrA Test substance: Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester Batch: R323/681 Purity: 99.35% Replicates: 3 plates per test Concentrations: Standard plate test: 20 µg","page":12,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_003"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/d | - | oral | prenatal | developmental toxicity | {"citation":"Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental tox","dose":"SCCP/0996/06 Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance in...","effect":"SCCP/0996/06 Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Cytotoxicity Assay in vitro: Neutral Red (NR) Assay at simultaneous Irradiat","page":15,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_004"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw/d | - | oral | prenatal | developmental toxicity | {"citation":"Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental tox","dose":"SCCP/0996/06 Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance in...","effect":"SCCP/0996/06 Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Cytotoxicity Assay in vitro: Neutral Red (NR) Assay at simultaneous Irradiation wit","page":15,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.093 | mg/kg | rat | oral | 90-day | developmental toxicity | {"dose":"Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No obs...","effect":"CALCULATION OF THE MARGIN OF SAFETY Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/d. In a prenatal development","page":20,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_008"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg | rat | oral | 90-day | developmental toxicity | {"dose":"Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No obs...","effect":"oic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/d. In a prenatal development toxicity stud","page":20,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_009"} |
| SCCS_vision_codex | NOAEL | =2000 | mg/kg bw | rat | oral | 90-day | developmental toxicity | {"dose":"mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14.","effect":"mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/d. In a prenatal development toxicity study, the NOAEL for maternal toxicity was 200 mg/kg bw/d and 1000 mg/kg bw for prenatal developmental toxicity. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin of guinea pigs for treatments up to 14 days. It caused transient irritation to the rabbit eye. A study of skin sensitisation in guinea pigs cannot be evaluated. The percutaneous absorption was 0.100 ± 0.11","page":20,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_011"} |
| SCCS_vision_codex | NOAEL | =15000 | ppm | rat | - | - | reproductive toxicity | {"citation":"Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day)","dose":"All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.","effect":"ated. All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Conclusion The study authors considered that the NOAEL was equal to the highest dose used. That is 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day).","page":14,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_001"} |
| SCCS_vision_codex | NOAEL | =3000 | ppm | rat | - | - | reproductive toxicity | {"citation":"Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day)","dose":"l and high dose males and/or females.","effect":"l and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Conclusion The study authors considered that the NOAEL was equal to the highest dose used. That is 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day).","page":14,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_002"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/d | - | oral | prenatal | developmental toxicity | {"citation":"Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental t","dose":"ced food consumption on day 6 - 13 p.c. and slight alterations in absolute and corrected body weight gain were noted at 1,000 mg/kg bw/day.","effect":"ced food consumption on day 6 - 13 p.c. and slight alterations in absolute and corrected body weight gain were noted at 1,000 mg/kg bw/day. No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/d. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted","page":18,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_003"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw/day | - | oral | prenatal | developmental toxicity | {"citation":"Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental t","dose":"p.c. and slight alterations in absolute and corrected body weight gain were noted at 1,000 mg/kg bw/day.","effect":"p.c. and slight alterations in absolute and corrected body weight gain were noted at 1,000 mg/kg bw/day. No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/d. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted","page":18,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.09 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No obser...","effect":"realistic value. Thus, for the calculation of MoS it is assumed that (17.79 + 18.0 ~ 36) 36 g cosmetics per day containing 10% diethylamino hydroxybenzoyl hexyl benzoate is used. Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2222 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered (It has been proposed that Uvinul A Plus should be labelled R53: May cause long-term adverse effects in the aquatic environment [draft 31st adaptation to technical progress of directive 67/584/EEC on dangerous substances]. Diethy","page":23,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_007"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw | rat | oral | - | dermal absorption | {"dose":"Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No obser...","effect":"n of MoS it is assumed that (17.79 + 18.0 ~ 36) 36 g cosmetics per day containing 10% diethylamino hydroxybenzoyl hexyl benzoate is used. Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2222 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered (It has been proposed that Uvinul A Plus should be labelled R53: May cause long-term adverse effects in the aquatic environment [draft 31st adaptation to technical progress of directive 67/584/EEC on dangerous substances]. Diethylamino hydroxy","page":23,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_008"} |
| SCCS_vision_codex | NOAEL | =2000 | mg/kg bw | rat | oral | 90-day | developmental toxicity | {"dose":"Diethylamino hydroxybenzoyl hexyl benzoate has low acute oral toxicity; more than 2000 mg/kg bw in the rat.","effect":"D = 2222 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered (It has been proposed that Uvinul A Plus should be labelled R53: May cause long-term adverse effects in the aquatic environment [draft 31st adaptation to technical progress of directive 67/584/EEC on dangerous substances]. Diethylamino hydroxybenzoyl hexyl benzoate has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/day. In a prenatal development toxicity study, the NOAEL for maternal toxicity was 200 mg/kg bw/day and 1000 mg/kg bw for prenatal developmental toxicity. Diethylamino hydroxybenzoyl hexyl benzoate is not irritating to the skin of guinea pigs for treatments up to 14 days. It caused transient irritation to the rabbit eye. A study of skin sensitisation in guinea pigs cannot be evaluated. The percutaneous absorption was 0.10 ± 0.12 µg/cm² or 0.04 ± 0","page":23,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_010"} |
| SCCS_vision_codex | NOAEL | =15000 | ppm | rat | - | - | reproductive toxicity | {"citation":"Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day)","dose":"All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.","effect":"ated. All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Conclusion The study authors considered that the NOAEL was equal to the highest dose used. That is 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day).","page":14,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_001"} |
| SCCS_vision_codex | NOAEL | =3000 | ppm | rat | - | - | reproductive toxicity | {"citation":"Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day)","dose":"l and high dose males and/or females.","effect":"l and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Conclusion The study authors considered that the NOAEL was equal to the highest dose used. That is 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day).","page":14,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_002"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/d | - | oral | prenatal | developmental toxicity | {"citation":"Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental t","dose":"ced food consumption on day 6 - 13 p.c. and slight alterations in absolute and corrected body weight gain were noted at 1,000 mg/kg bw/day.","effect":"ced food consumption on day 6 - 13 p.c. and slight alterations in absolute and corrected body weight gain were noted at 1,000 mg/kg bw/day. No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/d. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted","page":18,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_003"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw/day | - | oral | prenatal | developmental toxicity | {"citation":"Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental t","dose":"p.c. and slight alterations in absolute and corrected body weight gain were noted at 1,000 mg/kg bw/day.","effect":"p.c. and slight alterations in absolute and corrected body weight gain were noted at 1,000 mg/kg bw/day. No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/d. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted","page":18,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.09 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No obser...","effect":"realistic value. Thus, for the calculation of MoS it is assumed that (17.79 + 18.0 ~ 36) 36 g cosmetics per day containing 10% diethylamino hydroxybenzoyl hexyl benzoate is used. Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2222 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered (It has been proposed that Uvinul A Plus should be labelled R53: May cause long-term adverse effects in the aquatic environment [draft 31st adaptation to technical progress of directive 67/584/EEC on dangerous substances]. Diethy","page":23,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_007"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw | rat | oral | - | dermal absorption | {"dose":"Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No obser...","effect":"n of MoS it is assumed that (17.79 + 18.0 ~ 36) 36 g cosmetics per day containing 10% diethylamino hydroxybenzoyl hexyl benzoate is used. Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2222 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered (It has been proposed that Uvinul A Plus should be labelled R53: May cause long-term adverse effects in the aquatic environment [draft 31st adaptation to technical progress of directive 67/584/EEC on dangerous substances]. Diethylamino hydroxy","page":23,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_008"} |
| SCCS_vision_codex | NOAEL | =2000 | mg/kg bw | rat | oral | 90-day | developmental toxicity | {"dose":"Diethylamino hydroxybenzoyl hexyl benzoate has low acute oral toxicity; more than 2000 mg/kg bw in the rat.","effect":"D = 2222 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered (It has been proposed that Uvinul A Plus should be labelled R53: May cause long-term adverse effects in the aquatic environment [draft 31st adaptation to technical progress of directive 67/584/EEC on dangerous substances]. Diethylamino hydroxybenzoyl hexyl benzoate has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/day. In a prenatal development toxicity study, the NOAEL for maternal toxicity was 200 mg/kg bw/day and 1000 mg/kg bw for prenatal developmental toxicity. Diethylamino hydroxybenzoyl hexyl benzoate is not irritating to the skin of guinea pigs for treatments up to 14 days. It caused transient irritation to the rabbit eye. A study of skin sensitisation in guinea pigs cannot be evaluated. The percutaneous absorption was 0.10 ± 0.12 µg/cm² or 0.04 ± 0","page":23,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_010"} |
| SCCS_vision_codex | NOAEL | =5 | mg/kg bw/d | rat | oral | Prenatal | reproductive toxicity | {"dose":"Of the 19 studies, the publication by Saillenfait (2013) was considered to be the most robust, reporting a NOAEL of 5 mg/kg bw/d.","effect":"of the CLP regulation regarding its endocrine active properties: https://echa.europa.eu/fr/registry-of-clh-intentions-until- outcome/-/dislist/details/0b0236e1892b821d As part of a risk assessment, Pirow et al. (2024, supplemental information) conducted a literature search on in vivo animal studies with at least three doses of DnHexP addressing the reproductive hazard of DnHexP in order to identify a PoD. Of the 19 studies, the publication by Saillenfait (2013) was considered to be the most robust, reporting a NOAEL of 5 mg/kg bw/d. The studies were also examined by the SCCS and are summarised below. 1. Prenatal developmental toxicity study in rats The study evaluated the dose–response relationship for the effects of DnHexP on the synthesis and production of testosterone in the fetal rat testis. Pregnant Sprague–Dawley rats were administered the vehicle (olive oil) and either DnHexP (5 to 625 mg kg–1 per day) or diethylhexyl phthalate (DEHP) (50 or 625 mg kg–1 per day), by gavage, from gestation day (GD) 12 to 19. Fetal te","page":13,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_001"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/d | rat | oral | 35-day | reproductive toxicity | {"citation":"Ref: Saillenfait 2009) 3","dose":"d DCHP induced a significant and dose-related decrease in the anogenital distance of male fetuses at all doses, and there was a significant increase in the incidence of male fetuses with undescended testis at 500 and 750 mg kg-1 per day of DnHP.","effect":"d DCHP induced a significant and dose-related decrease in the anogenital distance of male fetuses at all doses, and there was a significant increase in the incidence of male fetuses with undescended testis at 500 and 750 mg kg-1 per day of DnHP. In conclusion, DnHP showed clear embryo lethality and teratogenicity, but not DCHP. There was evidence that both phthalates could alter the development of the male reproductive system after in utero exposure, DnHP being much more potent than DCHP. The authors stated that a NOAEL could not be derived from this study, while the lowest observable adverse effect was judged to be 250 mg/kg bw/d. (Ref: Saillenfait 2009) 3. Study on Leydig cell hyperplasia DnHexP (in the publication abbreviated as DNHP) in doses of 0, 10, 100, and 1000 mg/kg was administered via gavage to 35-day-old male Sprague-Dawley rats for 21 days. Serum levels of testosterone, luteinizing hormone, follicle-stimulating hormone, Leydig cell number, the expression of Leydig and Sertoli cell genes and proteins were investig","page":14,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_004"} |
| SCCS_vision_codex | NOAEL | =18 | - | rat | - | - | reproductive toxicity | {"citation":"Ref: Furr 2014)","dose":"Dose-response studies also were conducted to determine their relative potencies.","effect":"ction (T Prod) was measured on GD 18. Dose-response studies also were conducted to determine their relative potencies. CD-1 mice were also exposed to varying dose levels of Dipentylphthalate (DPeP) from GD 13 to 17 to determine if DPeP reduced T Prod in this species since there is a discrepancy among the results of in utero studies of PEs in mice. Compared to the known male reproductive effects of the PEs in rats the FPS correctly identified all known “positives” and “negatives” tested. The study does not report a NOAEL, but from one of the graphic presentations showing an effect on testis testosterone production, a NOAEL of 10 mg kg bw/d could be deduced. (Ref: Furr 2014)","page":14,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_005"} |
| SCCS_vision_codex | NOAEL | =-1 | - | rat | - | - | reproductive toxicity | {"citation":"Ref: Furr 2014)","dose":"CD-1 mice were also exposed to varying dose levels of Dipentylphthalate (DPeP) from GD 13 to 17 to determine if DPeP reduced T Prod in this species since there is a discrepancy among the results of in utero studies of PEs in mice.","effect":"ive potencies. CD-1 mice were also exposed to varying dose levels of Dipentylphthalate (DPeP) from GD 13 to 17 to determine if DPeP reduced T Prod in this species since there is a discrepancy among the results of in utero studies of PEs in mice. Compared to the known male reproductive effects of the PEs in rats the FPS correctly identified all known “positives” and “negatives” tested. The study does not report a NOAEL, but from one of the graphic presentations showing an effect on testis testosterone production, a NOAEL of 10 mg kg bw/d could be deduced. (Ref: Furr 2014)","page":14,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_006"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/day | - | - | - | repeated dose toxicity | {"dose":"All experiments used the same doses of 0, 20, 100, and 500 mg/kg bw/day on gestational day 6 - 19.","effect":"of DnHexP on various fertility/reproductive toxicity parameters were investigated. All experiments used the same doses of 0, 20, 100, and 500 mg/kg bw/day on gestational day 6 - 19. Besides clinical serum and hematological parameters, decreased anogenital distance (AGD), decreased weight of the male reproductive organs and histopathological findings in the testes, prostate, epididymis and an increased number of abnormal sperm in the male offspring were observed. While a LOAEL of 20 mg/kg bw/day could be derived, a NOAEL was not established. In a recent publication with literature review (Pirow, 2024, Supplement) reservations were expressed regarding the reliability of the studies from this research group. 3.4.1 Repeated dose toxicity See section 3.4 above 3.4.2 Reproductive toxicity See section 3.4 above 3.4.3 Mutagenicity / genotoxicity No mutagenicity/genotoxicity studies are available. DnHexP shares the same mechanism of action with DEHP. EFSA (2019) considered DEHP along with Benzylbutylphthalate (BBB) and Di-n-Butylph","page":15,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_007"} |
| SCCS_vision_codex | NOAEL | =2.5 | mg/kg bw/d | - | oral | 1 year | NOAEL study | {"dose":"302776- 68-7/443-860-6) from cosmetic products ___________________________________________________________________________________________ ___________________________________________________________________________________________ 17 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) Back-calculations for dermal exposure of the maximum saf...","effect":"cument Scientific advice on the safety of Diethylamino Hydroxybenzoyl Hexyl Benzoate -DHHB – S83 (CAS/EC No. 302776- 68-7/443-860-6) from cosmetic products ___________________________________________________________________________________________ ___________________________________________________________________________________________ 17 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) Back-calculations for dermal exposure of the maximum safe levels of DnHexP from the SED derived from the (adjusted) NOAEL* = 2.5 mg/kg bw/d *) adjusted for 50% oral absorption (EFSA 2019) For childrens’ body weights, the SCCS used the conservative median (P50) values from EFSA (2012), which are 8.7 kg, 11.6 kg and 21.7 kg for the 0.5-1 year, 1-3 years and 6-10 years age groups, respectively. The SCCS recommends applying the more conservative EFSA P5 value of 14.0 kg (for children 3-10 years) for the 3-6 years age group. For the 10 – 14 years age group, a body weight of 43.4 kg was used. Corresponding estimates of children's body sur","page":17,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_008"} |
| SCCS_vision_codex | NOAEL | =50 | % | - | oral | - | NOAEL study | {"dose":"In Table 1 the SCCS has, for the respective age categories, back-calculated the fractions of DnHexP that can be considered safe, based on a SED of 0.025 mg/kg bw/d for DnHexP.","effect":"refinement for specific age categories was performed based on the skin surface areas and bodyweights as explained above (SSA/BW scaling approach). In Table 1 the SCCS has, for the respective age categories, back-calculated the fractions of DnHexP that can be considered safe, based on a SED of 0.025 mg/kg bw/d for DnHexP. In the absence of data that are specific for DnHexP and in view of EFSA’s considerations regarding the oral availability of phthalates (EFSA, 2019), the SCCS has applied a 50% adjustment to the NOAEL. Thus, the maximum SED that can be considered safe is derived from a MoS = 100, i.e. 0.01 X NOAEL(adj) = 0.025 mg/kg bw/d. This safe SED = Amount applied on skin in mg/d X %DHHB X %DnHexP in DHHB X %DermAbs)/Bodyweight Following this, the maximum safe fraction of DnHexP in DHHB is: 0.025 mg/kg bw/d divided by [product amount applied in mg/kg bw/d x fraction DHHB allowed in product x fraction DermAbs] For the product amount, the SCCS has used a (conservative) deterministic approach.","page":17,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_009"} |
| SCCS_vision_codex | NOAEL | =0.025 | mg/kg bw/d | - | oral | - | NOAEL study | {"dose":"In Table 1 the SCCS has, for the respective age categories, back-calculated the fractions of DnHexP that can be considered safe, based on a SED of 0.025 mg/kg bw/d for DnHexP.","effect":"ts as explained above (SSA/BW scaling approach). In Table 1 the SCCS has, for the respective age categories, back-calculated the fractions of DnHexP that can be considered safe, based on a SED of 0.025 mg/kg bw/d for DnHexP. In the absence of data that are specific for DnHexP and in view of EFSA’s considerations regarding the oral availability of phthalates (EFSA, 2019), the SCCS has applied a 50% adjustment to the NOAEL. Thus, the maximum SED that can be considered safe is derived from a MoS = 100, i.e. 0.01 X NOAEL(adj) = 0.025 mg/kg bw/d. This safe SED = Amount applied on skin in mg/d X %DHHB X %DnHexP in DHHB X %DermAbs)/Bodyweight Following this, the maximum safe fraction of DnHexP in DHHB is: 0.025 mg/kg bw/d divided by [product amount applied in mg/kg bw/d x fraction DHHB allowed in product x fraction DermAbs] For the product amount, the SCCS has used a (conservative) deterministic approach.","page":17,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_010"} |
| SCCS_vision_codex | NOAEL | =5 | mg/kg bw/d | rat | oral | Prenatal | reproductive toxicity | {"dose":"Of the 19 studies, the publication by Saillenfait (2013) was considered to be the most robust, reporting a NOAEL of 5 mg/kg bw/d.","effect":"of the CLP regulation regarding its endocrine active properties: https://echa.europa.eu/fr/registry-of-clh-intentions-until- outcome/-/dislist/details/0b0236e1892b821d As part of a risk assessment, Pirow et al. (2024, supplemental information) conducted a literature search on in vivo animal studies with at least three doses of DnHexP addressing the reproductive hazard of DnHexP in order to identify a PoD. Of the 19 studies, the publication by Saillenfait (2013) was considered to be the most robust, reporting a NOAEL of 5 mg/kg bw/d. The studies were also examined by the SCCS and are summarised below. 1. Prenatal developmental toxicity study in rats The study evaluated the dose–response relationship for the effects of DnHexP on the synthesis and production of testosterone in the fetal rat testis. Pregnant Sprague–Dawley rats were administered the vehicle (olive oil) and either DnHexP (5 to 625 mg kg–1 per day) or diethylhexyl phthalate (DEHP) (50 or 625 mg kg–1 per day), by gavage, from gestation day (GD) 12 to 19. Fetal te","page":13,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_001"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/d | rat | oral | 35-day | reproductive toxicity | {"citation":"Ref: Saillenfait 2009) 3","dose":"d DCHP induced a significant and dose-related decrease in the anogenital distance of male fetuses at all doses, and there was a significant increase in the incidence of male fetuses with undescended testis at 500 and 750 mg kg-1 per day of DnHP.","effect":"d DCHP induced a significant and dose-related decrease in the anogenital distance of male fetuses at all doses, and there was a significant increase in the incidence of male fetuses with undescended testis at 500 and 750 mg kg-1 per day of DnHP. In conclusion, DnHP showed clear embryo lethality and teratogenicity, but not DCHP. There was evidence that both phthalates could alter the development of the male reproductive system after in utero exposure, DnHP being much more potent than DCHP. The authors stated that a NOAEL could not be derived from this study, while the lowest observable adverse effect was judged to be 250 mg/kg bw/d. (Ref: Saillenfait 2009) 3. Study on Leydig cell hyperplasia DnHexP (in the publication abbreviated as DNHP) in doses of 0, 10, 100, and 1000 mg/kg was administered via gavage to 35-day-old male Sprague-Dawley rats for 21 days. Serum levels of testosterone, luteinizing hormone, follicle-stimulating hormone, Leydig cell number, the expression of Leydig and Sertoli cell genes and proteins were investig","page":14,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_004"} |
| SCCS_vision_codex | NOAEL | =18 | - | rat | - | - | reproductive toxicity | {"citation":"Ref: Furr 2014)","dose":"Dose-response studies also were conducted to determine their relative potencies.","effect":"ction (T Prod) was measured on GD 18. Dose-response studies also were conducted to determine their relative potencies. CD-1 mice were also exposed to varying dose levels of Dipentylphthalate (DPeP) from GD 13 to 17 to determine if DPeP reduced T Prod in this species since there is a discrepancy among the results of in utero studies of PEs in mice. Compared to the known male reproductive effects of the PEs in rats the FPS correctly identified all known “positives” and “negatives” tested. The study does not report a NOAEL, but from one of the graphic presentations showing an effect on testis testosterone production, a NOAEL of 10 mg kg bw/d could be deduced. (Ref: Furr 2014)","page":14,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_005"} |
| SCCS_vision_codex | NOAEL | =-1 | - | rat | - | - | reproductive toxicity | {"citation":"Ref: Furr 2014)","dose":"CD-1 mice were also exposed to varying dose levels of Dipentylphthalate (DPeP) from GD 13 to 17 to determine if DPeP reduced T Prod in this species since there is a discrepancy among the results of in utero studies of PEs in mice.","effect":"ive potencies. CD-1 mice were also exposed to varying dose levels of Dipentylphthalate (DPeP) from GD 13 to 17 to determine if DPeP reduced T Prod in this species since there is a discrepancy among the results of in utero studies of PEs in mice. Compared to the known male reproductive effects of the PEs in rats the FPS correctly identified all known “positives” and “negatives” tested. The study does not report a NOAEL, but from one of the graphic presentations showing an effect on testis testosterone production, a NOAEL of 10 mg kg bw/d could be deduced. (Ref: Furr 2014)","page":14,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_006"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/day | - | - | - | repeated dose toxicity | {"dose":"All experiments used the same doses of 0, 20, 100, and 500 mg/kg bw/day on gestational day 6 - 19.","effect":"of DnHexP on various fertility/reproductive toxicity parameters were investigated. All experiments used the same doses of 0, 20, 100, and 500 mg/kg bw/day on gestational day 6 - 19. Besides clinical serum and hematological parameters, decreased anogenital distance (AGD), decreased weight of the male reproductive organs and histopathological findings in the testes, prostate, epididymis and an increased number of abnormal sperm in the male offspring were observed. While a LOAEL of 20 mg/kg bw/day could be derived, a NOAEL was not established. In a recent publication with literature review (Pirow, 2024, Supplement) reservations were expressed regarding the reliability of the studies from this research group. 3.4.1 Repeated dose toxicity See section 3.4 above 3.4.2 Reproductive toxicity See section 3.4 above 3.4.3 Mutagenicity / genotoxicity No mutagenicity/genotoxicity studies are available. DnHexP shares the same mechanism of action with DEHP. EFSA (2019) considered DEHP along with Benzylbutylphthalate (BBB) and Di-n-Butylph","page":15,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_007"} |
| SCCS_vision_codex | NOAEL | =2.5 | mg/kg bw/d | - | oral | 1 year | NOAEL study | {"dose":"302776- 68-7/443-860-6) from cosmetic products ___________________________________________________________________________________________ ___________________________________________________________________________________________ 17 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) Back-calculations for dermal exposure of the maximum saf...","effect":"cument Scientific advice on the safety of Diethylamino Hydroxybenzoyl Hexyl Benzoate -DHHB – S83 (CAS/EC No. 302776- 68-7/443-860-6) from cosmetic products ___________________________________________________________________________________________ ___________________________________________________________________________________________ 17 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) Back-calculations for dermal exposure of the maximum safe levels of DnHexP from the SED derived from the (adjusted) NOAEL* = 2.5 mg/kg bw/d *) adjusted for 50% oral absorption (EFSA 2019) For childrens’ body weights, the SCCS used the conservative median (P50) values from EFSA (2012), which are 8.7 kg, 11.6 kg and 21.7 kg for the 0.5-1 year, 1-3 years and 6-10 years age groups, respectively. The SCCS recommends applying the more conservative EFSA P5 value of 14.0 kg (for children 3-10 years) for the 3-6 years age group. For the 10 – 14 years age group, a body weight of 43.4 kg was used. Corresponding estimates of children's body sur","page":17,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_008"} |
| SCCS_vision_codex | NOAEL | =50 | % | - | oral | - | NOAEL study | {"dose":"In Table 1 the SCCS has, for the respective age categories, back-calculated the fractions of DnHexP that can be considered safe, based on a SED of 0.025 mg/kg bw/d for DnHexP.","effect":"refinement for specific age categories was performed based on the skin surface areas and bodyweights as explained above (SSA/BW scaling approach). In Table 1 the SCCS has, for the respective age categories, back-calculated the fractions of DnHexP that can be considered safe, based on a SED of 0.025 mg/kg bw/d for DnHexP. In the absence of data that are specific for DnHexP and in view of EFSA’s considerations regarding the oral availability of phthalates (EFSA, 2019), the SCCS has applied a 50% adjustment to the NOAEL. Thus, the maximum SED that can be considered safe is derived from a MoS = 100, i.e. 0.01 X NOAEL(adj) = 0.025 mg/kg bw/d. This safe SED = Amount applied on skin in mg/d X %DHHB X %DnHexP in DHHB X %DermAbs)/Bodyweight Following this, the maximum safe fraction of DnHexP in DHHB is: 0.025 mg/kg bw/d divided by [product amount applied in mg/kg bw/d x fraction DHHB allowed in product x fraction DermAbs] For the product amount, the SCCS has used a (conservative) deterministic approach.","page":17,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_009"} |
| SCCS_vision_codex | NOAEL | =0.025 | mg/kg bw/d | - | oral | - | NOAEL study | {"dose":"In Table 1 the SCCS has, for the respective age categories, back-calculated the fractions of DnHexP that can be considered safe, based on a SED of 0.025 mg/kg bw/d for DnHexP.","effect":"ts as explained above (SSA/BW scaling approach). In Table 1 the SCCS has, for the respective age categories, back-calculated the fractions of DnHexP that can be considered safe, based on a SED of 0.025 mg/kg bw/d for DnHexP. In the absence of data that are specific for DnHexP and in view of EFSA’s considerations regarding the oral availability of phthalates (EFSA, 2019), the SCCS has applied a 50% adjustment to the NOAEL. Thus, the maximum SED that can be considered safe is derived from a MoS = 100, i.e. 0.01 X NOAEL(adj) = 0.025 mg/kg bw/d. This safe SED = Amount applied on skin in mg/d X %DHHB X %DnHexP in DHHB X %DermAbs)/Bodyweight Following this, the maximum safe fraction of DnHexP in DHHB is: 0.025 mg/kg bw/d divided by [product amount applied in mg/kg bw/d x fraction DHHB allowed in product x fraction DermAbs] For the product amount, the SCCS has used a (conservative) deterministic approach.","page":17,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_010"} |
| SCCS_vision_codex | NOAEL | =15000 | ppm | rat | - | Chronic | reproductive toxicity | {"citation":"Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248","dose":"All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.","effect":"egard this as treatment related. All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/d in females). Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3,000 ppm (250 mg/kg bw/d). 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strains: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Esche","page":12,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_001"} |
| SCCS_vision_codex | NOAEL | =3000 | ppm | rat | - | Chronic | reproductive toxicity | {"citation":"Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248","dose":"in control and high dose males and/or females.","effect":"in control and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/d in females). Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3,000 ppm (250 mg/kg bw/d). 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strains: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2 uvrA Test substance: Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester Batch: R323/681 Purity: 99.35% Replicates: 3 plates per test Concentrations: Standard plate test: 20 µg","page":12,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_003"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/d | - | oral | prenatal | developmental toxicity | {"citation":"Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental tox","dose":"SCCP/0996/06 Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance in...","effect":"SCCP/0996/06 Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Cytotoxicity Assay in vitro: Neutral Red (NR) Assay at simultaneous Irradiat","page":15,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_004"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw/d | - | oral | prenatal | developmental toxicity | {"citation":"Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental tox","dose":"SCCP/0996/06 Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance in...","effect":"SCCP/0996/06 Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Cytotoxicity Assay in vitro: Neutral Red (NR) Assay at simultaneous Irradiation wit","page":15,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.093 | mg/kg | rat | oral | 90-day | developmental toxicity | {"dose":"Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No obs...","effect":"CALCULATION OF THE MARGIN OF SAFETY Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/d. In a prenatal development","page":20,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_008"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg | rat | oral | 90-day | developmental toxicity | {"dose":"Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No obs...","effect":"oic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/d. In a prenatal development toxicity stud","page":20,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_009"} |
| SCCS_vision_codex | NOAEL | =2000 | mg/kg bw | rat | oral | 90-day | developmental toxicity | {"dose":"mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14.","effect":"mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/d. In a prenatal development toxicity study, the NOAEL for maternal toxicity was 200 mg/kg bw/d and 1000 mg/kg bw for prenatal developmental toxicity. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin of guinea pigs for treatments up to 14 days. It caused transient irritation to the rabbit eye. A study of skin sensitisation in guinea pigs cannot be evaluated. The percutaneous absorption was 0.100 ± 0.11","page":20,"pdf":"sccp_o_059.pdf","row_type":"noael_study","study_id":"sccp_o_059_noael_011"} |
| SCCS_vision_codex | NOAEL | =15000 | ppm | rat | - | - | reproductive toxicity | {"citation":"Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day)","dose":"All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.","effect":"ated. All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Conclusion The study authors considered that the NOAEL was equal to the highest dose used. That is 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day).","page":14,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_001"} |
| SCCS_vision_codex | NOAEL | =3000 | ppm | rat | - | - | reproductive toxicity | {"citation":"Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day)","dose":"l and high dose males and/or females.","effect":"l and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Conclusion The study authors considered that the NOAEL was equal to the highest dose used. That is 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day).","page":14,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_002"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/d | - | oral | prenatal | developmental toxicity | {"citation":"Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental t","dose":"ced food consumption on day 6 - 13 p.c. and slight alterations in absolute and corrected body weight gain were noted at 1,000 mg/kg bw/day.","effect":"ced food consumption on day 6 - 13 p.c. and slight alterations in absolute and corrected body weight gain were noted at 1,000 mg/kg bw/day. No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/d. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted","page":18,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_003"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw/day | - | oral | prenatal | developmental toxicity | {"citation":"Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental t","dose":"p.c. and slight alterations in absolute and corrected body weight gain were noted at 1,000 mg/kg bw/day.","effect":"p.c. and slight alterations in absolute and corrected body weight gain were noted at 1,000 mg/kg bw/day. No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/d. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted","page":18,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.09 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No obser...","effect":"realistic value. Thus, for the calculation of MoS it is assumed that (17.79 + 18.0 ~ 36) 36 g cosmetics per day containing 10% diethylamino hydroxybenzoyl hexyl benzoate is used. Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2222 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered (It has been proposed that Uvinul A Plus should be labelled R53: May cause long-term adverse effects in the aquatic environment [draft 31st adaptation to technical progress of directive 67/584/EEC on dangerous substances]. Diethy","page":23,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_007"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw | rat | oral | - | dermal absorption | {"dose":"Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No obser...","effect":"n of MoS it is assumed that (17.79 + 18.0 ~ 36) 36 g cosmetics per day containing 10% diethylamino hydroxybenzoyl hexyl benzoate is used. Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2222 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered (It has been proposed that Uvinul A Plus should be labelled R53: May cause long-term adverse effects in the aquatic environment [draft 31st adaptation to technical progress of directive 67/584/EEC on dangerous substances]. Diethylamino hydroxy","page":23,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_008"} |
| SCCS_vision_codex | NOAEL | =2000 | mg/kg bw | rat | oral | 90-day | developmental toxicity | {"dose":"Diethylamino hydroxybenzoyl hexyl benzoate has low acute oral toxicity; more than 2000 mg/kg bw in the rat.","effect":"D = 2222 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered (It has been proposed that Uvinul A Plus should be labelled R53: May cause long-term adverse effects in the aquatic environment [draft 31st adaptation to technical progress of directive 67/584/EEC on dangerous substances]. Diethylamino hydroxybenzoyl hexyl benzoate has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/day. In a prenatal development toxicity study, the NOAEL for maternal toxicity was 200 mg/kg bw/day and 1000 mg/kg bw for prenatal developmental toxicity. Diethylamino hydroxybenzoyl hexyl benzoate is not irritating to the skin of guinea pigs for treatments up to 14 days. It caused transient irritation to the rabbit eye. A study of skin sensitisation in guinea pigs cannot be evaluated. The percutaneous absorption was 0.10 ± 0.12 µg/cm² or 0.04 ± 0","page":23,"pdf":"sccp_o_130.pdf","row_type":"noael_study","study_id":"sccp_o_130_noael_010"} |
| SCCS_vision_codex | NOAEL | =5 | mg/kg bw/d | rat | oral | Prenatal | reproductive toxicity | {"dose":"Of the 19 studies, the publication by Saillenfait (2013) was considered to be the most robust, reporting a NOAEL of 5 mg/kg bw/d.","effect":"of the CLP regulation regarding its endocrine active properties: https://echa.europa.eu/fr/registry-of-clh-intentions-until- outcome/-/dislist/details/0b0236e1892b821d As part of a risk assessment, Pirow et al. (2024, supplemental information) conducted a literature search on in vivo animal studies with at least three doses of DnHexP addressing the reproductive hazard of DnHexP in order to identify a PoD. Of the 19 studies, the publication by Saillenfait (2013) was considered to be the most robust, reporting a NOAEL of 5 mg/kg bw/d. The studies were also examined by the SCCS and are summarised below. 1. Prenatal developmental toxicity study in rats The study evaluated the dose–response relationship for the effects of DnHexP on the synthesis and production of testosterone in the fetal rat testis. Pregnant Sprague–Dawley rats were administered the vehicle (olive oil) and either DnHexP (5 to 625 mg kg–1 per day) or diethylhexyl phthalate (DEHP) (50 or 625 mg kg–1 per day), by gavage, from gestation day (GD) 12 to 19. Fetal te","page":13,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_001"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/d | rat | oral | 35-day | reproductive toxicity | {"citation":"Ref: Saillenfait 2009) 3","dose":"d DCHP induced a significant and dose-related decrease in the anogenital distance of male fetuses at all doses, and there was a significant increase in the incidence of male fetuses with undescended testis at 500 and 750 mg kg-1 per day of DnHP.","effect":"d DCHP induced a significant and dose-related decrease in the anogenital distance of male fetuses at all doses, and there was a significant increase in the incidence of male fetuses with undescended testis at 500 and 750 mg kg-1 per day of DnHP. In conclusion, DnHP showed clear embryo lethality and teratogenicity, but not DCHP. There was evidence that both phthalates could alter the development of the male reproductive system after in utero exposure, DnHP being much more potent than DCHP. The authors stated that a NOAEL could not be derived from this study, while the lowest observable adverse effect was judged to be 250 mg/kg bw/d. (Ref: Saillenfait 2009) 3. Study on Leydig cell hyperplasia DnHexP (in the publication abbreviated as DNHP) in doses of 0, 10, 100, and 1000 mg/kg was administered via gavage to 35-day-old male Sprague-Dawley rats for 21 days. Serum levels of testosterone, luteinizing hormone, follicle-stimulating hormone, Leydig cell number, the expression of Leydig and Sertoli cell genes and proteins were investig","page":14,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_004"} |
| SCCS_vision_codex | NOAEL | =18 | - | rat | - | - | reproductive toxicity | {"citation":"Ref: Furr 2014)","dose":"Dose-response studies also were conducted to determine their relative potencies.","effect":"ction (T Prod) was measured on GD 18. Dose-response studies also were conducted to determine their relative potencies. CD-1 mice were also exposed to varying dose levels of Dipentylphthalate (DPeP) from GD 13 to 17 to determine if DPeP reduced T Prod in this species since there is a discrepancy among the results of in utero studies of PEs in mice. Compared to the known male reproductive effects of the PEs in rats the FPS correctly identified all known “positives” and “negatives” tested. The study does not report a NOAEL, but from one of the graphic presentations showing an effect on testis testosterone production, a NOAEL of 10 mg kg bw/d could be deduced. (Ref: Furr 2014)","page":14,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_005"} |
| SCCS_vision_codex | NOAEL | =-1 | - | rat | - | - | reproductive toxicity | {"citation":"Ref: Furr 2014)","dose":"CD-1 mice were also exposed to varying dose levels of Dipentylphthalate (DPeP) from GD 13 to 17 to determine if DPeP reduced T Prod in this species since there is a discrepancy among the results of in utero studies of PEs in mice.","effect":"ive potencies. CD-1 mice were also exposed to varying dose levels of Dipentylphthalate (DPeP) from GD 13 to 17 to determine if DPeP reduced T Prod in this species since there is a discrepancy among the results of in utero studies of PEs in mice. Compared to the known male reproductive effects of the PEs in rats the FPS correctly identified all known “positives” and “negatives” tested. The study does not report a NOAEL, but from one of the graphic presentations showing an effect on testis testosterone production, a NOAEL of 10 mg kg bw/d could be deduced. (Ref: Furr 2014)","page":14,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_006"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/day | - | - | - | repeated dose toxicity | {"dose":"All experiments used the same doses of 0, 20, 100, and 500 mg/kg bw/day on gestational day 6 - 19.","effect":"of DnHexP on various fertility/reproductive toxicity parameters were investigated. All experiments used the same doses of 0, 20, 100, and 500 mg/kg bw/day on gestational day 6 - 19. Besides clinical serum and hematological parameters, decreased anogenital distance (AGD), decreased weight of the male reproductive organs and histopathological findings in the testes, prostate, epididymis and an increased number of abnormal sperm in the male offspring were observed. While a LOAEL of 20 mg/kg bw/day could be derived, a NOAEL was not established. In a recent publication with literature review (Pirow, 2024, Supplement) reservations were expressed regarding the reliability of the studies from this research group. 3.4.1 Repeated dose toxicity See section 3.4 above 3.4.2 Reproductive toxicity See section 3.4 above 3.4.3 Mutagenicity / genotoxicity No mutagenicity/genotoxicity studies are available. DnHexP shares the same mechanism of action with DEHP. EFSA (2019) considered DEHP along with Benzylbutylphthalate (BBB) and Di-n-Butylph","page":15,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_007"} |
| SCCS_vision_codex | NOAEL | =2.5 | mg/kg bw/d | - | oral | 1 year | NOAEL study | {"dose":"302776- 68-7/443-860-6) from cosmetic products ___________________________________________________________________________________________ ___________________________________________________________________________________________ 17 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) Back-calculations for dermal exposure of the maximum saf...","effect":"cument Scientific advice on the safety of Diethylamino Hydroxybenzoyl Hexyl Benzoate -DHHB – S83 (CAS/EC No. 302776- 68-7/443-860-6) from cosmetic products ___________________________________________________________________________________________ ___________________________________________________________________________________________ 17 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) Back-calculations for dermal exposure of the maximum safe levels of DnHexP from the SED derived from the (adjusted) NOAEL* = 2.5 mg/kg bw/d *) adjusted for 50% oral absorption (EFSA 2019) For childrens’ body weights, the SCCS used the conservative median (P50) values from EFSA (2012), which are 8.7 kg, 11.6 kg and 21.7 kg for the 0.5-1 year, 1-3 years and 6-10 years age groups, respectively. The SCCS recommends applying the more conservative EFSA P5 value of 14.0 kg (for children 3-10 years) for the 3-6 years age group. For the 10 – 14 years age group, a body weight of 43.4 kg was used. Corresponding estimates of children's body sur","page":17,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_008"} |
| SCCS_vision_codex | NOAEL | =50 | % | - | oral | - | NOAEL study | {"dose":"In Table 1 the SCCS has, for the respective age categories, back-calculated the fractions of DnHexP that can be considered safe, based on a SED of 0.025 mg/kg bw/d for DnHexP.","effect":"refinement for specific age categories was performed based on the skin surface areas and bodyweights as explained above (SSA/BW scaling approach). In Table 1 the SCCS has, for the respective age categories, back-calculated the fractions of DnHexP that can be considered safe, based on a SED of 0.025 mg/kg bw/d for DnHexP. In the absence of data that are specific for DnHexP and in view of EFSA’s considerations regarding the oral availability of phthalates (EFSA, 2019), the SCCS has applied a 50% adjustment to the NOAEL. Thus, the maximum SED that can be considered safe is derived from a MoS = 100, i.e. 0.01 X NOAEL(adj) = 0.025 mg/kg bw/d. This safe SED = Amount applied on skin in mg/d X %DHHB X %DnHexP in DHHB X %DermAbs)/Bodyweight Following this, the maximum safe fraction of DnHexP in DHHB is: 0.025 mg/kg bw/d divided by [product amount applied in mg/kg bw/d x fraction DHHB allowed in product x fraction DermAbs] For the product amount, the SCCS has used a (conservative) deterministic approach.","page":17,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_009"} |
| SCCS_vision_codex | NOAEL | =0.025 | mg/kg bw/d | - | oral | - | NOAEL study | {"dose":"In Table 1 the SCCS has, for the respective age categories, back-calculated the fractions of DnHexP that can be considered safe, based on a SED of 0.025 mg/kg bw/d for DnHexP.","effect":"ts as explained above (SSA/BW scaling approach). In Table 1 the SCCS has, for the respective age categories, back-calculated the fractions of DnHexP that can be considered safe, based on a SED of 0.025 mg/kg bw/d for DnHexP. In the absence of data that are specific for DnHexP and in view of EFSA’s considerations regarding the oral availability of phthalates (EFSA, 2019), the SCCS has applied a 50% adjustment to the NOAEL. Thus, the maximum SED that can be considered safe is derived from a MoS = 100, i.e. 0.01 X NOAEL(adj) = 0.025 mg/kg bw/d. This safe SED = Amount applied on skin in mg/d X %DHHB X %DnHexP in DHHB X %DermAbs)/Bodyweight Following this, the maximum safe fraction of DnHexP in DHHB is: 0.025 mg/kg bw/d divided by [product amount applied in mg/kg bw/d x fraction DHHB allowed in product x fraction DermAbs] For the product amount, the SCCS has used a (conservative) deterministic approach.","page":17,"pdf":"sccs_o_299.pdf","row_type":"noael_study","study_id":"sccs_o_299_noael_010"} |
ToxValDB_ECHA_IUCLID 5 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | NOAEL | >=1000 | mg/kg bw/day | Rat | oral | - | developmental | GUIDELINE=OECD Guideline 414 (Prenatal Developmental Toxicity Study); QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac1ae4b0a7c65d1bd610; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/29413?documentUUID=31971d96-ae18-48a4-a10c-892a4a9f3930; YEAR=2003; ORIGINAL_YEAR=2003; STUDY_GROUP=ECHA IUCLID:15821819:M/F:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_3ae3ec106169c53dd08165876df6d74c |
| ToxValDB_ECHA_IUCLID | NOAEL | =200 | mg/kg bw/day | Rat | oral | - | reproduction developmental | GUIDELINE=OECD Guideline 414 (Prenatal Developmental Toxicity Study); QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac1ae4b0a7c65d1bd610; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/29413?documentUUID=31971d96-ae18-48a4-a10c-892a4a9f3930; YEAR=2003; ORIGINAL_YEAR=2003; STUDY_GROUP=ECHA IUCLID:15823099:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_cd0871082086d09f32904ea0e4fa5913 |
| ToxValDB_ECHA_IUCLID | NOAEL | >=1440 | mg/kg bw/day | Rat | oral | subchronic; 90 days | subchronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae13e4b0a7c65d1c74c5; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/29413?documentUUID=31971d96-ae18-48a4-a10c-892a4a9f3930; YEAR=2003; ORIGINAL_YEAR=2003; STUDY_GROUP=ECHA IUCLID:15834947:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_af3fd1a85eaec94c9bb54c2424d0791e |
| ToxValDB_ECHA_IUCLID | NOAEL | =100 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaaeee4b0a7c65d1b80ab; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/29413?documentUUID=31971d96-ae18-48a4-a10c-892a4a9f3930; YEAR=2003; ORIGINAL_YEAR=2003; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15855652_15856427:M/F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_3dbe25eed28aa0b43a80da29ee52e404 |
| ToxValDB_ECHA_IUCLID | NOAEL | =300 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaaeee4b0a7c65d1b80ab; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/29413?documentUUID=31971d96-ae18-48a4-a10c-892a4a9f3930; YEAR=2003; ORIGINAL_YEAR=2003; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15855652_15856427:M/F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_c869cfb789e5f09c5bb946d39684d6ec |
ToxValDB_GESTIS_DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_GESTIS_DNEL | DNEL systemic | =10 | mg/m3 | Human | inhalation | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL:15632559:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_8c2867803bb589c7ef4e2799f243bed4 |
UnifiedCodex:SCCNFP:beta.noael_studies 19 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 1350 | mg/kg bw | rat | oral | 90-day | - | SOURCE_SUBDIR=out223_en; REPORT_TITLE=OPINION CONCERNING BENZOIC ACID, 2-[4-(DIETHYLAMINO)-2-HYDROXYBENZOYL]-, HEXYLESTER; OPINION_NUMBER=SCCNFP/0650/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=1350; DOSE=Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat.; EFFECT=of 1.05. This, however, is not biologically relevant in this case. No phototoxic potential can be predicted. Conclusion In the study described and under the experimental conditions reported no phototoxic potential was observed after treatment of Balb/c3T3 cells in the absence and in the presence of artificial sunlight. Ref. : 9 2.11. Safety evaluation NOT APPLICABLE 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while > 1000 mg/kg bw can be regarded as NOEL for pre-natal development. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin and mucous membranes in rabbits. It is not a dermal sensitiser. The percutaneous; CITATION=Ref. : 9 2; CITATION_NUMBERS=[9,2]; REFERENCE=Ref. : 9 2; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref. : 9 2","dose":"Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat.","duration":"90-day","effect":"of 1.05. This, however, is not biologically relevant in this case. No phototoxic potential can be predicted. Conclusion In the study described and under the experimental conditions reported no phototoxic potential was observed after treatment of Balb/c3T3 cells in the absence and in the presence of artificial sunlight. Ref. : 9 2.11. Safety evaluation NOT APPLICABLE 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while > 1000 mg/kg bw can be regarded as NOEL for pre-natal development. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin and mucous membranes in rabbits. It is not a dermal sensitiser. The percutaneous","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1350","page":14,"route":"oral","species":"rat","study_id":"out223_en_noael_006"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 200 | mg/kg | rat | oral | - | - | SOURCE_SUBDIR=out241_en; REPORT_TITLE=OPINION CONCERNING BENZOIC ACID, 2-[4-(DIETHYLAMINO)-2-HYDROXYBENZOYL]-, HEXYLESTER; OPINION_NUMBER=SCCNFP/0756/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=200; DOSE=No observed effect level (mg/kg) (rat, teratogenicity oral) | NOAEL | = | 200 mg/kg; EFFECT=CALCULATION OF THE MARGIN OF SAFETY: No observed effect level (mg/kg) (rat, teratogenicity oral) | NOAEL | = | 200 mg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"302776-68-7","citation":"","dose":"No observed effect level (mg/kg) (rat, teratogenicity oral) | NOAEL | = | 200 mg/kg","duration":"","effect":"CALCULATION OF THE MARGIN OF SAFETY: No observed effect level (mg/kg) (rat, teratogenicity oral) | NOAEL | = | 200 mg/kg","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg","noael_value":"200","page":15,"route":"oral","species":"rat","study_id":"out241_en_noael_012"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | >1000 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=out223_en; REPORT_TITLE=OPINION CONCERNING BENZOIC ACID, 2-[4-(DIETHYLAMINO)-2-HYDROXYBENZOYL]-, HEXYLESTER; OPINION_NUMBER=SCCNFP/0650/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=> 1000; DOSE=Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat.; EFFECT=ght. Ref. : 9 2.11. Safety evaluation NOT APPLICABLE 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while > 1000 mg/kg bw can be regarded as NOEL for pre-natal development. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin and mucous membranes in rabbits. It is not a dermal sensitiser. The percutaneous absorption study is inadequate. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is neither phototoxic nor photosensitising. It is not mutagenic/photo-mutagenic in vitro. As to a safety assessment of an use of UV-filters by children over the age of 1 year, the SCCNFP issued a position statement (SCC; CITATION=Ref. : 9 2; CITATION_NUMBERS=[9,2]; REFERENCE=Ref. : 9 2; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref. : 9 2","dose":"Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat.","duration":"90-day","effect":"ght. Ref. : 9 2.11. Safety evaluation NOT APPLICABLE 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while > 1000 mg/kg bw can be regarded as NOEL for pre-natal development. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin and mucous membranes in rabbits. It is not a dermal sensitiser. The percutaneous absorption study is inadequate. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is neither phototoxic nor photosensitising. It is not mutagenic/photo-mutagenic in vitro. As to a safety assessment of an use of UV-filters by children over the age of 1 year, the SCCNFP issued a position statement (SCC","endpoint":"dermal absorption","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw","noael_value":"> 1000","page":14,"route":"oral","species":"rat","study_id":"out223_en_noael_007"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 2000 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=out241_en; REPORT_TITLE=OPINION CONCERNING BENZOIC ACID, 2-[4-(DIETHYLAMINO)-2-HYDROXYBENZOYL]-, HEXYLESTER; OPINION_NUMBER=SCCNFP/0756/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=2000; DOSE=xybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 (Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) Maximum absorption through the skin A (µg/cm²) = 0.1 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Der...; EFFECT=xybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 (Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) Maximum absorption through the skin A (µg/cm²) = 0.1 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.001 = 1.800 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0. 03 mg/kg No observed effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral) Margin of Safety NOAEL / SED = 6667 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"302776-68-7","citation":"","dose":"xybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 (Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) Maximum absorption through the skin A (µg/cm²) = 0.1 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Der...","duration":"90-day","effect":"xybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 (Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) Maximum absorption through the skin A (µg/cm²) = 0.1 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.001 = 1.800 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0. 03 mg/kg No observed effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral) Margin of Safety NOAEL / SED = 6667 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while","endpoint":"dermal absorption","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw","noael_value":"2000","page":15,"route":"oral","species":"rat","study_id":"out241_en_noael_008"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 2000 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=out241_en; REPORT_TITLE=OPINION CONCERNING BENZOIC ACID, 2-[4-(DIETHYLAMINO)-2-HYDROXYBENZOYL]-, HEXYLESTER; OPINION_NUMBER=SCCNFP/0756/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=2000; DOSE=______________________________________________ 15 (Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) Maximum absorption through the skin A (µg/cm²) = 0.1 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.001 = 1.800 mg Systemic expos...; EFFECT=______________________________________________ 15 (Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) Maximum absorption through the skin A (µg/cm²) = 0.1 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.001 = 1.800 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0. 03 mg/kg No observed effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral) Margin of Safety NOAEL / SED = 6667 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while > 1000 mg/kg bw can be regarded as NOEL for pre-natal development. Be; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"302776-68-7","citation":"","dose":"______________________________________________ 15 (Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) Maximum absorption through the skin A (µg/cm²) = 0.1 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.001 = 1.800 mg Systemic expos...","duration":"90-day","effect":"______________________________________________ 15 (Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) Maximum absorption through the skin A (µg/cm²) = 0.1 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.001 = 1.800 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0. 03 mg/kg No observed effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral) Margin of Safety NOAEL / SED = 6667 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while > 1000 mg/kg bw can be regarded as NOEL for pre-natal development. Be","endpoint":"dermal absorption","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw","noael_value":"2000","page":15,"route":"oral","species":"rat","study_id":"out241_en_noael_009"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 1350 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=out241_en; REPORT_TITLE=OPINION CONCERNING BENZOIC ACID, 2-[4-(DIETHYLAMINO)-2-HYDROXYBENZOYL]-, HEXYLESTER; OPINION_NUMBER=SCCNFP/0756/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=1350; DOSE=cm²) = 0.1 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.001 = 1.800 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.; EFFECT=cm²) = 0.1 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.001 = 1.800 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0. 03 mg/kg No observed effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral) Margin of Safety NOAEL / SED = 6667 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while > 1000 mg/kg bw can be regarded as NOEL for pre-natal development. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin and mucous membranes in rabbits. It is not a dermal sensitiser. The percutaneo; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"302776-68-7","citation":"","dose":"cm²) = 0.1 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.001 = 1.800 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.","duration":"90-day","effect":"cm²) = 0.1 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.001 = 1.800 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0. 03 mg/kg No observed effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral) Margin of Safety NOAEL / SED = 6667 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while > 1000 mg/kg bw can be regarded as NOEL for pre-natal development. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin and mucous membranes in rabbits. It is not a dermal sensitiser. The percutaneo","endpoint":"dermal absorption","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1350","page":15,"route":"oral","species":"rat","study_id":"out241_en_noael_010"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 0.1 | µg/cm | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=out241_en; REPORT_TITLE=OPINION CONCERNING BENZOIC ACID, 2-[4-(DIETHYLAMINO)-2-HYDROXYBENZOYL]-, HEXYLESTER; OPINION_NUMBER=SCCNFP/0756/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=0.1; DOSE=Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat.; EFFECT=y oral) Margin of Safety NOAEL / SED = 6667 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while > 1000 mg/kg bw can be regarded as NOEL for pre-natal development. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin and mucous membranes in rabbits. It is not a dermal sensitiser. The percutaneous absorption was set at 0.1 µg/cm². Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is neither phototoxic nor photosensitising. It is not mutagenic/photo-mutagenic in vitro. As to a safety assessment for use of UV-filters by children over the age of 1 year, the SCCNFP issued a position statement; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"302776-68-7","citation":"","dose":"Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat.","duration":"90-day","effect":"y oral) Margin of Safety NOAEL / SED = 6667 2.12. Conclusions Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats is about 1350 mg/kg bw and can be applied to a safety evaluation. In a pre-natal development toxicity study, maternal toxicity was between 200-1000 mg/kg bw, obviously due to the kind of administration (gavage as bolus in oil), while > 1000 mg/kg bw can be regarded as NOEL for pre-natal development. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin and mucous membranes in rabbits. It is not a dermal sensitiser. The percutaneous absorption was set at 0.1 µg/cm². Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is neither phototoxic nor photosensitising. It is not mutagenic/photo-mutagenic in vitro. As to a safety assessment for use of UV-filters by children over the age of 1 year, the SCCNFP issued a position statement","endpoint":"dermal absorption","ingredient":"codes","loael_value":"","noael_unit":"µg/cm","noael_value":"0.1","page":15,"route":"oral","species":"rat","study_id":"out241_en_noael_011"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 200 | mg/kg bw/day | - | oral | prenatal | developmental toxicity | SOURCE_SUBDIR=out223_en; REPORT_TITLE=OPINION CONCERNING BENZOIC ACID, 2-[4-(DIETHYLAMINO)-2-HYDROXYBENZOYL]-, HEXYLESTER; OPINION_NUMBER=SCCNFP/0650/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=200-1000; DOSE=No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/day.; EFFECT=icity, by transient salivation, reduced food consumption on days 6 - 13 p.c. and slight impairments in absolute and corrected body weight gain was noted. No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/day. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day). The no observed adverse effect level (NOAEL) for maternal toxicity is 200-1000 mg/kg bw/day, while it is > 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. The slight difference, compared with the NOAEL derived from the 90-day study may be due to the kind of administration (diet versus gavage of an oily suspension as bolus and consequently reaching actual higher systemic levels). Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Test substance : 10 % a.i. in a cosmetic formulation (o/w; CITATION=Ref. : 12 2; CITATION_NUMBERS=[12,2]; REFERENCE=Ref. : 12 2; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref. : 12 2","dose":"No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/day.","duration":"prenatal","effect":"icity, by transient salivation, reduced food consumption on days 6 - 13 p.c. and slight impairments in absolute and corrected body weight gain was noted. No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/day. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day). The no observed adverse effect level (NOAEL) for maternal toxicity is 200-1000 mg/kg bw/day, while it is > 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. The slight difference, compared with the NOAEL derived from the 90-day study may be due to the kind of administration (diet versus gavage of an oily suspension as bolus and consequently reaching actual higher systemic levels). Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Test substance : 10 % a.i. in a cosmetic formulation (o/w","endpoint":"developmental toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200-1000","page":8,"route":"oral","species":"","study_id":"out223_en_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 200 | mg/kg bw/day | - | oral | prenatal | developmental toxicity | SOURCE_SUBDIR=out223_en; REPORT_TITLE=OPINION CONCERNING BENZOIC ACID, 2-[4-(DIETHYLAMINO)-2-HYDROXYBENZOYL]-, HEXYLESTER; OPINION_NUMBER=SCCNFP/0650/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=200-1000; DOSE=No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/day.; EFFECT=duced food consumption on days 6 - 13 p.c. and slight impairments in absolute and corrected body weight gain was noted. No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/day. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day). The no observed adverse effect level (NOAEL) for maternal toxicity is 200-1000 mg/kg bw/day, while it is > 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. The slight difference, compared with the NOAEL derived from the 90-day study may be due to the kind of administration (diet versus gavage of an oily suspension as bolus and consequently reaching actual higher systemic levels). Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Test substance : 10 % a.i. in a cosmetic formulation (o/w emulsio; CITATION=Ref. : 12 2; CITATION_NUMBERS=[12,2]; REFERENCE=Ref. : 12 2; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref. : 12 2","dose":"No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/day.","duration":"prenatal","effect":"duced food consumption on days 6 - 13 p.c. and slight impairments in absolute and corrected body weight gain was noted. No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/day. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day). The no observed adverse effect level (NOAEL) for maternal toxicity is 200-1000 mg/kg bw/day, while it is > 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. The slight difference, compared with the NOAEL derived from the 90-day study may be due to the kind of administration (diet versus gavage of an oily suspension as bolus and consequently reaching actual higher systemic levels). Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Test substance : 10 % a.i. in a cosmetic formulation (o/w emulsio","endpoint":"developmental toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200-1000","page":8,"route":"oral","species":"","study_id":"out223_en_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | >1000 | mg/kg bw/day | pig | oral | prenatal | developmental toxicity | SOURCE_SUBDIR=out223_en; REPORT_TITLE=OPINION CONCERNING BENZOIC ACID, 2-[4-(DIETHYLAMINO)-2-HYDROXYBENZOYL]-, HEXYLESTER; OPINION_NUMBER=SCCNFP/0650/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=> 1000; DOSE=els of 40 or 200 mg/kg bw/day.; EFFECT=els of 40 or 200 mg/kg bw/day. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day). The no observed adverse effect level (NOAEL) for maternal toxicity is 200-1000 mg/kg bw/day, while it is > 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. The slight difference, compared with the NOAEL derived from the 90-day study may be due to the kind of administration (diet versus gavage of an oily suspension as bolus and consequently reaching actual higher systemic levels). Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Test substance : 10 % a.i. in a cosmetic formulation (o/w emulsion, no composition stated). Solubility in receptor fluid is 1.28 mg/ml. Batch n° : R323/681 Purity : 99.35 % Dosage : 2 mg/cm² and 10 mg/cm² Skin preparation : full-thickness pig skin. The; CITATION=Ref. : 12 2; CITATION_NUMBERS=[12,2]; REFERENCE=Ref. : 12 2; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref. : 12 2","dose":"els of 40 or 200 mg/kg bw/day.","duration":"prenatal","effect":"els of 40 or 200 mg/kg bw/day. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day). The no observed adverse effect level (NOAEL) for maternal toxicity is 200-1000 mg/kg bw/day, while it is > 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. The slight difference, compared with the NOAEL derived from the 90-day study may be due to the kind of administration (diet versus gavage of an oily suspension as bolus and consequently reaching actual higher systemic levels). Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Test substance : 10 % a.i. in a cosmetic formulation (o/w emulsion, no composition stated). Solubility in receptor fluid is 1.28 mg/ml. Batch n° : R323/681 Purity : 99.35 % Dosage : 2 mg/cm² and 10 mg/cm² Skin preparation : full-thickness pig skin. The","endpoint":"developmental toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"> 1000","page":8,"route":"oral","species":"pig","study_id":"out223_en_noael_005"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 200 | mg/kg bw/day | - | oral | prenatal | developmental toxicity | SOURCE_SUBDIR=out241_en; REPORT_TITLE=OPINION CONCERNING BENZOIC ACID, 2-[4-(DIETHYLAMINO)-2-HYDROXYBENZOYL]-, HEXYLESTER; OPINION_NUMBER=SCCNFP/0756/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=200-1000; DOSE=No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/day.; EFFECT=city, by transient salivation, reduced food consumption on days 6 - 13 p.c. and slight impairments in absolute and corrected body weight gain was noted. No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/day. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day). The no observed adverse effect level (NOAEL) for maternal toxicity is 200-1000 mg/kg bw/day, while it is > 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by and due to the kind of administration (diet versus gavage of an oily suspension as bolus and consequently reaching actual higher systemic levels). Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Stu; CITATION=Ref. : 12 2; CITATION_NUMBERS=[12,2]; REFERENCE=Ref. : 12 2; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref. : 12 2","dose":"No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/day.","duration":"prenatal","effect":"city, by transient salivation, reduced food consumption on days 6 - 13 p.c. and slight impairments in absolute and corrected body weight gain was noted. No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/day. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day). The no observed adverse effect level (NOAEL) for maternal toxicity is 200-1000 mg/kg bw/day, while it is > 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by and due to the kind of administration (diet versus gavage of an oily suspension as bolus and consequently reaching actual higher systemic levels). Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Stu","endpoint":"developmental toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200-1000","page":8,"route":"oral","species":"","study_id":"out241_en_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 200 | mg/kg bw/day | - | oral | prenatal | developmental toxicity | SOURCE_SUBDIR=out241_en; REPORT_TITLE=OPINION CONCERNING BENZOIC ACID, 2-[4-(DIETHYLAMINO)-2-HYDROXYBENZOYL]-, HEXYLESTER; OPINION_NUMBER=SCCNFP/0756/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=200-1000; DOSE=No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/day.; EFFECT=uced food consumption on days 6 - 13 p.c. and slight impairments in absolute and corrected body weight gain was noted. No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/day. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day). The no observed adverse effect level (NOAEL) for maternal toxicity is 200-1000 mg/kg bw/day, while it is > 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by and due to the kind of administration (diet versus gavage of an oily suspension as bolus and consequently reaching actual higher systemic levels). Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Study 1; CITATION=Ref. : 12 2; CITATION_NUMBERS=[12,2]; REFERENCE=Ref. : 12 2; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref. : 12 2","dose":"No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/day.","duration":"prenatal","effect":"uced food consumption on days 6 - 13 p.c. and slight impairments in absolute and corrected body weight gain was noted. No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/day. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day). The no observed adverse effect level (NOAEL) for maternal toxicity is 200-1000 mg/kg bw/day, while it is > 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by and due to the kind of administration (diet versus gavage of an oily suspension as bolus and consequently reaching actual higher systemic levels). Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Study 1","endpoint":"developmental toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200-1000","page":8,"route":"oral","species":"","study_id":"out241_en_noael_005"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | >1000 | mg/kg bw/day | - | oral | prenatal | developmental toxicity | SOURCE_SUBDIR=out241_en; REPORT_TITLE=OPINION CONCERNING BENZOIC ACID, 2-[4-(DIETHYLAMINO)-2-HYDROXYBENZOYL]-, HEXYLESTER; OPINION_NUMBER=SCCNFP/0756/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=> 1000; DOSE=nce-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day).; EFFECT=nce-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day). The no observed adverse effect level (NOAEL) for maternal toxicity is 200-1000 mg/kg bw/day, while it is > 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by and due to the kind of administration (diet versus gavage of an oily suspension as bolus and consequently reaching actual higher systemic levels). Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Study 1; CITATION=Ref. : 12 2; CITATION_NUMBERS=[12,2]; REFERENCE=Ref. : 12 2; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref. : 12 2","dose":"nce-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day).","duration":"prenatal","effect":"nce-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day). The no observed adverse effect level (NOAEL) for maternal toxicity is 200-1000 mg/kg bw/day, while it is > 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by and due to the kind of administration (diet versus gavage of an oily suspension as bolus and consequently reaching actual higher systemic levels). Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Study 1","endpoint":"developmental toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"> 1000","page":8,"route":"oral","species":"","study_id":"out241_en_noael_006"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | >1000 | mg/kg bw/day | - | oral | prenatal | developmental toxicity | SOURCE_SUBDIR=out241_en; REPORT_TITLE=OPINION CONCERNING BENZOIC ACID, 2-[4-(DIETHYLAMINO)-2-HYDROXYBENZOYL]-, HEXYLESTER; OPINION_NUMBER=SCCNFP/0756/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=> 1000; DOSE=ced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day).; EFFECT=ced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day). The no observed adverse effect level (NOAEL) for maternal toxicity is 200-1000 mg/kg bw/day, while it is > 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by and due to the kind of administration (diet versus gavage of an oily suspension as bolus and consequently reaching actual higher systemic levels). Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Study 1; CITATION=Ref. : 12 2; CITATION_NUMBERS=[12,2]; REFERENCE=Ref. : 12 2; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref. : 12 2","dose":"ced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day).","duration":"prenatal","effect":"ced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/day). The no observed adverse effect level (NOAEL) for maternal toxicity is 200-1000 mg/kg bw/day, while it is > 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by and due to the kind of administration (diet versus gavage of an oily suspension as bolus and consequently reaching actual higher systemic levels). Ref. : 12 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Study 1","endpoint":"developmental toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"> 1000","page":8,"route":"oral","species":"","study_id":"out241_en_noael_007"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 15000 | ppm | rabbit | dermal | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out223_en; REPORT_TITLE=OPINION CONCERNING BENZOIC ACID, 2-[4-(DIETHYLAMINO)-2-HYDROXYBENZOYL]-, HEXYLESTER; OPINION_NUMBER=SCCNFP/0650/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=15,000; DOSE=__________________________________________________________________ 6 All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.; EFFECT=__________________________________________________________________ 6 All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Ref. : 11 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Method : According to OECD n° 404 (1992); EU n° B.5 (1992); US EPA, Health Effects Test Guidelines OPPTS 870.2400 "Acute Eye Irritation" (1998) Test animals : 3 White New Zealand Rabbits Test substan; CITATION=Ref. : 11 2; CITATION_NUMBERS=[11,2]; REFERENCE=Ref. : 11 2; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref. : 11 2","dose":"__________________________________________________________________ 6 All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.","duration":"Sub-chronic","effect":"__________________________________________________________________ 6 All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Ref. : 11 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Method : According to OECD n° 404 (1992); EU n° B.5 (1992); US EPA, Health Effects Test Guidelines OPPTS 870.2400 \"Acute Eye Irritation\" (1998) Test animals : 3 White New Zealand Rabbits Test substan","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"ppm","noael_value":"15,000","page":6,"route":"dermal","species":"rabbit","study_id":"out223_en_noael_001"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 15000 | ppm | rabbit | dermal | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out223_en; REPORT_TITLE=OPINION CONCERNING BENZOIC ACID, 2-[4-(DIETHYLAMINO)-2-HYDROXYBENZOYL]-, HEXYLESTER; OPINION_NUMBER=SCCNFP/0650/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=15,000; DOSE=________________________________ 6 All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.; EFFECT=________________________________ 6 All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Ref. : 11 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Method : According to OECD n° 404 (1992); EU n° B.5 (1992); US EPA, Health Effects Test Guidelines OPPTS 870.2400 "Acute Eye Irritation" (1998) Test animals : 3 White New Zealand Rabbits Test substance : Be; CITATION=Ref. : 11 2; CITATION_NUMBERS=[11,2]; REFERENCE=Ref. : 11 2; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref. : 11 2","dose":"________________________________ 6 All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.","duration":"Sub-chronic","effect":"________________________________ 6 All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Ref. : 11 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Method : According to OECD n° 404 (1992); EU n° B.5 (1992); US EPA, Health Effects Test Guidelines OPPTS 870.2400 \"Acute Eye Irritation\" (1998) Test animals : 3 White New Zealand Rabbits Test substance : Be","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"ppm","noael_value":"15,000","page":6,"route":"dermal","species":"rabbit","study_id":"out223_en_noael_002"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 15000 | ppm | - | dermal | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out241_en; REPORT_TITLE=OPINION CONCERNING BENZOIC ACID, 2-[4-(DIETHYLAMINO)-2-HYDROXYBENZOYL]-, HEXYLESTER; OPINION_NUMBER=SCCNFP/0756/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=15,000; DOSE=n either males (- 3.6%) and females (-2.5%) in the high dose group.; EFFECT=n either males (- 3.6%) and females (-2.5%) in the high dose group. All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Under conservative judgement, the NOEL was set at 3000 ppm (250 mg/kg bw). Ref. : 11 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Method : According to OECD n° 404 (1992); EU n° B.5 (1992); US EPA, Health Effects Test Guidelines OPPTS 870.2; CITATION=Ref. : 11 2; CITATION_NUMBERS=[11,2]; REFERENCE=Ref. : 11 2; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref. : 11 2","dose":"n either males (- 3.6%) and females (-2.5%) in the high dose group.","duration":"Sub-chronic","effect":"n either males (- 3.6%) and females (-2.5%) in the high dose group. All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Under conservative judgement, the NOEL was set at 3000 ppm (250 mg/kg bw). Ref. : 11 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Method : According to OECD n° 404 (1992); EU n° B.5 (1992); US EPA, Health Effects Test Guidelines OPPTS 870.2","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"ppm","noael_value":"15,000","page":6,"route":"dermal","species":"","study_id":"out241_en_noael_001"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 15000 | ppm | - | dermal | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out241_en; REPORT_TITLE=OPINION CONCERNING BENZOIC ACID, 2-[4-(DIETHYLAMINO)-2-HYDROXYBENZOYL]-, HEXYLESTER; OPINION_NUMBER=SCCNFP/0756/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=15,000; DOSE=s (-2.5%) in the high dose group.; EFFECT=s (-2.5%) in the high dose group. All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Under conservative judgement, the NOEL was set at 3000 ppm (250 mg/kg bw). Ref. : 11 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Method : According to OECD n° 404 (1992); EU n° B.5 (1992); US EPA, Health Effects Test Guidelines OPPTS 870.2400 "Ac; CITATION=Ref. : 11 2; CITATION_NUMBERS=[11,2]; REFERENCE=Ref. : 11 2; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref. : 11 2","dose":"s (-2.5%) in the high dose group.","duration":"Sub-chronic","effect":"s (-2.5%) in the high dose group. All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Under conservative judgement, the NOEL was set at 3000 ppm (250 mg/kg bw). Ref. : 11 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Method : According to OECD n° 404 (1992); EU n° B.5 (1992); US EPA, Health Effects Test Guidelines OPPTS 870.2400 \"Ac","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"ppm","noael_value":"15,000","page":6,"route":"dermal","species":"","study_id":"out241_en_noael_002"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 3000 | ppm | rabbit | dermal | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out241_en; REPORT_TITLE=OPINION CONCERNING BENZOIC ACID, 2-[4-(DIETHYLAMINO)-2-HYDROXYBENZOYL]-, HEXYLESTER; OPINION_NUMBER=SCCNFP/0756/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=3000; DOSE=hey were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.; EFFECT=hey were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Under conservative judgement, the NOEL was set at 3000 ppm (250 mg/kg bw). Ref. : 11 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Method : According to OECD n° 404 (1992); EU n° B.5 (1992); US EPA, Health Effects Test Guidelines OPPTS 870.2400 "Acute Eye Irritation" (1998) Test animals : 3 White New Zealand Rabbits Test substance : Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester Batch no :; CITATION=Ref. : 11 2; CITATION_NUMBERS=[11,2]; REFERENCE=Ref. : 11 2; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref. : 11 2","dose":"hey were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.","duration":"Sub-chronic","effect":"hey were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Under conservative judgement, the NOEL was set at 3000 ppm (250 mg/kg bw). Ref. : 11 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Method : According to OECD n° 404 (1992); EU n° B.5 (1992); US EPA, Health Effects Test Guidelines OPPTS 870.2400 \"Acute Eye Irritation\" (1998) Test animals : 3 White New Zealand Rabbits Test substance : Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester Batch no :","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"ppm","noael_value":"3000","page":6,"route":"dermal","species":"rabbit","study_id":"out241_en_noael_003"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 23 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.09 | mg/kg bw/d | rat | oral | - | dermal absorption | SOURCE_SUBDIR=sccp_o_130; REPORT_TITLE=OPINION ON Diethylamino hydroxybenzoyl hexyl benzoate COLIPA n° S83; OPINION_NUMBER=SCCP/1166/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT== 0.09; DOSE=Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No obser...; EFFECT=realistic value. Thus, for the calculation of MoS it is assumed that (17.79 + 18.0 ~ 36) 36 g cosmetics per day containing 10% diethylamino hydroxybenzoyl hexyl benzoate is used. Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2222 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered (It has been proposed that Uvinul A Plus should be labelled R53: May cause long-term adverse effects in the aquatic environment [draft 31st adaptation to technical progress of directive 67/584/EEC on dangerous substances]. Diethy; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"302776-68-7","citation":"","dose":"Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No obser...","duration":"","effect":"realistic value. Thus, for the calculation of MoS it is assumed that (17.79 + 18.0 ~ 36) 36 g cosmetics per day containing 10% diethylamino hydroxybenzoyl hexyl benzoate is used. Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2222 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered (It has been proposed that Uvinul A Plus should be labelled R53: May cause long-term adverse effects in the aquatic environment [draft 31st adaptation to technical progress of directive 67/584/EEC on dangerous substances]. Diethy","endpoint":"dermal absorption","ingredient":"also","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.09","page":23,"route":"oral","species":"rat","study_id":"sccp_o_130_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =200 | mg/kg bw | rat | oral | - | dermal absorption | SOURCE_SUBDIR=sccp_o_130; REPORT_TITLE=OPINION ON Diethylamino hydroxybenzoyl hexyl benzoate COLIPA n° S83; OPINION_NUMBER=SCCP/1166/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT== 200; DOSE=Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No obser...; EFFECT=n of MoS it is assumed that (17.79 + 18.0 ~ 36) 36 g cosmetics per day containing 10% diethylamino hydroxybenzoyl hexyl benzoate is used. Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2222 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered (It has been proposed that Uvinul A Plus should be labelled R53: May cause long-term adverse effects in the aquatic environment [draft 31st adaptation to technical progress of directive 67/584/EEC on dangerous substances]. Diethylamino hydroxy; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"302776-68-7","citation":"","dose":"Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No obser...","duration":"","effect":"n of MoS it is assumed that (17.79 + 18.0 ~ 36) 36 g cosmetics per day containing 10% diethylamino hydroxybenzoyl hexyl benzoate is used. Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2222 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered (It has been proposed that Uvinul A Plus should be labelled R53: May cause long-term adverse effects in the aquatic environment [draft 31st adaptation to technical progress of directive 67/584/EEC on dangerous substances]. Diethylamino hydroxy","endpoint":"dermal absorption","ingredient":"also","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 200","page":23,"route":"oral","species":"rat","study_id":"sccp_o_130_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =200 | mg/kg bw | rat | oral | - | dermal absorption | SOURCE_SUBDIR=sccp_o_130; REPORT_TITLE=OPINION ON Diethylamino hydroxybenzoyl hexyl benzoate COLIPA n° S83; OPINION_NUMBER=SCCP/1166/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT== 200; DOSE=Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No obser...; EFFECT=diethylamino hydroxybenzoyl hexyl benzoate is used. Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2222 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered (It has been proposed that Uvinul A Plus should be labelled R53: May cause long-term adverse effects in the aquatic environment [draft 31st adaptation to technical progress of directive 67/584/EEC on dangerous substances]. Diethylamino hydroxybenzoyl hexyl benzoate has low acute oral toxicity; more than 2000 mg/kg bw in the ra; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"302776-68-7","citation":"","dose":"Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No obser...","duration":"","effect":"diethylamino hydroxybenzoyl hexyl benzoate is used. Total amount of cosmetics used A g/day = 36.0 g/day Concentration of the ingredient under study C (%) = 10% Total exposure of the ingredient under study T (mg/day) = 3600 mg/day Dermal Absorption expressed as a percentage DAP (%) = 0.15% Default human body weight = 60 kg Systemic Exposure Dosage (SED) (3600 x 0.015/60) = 0.09 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2222 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered (It has been proposed that Uvinul A Plus should be labelled R53: May cause long-term adverse effects in the aquatic environment [draft 31st adaptation to technical progress of directive 67/584/EEC on dangerous substances]. Diethylamino hydroxybenzoyl hexyl benzoate has low acute oral toxicity; more than 2000 mg/kg bw in the ra","endpoint":"dermal absorption","ingredient":"also","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 200","page":23,"route":"oral","species":"rat","study_id":"sccp_o_130_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1000 | mg/kg bw/d | - | oral | prenatal | developmental toxicity | SOURCE_SUBDIR=sccp_o_059; REPORT_TITLE=Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester COLIPA n° S83; OPINION_NUMBER=SCCP/0996/06; COMMITTEE=SCCP; REPORT_DATE=20 June 2006; VALUE_TEXT=1000; DOSE=SCCP/0996/06 Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance in...; EFFECT=SCCP/0996/06 Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Cytotoxicity Assay in vitro: Neutral Red (NR) Assay at simultaneous Irradiat; CITATION=Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental tox; CITATION_NUMBERS=[12,200,1000]; REFERENCE=Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental tox; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental tox","dose":"SCCP/0996/06 Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance in...","duration":"prenatal","effect":"SCCP/0996/06 Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Cytotoxicity Assay in vitro: Neutral Red (NR) Assay at simultaneous Irradiat","endpoint":"developmental toxicity","ingredient":"Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":15,"route":"oral","species":"","study_id":"sccp_o_059_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 200 | mg/kg bw/d | - | oral | prenatal | developmental toxicity | SOURCE_SUBDIR=sccp_o_059; REPORT_TITLE=Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester COLIPA n° S83; OPINION_NUMBER=SCCP/0996/06; COMMITTEE=SCCP; REPORT_DATE=20 June 2006; VALUE_TEXT=200; DOSE=SCCP/0996/06 Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance in...; EFFECT=SCCP/0996/06 Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Cytotoxicity Assay in vitro: Neutral Red (NR) Assay at simultaneous Irradiation wit; CITATION=Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental tox; CITATION_NUMBERS=[12,200,1000]; REFERENCE=Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental tox; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental tox","dose":"SCCP/0996/06 Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance in...","duration":"prenatal","effect":"SCCP/0996/06 Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester ____________________________________________________________________________________________ 15 There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Cytotoxicity Assay in vitro: Neutral Red (NR) Assay at simultaneous Irradiation wit","endpoint":"developmental toxicity","ingredient":"Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":15,"route":"oral","species":"","study_id":"sccp_o_059_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1000 | mg/kg bw/day | - | oral | prenatal | developmental toxicity | SOURCE_SUBDIR=sccp_o_059; REPORT_TITLE=Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester COLIPA n° S83; OPINION_NUMBER=SCCP/0996/06; COMMITTEE=SCCP; REPORT_DATE=20 June 2006; VALUE_TEXT=1000; DOSE=duced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d).; EFFECT=duced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Cytotoxicity Assay in vitro: Neutral Red (NR) Assay at simultaneous Irradiation with Artificial Sunlight Guideline: OECD draft ‘In vitro 3T3 NRU phototoxicity test, (2000) EU n° B.41 (2000) Species/strain: Balb/c 3T3 cells clone 31 Test substance: Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexyleste; CITATION=Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental tox; CITATION_NUMBERS=[12,200,1000]; REFERENCE=Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental tox; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental tox","dose":"duced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d).","duration":"prenatal","effect":"duced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Cytotoxicity Assay in vitro: Neutral Red (NR) Assay at simultaneous Irradiation with Artificial Sunlight Guideline: OECD draft ‘In vitro 3T3 NRU phototoxicity test, (2000) EU n° B.41 (2000) Species/strain: Balb/c 3T3 cells clone 31 Test substance: Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexyleste","endpoint":"developmental toxicity","ingredient":"Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":15,"route":"oral","species":"","study_id":"sccp_o_059_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1000 | mg/kg bw/day | - | oral | prenatal | developmental toxicity | SOURCE_SUBDIR=sccp_o_059; REPORT_TITLE=Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester COLIPA n° S83; OPINION_NUMBER=SCCP/0996/06; COMMITTEE=SCCP; REPORT_DATE=20 June 2006; VALUE_TEXT=1000; DOSE=ose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d).; EFFECT=ose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Cytotoxicity Assay in vitro: Neutral Red (NR) Assay at simultaneous Irradiation with Artificial Sunlight Guideline: OECD draft ‘In vitro 3T3 NRU phototoxicity test, (2000) EU n° B.41 (2000) Species/strain: Balb/c 3T3 cells clone 31 Test substance: Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester Batch; CITATION=Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental tox; CITATION_NUMBERS=[12,200,1000]; REFERENCE=Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental tox; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental tox","dose":"ose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d).","duration":"prenatal","effect":"ose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/d, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Cytotoxicity Assay in vitro: Neutral Red (NR) Assay at simultaneous Irradiation with Artificial Sunlight Guideline: OECD draft ‘In vitro 3T3 NRU phototoxicity test, (2000) EU n° B.41 (2000) Species/strain: Balb/c 3T3 cells clone 31 Test substance: Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester Batch","endpoint":"developmental toxicity","ingredient":"Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":15,"route":"oral","species":"","study_id":"sccp_o_059_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | =0.093 | mg/kg | rat | oral | 90-day | developmental toxicity | SOURCE_SUBDIR=sccp_o_059; REPORT_TITLE=Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester COLIPA n° S83; OPINION_NUMBER=SCCP/0996/06; COMMITTEE=SCCP; REPORT_DATE=20 June 2006; VALUE_TEXT== 0.093; DOSE=Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No obs...; EFFECT=CALCULATION OF THE MARGIN OF SAFETY Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/d. In a prenatal development; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"302776-68-7","citation":"","dose":"Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No obs...","duration":"90-day","effect":"CALCULATION OF THE MARGIN OF SAFETY Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/d. In a prenatal development","endpoint":"developmental toxicity","ingredient":"Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.093","page":20,"route":"oral","species":"rat","study_id":"sccp_o_059_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | =200 | mg/kg | rat | oral | 90-day | developmental toxicity | SOURCE_SUBDIR=sccp_o_059; REPORT_TITLE=Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester COLIPA n° S83; OPINION_NUMBER=SCCP/0996/06; COMMITTEE=SCCP; REPORT_DATE=20 June 2006; VALUE_TEXT== 200; DOSE=Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No obs...; EFFECT=oic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/d. In a prenatal development toxicity stud; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"302776-68-7","citation":"","dose":"Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No obs...","duration":"90-day","effect":"oic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester) (UV Filter) The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/d. In a prenatal development toxicity stud","endpoint":"developmental toxicity","ingredient":"Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester","loael_value":"","noael_unit":"mg/kg","noael_value":"= 200","page":20,"route":"oral","species":"rat","study_id":"sccp_o_059_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | =200 | mg/kg | rat | oral | 90-day | developmental toxicity | SOURCE_SUBDIR=sccp_o_059; REPORT_TITLE=Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester COLIPA n° S83; OPINION_NUMBER=SCCP/0996/06; COMMITTEE=SCCP; REPORT_DATE=20 June 2006; VALUE_TEXT== 200; DOSE=Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No obs...; EFFECT=ty calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/d. In a prenatal development toxicity study, the NOAEL for maternal toxicity was 200 mg/kg bw/d and 1000 mg/kg bw for prenata; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"302776-68-7","citation":"","dose":"Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No obs...","duration":"90-day","effect":"ty calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 0.310 µg/cm² Maximum absorption through the skin DAa (µg/cm²) = 0.31 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (whole body) SAS = 18 000 cm² Dermal absorption per treatment SAS x A x 0.00031 = 5.83 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/d. In a prenatal development toxicity study, the NOAEL for maternal toxicity was 200 mg/kg bw/d and 1000 mg/kg bw for prenata","endpoint":"developmental toxicity","ingredient":"Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester","loael_value":"","noael_unit":"mg/kg","noael_value":"= 200","page":20,"route":"oral","species":"rat","study_id":"sccp_o_059_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 2000 | mg/kg bw | rat | oral | 90-day | developmental toxicity | SOURCE_SUBDIR=sccp_o_059; REPORT_TITLE=Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester COLIPA n° S83; OPINION_NUMBER=SCCP/0996/06; COMMITTEE=SCCP; REPORT_DATE=20 June 2006; VALUE_TEXT=2000; DOSE=mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14.; EFFECT=mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/d. In a prenatal development toxicity study, the NOAEL for maternal toxicity was 200 mg/kg bw/d and 1000 mg/kg bw for prenatal developmental toxicity. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin of guinea pigs for treatments up to 14 days. It caused transient irritation to the rabbit eye. A study of skin sensitisation in guinea pigs cannot be evaluated. The percutaneous absorption was 0.100 ± 0.11; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"302776-68-7","citation":"","dose":"mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14.","duration":"90-day","effect":"mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.093 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/d. In a prenatal development toxicity study, the NOAEL for maternal toxicity was 200 mg/kg bw/d and 1000 mg/kg bw for prenatal developmental toxicity. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin of guinea pigs for treatments up to 14 days. It caused transient irritation to the rabbit eye. A study of skin sensitisation in guinea pigs cannot be evaluated. The percutaneous absorption was 0.100 ± 0.11","endpoint":"developmental toxicity","ingredient":"Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester","loael_value":"","noael_unit":"mg/kg bw","noael_value":"2000","page":20,"route":"oral","species":"rat","study_id":"sccp_o_059_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 200 | mg/kg bw/d | rat | oral | 90-day | developmental toxicity | SOURCE_SUBDIR=sccp_o_059; REPORT_TITLE=Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester COLIPA n° S83; OPINION_NUMBER=SCCP/0996/06; COMMITTEE=SCCP; REPORT_DATE=20 June 2006; VALUE_TEXT=200; DOSE=mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14.; EFFECT=mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/d. In a prenatal development toxicity study, the NOAEL for maternal toxicity was 200 mg/kg bw/d and 1000 mg/kg bw for prenatal developmental toxicity. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin of guinea pigs for treatments up to 14 days. It caused transient irritation to the rabbit eye. A study of skin sensitisation in guinea pigs cannot be evaluated. The percutaneous absorption was 0.100 ± 0.115 µg/cm2 or 0.042 ± 0.050% (Maximum value: 0.310 µg/cm2 or 0.149%). Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"302776-68-7","citation":"","dose":"mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14.","duration":"90-day","effect":"mg/kg (rat, teratogenicity oral, maternal toxicity) Margin of Safety NOAEL / SED = 2150 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/d. In a prenatal development toxicity study, the NOAEL for maternal toxicity was 200 mg/kg bw/d and 1000 mg/kg bw for prenatal developmental toxicity. Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester is not irritating to the skin of guinea pigs for treatments up to 14 days. It caused transient irritation to the rabbit eye. A study of skin sensitisation in guinea pigs cannot be evaluated. The percutaneous absorption was 0.100 ± 0.115 µg/cm2 or 0.042 ± 0.050% (Maximum value: 0.310 µg/cm2 or 0.149%). Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-","endpoint":"developmental toxicity","ingredient":"Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":20,"route":"oral","species":"rat","study_id":"sccp_o_059_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1000 | mg/kg bw/d | - | oral | prenatal | developmental toxicity | SOURCE_SUBDIR=sccp_o_130; REPORT_TITLE=OPINION ON Diethylamino hydroxybenzoyl hexyl benzoate COLIPA n° S83; OPINION_NUMBER=SCCP/1166/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=1000; DOSE=ced food consumption on day 6 - 13 p.c. and slight alterations in absolute and corrected body weight gain were noted at 1,000 mg/kg bw/day.; EFFECT=ced food consumption on day 6 - 13 p.c. and slight alterations in absolute and corrected body weight gain were noted at 1,000 mg/kg bw/day. No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/d. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted; CITATION=Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental t; CITATION_NUMBERS=[12,200,1000]; REFERENCE=Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental t; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental t","dose":"ced food consumption on day 6 - 13 p.c. and slight alterations in absolute and corrected body weight gain were noted at 1,000 mg/kg bw/day.","duration":"prenatal","effect":"ced food consumption on day 6 - 13 p.c. and slight alterations in absolute and corrected body weight gain were noted at 1,000 mg/kg bw/day. No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/d. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted","endpoint":"developmental toxicity","ingredient":"also","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":18,"route":"oral","species":"","study_id":"sccp_o_130_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 200 | mg/kg bw/day | - | oral | prenatal | developmental toxicity | SOURCE_SUBDIR=sccp_o_130; REPORT_TITLE=OPINION ON Diethylamino hydroxybenzoyl hexyl benzoate COLIPA n° S83; OPINION_NUMBER=SCCP/1166/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=200; DOSE=p.c. and slight alterations in absolute and corrected body weight gain were noted at 1,000 mg/kg bw/day.; EFFECT=p.c. and slight alterations in absolute and corrected body weight gain were noted at 1,000 mg/kg bw/day. No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/d. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted; CITATION=Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental t; CITATION_NUMBERS=[12,200,1000]; REFERENCE=Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental t; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental t","dose":"p.c. and slight alterations in absolute and corrected body weight gain were noted at 1,000 mg/kg bw/day.","duration":"prenatal","effect":"p.c. and slight alterations in absolute and corrected body weight gain were noted at 1,000 mg/kg bw/day. No signs of substance-induced maternal toxicity occurred at dose levels of 40 or 200 mg/kg bw/d. There were no substance-induced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted","endpoint":"developmental toxicity","ingredient":"also","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":18,"route":"oral","species":"","study_id":"sccp_o_130_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1000 | mg/kg bw/day | - | oral | prenatal | developmental toxicity | SOURCE_SUBDIR=sccp_o_130; REPORT_TITLE=OPINION ON Diethylamino hydroxybenzoyl hexyl benzoate COLIPA n° S83; OPINION_NUMBER=SCCP/1166/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=1000; DOSE=uced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d).; EFFECT=uced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted; CITATION=Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental t; CITATION_NUMBERS=[12,200,1000]; REFERENCE=Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental t; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental t","dose":"uced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d).","duration":"prenatal","effect":"uced, dose related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted","endpoint":"developmental toxicity","ingredient":"also","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":18,"route":"oral","species":"","study_id":"sccp_o_130_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1000 | mg/kg bw/day | - | oral | prenatal | developmental toxicity | SOURCE_SUBDIR=sccp_o_130; REPORT_TITLE=OPINION ON Diethylamino hydroxybenzoyl hexyl benzoate COLIPA n° S83; OPINION_NUMBER=SCCP/1166/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=1000; DOSE=se related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d).; EFFECT=se related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted; CITATION=Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental t; CITATION_NUMBERS=[12,200,1000]; REFERENCE=Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental t; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental t","dose":"se related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d).","duration":"prenatal","effect":"se related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to and including the highest dose level (1000 mg/kg bw/d). Ref.: 12 Comment The no observed adverse effect level (NOAEL) for maternal toxicity is 200 mg/kg bw/day, while it is 1000 mg/kg bw/day (highest applied dose) for prenatal developmental toxicity. A comparison between the above-mentioned results and those derived from the 90-day study (NOAEL / NOEL) may be influenced by administration (diet versus gavage). 3.3.9. Toxicokinetics No data submitted","endpoint":"developmental toxicity","ingredient":"also","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":18,"route":"oral","species":"","study_id":"sccp_o_130_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 2000 | mg/kg bw | rat | oral | 90-day | developmental toxicity | SOURCE_SUBDIR=sccp_o_130; REPORT_TITLE=OPINION ON Diethylamino hydroxybenzoyl hexyl benzoate COLIPA n° S83; OPINION_NUMBER=SCCP/1166/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=2000; DOSE=Diethylamino hydroxybenzoyl hexyl benzoate has low acute oral toxicity; more than 2000 mg/kg bw in the rat.; EFFECT=D = 2222 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered (It has been proposed that Uvinul A Plus should be labelled R53: May cause long-term adverse effects in the aquatic environment [draft 31st adaptation to technical progress of directive 67/584/EEC on dangerous substances]. Diethylamino hydroxybenzoyl hexyl benzoate has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/day. In a prenatal development toxicity study, the NOAEL for maternal toxicity was 200 mg/kg bw/day and 1000 mg/kg bw for prenatal developmental toxicity. Diethylamino hydroxybenzoyl hexyl benzoate is not irritating to the skin of guinea pigs for treatments up to 14 days. It caused transient irritation to the rabbit eye. A study of skin sensitisation in guinea pigs cannot be evaluated. The percutaneous absorption was 0.10 ± 0.12 µg/cm² or 0.04 ± 0; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"302776-68-7","citation":"","dose":"Diethylamino hydroxybenzoyl hexyl benzoate has low acute oral toxicity; more than 2000 mg/kg bw in the rat.","duration":"90-day","effect":"D = 2222 3.3.14. Discussion The safety has only been considered for dermal exposure. If it is intended that it should be widely used, the environmental aspects should be considered (It has been proposed that Uvinul A Plus should be labelled R53: May cause long-term adverse effects in the aquatic environment [draft 31st adaptation to technical progress of directive 67/584/EEC on dangerous substances]. Diethylamino hydroxybenzoyl hexyl benzoate has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/day. In a prenatal development toxicity study, the NOAEL for maternal toxicity was 200 mg/kg bw/day and 1000 mg/kg bw for prenatal developmental toxicity. Diethylamino hydroxybenzoyl hexyl benzoate is not irritating to the skin of guinea pigs for treatments up to 14 days. It caused transient irritation to the rabbit eye. A study of skin sensitisation in guinea pigs cannot be evaluated. The percutaneous absorption was 0.10 ± 0.12 µg/cm² or 0.04 ± 0","endpoint":"developmental toxicity","ingredient":"also","loael_value":"","noael_unit":"mg/kg bw","noael_value":"2000","page":23,"route":"oral","species":"rat","study_id":"sccp_o_130_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 200 | mg/kg bw/day | rat | oral | 90-day | developmental toxicity | SOURCE_SUBDIR=sccp_o_130; REPORT_TITLE=OPINION ON Diethylamino hydroxybenzoyl hexyl benzoate COLIPA n° S83; OPINION_NUMBER=SCCP/1166/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=200; DOSE=Diethylamino hydroxybenzoyl hexyl benzoate has low acute oral toxicity; more than 2000 mg/kg bw in the rat.; EFFECT=be widely used, the environmental aspects should be considered (It has been proposed that Uvinul A Plus should be labelled R53: May cause long-term adverse effects in the aquatic environment [draft 31st adaptation to technical progress of directive 67/584/EEC on dangerous substances]. Diethylamino hydroxybenzoyl hexyl benzoate has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/day. In a prenatal development toxicity study, the NOAEL for maternal toxicity was 200 mg/kg bw/day and 1000 mg/kg bw for prenatal developmental toxicity. Diethylamino hydroxybenzoyl hexyl benzoate is not irritating to the skin of guinea pigs for treatments up to 14 days. It caused transient irritation to the rabbit eye. A study of skin sensitisation in guinea pigs cannot be evaluated. The percutaneous absorption was 0.10 ± 0.12 µg/cm² or 0.04 ± 0.05% (Maximum value: 0.31 µg/cm² or 0.15%).; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"302776-68-7","citation":"","dose":"Diethylamino hydroxybenzoyl hexyl benzoate has low acute oral toxicity; more than 2000 mg/kg bw in the rat.","duration":"90-day","effect":"be widely used, the environmental aspects should be considered (It has been proposed that Uvinul A Plus should be labelled R53: May cause long-term adverse effects in the aquatic environment [draft 31st adaptation to technical progress of directive 67/584/EEC on dangerous substances]. Diethylamino hydroxybenzoyl hexyl benzoate has low acute oral toxicity; more than 2000 mg/kg bw in the rat. A NOEL, derived from an oral 90-day study in rats was about 250 mg/kg bw/day. In a prenatal development toxicity study, the NOAEL for maternal toxicity was 200 mg/kg bw/day and 1000 mg/kg bw for prenatal developmental toxicity. Diethylamino hydroxybenzoyl hexyl benzoate is not irritating to the skin of guinea pigs for treatments up to 14 days. It caused transient irritation to the rabbit eye. A study of skin sensitisation in guinea pigs cannot be evaluated. The percutaneous absorption was 0.10 ± 0.12 µg/cm² or 0.04 ± 0.05% (Maximum value: 0.31 µg/cm² or 0.15%).","endpoint":"developmental toxicity","ingredient":"also","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":23,"route":"oral","species":"rat","study_id":"sccp_o_130_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 15000 | ppm | rat | - | Chronic | reproductive toxicity | SOURCE_SUBDIR=sccp_o_059; REPORT_TITLE=Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester COLIPA n° S83; OPINION_NUMBER=SCCP/0996/06; COMMITTEE=SCCP; REPORT_DATE=20 June 2006; VALUE_TEXT=15,000; DOSE=All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.; EFFECT=egard this as treatment related. All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/d in females). Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3,000 ppm (250 mg/kg bw/d). 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strains: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Esche; CITATION=Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248; CITATION_NUMBERS=[11,15,1248]; REFERENCE=Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248","dose":"All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.","duration":"Chronic","effect":"egard this as treatment related. All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/d in females). Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3,000 ppm (250 mg/kg bw/d). 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strains: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Esche","endpoint":"reproductive toxicity","ingredient":"Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester","loael_value":"","noael_unit":"ppm","noael_value":"15,000","page":12,"route":"","species":"rat","study_id":"sccp_o_059_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 15000 | ppm | rat | - | Chronic | reproductive toxicity | SOURCE_SUBDIR=sccp_o_059; REPORT_TITLE=Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester COLIPA n° S83; OPINION_NUMBER=SCCP/0996/06; COMMITTEE=SCCP; REPORT_DATE=20 June 2006; VALUE_TEXT=15,000; DOSE=All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.; EFFECT=All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/d in females). Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3,000 ppm (250 mg/kg bw/d). 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strains: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia; CITATION=Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248; CITATION_NUMBERS=[11,15,1248]; REFERENCE=Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248","dose":"All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.","duration":"Chronic","effect":"All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/d in females). Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3,000 ppm (250 mg/kg bw/d). 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strains: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia","endpoint":"reproductive toxicity","ingredient":"Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester","loael_value":"","noael_unit":"ppm","noael_value":"15,000","page":12,"route":"","species":"rat","study_id":"sccp_o_059_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 3000 | ppm | rat | - | Chronic | reproductive toxicity | SOURCE_SUBDIR=sccp_o_059; REPORT_TITLE=Opinion on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester COLIPA n° S83; OPINION_NUMBER=SCCP/0996/06; COMMITTEE=SCCP; REPORT_DATE=20 June 2006; VALUE_TEXT=3,000; DOSE=in control and high dose males and/or females.; EFFECT=in control and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/d in females). Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3,000 ppm (250 mg/kg bw/d). 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strains: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2 uvrA Test substance: Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester Batch: R323/681 Purity: 99.35% Replicates: 3 plates per test Concentrations: Standard plate test: 20 µg; CITATION=Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248; CITATION_NUMBERS=[11,15,1248]; REFERENCE=Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248; DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248","dose":"in control and high dose males and/or females.","duration":"Chronic","effect":"in control and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Ref.: 11 Comment The no observed adverse effect level (NOAEL) under the conditions of this study was therefore 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/d in females). Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3,000 ppm (250 mg/kg bw/d). 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 Species/strains: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2 uvrA Test substance: Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester Batch: R323/681 Purity: 99.35% Replicates: 3 plates per test Concentrations: Standard plate test: 20 µg","endpoint":"reproductive toxicity","ingredient":"Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester","loael_value":"","noael_unit":"ppm","noael_value":"3,000","page":12,"route":"","species":"rat","study_id":"sccp_o_059_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 15000 | ppm | rat | - | - | reproductive toxicity | SOURCE_SUBDIR=sccp_o_130; REPORT_TITLE=OPINION ON Diethylamino hydroxybenzoyl hexyl benzoate COLIPA n° S83; OPINION_NUMBER=SCCP/1166/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=15,000; DOSE=All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.; EFFECT=ated. All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Conclusion The study authors considered that the NOAEL was equal to the highest dose used. That is 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day).; CITATION=Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day); CITATION_NUMBERS=[11,7,3000,250]; REFERENCE=Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day); DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day)","dose":"All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females.","duration":"","effect":"ated. All gross lesions and microscopic findings recorded were either single observations, or they occurred in control animals only, or they were recorded at low or comparable incidence and graded severity in control and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Conclusion The study authors considered that the NOAEL was equal to the highest dose used. That is 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day).","endpoint":"reproductive toxicity","ingredient":"also","loael_value":"","noael_unit":"ppm","noael_value":"15,000","page":14,"route":"","species":"rat","study_id":"sccp_o_130_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 3000 | ppm | rat | - | - | reproductive toxicity | SOURCE_SUBDIR=sccp_o_130; REPORT_TITLE=OPINION ON Diethylamino hydroxybenzoyl hexyl benzoate COLIPA n° S83; OPINION_NUMBER=SCCP/1166/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=15 April 2008; VALUE_TEXT=3000; DOSE=l and high dose males and/or females.; EFFECT=l and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Conclusion The study authors considered that the NOAEL was equal to the highest dose used. That is 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day).; CITATION=Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day); CITATION_NUMBERS=[11,7,3000,250]; REFERENCE=Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day); DETAILS_JSON={"cas_number":"302776-68-7","citation":"Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day)","dose":"l and high dose males and/or females.","duration":"","effect":"l and high dose males and/or females. These changes are all considered to be unrelated to treatments by the applicant. Comprehensive examinations of reproductive organs as well as sperm analysis did not give any indication for an impairment of fertility. Conclusion The study authors considered that the NOAEL was equal to the highest dose used. That is 15,000 ppm (1248.8 mg/kg bw/day in males; 1452.1 mg/kg bw/day in females). Ref.: 11 Comment Based on the increase in relative liver weight (+7% in male rats), the NOEL was set at 3000 ppm (250 mg/kg bw/day).","endpoint":"reproductive toxicity","ingredient":"also","loael_value":"","noael_unit":"ppm","noael_value":"3000","page":14,"route":"","species":"rat","study_id":"sccp_o_130_noael_002"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | ANQ870JD20 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C24H31NO4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"ANQ870JD20"} |
| openFDA substances | FDA UNII substance identifier | ANQ870JD20 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C24H31NO4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"ANQ870JD20"} |
| openFDA substances | FDA UNII substance identifier | ANQ870JD20 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C24H31NO4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"ANQ870JD20"} |
| openFDA substances | FDA UNII substance identifier | ANQ870JD20 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C24H31NO4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"ANQ870JD20"} |