NOAEL Studies
UV Filter / Sunscreen
Sulisobenzone (Benzophenone-4) NOAEL Studies
INCI: SULISOBENZONE
CAS: 4065-45-6
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
NTP_ICE_acute_oral 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_oral | LD50 | =3530 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_6313; row=4765; data_type=In Vivo; mixture=Chemical; chemical_name=Sulisobenzone; preferred_name=Sulisobenzone; dtxsid=DTXSID2042436; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2042436; source_file=acute_oral.xlsx |
NTP_ICE_adme_parameters 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_adme_parameters | Clint | 1.05 | uL/min/10^6 cells | Human | - | - | Measured; httk, Human Hepatic Intrinsic Clearance | sheet=Data; excel_row=1042; Record_ID=adme_parameters_1081; Data_Type=Measured; DTXSID=DTXSID2042436; Assay=httk, Human Hepatic Intrinsic Clearance; Endpoint=Clint; Response=1.05; Response_Unit=ul/min/10^6 cells; Species=Human; Reference=httk2.3.1, Wambaugh 2019; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2042436 |
| NTP_ICE_adme_parameters | Fu | 0.00942 | fraction | Human | - | - | Measured; httk, Human Plasma Fraction Unbound | sheet=Data; excel_row=1043; Record_ID=adme_parameters_1081; Data_Type=Measured; DTXSID=DTXSID2042436; Assay=httk, Human Plasma Fraction Unbound; Endpoint=Fu; Response=0.00942; Response_Unit=Unitless Fraction; Species=Human; Reference=httk2.3.1, Wambaugh 2019; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2042436 |
NTP_ICE_endocrine 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_endocrine | Model Score | 0 | unitless | - | - | - | ARPathway2016; AR Pathway Model, Antagonist | sheet=Integrated_approaches; excel_row=14988; RecordID=ARPathway2016_1192; DatasetName=ARPathway2016; DTXSID=DTXSID2042436; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2042436 |
SCCS_vision_codex 24 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =1239 | mg/kg/day | rat | - | 90-day | NOAEL study | {"dose":"rats exposed to the highest dose showed a decrease in body and liver weight, while female rats exposed to the middle dose showed an increase in adrenal gland weight.","effect":"rats exposed to the highest dose showed a decrease in body and liver weight, while female rats exposed to the middle dose showed an increase in adrenal gland weight. However, these changes were not associated with any adverse gross or histopathological findings. Overall, the study concluded that benzophenone-4 did not have significant toxic effects on the rats, as there were no adverse findings in the clinical examination or histopathological analysis. Therefore, the highest dose of 1239 mg/kg/day was taken as the NOAEL. (BASF AG 1996) SCCS comment Original study reports were not provided with the first submission, but the original study report of the 90-day repeat dose toxicity study was requested and received. A NOAEL of 1239 mg/kg/day was derived. The study report was not signed.","page":37,"pdf":"sccs_o_283.pdf","row_type":"noael_study","study_id":"sccs_o_283_noael_001"} |
| SCCS_vision_codex | NOAEL | =1250 | mg/kg/day | rat | - | - | NOAEL study | {"dose":"Based on the results reported, a NOAEL of 1250 mg/kg/day for male and female rats was considered.","effect":"l data showed no significant effects on T4, TSH, testosterone(males) and estradiol (females). No notable effects on organs or blood chemistry parameters were observed. Pregnancy rates, gestation length and litter size were not affected by treatment. No significant effects were seen on the number of live births, pup weight, pup survival or sex ratio. No test substance abnormalities were seen in pups. Special investigations on thyroid and parathyroid glands revealed no abnormalities. Based on the results reported, a NOAEL of 1250 mg/kg/day for male and female rats was considered. (Sustainability Support Services (Europe) AB 2018) SCCS comment The original study report was not provided with the initial submission, but was sent upon request. A number of deviations from OECD TG 422 were observed: - the study employed a dose volume of 2 ml/100g body weight, while the recommended guideline suggested using only 1 mg/100g body weight (with 2 ml being acceptable for aqueous solutions). Here corn oil has been used. - the report did not in","page":38,"pdf":"sccs_o_283.pdf","row_type":"noael_study","study_id":"sccs_o_283_noael_003"} |
| SCCS_vision_codex | NOAEL | =1239 | mg/kg bw/day | rat | oral | 90-day | repeated dose toxicity | {"dose":"19 20 21 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4.","effect":"11 12 3.4.10.4 In vivo adverse effects on endocrine relevant endpoints 13 14 / 15 16 SCCS comment 17 Based on the various studies provided, it can be concluded that benzophenone-4 does not 18 demonstrate endocrine-disrupting properties. 19 20 21 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4. As point of departure for 24 risk assessment, a NOAEL of 1239 mg/kg bw/day, based on a 90-day oral repeated dose rat 25 study is used (see section 3.4.4.2). As no good oral absorption study for benzophenone-4 is 26 available, the default value of 50 % is used for the oral absorption, resulting in an adjusted 27 NOAEL of 620 mg/kg bw/day. Following MoS calculations for separate product types and 28 aggregated exposure can be calculated: 29 30 31 Product type SED (mg/kg bw/day) adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face","page":59,"pdf":"sccs_o_283.pdf","row_type":"noael_study","study_id":"sccs_o_283_noael_004"} |
| SCCS_vision_codex | NOAEL | =620 | mg/kg bw/day | rat | oral | 90-day | repeated dose toxicity | {"dose":"LUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4.","effect":"LUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4. As point of departure for 24 risk assessment, a NOAEL of 1239 mg/kg bw/day, based on a 90-day oral repeated dose rat 25 study is used (see section 3.4.4.2). As no good oral absorption study for benzophenone-4 is 26 available, the default value of 50 % is used for the oral absorption, resulting in an adjusted 27 NOAEL of 620 mg/kg bw/day. Following MoS calculations for separate product types and 28 aggregated exposure can be calculated: 29 30 31 Product type SED (mg/kg bw/day) adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face cream* 0.006 620 103333 Hand cream* 0.008 620 77500 Dermal aggregate for leave-on and rinse-off products 0.067 620 9254 Oral exposure: Lip stick* 0.045 620 13778 Inhalatory exposure: Sunscreen propellant spray* 0.088 620 7046 Sunscreen pump spray 0.001 620 6","page":59,"pdf":"sccs_o_283.pdf","row_type":"noael_study","study_id":"sccs_o_283_noael_005"} |
| SCCS_vision_codex | NOAEL | =59 | - | - | - | - | NOAEL study | {"dose":"Product type | SED (mg/kg bw/day) | adjusted NOAEL (mg/kg bw/day) | MoS","effect":"Unlabeled table on page 59: Product type | SED (mg/kg bw/day) | adjusted NOAEL (mg/kg bw/day) | MoS","page":59,"pdf":"sccs_o_283.pdf","row_type":"noael_study","study_id":"sccs_o_283_noael_008"} |
| SCCS_vision_codex | NOAEL | =620 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 59: Sunscreen lotion | 0.069 | 620 | 8986","page":59,"pdf":"sccs_o_283.pdf","row_type":"noael_study","study_id":"sccs_o_283_noael_009"} |
| SCCS_vision_codex | NOAEL | =1239 | mg/kg/day | rat | - | 90-day | NOAEL study | {"dose":"rats exposed to the highest dose showed a decrease in body and liver weight, while female rats exposed to the middle dose showed an increase in adrenal gland weight.","effect":"rats exposed to the highest dose showed a decrease in body and liver weight, while female rats exposed to the middle dose showed an increase in adrenal gland weight. However, these changes were not associated with any adverse gross or histopathological findings. Overall, the study concluded that benzophenone-4 did not have significant toxic effects on the rats, as there were no adverse findings in the clinical examination or histopathological analysis. Therefore, the highest dose of 1239 mg/kg/day was taken as the NOAEL. (BASF AG 1996) SCCS comment Original study reports were not provided with the first submission, but the original study report of the 90-day repeat dose toxicity study was requested and received. A NOAEL of 1239 mg/kg/day was derived. The study report was not signed.","page":37,"pdf":"sccs_o_283.pdf","row_type":"noael_study","study_id":"sccs_o_283_noael_001"} |
| SCCS_vision_codex | NOAEL | =1250 | mg/kg/day | rat | - | - | NOAEL study | {"dose":"Based on the results reported, a NOAEL of 1250 mg/kg/day for male and female rats was considered.","effect":"l data showed no significant effects on T4, TSH, testosterone(males) and estradiol (females). No notable effects on organs or blood chemistry parameters were observed. Pregnancy rates, gestation length and litter size were not affected by treatment. No significant effects were seen on the number of live births, pup weight, pup survival or sex ratio. No test substance abnormalities were seen in pups. Special investigations on thyroid and parathyroid glands revealed no abnormalities. Based on the results reported, a NOAEL of 1250 mg/kg/day for male and female rats was considered. (Sustainability Support Services (Europe) AB 2018) SCCS comment The original study report was not provided with the initial submission, but was sent upon request. A number of deviations from OECD TG 422 were observed: - the study employed a dose volume of 2 ml/100g body weight, while the recommended guideline suggested using only 1 mg/100g body weight (with 2 ml being acceptable for aqueous solutions). Here corn oil has been used. - the report did not in","page":38,"pdf":"sccs_o_283.pdf","row_type":"noael_study","study_id":"sccs_o_283_noael_003"} |
| SCCS_vision_codex | NOAEL | =1239 | mg/kg bw/day | rat | oral | 90-day | repeated dose toxicity | {"dose":"19 20 21 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4.","effect":"11 12 3.4.10.4 In vivo adverse effects on endocrine relevant endpoints 13 14 / 15 16 SCCS comment 17 Based on the various studies provided, it can be concluded that benzophenone-4 does not 18 demonstrate endocrine-disrupting properties. 19 20 21 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4. As point of departure for 24 risk assessment, a NOAEL of 1239 mg/kg bw/day, based on a 90-day oral repeated dose rat 25 study is used (see section 3.4.4.2). As no good oral absorption study for benzophenone-4 is 26 available, the default value of 50 % is used for the oral absorption, resulting in an adjusted 27 NOAEL of 620 mg/kg bw/day. Following MoS calculations for separate product types and 28 aggregated exposure can be calculated: 29 30 31 Product type SED (mg/kg bw/day) adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face","page":59,"pdf":"sccs_o_283.pdf","row_type":"noael_study","study_id":"sccs_o_283_noael_004"} |
| SCCS_vision_codex | NOAEL | =620 | mg/kg bw/day | rat | oral | 90-day | repeated dose toxicity | {"dose":"LUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4.","effect":"LUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4. As point of departure for 24 risk assessment, a NOAEL of 1239 mg/kg bw/day, based on a 90-day oral repeated dose rat 25 study is used (see section 3.4.4.2). As no good oral absorption study for benzophenone-4 is 26 available, the default value of 50 % is used for the oral absorption, resulting in an adjusted 27 NOAEL of 620 mg/kg bw/day. Following MoS calculations for separate product types and 28 aggregated exposure can be calculated: 29 30 31 Product type SED (mg/kg bw/day) adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face cream* 0.006 620 103333 Hand cream* 0.008 620 77500 Dermal aggregate for leave-on and rinse-off products 0.067 620 9254 Oral exposure: Lip stick* 0.045 620 13778 Inhalatory exposure: Sunscreen propellant spray* 0.088 620 7046 Sunscreen pump spray 0.001 620 6","page":59,"pdf":"sccs_o_283.pdf","row_type":"noael_study","study_id":"sccs_o_283_noael_005"} |
| SCCS_vision_codex | NOAEL | =59 | - | - | - | - | NOAEL study | {"dose":"Product type | SED (mg/kg bw/day) | adjusted NOAEL (mg/kg bw/day) | MoS","effect":"Unlabeled table on page 59: Product type | SED (mg/kg bw/day) | adjusted NOAEL (mg/kg bw/day) | MoS","page":59,"pdf":"sccs_o_283.pdf","row_type":"noael_study","study_id":"sccs_o_283_noael_008"} |
| SCCS_vision_codex | NOAEL | =620 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 59: Sunscreen lotion | 0.069 | 620 | 8986","page":59,"pdf":"sccs_o_283.pdf","row_type":"noael_study","study_id":"sccs_o_283_noael_009"} |
| SCCS_vision_codex | NOAEL | =1239 | mg/kg/day | rat | - | 90-day | NOAEL study | {"dose":"rats exposed to the highest dose showed a decrease in body and liver weight, while female rats exposed to the middle dose showed an increase in adrenal gland weight.","effect":"rats exposed to the highest dose showed a decrease in body and liver weight, while female rats exposed to the middle dose showed an increase in adrenal gland weight. However, these changes were not associated with any adverse gross or histopathological findings. Overall, the study concluded that benzophenone-4 did not have significant toxic effects on the rats, as there were no adverse findings in the clinical examination or histopathological analysis. Therefore, the highest dose of 1239 mg/kg/day was taken as the NOAEL. (BASF AG 1996) SCCS comment Original study reports were not provided with the first submission, but the original study report of the 90-day repeat dose toxicity study was requested and received. A NOAEL of 1239 mg/kg/day was derived. The study report was not signed.","page":37,"pdf":"sccs_o_283.pdf","row_type":"noael_study","study_id":"sccs_o_283_noael_001"} |
| SCCS_vision_codex | NOAEL | =1250 | mg/kg/day | rat | - | - | NOAEL study | {"dose":"Based on the results reported, a NOAEL of 1250 mg/kg/day for male and female rats was considered.","effect":"l data showed no significant effects on T4, TSH, testosterone(males) and estradiol (females). No notable effects on organs or blood chemistry parameters were observed. Pregnancy rates, gestation length and litter size were not affected by treatment. No significant effects were seen on the number of live births, pup weight, pup survival or sex ratio. No test substance abnormalities were seen in pups. Special investigations on thyroid and parathyroid glands revealed no abnormalities. Based on the results reported, a NOAEL of 1250 mg/kg/day for male and female rats was considered. (Sustainability Support Services (Europe) AB 2018) SCCS comment The original study report was not provided with the initial submission, but was sent upon request. A number of deviations from OECD TG 422 were observed: - the study employed a dose volume of 2 ml/100g body weight, while the recommended guideline suggested using only 1 mg/100g body weight (with 2 ml being acceptable for aqueous solutions). Here corn oil has been used. - the report did not in","page":38,"pdf":"sccs_o_283.pdf","row_type":"noael_study","study_id":"sccs_o_283_noael_003"} |
| SCCS_vision_codex | NOAEL | =1239 | mg/kg bw/day | rat | oral | 90-day | repeated dose toxicity | {"dose":"19 20 21 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4.","effect":"11 12 3.4.10.4 In vivo adverse effects on endocrine relevant endpoints 13 14 / 15 16 SCCS comment 17 Based on the various studies provided, it can be concluded that benzophenone-4 does not 18 demonstrate endocrine-disrupting properties. 19 20 21 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4. As point of departure for 24 risk assessment, a NOAEL of 1239 mg/kg bw/day, based on a 90-day oral repeated dose rat 25 study is used (see section 3.4.4.2). As no good oral absorption study for benzophenone-4 is 26 available, the default value of 50 % is used for the oral absorption, resulting in an adjusted 27 NOAEL of 620 mg/kg bw/day. Following MoS calculations for separate product types and 28 aggregated exposure can be calculated: 29 30 31 Product type SED (mg/kg bw/day) adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face","page":59,"pdf":"sccs_o_283.pdf","row_type":"noael_study","study_id":"sccs_o_283_noael_004"} |
| SCCS_vision_codex | NOAEL | =620 | mg/kg bw/day | rat | oral | 90-day | repeated dose toxicity | {"dose":"LUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4.","effect":"LUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4. As point of departure for 24 risk assessment, a NOAEL of 1239 mg/kg bw/day, based on a 90-day oral repeated dose rat 25 study is used (see section 3.4.4.2). As no good oral absorption study for benzophenone-4 is 26 available, the default value of 50 % is used for the oral absorption, resulting in an adjusted 27 NOAEL of 620 mg/kg bw/day. Following MoS calculations for separate product types and 28 aggregated exposure can be calculated: 29 30 31 Product type SED (mg/kg bw/day) adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face cream* 0.006 620 103333 Hand cream* 0.008 620 77500 Dermal aggregate for leave-on and rinse-off products 0.067 620 9254 Oral exposure: Lip stick* 0.045 620 13778 Inhalatory exposure: Sunscreen propellant spray* 0.088 620 7046 Sunscreen pump spray 0.001 620 6","page":59,"pdf":"sccs_o_283.pdf","row_type":"noael_study","study_id":"sccs_o_283_noael_005"} |
| SCCS_vision_codex | NOAEL | =59 | - | - | - | - | NOAEL study | {"dose":"Product type | SED (mg/kg bw/day) | adjusted NOAEL (mg/kg bw/day) | MoS","effect":"Unlabeled table on page 59: Product type | SED (mg/kg bw/day) | adjusted NOAEL (mg/kg bw/day) | MoS","page":59,"pdf":"sccs_o_283.pdf","row_type":"noael_study","study_id":"sccs_o_283_noael_008"} |
| SCCS_vision_codex | NOAEL | =620 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 59: Sunscreen lotion | 0.069 | 620 | 8986","page":59,"pdf":"sccs_o_283.pdf","row_type":"noael_study","study_id":"sccs_o_283_noael_009"} |
| SCCS_vision_codex | NOAEL | =1239 | mg/kg/day | rat | - | 90-day | NOAEL study | {"dose":"rats exposed to the highest dose showed a decrease in body and liver weight, while female rats exposed to the middle dose showed an increase in adrenal gland weight.","effect":"rats exposed to the highest dose showed a decrease in body and liver weight, while female rats exposed to the middle dose showed an increase in adrenal gland weight. However, these changes were not associated with any adverse gross or histopathological findings. Overall, the study concluded that benzophenone-4 did not have significant toxic effects on the rats, as there were no adverse findings in the clinical examination or histopathological analysis. Therefore, the highest dose of 1239 mg/kg/day was taken as the NOAEL. (BASF AG 1996) SCCS comment Original study reports were not provided with the first submission, but the original study report of the 90-day repeat dose toxicity study was requested and received. A NOAEL of 1239 mg/kg/day was derived. The study report was not signed.","page":37,"pdf":"sccs_o_283.pdf","row_type":"noael_study","study_id":"sccs_o_283_noael_001"} |
| SCCS_vision_codex | NOAEL | =1250 | mg/kg/day | rat | - | - | NOAEL study | {"dose":"Based on the results reported, a NOAEL of 1250 mg/kg/day for male and female rats was considered.","effect":"l data showed no significant effects on T4, TSH, testosterone(males) and estradiol (females). No notable effects on organs or blood chemistry parameters were observed. Pregnancy rates, gestation length and litter size were not affected by treatment. No significant effects were seen on the number of live births, pup weight, pup survival or sex ratio. No test substance abnormalities were seen in pups. Special investigations on thyroid and parathyroid glands revealed no abnormalities. Based on the results reported, a NOAEL of 1250 mg/kg/day for male and female rats was considered. (Sustainability Support Services (Europe) AB 2018) SCCS comment The original study report was not provided with the initial submission, but was sent upon request. A number of deviations from OECD TG 422 were observed: - the study employed a dose volume of 2 ml/100g body weight, while the recommended guideline suggested using only 1 mg/100g body weight (with 2 ml being acceptable for aqueous solutions). Here corn oil has been used. - the report did not in","page":38,"pdf":"sccs_o_283.pdf","row_type":"noael_study","study_id":"sccs_o_283_noael_003"} |
| SCCS_vision_codex | NOAEL | =1239 | mg/kg bw/day | rat | oral | 90-day | repeated dose toxicity | {"dose":"19 20 21 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4.","effect":"11 12 3.4.10.4 In vivo adverse effects on endocrine relevant endpoints 13 14 / 15 16 SCCS comment 17 Based on the various studies provided, it can be concluded that benzophenone-4 does not 18 demonstrate endocrine-disrupting properties. 19 20 21 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4. As point of departure for 24 risk assessment, a NOAEL of 1239 mg/kg bw/day, based on a 90-day oral repeated dose rat 25 study is used (see section 3.4.4.2). As no good oral absorption study for benzophenone-4 is 26 available, the default value of 50 % is used for the oral absorption, resulting in an adjusted 27 NOAEL of 620 mg/kg bw/day. Following MoS calculations for separate product types and 28 aggregated exposure can be calculated: 29 30 31 Product type SED (mg/kg bw/day) adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face","page":59,"pdf":"sccs_o_283.pdf","row_type":"noael_study","study_id":"sccs_o_283_noael_004"} |
| SCCS_vision_codex | NOAEL | =620 | mg/kg bw/day | rat | oral | 90-day | repeated dose toxicity | {"dose":"LUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4.","effect":"LUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4. As point of departure for 24 risk assessment, a NOAEL of 1239 mg/kg bw/day, based on a 90-day oral repeated dose rat 25 study is used (see section 3.4.4.2). As no good oral absorption study for benzophenone-4 is 26 available, the default value of 50 % is used for the oral absorption, resulting in an adjusted 27 NOAEL of 620 mg/kg bw/day. Following MoS calculations for separate product types and 28 aggregated exposure can be calculated: 29 30 31 Product type SED (mg/kg bw/day) adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face cream* 0.006 620 103333 Hand cream* 0.008 620 77500 Dermal aggregate for leave-on and rinse-off products 0.067 620 9254 Oral exposure: Lip stick* 0.045 620 13778 Inhalatory exposure: Sunscreen propellant spray* 0.088 620 7046 Sunscreen pump spray 0.001 620 6","page":59,"pdf":"sccs_o_283.pdf","row_type":"noael_study","study_id":"sccs_o_283_noael_005"} |
| SCCS_vision_codex | NOAEL | =59 | - | - | - | - | NOAEL study | {"dose":"Product type | SED (mg/kg bw/day) | adjusted NOAEL (mg/kg bw/day) | MoS","effect":"Unlabeled table on page 59: Product type | SED (mg/kg bw/day) | adjusted NOAEL (mg/kg bw/day) | MoS","page":59,"pdf":"sccs_o_283.pdf","row_type":"noael_study","study_id":"sccs_o_283_noael_008"} |
| SCCS_vision_codex | NOAEL | =620 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 59: Sunscreen lotion | 0.069 | 620 | 8986","page":59,"pdf":"sccs_o_283.pdf","row_type":"noael_study","study_id":"sccs_o_283_noael_009"} |
ToxValDB_GESTIS_DNEL 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_GESTIS_DNEL | DNEL systemic | =61.7 | 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_dup_-_15635016_15635017:-:--; 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_5ec3b5a11e24024d422ff47a649bbf50 |
| 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_dup_-_15635016_15635017:-:--; 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_787f71bce80e8c9aab57060e8e3efeda |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 15 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 1239 | mg/kg/day | rat | - | 90-day | - | SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=1239; DOSE=rats exposed to the highest dose showed a decrease in body and liver weight, while female rats exposed to the middle dose showed an increase in adrenal gland weight.; EFFECT=rats exposed to the highest dose showed a decrease in body and liver weight, while female rats exposed to the middle dose showed an increase in adrenal gland weight. However, these changes were not associated with any adverse gross or histopathological findings. Overall, the study concluded that benzophenone-4 did not have significant toxic effects on the rats, as there were no adverse findings in the clinical examination or histopathological analysis. Therefore, the highest dose of 1239 mg/kg/day was taken as the NOAEL. (BASF AG 1996) SCCS comment Original study reports were not provided with the first submission, but the original study report of the 90-day repeat dose toxicity study was requested and received. A NOAEL of 1239 mg/kg/day was derived. The study report was not signed.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"rats exposed to the highest dose showed a decrease in body and liver weight, while female rats exposed to the middle dose showed an increase in adrenal gland weight.","duration":"90-day","effect":"rats exposed to the highest dose showed a decrease in body and liver weight, while female rats exposed to the middle dose showed an increase in adrenal gland weight. However, these changes were not associated with any adverse gross or histopathological findings. Overall, the study concluded that benzophenone-4 did not have significant toxic effects on the rats, as there were no adverse findings in the clinical examination or histopathological analysis. Therefore, the highest dose of 1239 mg/kg/day was taken as the NOAEL. (BASF AG 1996) SCCS comment Original study reports were not provided with the first submission, but the original study report of the 90-day repeat dose toxicity study was requested and received. A NOAEL of 1239 mg/kg/day was derived. The study report was not signed.","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1239","page":37,"route":"","species":"rat","study_id":"sccs_o_283_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 1239 | mg/kg/day | rat | - | 90-day | - | SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=1239; DOSE=Therefore, the highest dose of 1239 mg/kg/day was taken as the NOAEL.; EFFECT=ed with any adverse gross or histopathological findings. Overall, the study concluded that benzophenone-4 did not have significant toxic effects on the rats, as there were no adverse findings in the clinical examination or histopathological analysis. Therefore, the highest dose of 1239 mg/kg/day was taken as the NOAEL. (BASF AG 1996) SCCS comment Original study reports were not provided with the first submission, but the original study report of the 90-day repeat dose toxicity study was requested and received. A NOAEL of 1239 mg/kg/day was derived. The study report was not signed.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"Therefore, the highest dose of 1239 mg/kg/day was taken as the NOAEL.","duration":"90-day","effect":"ed with any adverse gross or histopathological findings. Overall, the study concluded that benzophenone-4 did not have significant toxic effects on the rats, as there were no adverse findings in the clinical examination or histopathological analysis. Therefore, the highest dose of 1239 mg/kg/day was taken as the NOAEL. (BASF AG 1996) SCCS comment Original study reports were not provided with the first submission, but the original study report of the 90-day repeat dose toxicity study was requested and received. A NOAEL of 1239 mg/kg/day was derived. The study report was not signed.","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1239","page":37,"route":"","species":"rat","study_id":"sccs_o_283_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 1250 | mg/kg/day | rat | - | - | - | SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=1250; DOSE=Based on the results reported, a NOAEL of 1250 mg/kg/day for male and female rats was considered.; EFFECT=l data showed no significant effects on T4, TSH, testosterone(males) and estradiol (females). No notable effects on organs or blood chemistry parameters were observed. Pregnancy rates, gestation length and litter size were not affected by treatment. No significant effects were seen on the number of live births, pup weight, pup survival or sex ratio. No test substance abnormalities were seen in pups. Special investigations on thyroid and parathyroid glands revealed no abnormalities. Based on the results reported, a NOAEL of 1250 mg/kg/day for male and female rats was considered. (Sustainability Support Services (Europe) AB 2018) SCCS comment The original study report was not provided with the initial submission, but was sent upon request. A number of deviations from OECD TG 422 were observed: - the study employed a dose volume of 2 ml/100g body weight, while the recommended guideline suggested using only 1 mg/100g body weight (with 2 ml being acceptable for aqueous solutions). Here corn oil has been used. - the report did not in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"Based on the results reported, a NOAEL of 1250 mg/kg/day for male and female rats was considered.","duration":"","effect":"l data showed no significant effects on T4, TSH, testosterone(males) and estradiol (females). No notable effects on organs or blood chemistry parameters were observed. Pregnancy rates, gestation length and litter size were not affected by treatment. No significant effects were seen on the number of live births, pup weight, pup survival or sex ratio. No test substance abnormalities were seen in pups. Special investigations on thyroid and parathyroid glands revealed no abnormalities. Based on the results reported, a NOAEL of 1250 mg/kg/day for male and female rats was considered. (Sustainability Support Services (Europe) AB 2018) SCCS comment The original study report was not provided with the initial submission, but was sent upon request. A number of deviations from OECD TG 422 were observed: - the study employed a dose volume of 2 ml/100g body weight, while the recommended guideline suggested using only 1 mg/100g body weight (with 2 ml being acceptable for aqueous solutions). Here corn oil has been used. - the report did not in","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1250","page":38,"route":"","species":"rat","study_id":"sccs_o_283_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 59 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=unclear:Unlabeled table on page 59: Product type | SED (mg/kg bw/day) | adjusted NOAEL (mg/kg bw/day) | MoS; DOSE=Product type | SED (mg/kg bw/day) | adjusted NOAEL (mg/kg bw/day) | MoS; EFFECT=Unlabeled table on page 59: Product type | SED (mg/kg bw/day) | adjusted NOAEL (mg/kg bw/day) | MoS; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"Product type | SED (mg/kg bw/day) | adjusted NOAEL (mg/kg bw/day) | MoS","duration":"","effect":"Unlabeled table on page 59: Product type | SED (mg/kg bw/day) | adjusted NOAEL (mg/kg bw/day) | MoS","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 59: Product type | SED (mg/kg bw/day) | adjusted NOAEL (mg/kg bw/day) | MoS","page":59,"route":"","species":"","study_id":"sccs_o_283_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 620 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=620; EFFECT=Unlabeled table on page 59: Sunscreen lotion | 0.069 | 620 | 8986; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 59: Sunscreen lotion | 0.069 | 620 | 8986","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"620","page":59,"route":"","species":"","study_id":"sccs_o_283_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 620 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=620; EFFECT=Unlabeled table on page 59: Face cream* | 0.006 | 620 | 103333; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 59: Face cream* | 0.006 | 620 | 103333","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"620","page":59,"route":"","species":"","study_id":"sccs_o_283_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 620 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=620; EFFECT=Unlabeled table on page 59: Hand cream* | 0.008 | 620 | 77500; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 59: Hand cream* | 0.008 | 620 | 77500","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"620","page":59,"route":"","species":"","study_id":"sccs_o_283_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 620 | - | - | dermal | - | - | SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=620; EFFECT=Unlabeled table on page 59: Dermal aggregate for leave-on and rinse-off products | 0.067 | 620 | 9254; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 59: Dermal aggregate for leave-on and rinse-off products | 0.067 | 620 | 9254","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"620","page":59,"route":"dermal","species":"","study_id":"sccs_o_283_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 620 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=620; EFFECT=Unlabeled table on page 59: Lip stick* | 0.045 | 620 | 13778; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 59: Lip stick* | 0.045 | 620 | 13778","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"620","page":59,"route":"","species":"","study_id":"sccs_o_283_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 620 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=620; EFFECT=Unlabeled table on page 59: Sunscreen propellant spray* | 0.088 | 620 | 7046; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 59: Sunscreen propellant spray* | 0.088 | 620 | 7046","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"620","page":59,"route":"","species":"","study_id":"sccs_o_283_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 620 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=620; EFFECT=Unlabeled table on page 59: Sunscreen pump spray | 0.001 | 620 | 620000; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 59: Sunscreen pump spray | 0.001 | 620 | 620000","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"620","page":59,"route":"","species":"","study_id":"sccs_o_283_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 1239 | mg/kg bw/day | rat | oral | 90-day | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=1239; DOSE=19 20 21 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4.; EFFECT=11 12 3.4.10.4 In vivo adverse effects on endocrine relevant endpoints 13 14 / 15 16 SCCS comment 17 Based on the various studies provided, it can be concluded that benzophenone-4 does not 18 demonstrate endocrine-disrupting properties. 19 20 21 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4. As point of departure for 24 risk assessment, a NOAEL of 1239 mg/kg bw/day, based on a 90-day oral repeated dose rat 25 study is used (see section 3.4.4.2). As no good oral absorption study for benzophenone-4 is 26 available, the default value of 50 % is used for the oral absorption, resulting in an adjusted 27 NOAEL of 620 mg/kg bw/day. Following MoS calculations for separate product types and 28 aggregated exposure can be calculated: 29 30 31 Product type SED (mg/kg bw/day) adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"19 20 21 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4.","duration":"90-day","effect":"11 12 3.4.10.4 In vivo adverse effects on endocrine relevant endpoints 13 14 / 15 16 SCCS comment 17 Based on the various studies provided, it can be concluded that benzophenone-4 does not 18 demonstrate endocrine-disrupting properties. 19 20 21 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4. As point of departure for 24 risk assessment, a NOAEL of 1239 mg/kg bw/day, based on a 90-day oral repeated dose rat 25 study is used (see section 3.4.4.2). As no good oral absorption study for benzophenone-4 is 26 available, the default value of 50 % is used for the oral absorption, resulting in an adjusted 27 NOAEL of 620 mg/kg bw/day. Following MoS calculations for separate product types and 28 aggregated exposure can be calculated: 29 30 31 Product type SED (mg/kg bw/day) adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1239","page":59,"route":"oral","species":"rat","study_id":"sccs_o_283_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 620 | mg/kg bw/day | rat | oral | 90-day | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=620; DOSE=LUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4.; EFFECT=LUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4. As point of departure for 24 risk assessment, a NOAEL of 1239 mg/kg bw/day, based on a 90-day oral repeated dose rat 25 study is used (see section 3.4.4.2). As no good oral absorption study for benzophenone-4 is 26 available, the default value of 50 % is used for the oral absorption, resulting in an adjusted 27 NOAEL of 620 mg/kg bw/day. Following MoS calculations for separate product types and 28 aggregated exposure can be calculated: 29 30 31 Product type SED (mg/kg bw/day) adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face cream* 0.006 620 103333 Hand cream* 0.008 620 77500 Dermal aggregate for leave-on and rinse-off products 0.067 620 9254 Oral exposure: Lip stick* 0.045 620 13778 Inhalatory exposure: Sunscreen propellant spray* 0.088 620 7046 Sunscreen pump spray 0.001 620 6; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"LUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4.","duration":"90-day","effect":"LUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4. As point of departure for 24 risk assessment, a NOAEL of 1239 mg/kg bw/day, based on a 90-day oral repeated dose rat 25 study is used (see section 3.4.4.2). As no good oral absorption study for benzophenone-4 is 26 available, the default value of 50 % is used for the oral absorption, resulting in an adjusted 27 NOAEL of 620 mg/kg bw/day. Following MoS calculations for separate product types and 28 aggregated exposure can be calculated: 29 30 31 Product type SED (mg/kg bw/day) adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face cream* 0.006 620 103333 Hand cream* 0.008 620 77500 Dermal aggregate for leave-on and rinse-off products 0.067 620 9254 Oral exposure: Lip stick* 0.045 620 13778 Inhalatory exposure: Sunscreen propellant spray* 0.088 620 7046 Sunscreen pump spray 0.001 620 6","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"620","page":59,"route":"oral","species":"rat","study_id":"sccs_o_283_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 620 | mg/kg bw/day | rat | oral | 90-day | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=620; DOSE=As point of departure for 24 risk assessment, a NOAEL of 1239 mg/kg bw/day, based on a 90-day oral repeated dose rat 25 study is used (see section 3.4.4.2).; EFFECT=described in section 3.2.4. As point of departure for 24 risk assessment, a NOAEL of 1239 mg/kg bw/day, based on a 90-day oral repeated dose rat 25 study is used (see section 3.4.4.2). As no good oral absorption study for benzophenone-4 is 26 available, the default value of 50 % is used for the oral absorption, resulting in an adjusted 27 NOAEL of 620 mg/kg bw/day. Following MoS calculations for separate product types and 28 aggregated exposure can be calculated: 29 30 31 Product type SED (mg/kg bw/day) adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face cream* 0.006 620 103333 Hand cream* 0.008 620 77500 Dermal aggregate for leave-on and rinse-off products 0.067 620 9254 Oral exposure: Lip stick* 0.045 620 13778 Inhalatory exposure: Sunscreen propellant spray* 0.088 620 7046 Sunscreen pump spray 0.001 620 620000 Overall aggregate* (deterministic) 0.147 620 4218 32 33 Considering the different cosmetic products either directly applied on the skin or by spray, at 34 the maximum conc; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"As point of departure for 24 risk assessment, a NOAEL of 1239 mg/kg bw/day, based on a 90-day oral repeated dose rat 25 study is used (see section 3.4.4.2).","duration":"90-day","effect":"described in section 3.2.4. As point of departure for 24 risk assessment, a NOAEL of 1239 mg/kg bw/day, based on a 90-day oral repeated dose rat 25 study is used (see section 3.4.4.2). As no good oral absorption study for benzophenone-4 is 26 available, the default value of 50 % is used for the oral absorption, resulting in an adjusted 27 NOAEL of 620 mg/kg bw/day. Following MoS calculations for separate product types and 28 aggregated exposure can be calculated: 29 30 31 Product type SED (mg/kg bw/day) adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face cream* 0.006 620 103333 Hand cream* 0.008 620 77500 Dermal aggregate for leave-on and rinse-off products 0.067 620 9254 Oral exposure: Lip stick* 0.045 620 13778 Inhalatory exposure: Sunscreen propellant spray* 0.088 620 7046 Sunscreen pump spray 0.001 620 620000 Overall aggregate* (deterministic) 0.147 620 4218 32 33 Considering the different cosmetic products either directly applied on the skin or by spray, at 34 the maximum conc","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"620","page":59,"route":"oral","species":"rat","study_id":"sccs_o_283_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 1239 | mg/kg bw/day | rat | oral | 90-day | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=1239; DOSE=223-772-2) _________________________________________________________________________________ ___________________________________________________________________________________________ 61 1 Repeated dose toxicity 2 From the 90-day repeat dose oral toxicity study in rats, a NOAEL of 1239 mg/kg bw/day could 3 be derived.; EFFECT=SCCS/1660/23 Final Opinion Opinion on benzophenone – 4 (CAS No. 4065-45-6, EC No. 223-772-2) _________________________________________________________________________________ ___________________________________________________________________________________________ 61 1 Repeated dose toxicity 2 From the 90-day repeat dose oral toxicity study in rats, a NOAEL of 1239 mg/kg bw/day could 3 be derived. 4 5 Reproductive toxicity 6 Subject to change whether a typo is present or not in the report of the conducted OECD TG 7 422 study, no treatment related changes were noted up to 1250 mg/kg bw /day. 8 9 Mutagenicity / genotoxicity 10 Benzophenone-4 has no in vitro genotoxic potential. 11 12 Carcinogenicity 13 No data. 14 15 Photo-induced toxicity 16 Benzophenone-4 is not phototoxic, not photosensitising, not photomutagenic and not 17 photoclastogenic. 18 19 Human data 20; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"223-772-2) _________________________________________________________________________________ ___________________________________________________________________________________________ 61 1 Repeated dose toxicity 2 From the 90-day repeat dose oral toxicity study in rats, a NOAEL of 1239 mg/kg bw/day could 3 be derived.","duration":"90-day","effect":"SCCS/1660/23 Final Opinion Opinion on benzophenone – 4 (CAS No. 4065-45-6, EC No. 223-772-2) _________________________________________________________________________________ ___________________________________________________________________________________________ 61 1 Repeated dose toxicity 2 From the 90-day repeat dose oral toxicity study in rats, a NOAEL of 1239 mg/kg bw/day could 3 be derived. 4 5 Reproductive toxicity 6 Subject to change whether a typo is present or not in the report of the conducted OECD TG 7 422 study, no treatment related changes were noted up to 1250 mg/kg bw /day. 8 9 Mutagenicity / genotoxicity 10 Benzophenone-4 has no in vitro genotoxic potential. 11 12 Carcinogenicity 13 No data. 14 15 Photo-induced toxicity 16 Benzophenone-4 is not phototoxic, not photosensitising, not photomutagenic and not 17 photoclastogenic. 18 19 Human data 20","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1239","page":61,"route":"oral","species":"rat","study_id":"sccs_o_283_noael_007"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 1W6L629B4K | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C14H12O6S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"1W6L629B4K"} |
| openFDA substances | FDA UNII substance identifier | 1W6L629B4K | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C14H12O6S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"1W6L629B4K"} |
| openFDA substances | FDA UNII substance identifier | 1W6L629B4K | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C14H12O6S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"1W6L629B4K"} |
| openFDA substances | FDA UNII substance identifier | 1W6L629B4K | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C14H12O6S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"1W6L629B4K"} |