NOAEL Studies
Cosmetic Ingredient
Camphor Benzalkonium Methosulfate NOAEL Studies
INCI: CAMPHOR BENZALKONIUM METHOSULFATE
CAS: 52793-97-2
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 | 300 | mg/kg bw/day | rat | oral | 90 day | Subchronic | SCCP; O. Boutherin-Falson. Mexoryl SO – 13 week oral (gavage) toxicity study in the rat followed by a 4 week treatment-free period. MDS Pharma Services Study No. AA21484, 2005 |
| COSMOS_DB | NOAEL | 100 | mg/kg bw/day | rat | oral | 90 day | Subchronic | SCCP; O. Boutherin-Falson. Mexoryl SO – 13 week oral (gavage) toxicity study in the rat followed by a 4 week treatment-free period. MDS Pharma Services Study No. AA21484, 2005 |
SCCS_vision_codex 36 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =300 | mg/kg/day | rat | oral | 13 weeks | NOAEL study | {"dose":"Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated.","effect":"y. A marked sex-related difference was observed in AUC values and was confirmed by Cmax values. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL) was considered to be 300 mg/kg/day. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL), was consi","page":13,"pdf":"sccp_o_080.pdf","row_type":"noael_study","study_id":"sccp_o_080_noael_001"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg/day | rat | - | developmental | developmental toxicity | {"citation":"Ref.: 19 3","dose":"tuses with other anomalies (i.e., slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls.","effect":"tuses with other anomalies (i.e., slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls. However, these slight changes did not indicate any adverse effects of Mexoryl SO, as the observed incidences were within the historical control values. Conclusion There were no teratogenic effects under the conditions of the study. For maternal toxicity, the No Adverse Effect Level (NOAEL) and the No Effect Level (NOEL) were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the No Effect Level (NOEL) was 1000 mg/kg/day in this study. Ref.: 19 3.3.9. Toxicokinetics See 3.3.5.2. toxicokinetics data in Sprague-Dawley rats.","page":17,"pdf":"sccp_o_080.pdf","row_type":"noael_study","study_id":"sccp_o_080_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.819 | mg/kg | rat | oral | 90-day | dermal absorption | {"citation":"(ref. 20)","dose":"CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding...","effect":"ating the Margin of Safety, the mean + 2 standard deviations of the dermal absorption through human dermatomed skin (ref. 20) is used. The maximum dermal absorption observed was 3.73 µg/cm²; it appears to be an outlier. CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding to 89.1 mg/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 3.3.14. Discussion Physico-chemical properties Camphor Benzalkonium Methosulphate is used up to a maximum concentration of 6.0% in sun screen formulations (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium","page":22,"pdf":"sccp_o_080.pdf","row_type":"noael_study","study_id":"sccp_o_080_noael_008"} |
| SCCS_vision_codex | NOAEL | =89.1 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding...","effect":"ed. The maximum dermal absorption observed was 3.73 µg/cm²; it appears to be an outlier. CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding to 89.1 mg/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 3.3.14. Discussion Physico-chemical properties Camphor Benzalkonium Methosulphate is used up to a maximum concentration of 6.0% in sun screen formulations (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw. In a 90-day study, the NOAEL was considered to be 300 mg/kg/day. For maternal toxicity, the NOAEL","page":22,"pdf":"sccp_o_080.pdf","row_type":"noael_study","study_id":"sccp_o_080_noael_009"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg/day | rat | oral | 13 weeks | genotoxicity | {"citation":"Ref.: 11 3","dose":"Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated.","effect":"y. A marked sex-related difference was observed in AUC values and was confirmed by Cmax values. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL), was considered to be 300 mg/kg/day. Ref.: 11 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 401 Species/strain Five strains of Salmonella typhimurium (TA 1535, TA 1537, TA 98, TA 100 and TA 102) Test substance: Mexoryl SO Batch: 0106845 (active ingredient content of 30.3%) Purity: / Concentration: 312.5, 625, 1250, 2500 and 5000 µg/plate both in the presence and","page":14,"pdf":"sccp_o_168.pdf","row_type":"noael_study","study_id":"sccp_o_168_noael_001"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg/day | rat | - | developmental | developmental toxicity | {"citation":"Ref.: 19 3","dose":"tuses with other anomalies (i.e., slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls.","effect":"tuses with other anomalies (i.e., slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls. However, these slight changes did not indicate any adverse effects of Mexoryl SO, as the observed incidences were within the historical control values. Conclusion There were no teratogenic effects under the conditions of the study. For maternal toxicity, the No Adverse Effect Level (NOAEL) and the No Effect Level (NOEL) were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the No Effect Level (NOEL) was 1000 mg/kg/day in this study. Ref.: 19 3.3.9. Toxicokinetics See 3.3.5.2. toxicokinetics data in Sprague-Dawley rats","page":18,"pdf":"sccp_o_168.pdf","row_type":"noael_study","study_id":"sccp_o_168_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.819 | mg/kg | rat | oral | 90-day | dermal absorption | {"citation":"(ref. 20)","dose":"CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (μg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding...","effect":"ating the Margin of Safety, the mean + 2 standard deviations of the dermal absorption through human dermatomed skin (ref. 20) is used. The maximum dermal absorption observed was 3.73 µg/cm²; it appears to be an outlier. CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (μg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding to 89.1 mg/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 * * The Margin of Safety has been calculated on the basis of the dermal absorption from a typical sunscreen formulation containing 6% Camphor Benzalkonium Methosulphate. No specific dermal absorption study has been performed with the 3% concentration; so a direct calculation of the MOS for a 3% concentration cannot be done. 3.3.14. Discussion In its previous opinion on c","page":22,"pdf":"sccp_o_168.pdf","row_type":"noael_study","study_id":"sccp_o_168_noael_006"} |
| SCCS_vision_codex | NOAEL | =89.1 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (μg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding...","effect":"ed. The maximum dermal absorption observed was 3.73 µg/cm²; it appears to be an outlier. CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (μg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding to 89.1 mg/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 * * The Margin of Safety has been calculated on the basis of the dermal absorption from a typical sunscreen formulation containing 6% Camphor Benzalkonium Methosulphate. No specific dermal absorption study has been performed with the 3% concentration; so a direct calculation of the MOS for a 3% concentration cannot be done. 3.3.14. Discussion In its previous opinion on camphor benzalkonium methosulphate as a UV-filter, the SCCP stated that the use at a maximum concentration of 6.0% in the cosmetic s","page":22,"pdf":"sccp_o_168.pdf","row_type":"noael_study","study_id":"sccp_o_168_noael_007"} |
| SCCS_vision_codex | NOAEL | =3 | % | - | dermal | - | dermal absorption | {"effect":"ting a new dermal absorption study. For dermal absorption, a linear extrapolation from 6.0 to 3.0% cannot be made. Therefore, no MOS for the 3% concentration can be calculated. However, as the skin absorption of a substance decrease when the applied concentration is lowered, the amount absorbed from a 3% concentration would decrease in comparison to the 6% concentration. Taking into account the decreased absorption at lower concentration and considering the fact that the MoS calculation was based on a conservative NOAEL (local effects in the GI tract), the use of camphor benzalkonium methosulfate at the reduced maximum concentration of 3% in the final products may be considered as safe for all types of cosmetic products. Camphor benzalkonium methosulfate (Mexoryl SO ; S57) is irritating to the eyes at the concentration of 6%. No study of eye irritation has been conducted with a 3% concentration","page":22,"pdf":"sccp_o_168.pdf","row_type":"noael_study","study_id":"sccp_o_168_noael_008"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg/day | rat | oral | 13 weeks | NOAEL study | {"dose":"Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated.","effect":"y. A marked sex-related difference was observed in AUC values and was confirmed by Cmax values. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL) was considered to be 300 mg/kg/day. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL), was consi","page":13,"pdf":"sccp_o_080.pdf","row_type":"noael_study","study_id":"sccp_o_080_noael_001"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg/day | rat | - | developmental | developmental toxicity | {"citation":"Ref.: 19 3","dose":"tuses with other anomalies (i.e., slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls.","effect":"tuses with other anomalies (i.e., slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls. However, these slight changes did not indicate any adverse effects of Mexoryl SO, as the observed incidences were within the historical control values. Conclusion There were no teratogenic effects under the conditions of the study. For maternal toxicity, the No Adverse Effect Level (NOAEL) and the No Effect Level (NOEL) were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the No Effect Level (NOEL) was 1000 mg/kg/day in this study. Ref.: 19 3.3.9. Toxicokinetics See 3.3.5.2. toxicokinetics data in Sprague-Dawley rats.","page":17,"pdf":"sccp_o_080.pdf","row_type":"noael_study","study_id":"sccp_o_080_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.819 | mg/kg | rat | oral | 90-day | dermal absorption | {"citation":"(ref. 20)","dose":"CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding...","effect":"ating the Margin of Safety, the mean + 2 standard deviations of the dermal absorption through human dermatomed skin (ref. 20) is used. The maximum dermal absorption observed was 3.73 µg/cm²; it appears to be an outlier. CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding to 89.1 mg/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 3.3.14. Discussion Physico-chemical properties Camphor Benzalkonium Methosulphate is used up to a maximum concentration of 6.0% in sun screen formulations (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium","page":22,"pdf":"sccp_o_080.pdf","row_type":"noael_study","study_id":"sccp_o_080_noael_008"} |
| SCCS_vision_codex | NOAEL | =89.1 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding...","effect":"ed. The maximum dermal absorption observed was 3.73 µg/cm²; it appears to be an outlier. CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding to 89.1 mg/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 3.3.14. Discussion Physico-chemical properties Camphor Benzalkonium Methosulphate is used up to a maximum concentration of 6.0% in sun screen formulations (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw. In a 90-day study, the NOAEL was considered to be 300 mg/kg/day. For maternal toxicity, the NOAEL","page":22,"pdf":"sccp_o_080.pdf","row_type":"noael_study","study_id":"sccp_o_080_noael_009"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg/day | rat | oral | 13 weeks | NOAEL study | {"dose":"Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated.","effect":"y. A marked sex-related difference was observed in AUC values and was confirmed by Cmax values. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL) was considered to be 300 mg/kg/day. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL), was consi","page":13,"pdf":"sccp_o_080.pdf","row_type":"noael_study","study_id":"sccp_o_080_noael_001"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg/day | rat | - | developmental | developmental toxicity | {"citation":"Ref.: 19 3","dose":"tuses with other anomalies (i.e., slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls.","effect":"tuses with other anomalies (i.e., slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls. However, these slight changes did not indicate any adverse effects of Mexoryl SO, as the observed incidences were within the historical control values. Conclusion There were no teratogenic effects under the conditions of the study. For maternal toxicity, the No Adverse Effect Level (NOAEL) and the No Effect Level (NOEL) were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the No Effect Level (NOEL) was 1000 mg/kg/day in this study. Ref.: 19 3.3.9. Toxicokinetics See 3.3.5.2. toxicokinetics data in Sprague-Dawley rats.","page":17,"pdf":"sccp_o_080.pdf","row_type":"noael_study","study_id":"sccp_o_080_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.819 | mg/kg | rat | oral | 90-day | dermal absorption | {"citation":"(ref. 20)","dose":"CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding...","effect":"ating the Margin of Safety, the mean + 2 standard deviations of the dermal absorption through human dermatomed skin (ref. 20) is used. The maximum dermal absorption observed was 3.73 µg/cm²; it appears to be an outlier. CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding to 89.1 mg/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 3.3.14. Discussion Physico-chemical properties Camphor Benzalkonium Methosulphate is used up to a maximum concentration of 6.0% in sun screen formulations (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium","page":22,"pdf":"sccp_o_080.pdf","row_type":"noael_study","study_id":"sccp_o_080_noael_008"} |
| SCCS_vision_codex | NOAEL | =89.1 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding...","effect":"ed. The maximum dermal absorption observed was 3.73 µg/cm²; it appears to be an outlier. CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding to 89.1 mg/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 3.3.14. Discussion Physico-chemical properties Camphor Benzalkonium Methosulphate is used up to a maximum concentration of 6.0% in sun screen formulations (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw. In a 90-day study, the NOAEL was considered to be 300 mg/kg/day. For maternal toxicity, the NOAEL","page":22,"pdf":"sccp_o_080.pdf","row_type":"noael_study","study_id":"sccp_o_080_noael_009"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg/day | rat | oral | 13 weeks | genotoxicity | {"citation":"Ref.: 11 3","dose":"Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated.","effect":"y. A marked sex-related difference was observed in AUC values and was confirmed by Cmax values. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL), was considered to be 300 mg/kg/day. Ref.: 11 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 401 Species/strain Five strains of Salmonella typhimurium (TA 1535, TA 1537, TA 98, TA 100 and TA 102) Test substance: Mexoryl SO Batch: 0106845 (active ingredient content of 30.3%) Purity: / Concentration: 312.5, 625, 1250, 2500 and 5000 µg/plate both in the presence and","page":14,"pdf":"sccp_o_168.pdf","row_type":"noael_study","study_id":"sccp_o_168_noael_001"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg/day | rat | - | developmental | developmental toxicity | {"citation":"Ref.: 19 3","dose":"tuses with other anomalies (i.e., slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls.","effect":"tuses with other anomalies (i.e., slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls. However, these slight changes did not indicate any adverse effects of Mexoryl SO, as the observed incidences were within the historical control values. Conclusion There were no teratogenic effects under the conditions of the study. For maternal toxicity, the No Adverse Effect Level (NOAEL) and the No Effect Level (NOEL) were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the No Effect Level (NOEL) was 1000 mg/kg/day in this study. Ref.: 19 3.3.9. Toxicokinetics See 3.3.5.2. toxicokinetics data in Sprague-Dawley rats","page":18,"pdf":"sccp_o_168.pdf","row_type":"noael_study","study_id":"sccp_o_168_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.819 | mg/kg | rat | oral | 90-day | dermal absorption | {"citation":"(ref. 20)","dose":"CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (μg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding...","effect":"ating the Margin of Safety, the mean + 2 standard deviations of the dermal absorption through human dermatomed skin (ref. 20) is used. The maximum dermal absorption observed was 3.73 µg/cm²; it appears to be an outlier. CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (μg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding to 89.1 mg/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 * * The Margin of Safety has been calculated on the basis of the dermal absorption from a typical sunscreen formulation containing 6% Camphor Benzalkonium Methosulphate. No specific dermal absorption study has been performed with the 3% concentration; so a direct calculation of the MOS for a 3% concentration cannot be done. 3.3.14. Discussion In its previous opinion on c","page":22,"pdf":"sccp_o_168.pdf","row_type":"noael_study","study_id":"sccp_o_168_noael_006"} |
| SCCS_vision_codex | NOAEL | =89.1 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (μg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding...","effect":"ed. The maximum dermal absorption observed was 3.73 µg/cm²; it appears to be an outlier. CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (μg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding to 89.1 mg/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 * * The Margin of Safety has been calculated on the basis of the dermal absorption from a typical sunscreen formulation containing 6% Camphor Benzalkonium Methosulphate. No specific dermal absorption study has been performed with the 3% concentration; so a direct calculation of the MOS for a 3% concentration cannot be done. 3.3.14. Discussion In its previous opinion on camphor benzalkonium methosulphate as a UV-filter, the SCCP stated that the use at a maximum concentration of 6.0% in the cosmetic s","page":22,"pdf":"sccp_o_168.pdf","row_type":"noael_study","study_id":"sccp_o_168_noael_007"} |
| SCCS_vision_codex | NOAEL | =3 | % | - | dermal | - | dermal absorption | {"effect":"ting a new dermal absorption study. For dermal absorption, a linear extrapolation from 6.0 to 3.0% cannot be made. Therefore, no MOS for the 3% concentration can be calculated. However, as the skin absorption of a substance decrease when the applied concentration is lowered, the amount absorbed from a 3% concentration would decrease in comparison to the 6% concentration. Taking into account the decreased absorption at lower concentration and considering the fact that the MoS calculation was based on a conservative NOAEL (local effects in the GI tract), the use of camphor benzalkonium methosulfate at the reduced maximum concentration of 3% in the final products may be considered as safe for all types of cosmetic products. Camphor benzalkonium methosulfate (Mexoryl SO ; S57) is irritating to the eyes at the concentration of 6%. No study of eye irritation has been conducted with a 3% concentration","page":22,"pdf":"sccp_o_168.pdf","row_type":"noael_study","study_id":"sccp_o_168_noael_008"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg/day | rat | oral | 13 weeks | genotoxicity | {"citation":"Ref.: 11 3","dose":"Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated.","effect":"y. A marked sex-related difference was observed in AUC values and was confirmed by Cmax values. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL), was considered to be 300 mg/kg/day. Ref.: 11 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 401 Species/strain Five strains of Salmonella typhimurium (TA 1535, TA 1537, TA 98, TA 100 and TA 102) Test substance: Mexoryl SO Batch: 0106845 (active ingredient content of 30.3%) Purity: / Concentration: 312.5, 625, 1250, 2500 and 5000 µg/plate both in the presence and","page":14,"pdf":"sccp_o_168.pdf","row_type":"noael_study","study_id":"sccp_o_168_noael_001"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg/day | rat | - | developmental | developmental toxicity | {"citation":"Ref.: 19 3","dose":"tuses with other anomalies (i.e., slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls.","effect":"tuses with other anomalies (i.e., slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls. However, these slight changes did not indicate any adverse effects of Mexoryl SO, as the observed incidences were within the historical control values. Conclusion There were no teratogenic effects under the conditions of the study. For maternal toxicity, the No Adverse Effect Level (NOAEL) and the No Effect Level (NOEL) were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the No Effect Level (NOEL) was 1000 mg/kg/day in this study. Ref.: 19 3.3.9. Toxicokinetics See 3.3.5.2. toxicokinetics data in Sprague-Dawley rats","page":18,"pdf":"sccp_o_168.pdf","row_type":"noael_study","study_id":"sccp_o_168_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.819 | mg/kg | rat | oral | 90-day | dermal absorption | {"citation":"(ref. 20)","dose":"CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (μg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding...","effect":"ating the Margin of Safety, the mean + 2 standard deviations of the dermal absorption through human dermatomed skin (ref. 20) is used. The maximum dermal absorption observed was 3.73 µg/cm²; it appears to be an outlier. CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (μg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding to 89.1 mg/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 * * The Margin of Safety has been calculated on the basis of the dermal absorption from a typical sunscreen formulation containing 6% Camphor Benzalkonium Methosulphate. No specific dermal absorption study has been performed with the 3% concentration; so a direct calculation of the MOS for a 3% concentration cannot be done. 3.3.14. Discussion In its previous opinion on c","page":22,"pdf":"sccp_o_168.pdf","row_type":"noael_study","study_id":"sccp_o_168_noael_006"} |
| SCCS_vision_codex | NOAEL | =89.1 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (μg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding...","effect":"ed. The maximum dermal absorption observed was 3.73 µg/cm²; it appears to be an outlier. CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (μg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding to 89.1 mg/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 * * The Margin of Safety has been calculated on the basis of the dermal absorption from a typical sunscreen formulation containing 6% Camphor Benzalkonium Methosulphate. No specific dermal absorption study has been performed with the 3% concentration; so a direct calculation of the MOS for a 3% concentration cannot be done. 3.3.14. Discussion In its previous opinion on camphor benzalkonium methosulphate as a UV-filter, the SCCP stated that the use at a maximum concentration of 6.0% in the cosmetic s","page":22,"pdf":"sccp_o_168.pdf","row_type":"noael_study","study_id":"sccp_o_168_noael_007"} |
| SCCS_vision_codex | NOAEL | =3 | % | - | dermal | - | dermal absorption | {"effect":"ting a new dermal absorption study. For dermal absorption, a linear extrapolation from 6.0 to 3.0% cannot be made. Therefore, no MOS for the 3% concentration can be calculated. However, as the skin absorption of a substance decrease when the applied concentration is lowered, the amount absorbed from a 3% concentration would decrease in comparison to the 6% concentration. Taking into account the decreased absorption at lower concentration and considering the fact that the MoS calculation was based on a conservative NOAEL (local effects in the GI tract), the use of camphor benzalkonium methosulfate at the reduced maximum concentration of 3% in the final products may be considered as safe for all types of cosmetic products. Camphor benzalkonium methosulfate (Mexoryl SO ; S57) is irritating to the eyes at the concentration of 6%. No study of eye irritation has been conducted with a 3% concentration","page":22,"pdf":"sccp_o_168.pdf","row_type":"noael_study","study_id":"sccp_o_168_noael_008"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg/day | rat | oral | 13 weeks | NOAEL study | {"dose":"Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated.","effect":"y. A marked sex-related difference was observed in AUC values and was confirmed by Cmax values. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL) was considered to be 300 mg/kg/day. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL), was consi","page":13,"pdf":"sccp_o_080.pdf","row_type":"noael_study","study_id":"sccp_o_080_noael_001"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg/day | rat | - | developmental | developmental toxicity | {"citation":"Ref.: 19 3","dose":"tuses with other anomalies (i.e., slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls.","effect":"tuses with other anomalies (i.e., slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls. However, these slight changes did not indicate any adverse effects of Mexoryl SO, as the observed incidences were within the historical control values. Conclusion There were no teratogenic effects under the conditions of the study. For maternal toxicity, the No Adverse Effect Level (NOAEL) and the No Effect Level (NOEL) were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the No Effect Level (NOEL) was 1000 mg/kg/day in this study. Ref.: 19 3.3.9. Toxicokinetics See 3.3.5.2. toxicokinetics data in Sprague-Dawley rats.","page":17,"pdf":"sccp_o_080.pdf","row_type":"noael_study","study_id":"sccp_o_080_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.819 | mg/kg | rat | oral | 90-day | dermal absorption | {"citation":"(ref. 20)","dose":"CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding...","effect":"ating the Margin of Safety, the mean + 2 standard deviations of the dermal absorption through human dermatomed skin (ref. 20) is used. The maximum dermal absorption observed was 3.73 µg/cm²; it appears to be an outlier. CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding to 89.1 mg/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 3.3.14. Discussion Physico-chemical properties Camphor Benzalkonium Methosulphate is used up to a maximum concentration of 6.0% in sun screen formulations (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium","page":22,"pdf":"sccp_o_080.pdf","row_type":"noael_study","study_id":"sccp_o_080_noael_008"} |
| SCCS_vision_codex | NOAEL | =89.1 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding...","effect":"ed. The maximum dermal absorption observed was 3.73 µg/cm²; it appears to be an outlier. CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding to 89.1 mg/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 3.3.14. Discussion Physico-chemical properties Camphor Benzalkonium Methosulphate is used up to a maximum concentration of 6.0% in sun screen formulations (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw. In a 90-day study, the NOAEL was considered to be 300 mg/kg/day. For maternal toxicity, the NOAEL","page":22,"pdf":"sccp_o_080.pdf","row_type":"noael_study","study_id":"sccp_o_080_noael_009"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg/day | rat | oral | 13 weeks | genotoxicity | {"citation":"Ref.: 11 3","dose":"Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated.","effect":"y. A marked sex-related difference was observed in AUC values and was confirmed by Cmax values. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL), was considered to be 300 mg/kg/day. Ref.: 11 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 401 Species/strain Five strains of Salmonella typhimurium (TA 1535, TA 1537, TA 98, TA 100 and TA 102) Test substance: Mexoryl SO Batch: 0106845 (active ingredient content of 30.3%) Purity: / Concentration: 312.5, 625, 1250, 2500 and 5000 µg/plate both in the presence and","page":14,"pdf":"sccp_o_168.pdf","row_type":"noael_study","study_id":"sccp_o_168_noael_001"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg/day | rat | - | developmental | developmental toxicity | {"citation":"Ref.: 19 3","dose":"tuses with other anomalies (i.e., slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls.","effect":"tuses with other anomalies (i.e., slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls. However, these slight changes did not indicate any adverse effects of Mexoryl SO, as the observed incidences were within the historical control values. Conclusion There were no teratogenic effects under the conditions of the study. For maternal toxicity, the No Adverse Effect Level (NOAEL) and the No Effect Level (NOEL) were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the No Effect Level (NOEL) was 1000 mg/kg/day in this study. Ref.: 19 3.3.9. Toxicokinetics See 3.3.5.2. toxicokinetics data in Sprague-Dawley rats","page":18,"pdf":"sccp_o_168.pdf","row_type":"noael_study","study_id":"sccp_o_168_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.819 | mg/kg | rat | oral | 90-day | dermal absorption | {"citation":"(ref. 20)","dose":"CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (μg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding...","effect":"ating the Margin of Safety, the mean + 2 standard deviations of the dermal absorption through human dermatomed skin (ref. 20) is used. The maximum dermal absorption observed was 3.73 µg/cm²; it appears to be an outlier. CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (μg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding to 89.1 mg/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 * * The Margin of Safety has been calculated on the basis of the dermal absorption from a typical sunscreen formulation containing 6% Camphor Benzalkonium Methosulphate. No specific dermal absorption study has been performed with the 3% concentration; so a direct calculation of the MOS for a 3% concentration cannot be done. 3.3.14. Discussion In its previous opinion on c","page":22,"pdf":"sccp_o_168.pdf","row_type":"noael_study","study_id":"sccp_o_168_noael_006"} |
| SCCS_vision_codex | NOAEL | =89.1 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (μg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding...","effect":"ed. The maximum dermal absorption observed was 3.73 µg/cm²; it appears to be an outlier. CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (μg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding to 89.1 mg/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 * * The Margin of Safety has been calculated on the basis of the dermal absorption from a typical sunscreen formulation containing 6% Camphor Benzalkonium Methosulphate. No specific dermal absorption study has been performed with the 3% concentration; so a direct calculation of the MOS for a 3% concentration cannot be done. 3.3.14. Discussion In its previous opinion on camphor benzalkonium methosulphate as a UV-filter, the SCCP stated that the use at a maximum concentration of 6.0% in the cosmetic s","page":22,"pdf":"sccp_o_168.pdf","row_type":"noael_study","study_id":"sccp_o_168_noael_007"} |
| SCCS_vision_codex | NOAEL | =3 | % | - | dermal | - | dermal absorption | {"effect":"ting a new dermal absorption study. For dermal absorption, a linear extrapolation from 6.0 to 3.0% cannot be made. Therefore, no MOS for the 3% concentration can be calculated. However, as the skin absorption of a substance decrease when the applied concentration is lowered, the amount absorbed from a 3% concentration would decrease in comparison to the 6% concentration. Taking into account the decreased absorption at lower concentration and considering the fact that the MoS calculation was based on a conservative NOAEL (local effects in the GI tract), the use of camphor benzalkonium methosulfate at the reduced maximum concentration of 3% in the final products may be considered as safe for all types of cosmetic products. Camphor benzalkonium methosulfate (Mexoryl SO ; S57) is irritating to the eyes at the concentration of 6%. No study of eye irritation has been conducted with a 3% concentration","page":22,"pdf":"sccp_o_168.pdf","row_type":"noael_study","study_id":"sccp_o_168_noael_008"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 25 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 300 | mg/kg/day | rat | oral | 13 weeks | - | SOURCE_SUBDIR=sccp_o_080; REPORT_TITLE=OPINION ON CAMPHOR BENZALKONIUM METHOSULFATE COLIPA n° S57; OPINION_NUMBER=SCCP/1015/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=300; DOSE=Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated.; EFFECT=y. A marked sex-related difference was observed in AUC values and was confirmed by Cmax values. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL) was considered to be 300 mg/kg/day. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL), was consi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"52793-97-2","citation":"","dose":"Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated.","duration":"13 weeks","effect":"y. A marked sex-related difference was observed in AUC values and was confirmed by Cmax values. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL) was considered to be 300 mg/kg/day. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL), was consi","endpoint":"","ingredient":"Camphor benzalkonium methosulfate (INCI name)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"300","page":13,"route":"oral","species":"rat","study_id":"sccp_o_080_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 300 | mg/kg/day | rat | oral | 13 weeks | - | SOURCE_SUBDIR=sccp_o_080; REPORT_TITLE=OPINION ON CAMPHOR BENZALKONIUM METHOSULFATE COLIPA n° S57; OPINION_NUMBER=SCCP/1015/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=300; DOSE=Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated.; EFFECT=was observed in AUC values and was confirmed by Cmax values. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL) was considered to be 300 mg/kg/day. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL), was considered t; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"52793-97-2","citation":"","dose":"Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated.","duration":"13 weeks","effect":"was observed in AUC values and was confirmed by Cmax values. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL) was considered to be 300 mg/kg/day. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL), was considered t","endpoint":"","ingredient":"Camphor benzalkonium methosulfate (INCI name)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"300","page":13,"route":"oral","species":"rat","study_id":"sccp_o_080_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.819 | mg/kg | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccp_o_080; REPORT_TITLE=OPINION ON CAMPHOR BENZALKONIUM METHOSULFATE COLIPA n° S57; OPINION_NUMBER=SCCP/1015/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT== 0.819; DOSE=CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding...; EFFECT=ating the Margin of Safety, the mean + 2 standard deviations of the dermal absorption through human dermatomed skin (ref. 20) is used. The maximum dermal absorption observed was 3.73 µg/cm²; it appears to be an outlier. CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding to 89.1 mg/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 3.3.14. Discussion Physico-chemical properties Camphor Benzalkonium Methosulphate is used up to a maximum concentration of 6.0% in sun screen formulations (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium; CITATION=(ref. 20); CITATION_NUMBERS=[20]; REFERENCE=(ref. 20); DETAILS_JSON={"cas_number":"52793-97-2","citation":"(ref. 20)","dose":"CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding...","duration":"90-day","effect":"ating the Margin of Safety, the mean + 2 standard deviations of the dermal absorption through human dermatomed skin (ref. 20) is used. The maximum dermal absorption observed was 3.73 µg/cm²; it appears to be an outlier. CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding to 89.1 mg/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 3.3.14. Discussion Physico-chemical properties Camphor Benzalkonium Methosulphate is used up to a maximum concentration of 6.0% in sun screen formulations (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium","endpoint":"dermal absorption","ingredient":"Camphor benzalkonium methosulfate (INCI name)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.819","page":22,"route":"oral","species":"rat","study_id":"sccp_o_080_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =89.1 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccp_o_080; REPORT_TITLE=OPINION ON CAMPHOR BENZALKONIUM METHOSULFATE COLIPA n° S57; OPINION_NUMBER=SCCP/1015/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT== 89.1; DOSE=CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding...; EFFECT=ed. The maximum dermal absorption observed was 3.73 µg/cm²; it appears to be an outlier. CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding to 89.1 mg/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 3.3.14. Discussion Physico-chemical properties Camphor Benzalkonium Methosulphate is used up to a maximum concentration of 6.0% in sun screen formulations (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw. In a 90-day study, the NOAEL was considered to be 300 mg/kg/day. For maternal toxicity, the NOAEL; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"52793-97-2","citation":"","dose":"CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding...","duration":"90-day","effect":"ed. The maximum dermal absorption observed was 3.73 µg/cm²; it appears to be an outlier. CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding to 89.1 mg/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 3.3.14. Discussion Physico-chemical properties Camphor Benzalkonium Methosulphate is used up to a maximum concentration of 6.0% in sun screen formulations (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw. In a 90-day study, the NOAEL was considered to be 300 mg/kg/day. For maternal toxicity, the NOAEL","endpoint":"dermal absorption","ingredient":"Camphor benzalkonium methosulfate (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 89.1","page":22,"route":"oral","species":"rat","study_id":"sccp_o_080_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.819 | mg/kg | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccp_o_168; REPORT_TITLE=OPINION ON Camphor benzalkonium methosulfate COLIPA n° S57; OPINION_NUMBER=SCCP/1202/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT== 0.819; DOSE=CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (μg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding...; EFFECT=ating the Margin of Safety, the mean + 2 standard deviations of the dermal absorption through human dermatomed skin (ref. 20) is used. The maximum dermal absorption observed was 3.73 µg/cm²; it appears to be an outlier. CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (μg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding to 89.1 mg/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 * * The Margin of Safety has been calculated on the basis of the dermal absorption from a typical sunscreen formulation containing 6% Camphor Benzalkonium Methosulphate. No specific dermal absorption study has been performed with the 3% concentration; so a direct calculation of the MOS for a 3% concentration cannot be done. 3.3.14. Discussion In its previous opinion on c; CITATION=(ref. 20); CITATION_NUMBERS=[20]; REFERENCE=(ref. 20); DETAILS_JSON={"cas_number":"52793-97-2","citation":"(ref. 20)","dose":"CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (μg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding...","duration":"90-day","effect":"ating the Margin of Safety, the mean + 2 standard deviations of the dermal absorption through human dermatomed skin (ref. 20) is used. The maximum dermal absorption observed was 3.73 µg/cm²; it appears to be an outlier. CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (μg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding to 89.1 mg/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 * * The Margin of Safety has been calculated on the basis of the dermal absorption from a typical sunscreen formulation containing 6% Camphor Benzalkonium Methosulphate. No specific dermal absorption study has been performed with the 3% concentration; so a direct calculation of the MOS for a 3% concentration cannot be done. 3.3.14. Discussion In its previous opinion on c","endpoint":"dermal absorption","ingredient":"name N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulphate","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.819","page":22,"route":"oral","species":"rat","study_id":"sccp_o_168_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =89.1 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccp_o_168; REPORT_TITLE=OPINION ON Camphor benzalkonium methosulfate COLIPA n° S57; OPINION_NUMBER=SCCP/1202/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT== 89.1; DOSE=CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (μg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding...; EFFECT=ed. The maximum dermal absorption observed was 3.73 µg/cm²; it appears to be an outlier. CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (μg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding to 89.1 mg/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 * * The Margin of Safety has been calculated on the basis of the dermal absorption from a typical sunscreen formulation containing 6% Camphor Benzalkonium Methosulphate. No specific dermal absorption study has been performed with the 3% concentration; so a direct calculation of the MOS for a 3% concentration cannot be done. 3.3.14. Discussion In its previous opinion on camphor benzalkonium methosulphate as a UV-filter, the SCCP stated that the use at a maximum concentration of 6.0% in the cosmetic s; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"52793-97-2","citation":"","dose":"CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (μg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding...","duration":"90-day","effect":"ed. The maximum dermal absorption observed was 3.73 µg/cm²; it appears to be an outlier. CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (μg/cm2) = 2.73 µg/cm² Skin Area surface SAS (cm2) = 18000 cm2 Dermal absorption per treatment SAS x A x 0.001 = 49.14 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.819 mg/kg NOAEL (rat, 90-day, oral) of 300 mg/kg corresponding to 89.1 mg/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 * * The Margin of Safety has been calculated on the basis of the dermal absorption from a typical sunscreen formulation containing 6% Camphor Benzalkonium Methosulphate. No specific dermal absorption study has been performed with the 3% concentration; so a direct calculation of the MOS for a 3% concentration cannot be done. 3.3.14. Discussion In its previous opinion on camphor benzalkonium methosulphate as a UV-filter, the SCCP stated that the use at a maximum concentration of 6.0% in the cosmetic s","endpoint":"dermal absorption","ingredient":"name N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulphate","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 89.1","page":22,"route":"oral","species":"rat","study_id":"sccp_o_168_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | 3 | % | - | dermal | - | dermal absorption | SOURCE_SUBDIR=sccp_o_168; REPORT_TITLE=OPINION ON Camphor benzalkonium methosulfate COLIPA n° S57; OPINION_NUMBER=SCCP/1202/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=3; EFFECT=ting a new dermal absorption study. For dermal absorption, a linear extrapolation from 6.0 to 3.0% cannot be made. Therefore, no MOS for the 3% concentration can be calculated. However, as the skin absorption of a substance decrease when the applied concentration is lowered, the amount absorbed from a 3% concentration would decrease in comparison to the 6% concentration. Taking into account the decreased absorption at lower concentration and considering the fact that the MoS calculation was based on a conservative NOAEL (local effects in the GI tract), the use of camphor benzalkonium methosulfate at the reduced maximum concentration of 3% in the final products may be considered as safe for all types of cosmetic products. Camphor benzalkonium methosulfate (Mexoryl SO ; S57) is irritating to the eyes at the concentration of 6%. No study of eye irritation has been conducted with a 3% concentration; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"52793-97-2","citation":"","dose":"","duration":"","effect":"ting a new dermal absorption study. For dermal absorption, a linear extrapolation from 6.0 to 3.0% cannot be made. Therefore, no MOS for the 3% concentration can be calculated. However, as the skin absorption of a substance decrease when the applied concentration is lowered, the amount absorbed from a 3% concentration would decrease in comparison to the 6% concentration. Taking into account the decreased absorption at lower concentration and considering the fact that the MoS calculation was based on a conservative NOAEL (local effects in the GI tract), the use of camphor benzalkonium methosulfate at the reduced maximum concentration of 3% in the final products may be considered as safe for all types of cosmetic products. Camphor benzalkonium methosulfate (Mexoryl SO ; S57) is irritating to the eyes at the concentration of 6%. No study of eye irritation has been conducted with a 3% concentration","endpoint":"dermal absorption","ingredient":"name N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulphate","loael_value":"","noael_unit":"%","noael_value":"3","page":22,"route":"dermal","species":"","study_id":"sccp_o_168_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1000 | mg/kg/day | rat | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_080; REPORT_TITLE=OPINION ON CAMPHOR BENZALKONIUM METHOSULFATE COLIPA n° S57; OPINION_NUMBER=SCCP/1015/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=1000; DOSE=tuses with other anomalies (i.e., slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls.; EFFECT=tuses with other anomalies (i.e., slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls. However, these slight changes did not indicate any adverse effects of Mexoryl SO, as the observed incidences were within the historical control values. Conclusion There were no teratogenic effects under the conditions of the study. For maternal toxicity, the No Adverse Effect Level (NOAEL) and the No Effect Level (NOEL) were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the No Effect Level (NOEL) was 1000 mg/kg/day in this study. Ref.: 19 3.3.9. Toxicokinetics See 3.3.5.2. toxicokinetics data in Sprague-Dawley rats.; CITATION=Ref.: 19 3; CITATION_NUMBERS=[19,3]; REFERENCE=Ref.: 19 3; DETAILS_JSON={"cas_number":"52793-97-2","citation":"Ref.: 19 3","dose":"tuses with other anomalies (i.e., slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls.","duration":"developmental","effect":"tuses with other anomalies (i.e., slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls. However, these slight changes did not indicate any adverse effects of Mexoryl SO, as the observed incidences were within the historical control values. Conclusion There were no teratogenic effects under the conditions of the study. For maternal toxicity, the No Adverse Effect Level (NOAEL) and the No Effect Level (NOEL) were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the No Effect Level (NOEL) was 1000 mg/kg/day in this study. Ref.: 19 3.3.9. Toxicokinetics See 3.3.5.2. toxicokinetics data in Sprague-Dawley rats.","endpoint":"developmental toxicity","ingredient":"Camphor benzalkonium methosulfate (INCI name)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":17,"route":"","species":"rat","study_id":"sccp_o_080_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1000 | mg/kg/day | rat | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_080; REPORT_TITLE=OPINION ON CAMPHOR BENZALKONIUM METHOSULFATE COLIPA n° S57; OPINION_NUMBER=SCCP/1015/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=1000; DOSE=, slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls.; EFFECT=, slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls. However, these slight changes did not indicate any adverse effects of Mexoryl SO, as the observed incidences were within the historical control values. Conclusion There were no teratogenic effects under the conditions of the study. For maternal toxicity, the No Adverse Effect Level (NOAEL) and the No Effect Level (NOEL) were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the No Effect Level (NOEL) was 1000 mg/kg/day in this study. Ref.: 19 3.3.9. Toxicokinetics See 3.3.5.2. toxicokinetics data in Sprague-Dawley rats.; CITATION=Ref.: 19 3; CITATION_NUMBERS=[19,3]; REFERENCE=Ref.: 19 3; DETAILS_JSON={"cas_number":"52793-97-2","citation":"Ref.: 19 3","dose":", slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls.","duration":"developmental","effect":", slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls. However, these slight changes did not indicate any adverse effects of Mexoryl SO, as the observed incidences were within the historical control values. Conclusion There were no teratogenic effects under the conditions of the study. For maternal toxicity, the No Adverse Effect Level (NOAEL) and the No Effect Level (NOEL) were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the No Effect Level (NOEL) was 1000 mg/kg/day in this study. Ref.: 19 3.3.9. Toxicokinetics See 3.3.5.2. toxicokinetics data in Sprague-Dawley rats.","endpoint":"developmental toxicity","ingredient":"Camphor benzalkonium methosulfate (INCI name)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":17,"route":"","species":"rat","study_id":"sccp_o_080_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1000 | mg/kg/day | rat | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_080; REPORT_TITLE=OPINION ON CAMPHOR BENZALKONIUM METHOSULFATE COLIPA n° S57; OPINION_NUMBER=SCCP/1015/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=1000; DOSE=For maternal toxicity, the No Adverse Effect Level (NOAEL) and the No Effect Level (NOEL) were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively.; EFFECT=groups than for controls. However, these slight changes did not indicate any adverse effects of Mexoryl SO, as the observed incidences were within the historical control values. Conclusion There were no teratogenic effects under the conditions of the study. For maternal toxicity, the No Adverse Effect Level (NOAEL) and the No Effect Level (NOEL) were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the No Effect Level (NOEL) was 1000 mg/kg/day in this study. Ref.: 19 3.3.9. Toxicokinetics See 3.3.5.2. toxicokinetics data in Sprague-Dawley rats.; CITATION=Ref.: 19 3; CITATION_NUMBERS=[19,3]; REFERENCE=Ref.: 19 3; DETAILS_JSON={"cas_number":"52793-97-2","citation":"Ref.: 19 3","dose":"For maternal toxicity, the No Adverse Effect Level (NOAEL) and the No Effect Level (NOEL) were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively.","duration":"developmental","effect":"groups than for controls. However, these slight changes did not indicate any adverse effects of Mexoryl SO, as the observed incidences were within the historical control values. Conclusion There were no teratogenic effects under the conditions of the study. For maternal toxicity, the No Adverse Effect Level (NOAEL) and the No Effect Level (NOEL) were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the No Effect Level (NOEL) was 1000 mg/kg/day in this study. Ref.: 19 3.3.9. Toxicokinetics See 3.3.5.2. toxicokinetics data in Sprague-Dawley rats.","endpoint":"developmental toxicity","ingredient":"Camphor benzalkonium methosulfate (INCI name)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":17,"route":"","species":"rat","study_id":"sccp_o_080_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 300 | mg/kg/day | guinea pig | - | 90-day | developmental toxicity | SOURCE_SUBDIR=sccp_o_080; REPORT_TITLE=OPINION ON CAMPHOR BENZALKONIUM METHOSULFATE COLIPA n° S57; OPINION_NUMBER=SCCP/1015/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=300; DOSE=g/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 3.3.14.; EFFECT=g/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 3.3.14. Discussion Physico-chemical properties Camphor Benzalkonium Methosulphate is used up to a maximum concentration of 6.0% in sun screen formulations (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw. In a 90-day study, the NOAEL was considered to be 300 mg/kg/day. For maternal toxicity, the NOAEL and the NOEL were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the NOEL was 1000 mg/kg/day. Irritation / sensitisation Mexoryl SO is not irritating to the skin; it has a mild irritating potential to the eye when used undiluted or as a 20% aqueous solution. Mexoryl SO was a non-sensitiser in a Guinea Pig Maximisation Test. Percutaneous absorption T; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"52793-97-2","citation":"","dose":"g/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 3.3.14.","duration":"90-day","effect":"g/kg bw/day of active ingredient = 89.1 mg/kg bw Margin of Safety NOAEL / SED = 109 3.3.14. Discussion Physico-chemical properties Camphor Benzalkonium Methosulphate is used up to a maximum concentration of 6.0% in sun screen formulations (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw. In a 90-day study, the NOAEL was considered to be 300 mg/kg/day. For maternal toxicity, the NOAEL and the NOEL were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the NOEL was 1000 mg/kg/day. Irritation / sensitisation Mexoryl SO is not irritating to the skin; it has a mild irritating potential to the eye when used undiluted or as a 20% aqueous solution. Mexoryl SO was a non-sensitiser in a Guinea Pig Maximisation Test. Percutaneous absorption T","endpoint":"developmental toxicity","ingredient":"Camphor benzalkonium methosulfate (INCI name)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"300","page":22,"route":"","species":"guinea pig","study_id":"sccp_o_080_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1000 | mg/kg/day | guinea pig | dermal | 90-day | developmental toxicity | SOURCE_SUBDIR=sccp_o_080; REPORT_TITLE=OPINION ON CAMPHOR BENZALKONIUM METHOSULFATE COLIPA n° S57; OPINION_NUMBER=SCCP/1015/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=1000; DOSE=A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw.; EFFECT=NOAEL / SED = 109 3.3.14. Discussion Physico-chemical properties Camphor Benzalkonium Methosulphate is used up to a maximum concentration of 6.0% in sun screen formulations (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw. In a 90-day study, the NOAEL was considered to be 300 mg/kg/day. For maternal toxicity, the NOAEL and the NOEL were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the NOEL was 1000 mg/kg/day. Irritation / sensitisation Mexoryl SO is not irritating to the skin; it has a mild irritating potential to the eye when used undiluted or as a 20% aqueous solution. Mexoryl SO was a non-sensitiser in a Guinea Pig Maximisation Test. Percutaneous absorption The dermal absorption (sum of the amounts measured in the living epide; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"52793-97-2","citation":"","dose":"A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw.","duration":"90-day","effect":"NOAEL / SED = 109 3.3.14. Discussion Physico-chemical properties Camphor Benzalkonium Methosulphate is used up to a maximum concentration of 6.0% in sun screen formulations (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw. In a 90-day study, the NOAEL was considered to be 300 mg/kg/day. For maternal toxicity, the NOAEL and the NOEL were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the NOEL was 1000 mg/kg/day. Irritation / sensitisation Mexoryl SO is not irritating to the skin; it has a mild irritating potential to the eye when used undiluted or as a 20% aqueous solution. Mexoryl SO was a non-sensitiser in a Guinea Pig Maximisation Test. Percutaneous absorption The dermal absorption (sum of the amounts measured in the living epide","endpoint":"developmental toxicity","ingredient":"Camphor benzalkonium methosulfate (INCI name)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":22,"route":"dermal","species":"guinea pig","study_id":"sccp_o_080_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1000 | mg/kg/day | guinea pig | dermal | 90-day | developmental toxicity | SOURCE_SUBDIR=sccp_o_080; REPORT_TITLE=OPINION ON CAMPHOR BENZALKONIUM METHOSULFATE COLIPA n° S57; OPINION_NUMBER=SCCP/1015/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=1000; DOSE=A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw.; EFFECT=109 3.3.14. Discussion Physico-chemical properties Camphor Benzalkonium Methosulphate is used up to a maximum concentration of 6.0% in sun screen formulations (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw. In a 90-day study, the NOAEL was considered to be 300 mg/kg/day. For maternal toxicity, the NOAEL and the NOEL were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the NOEL was 1000 mg/kg/day. Irritation / sensitisation Mexoryl SO is not irritating to the skin; it has a mild irritating potential to the eye when used undiluted or as a 20% aqueous solution. Mexoryl SO was a non-sensitiser in a Guinea Pig Maximisation Test. Percutaneous absorption The dermal absorption (sum of the amounts measured in the living epidermis/dermis a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"52793-97-2","citation":"","dose":"A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw.","duration":"90-day","effect":"109 3.3.14. Discussion Physico-chemical properties Camphor Benzalkonium Methosulphate is used up to a maximum concentration of 6.0% in sun screen formulations (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw. In a 90-day study, the NOAEL was considered to be 300 mg/kg/day. For maternal toxicity, the NOAEL and the NOEL were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the NOEL was 1000 mg/kg/day. Irritation / sensitisation Mexoryl SO is not irritating to the skin; it has a mild irritating potential to the eye when used undiluted or as a 20% aqueous solution. Mexoryl SO was a non-sensitiser in a Guinea Pig Maximisation Test. Percutaneous absorption The dermal absorption (sum of the amounts measured in the living epidermis/dermis a","endpoint":"developmental toxicity","ingredient":"Camphor benzalkonium methosulfate (INCI name)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":22,"route":"dermal","species":"guinea pig","study_id":"sccp_o_080_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1000 | mg/kg/day | guinea pig | dermal | 90-day | developmental toxicity | SOURCE_SUBDIR=sccp_o_080; REPORT_TITLE=OPINION ON CAMPHOR BENZALKONIUM METHOSULFATE COLIPA n° S57; OPINION_NUMBER=SCCP/1015/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=1000; DOSE=A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw.; EFFECT=ions (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw. In a 90-day study, the NOAEL was considered to be 300 mg/kg/day. For maternal toxicity, the NOAEL and the NOEL were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the NOEL was 1000 mg/kg/day. Irritation / sensitisation Mexoryl SO is not irritating to the skin; it has a mild irritating potential to the eye when used undiluted or as a 20% aqueous solution. Mexoryl SO was a non-sensitiser in a Guinea Pig Maximisation Test. Percutaneous absorption The dermal absorption (sum of the amounts measured in the living epidermis/dermis and receptor fluid) of Camphor Benzalkonium Methosulphate from a typical sunscreen formulation containing Mexoryl SO at 20% (corresponding to 6% Camphor Benzal; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"52793-97-2","citation":"","dose":"A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw.","duration":"90-day","effect":"ions (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. A UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw. In a 90-day study, the NOAEL was considered to be 300 mg/kg/day. For maternal toxicity, the NOAEL and the NOEL were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the NOEL was 1000 mg/kg/day. Irritation / sensitisation Mexoryl SO is not irritating to the skin; it has a mild irritating potential to the eye when used undiluted or as a 20% aqueous solution. Mexoryl SO was a non-sensitiser in a Guinea Pig Maximisation Test. Percutaneous absorption The dermal absorption (sum of the amounts measured in the living epidermis/dermis and receptor fluid) of Camphor Benzalkonium Methosulphate from a typical sunscreen formulation containing Mexoryl SO at 20% (corresponding to 6% Camphor Benzal","endpoint":"developmental toxicity","ingredient":"Camphor benzalkonium methosulfate (INCI name)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":22,"route":"dermal","species":"guinea pig","study_id":"sccp_o_080_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1000 | mg/kg/day | rat | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_168; REPORT_TITLE=OPINION ON Camphor benzalkonium methosulfate COLIPA n° S57; OPINION_NUMBER=SCCP/1202/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=1000; DOSE=tuses with other anomalies (i.e., slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls.; EFFECT=tuses with other anomalies (i.e., slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls. However, these slight changes did not indicate any adverse effects of Mexoryl SO, as the observed incidences were within the historical control values. Conclusion There were no teratogenic effects under the conditions of the study. For maternal toxicity, the No Adverse Effect Level (NOAEL) and the No Effect Level (NOEL) were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the No Effect Level (NOEL) was 1000 mg/kg/day in this study. Ref.: 19 3.3.9. Toxicokinetics See 3.3.5.2. toxicokinetics data in Sprague-Dawley rats; CITATION=Ref.: 19 3; CITATION_NUMBERS=[19,3]; REFERENCE=Ref.: 19 3; DETAILS_JSON={"cas_number":"52793-97-2","citation":"Ref.: 19 3","dose":"tuses with other anomalies (i.e., slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls.","duration":"developmental","effect":"tuses with other anomalies (i.e., slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls. However, these slight changes did not indicate any adverse effects of Mexoryl SO, as the observed incidences were within the historical control values. Conclusion There were no teratogenic effects under the conditions of the study. For maternal toxicity, the No Adverse Effect Level (NOAEL) and the No Effect Level (NOEL) were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the No Effect Level (NOEL) was 1000 mg/kg/day in this study. Ref.: 19 3.3.9. Toxicokinetics See 3.3.5.2. toxicokinetics data in Sprague-Dawley rats","endpoint":"developmental toxicity","ingredient":"name N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulphate","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":18,"route":"","species":"rat","study_id":"sccp_o_168_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1000 | mg/kg/day | rat | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_168; REPORT_TITLE=OPINION ON Camphor benzalkonium methosulfate COLIPA n° S57; OPINION_NUMBER=SCCP/1202/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=1000; DOSE=, slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls.; EFFECT=, slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls. However, these slight changes did not indicate any adverse effects of Mexoryl SO, as the observed incidences were within the historical control values. Conclusion There were no teratogenic effects under the conditions of the study. For maternal toxicity, the No Adverse Effect Level (NOAEL) and the No Effect Level (NOEL) were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the No Effect Level (NOEL) was 1000 mg/kg/day in this study. Ref.: 19 3.3.9. Toxicokinetics See 3.3.5.2. toxicokinetics data in Sprague-Dawley rats; CITATION=Ref.: 19 3; CITATION_NUMBERS=[19,3]; REFERENCE=Ref.: 19 3; DETAILS_JSON={"cas_number":"52793-97-2","citation":"Ref.: 19 3","dose":", slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls.","duration":"developmental","effect":", slightly dilated renal pelves and/or convoluted urethras) were slightly (but not statistically significant and with no dose relationship) higher in the 300 and 1000 mg/kg/day groups than for controls. However, these slight changes did not indicate any adverse effects of Mexoryl SO, as the observed incidences were within the historical control values. Conclusion There were no teratogenic effects under the conditions of the study. For maternal toxicity, the No Adverse Effect Level (NOAEL) and the No Effect Level (NOEL) were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the No Effect Level (NOEL) was 1000 mg/kg/day in this study. Ref.: 19 3.3.9. Toxicokinetics See 3.3.5.2. toxicokinetics data in Sprague-Dawley rats","endpoint":"developmental toxicity","ingredient":"name N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulphate","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":18,"route":"","species":"rat","study_id":"sccp_o_168_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1000 | mg/kg/day | rat | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_168; REPORT_TITLE=OPINION ON Camphor benzalkonium methosulfate COLIPA n° S57; OPINION_NUMBER=SCCP/1202/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=1000; DOSE=For maternal toxicity, the No Adverse Effect Level (NOAEL) and the No Effect Level (NOEL) were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively.; EFFECT=groups than for controls. However, these slight changes did not indicate any adverse effects of Mexoryl SO, as the observed incidences were within the historical control values. Conclusion There were no teratogenic effects under the conditions of the study. For maternal toxicity, the No Adverse Effect Level (NOAEL) and the No Effect Level (NOEL) were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the No Effect Level (NOEL) was 1000 mg/kg/day in this study. Ref.: 19 3.3.9. Toxicokinetics See 3.3.5.2. toxicokinetics data in Sprague-Dawley rats; CITATION=Ref.: 19 3; CITATION_NUMBERS=[19,3]; REFERENCE=Ref.: 19 3; DETAILS_JSON={"cas_number":"52793-97-2","citation":"Ref.: 19 3","dose":"For maternal toxicity, the No Adverse Effect Level (NOAEL) and the No Effect Level (NOEL) were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively.","duration":"developmental","effect":"groups than for controls. However, these slight changes did not indicate any adverse effects of Mexoryl SO, as the observed incidences were within the historical control values. Conclusion There were no teratogenic effects under the conditions of the study. For maternal toxicity, the No Adverse Effect Level (NOAEL) and the No Effect Level (NOEL) were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the No Effect Level (NOEL) was 1000 mg/kg/day in this study. Ref.: 19 3.3.9. Toxicokinetics See 3.3.5.2. toxicokinetics data in Sprague-Dawley rats","endpoint":"developmental toxicity","ingredient":"name N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulphate","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":18,"route":"","species":"rat","study_id":"sccp_o_168_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 300 | mg/kg/day | guinea pig | - | 90-day | developmental toxicity | SOURCE_SUBDIR=sccp_o_168; REPORT_TITLE=OPINION ON Camphor benzalkonium methosulfate COLIPA n° S57; OPINION_NUMBER=SCCP/1202/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=300; DOSE=An UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw.; EFFECT=SCCP/1202/08 Opinion on camphor benzalkonium methosulfate 23 Physico-chemical properties Camphor Benzalkonium Methosulfate is used up to a maximum concentration of 6.0% in sun screen formulations (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. An UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw. In a 90-day study, the NOAEL was considered to be 300 mg/kg/day. For maternal toxicity, the NOAEL and the NOEL were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the NOEL was 1000 mg/kg/day. Irritation / sensitisation Mexoryl SO is not irritating to the skin; it has a mild irritating potential to the eye when used undiluted or as a 20% aqueous solution. Mexoryl SO was a non-sensitiser in a Guinea Pig Maximisation Test. Percutaneous absorption; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"52793-97-2","citation":"","dose":"An UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw.","duration":"90-day","effect":"SCCP/1202/08 Opinion on camphor benzalkonium methosulfate 23 Physico-chemical properties Camphor Benzalkonium Methosulfate is used up to a maximum concentration of 6.0% in sun screen formulations (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. An UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw. In a 90-day study, the NOAEL was considered to be 300 mg/kg/day. For maternal toxicity, the NOAEL and the NOEL were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the NOEL was 1000 mg/kg/day. Irritation / sensitisation Mexoryl SO is not irritating to the skin; it has a mild irritating potential to the eye when used undiluted or as a 20% aqueous solution. Mexoryl SO was a non-sensitiser in a Guinea Pig Maximisation Test. Percutaneous absorption","endpoint":"developmental toxicity","ingredient":"name N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulphate","loael_value":"","noael_unit":"mg/kg/day","noael_value":"300","page":23,"route":"","species":"guinea pig","study_id":"sccp_o_168_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1000 | mg/kg/day | guinea pig | dermal | 90-day | developmental toxicity | SOURCE_SUBDIR=sccp_o_168; REPORT_TITLE=OPINION ON Camphor benzalkonium methosulfate COLIPA n° S57; OPINION_NUMBER=SCCP/1202/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=1000; DOSE=An UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw.; EFFECT=camphor benzalkonium methosulfate 23 Physico-chemical properties Camphor Benzalkonium Methosulfate is used up to a maximum concentration of 6.0% in sun screen formulations (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. An UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw. In a 90-day study, the NOAEL was considered to be 300 mg/kg/day. For maternal toxicity, the NOAEL and the NOEL were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the NOEL was 1000 mg/kg/day. Irritation / sensitisation Mexoryl SO is not irritating to the skin; it has a mild irritating potential to the eye when used undiluted or as a 20% aqueous solution. Mexoryl SO was a non-sensitiser in a Guinea Pig Maximisation Test. Percutaneous absorption The dermal absorption (sum of the amounts measured in the living epi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"52793-97-2","citation":"","dose":"An UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw.","duration":"90-day","effect":"camphor benzalkonium methosulfate 23 Physico-chemical properties Camphor Benzalkonium Methosulfate is used up to a maximum concentration of 6.0% in sun screen formulations (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. An UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw. In a 90-day study, the NOAEL was considered to be 300 mg/kg/day. For maternal toxicity, the NOAEL and the NOEL were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the NOEL was 1000 mg/kg/day. Irritation / sensitisation Mexoryl SO is not irritating to the skin; it has a mild irritating potential to the eye when used undiluted or as a 20% aqueous solution. Mexoryl SO was a non-sensitiser in a Guinea Pig Maximisation Test. Percutaneous absorption The dermal absorption (sum of the amounts measured in the living epi","endpoint":"developmental toxicity","ingredient":"name N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulphate","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":23,"route":"dermal","species":"guinea pig","study_id":"sccp_o_168_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1000 | mg/kg/day | guinea pig | dermal | 90-day | developmental toxicity | SOURCE_SUBDIR=sccp_o_168; REPORT_TITLE=OPINION ON Camphor benzalkonium methosulfate COLIPA n° S57; OPINION_NUMBER=SCCP/1202/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=1000; DOSE=An UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw.; EFFECT=lkonium methosulfate 23 Physico-chemical properties Camphor Benzalkonium Methosulfate is used up to a maximum concentration of 6.0% in sun screen formulations (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. An UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw. In a 90-day study, the NOAEL was considered to be 300 mg/kg/day. For maternal toxicity, the NOAEL and the NOEL were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the NOEL was 1000 mg/kg/day. Irritation / sensitisation Mexoryl SO is not irritating to the skin; it has a mild irritating potential to the eye when used undiluted or as a 20% aqueous solution. Mexoryl SO was a non-sensitiser in a Guinea Pig Maximisation Test. Percutaneous absorption The dermal absorption (sum of the amounts measured in the living epidermis/dermis; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"52793-97-2","citation":"","dose":"An UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw.","duration":"90-day","effect":"lkonium methosulfate 23 Physico-chemical properties Camphor Benzalkonium Methosulfate is used up to a maximum concentration of 6.0% in sun screen formulations (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. An UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw. In a 90-day study, the NOAEL was considered to be 300 mg/kg/day. For maternal toxicity, the NOAEL and the NOEL were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the NOEL was 1000 mg/kg/day. Irritation / sensitisation Mexoryl SO is not irritating to the skin; it has a mild irritating potential to the eye when used undiluted or as a 20% aqueous solution. Mexoryl SO was a non-sensitiser in a Guinea Pig Maximisation Test. Percutaneous absorption The dermal absorption (sum of the amounts measured in the living epidermis/dermis","endpoint":"developmental toxicity","ingredient":"name N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulphate","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":23,"route":"dermal","species":"guinea pig","study_id":"sccp_o_168_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1000 | mg/kg/day | guinea pig | dermal | 90-day | developmental toxicity | SOURCE_SUBDIR=sccp_o_168; REPORT_TITLE=OPINION ON Camphor benzalkonium methosulfate COLIPA n° S57; OPINION_NUMBER=SCCP/1202/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=1000; DOSE=An UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw.; EFFECT=ns (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. An UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw. In a 90-day study, the NOAEL was considered to be 300 mg/kg/day. For maternal toxicity, the NOAEL and the NOEL were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the NOEL was 1000 mg/kg/day. Irritation / sensitisation Mexoryl SO is not irritating to the skin; it has a mild irritating potential to the eye when used undiluted or as a 20% aqueous solution. Mexoryl SO was a non-sensitiser in a Guinea Pig Maximisation Test. Percutaneous absorption The dermal absorption (sum of the amounts measured in the living epidermis/dermis and receptor fluid) of camphor benzalkonium methosulfate from a typical sunscreen formulation containing Mexoryl SO at 20% (corresponding to 6% camphor benza; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"52793-97-2","citation":"","dose":"An UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw.","duration":"90-day","effect":"ns (provided by Mexoryl SO at a maximum concentration of 20%). Batches 0106845; M171; op565-566; CFQ 14151 were used but not characterised. An UV-spectrum was not submitted General toxicity The LD50 (camphor benzalkonium methosulfate) is > 600 mg/kg bw. In a 90-day study, the NOAEL was considered to be 300 mg/kg/day. For maternal toxicity, the NOAEL and the NOEL were 1000 mg/kg/day (characterised by a minor transient depression in food consumption) and 300 mg/kg/day, respectively. For developmental toxicity, the NOEL was 1000 mg/kg/day. Irritation / sensitisation Mexoryl SO is not irritating to the skin; it has a mild irritating potential to the eye when used undiluted or as a 20% aqueous solution. Mexoryl SO was a non-sensitiser in a Guinea Pig Maximisation Test. Percutaneous absorption The dermal absorption (sum of the amounts measured in the living epidermis/dermis and receptor fluid) of camphor benzalkonium methosulfate from a typical sunscreen formulation containing Mexoryl SO at 20% (corresponding to 6% camphor benza","endpoint":"developmental toxicity","ingredient":"name N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulphate","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":23,"route":"dermal","species":"guinea pig","study_id":"sccp_o_168_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 300 | mg/kg/day | rat | oral | 13 weeks | genotoxicity | SOURCE_SUBDIR=sccp_o_080; REPORT_TITLE=OPINION ON CAMPHOR BENZALKONIUM METHOSULFATE COLIPA n° S57; OPINION_NUMBER=SCCP/1015/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=300; DOSE=s of the study the No Observed Adverse Effect Level (NOAEL) was considered to be 300 mg/kg/day.; EFFECT=s of the study the No Observed Adverse Effect Level (NOAEL) was considered to be 300 mg/kg/day. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL), was considered to be 300 mg/kg/day. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity / 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 401; CITATION=Ref.: 11 3; CITATION_NUMBERS=[11,3]; REFERENCE=Ref.: 11 3; DETAILS_JSON={"cas_number":"52793-97-2","citation":"Ref.: 11 3","dose":"s of the study the No Observed Adverse Effect Level (NOAEL) was considered to be 300 mg/kg/day.","duration":"13 weeks","effect":"s of the study the No Observed Adverse Effect Level (NOAEL) was considered to be 300 mg/kg/day. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL), was considered to be 300 mg/kg/day. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity / 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 401","endpoint":"genotoxicity","ingredient":"Camphor benzalkonium methosulfate (INCI name)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"300","page":13,"route":"oral","species":"rat","study_id":"sccp_o_080_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 300 | mg/kg/day | rat | oral | 13 weeks | genotoxicity | SOURCE_SUBDIR=sccp_o_080; REPORT_TITLE=OPINION ON CAMPHOR BENZALKONIUM METHOSULFATE COLIPA n° S57; OPINION_NUMBER=SCCP/1015/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=300; DOSE=erse Effect Level (NOAEL) was considered to be 300 mg/kg/day.; EFFECT=erse Effect Level (NOAEL) was considered to be 300 mg/kg/day. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL), was considered to be 300 mg/kg/day. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity / 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 401; CITATION=Ref.: 11 3; CITATION_NUMBERS=[11,3]; REFERENCE=Ref.: 11 3; DETAILS_JSON={"cas_number":"52793-97-2","citation":"Ref.: 11 3","dose":"erse Effect Level (NOAEL) was considered to be 300 mg/kg/day.","duration":"13 weeks","effect":"erse Effect Level (NOAEL) was considered to be 300 mg/kg/day. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL), was considered to be 300 mg/kg/day. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity / 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 401","endpoint":"genotoxicity","ingredient":"Camphor benzalkonium methosulfate (INCI name)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"300","page":13,"route":"oral","species":"rat","study_id":"sccp_o_080_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 300 | mg/kg/day | rat | oral | 13 weeks | genotoxicity | SOURCE_SUBDIR=sccp_o_168; REPORT_TITLE=OPINION ON Camphor benzalkonium methosulfate COLIPA n° S57; OPINION_NUMBER=SCCP/1202/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=300; DOSE=Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated.; EFFECT=y. A marked sex-related difference was observed in AUC values and was confirmed by Cmax values. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL), was considered to be 300 mg/kg/day. Ref.: 11 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 401 Species/strain Five strains of Salmonella typhimurium (TA 1535, TA 1537, TA 98, TA 100 and TA 102) Test substance: Mexoryl SO Batch: 0106845 (active ingredient content of 30.3%) Purity: / Concentration: 312.5, 625, 1250, 2500 and 5000 µg/plate both in the presence and; CITATION=Ref.: 11 3; CITATION_NUMBERS=[11,3]; REFERENCE=Ref.: 11 3; DETAILS_JSON={"cas_number":"52793-97-2","citation":"Ref.: 11 3","dose":"Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated.","duration":"13 weeks","effect":"y. A marked sex-related difference was observed in AUC values and was confirmed by Cmax values. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL), was considered to be 300 mg/kg/day. Ref.: 11 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 401 Species/strain Five strains of Salmonella typhimurium (TA 1535, TA 1537, TA 98, TA 100 and TA 102) Test substance: Mexoryl SO Batch: 0106845 (active ingredient content of 30.3%) Purity: / Concentration: 312.5, 625, 1250, 2500 and 5000 µg/plate both in the presence and","endpoint":"genotoxicity","ingredient":"name N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulphate","loael_value":"","noael_unit":"mg/kg/day","noael_value":"300","page":14,"route":"oral","species":"rat","study_id":"sccp_o_168_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 300 | mg/kg/day | rat | oral | 13 weeks | genotoxicity | SOURCE_SUBDIR=sccp_o_168; REPORT_TITLE=OPINION ON Camphor benzalkonium methosulfate COLIPA n° S57; OPINION_NUMBER=SCCP/1202/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 January 2009; VALUE_TEXT=300; DOSE=Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated.; EFFECT=was observed in AUC values and was confirmed by Cmax values. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL), was considered to be 300 mg/kg/day. Ref.: 11 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 401 Species/strain Five strains of Salmonella typhimurium (TA 1535, TA 1537, TA 98, TA 100 and TA 102) Test substance: Mexoryl SO Batch: 0106845 (active ingredient content of 30.3%) Purity: / Concentration: 312.5, 625, 1250, 2500 and 5000 µg/plate both in the presence and the ab; CITATION=Ref.: 11 3; CITATION_NUMBERS=[11,3]; REFERENCE=Ref.: 11 3; DETAILS_JSON={"cas_number":"52793-97-2","citation":"Ref.: 11 3","dose":"Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated.","duration":"13 weeks","effect":"was observed in AUC values and was confirmed by Cmax values. Conclusion According to the authors, the repeated daily oral administration to rats of Mexoryl SO at levels up to 1000 mg/kg/day for 13 weeks was well tolerated. At necropsy, discolouration in the digestive tract was seen at 300 and 1000 mg/kg/day, and erosion of the mucosa was observed in the stomach or duodenum from some rats given 1000 mg/kg/day, at a low incidence. Accordingly, under the conditions of the study the No Observed Adverse Effect Level (NOAEL), was considered to be 300 mg/kg/day. Ref.: 11 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 401 Species/strain Five strains of Salmonella typhimurium (TA 1535, TA 1537, TA 98, TA 100 and TA 102) Test substance: Mexoryl SO Batch: 0106845 (active ingredient content of 30.3%) Purity: / Concentration: 312.5, 625, 1250, 2500 and 5000 µg/plate both in the presence and the ab","endpoint":"genotoxicity","ingredient":"name N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulphate","loael_value":"","noael_unit":"mg/kg/day","noael_value":"300","page":14,"route":"oral","species":"rat","study_id":"sccp_o_168_noael_002"} |