s with potential endocrine disrupting, s, toys, textiles, clothing,, Benzophenone-4

{"absorption_percent":"5%; 0.13%; 0.46%; 5.22 µg/cm2; 7.32 µg/cm2","basis":"As explained in section 3.2, in the absence of data on dermal absorption of BP-5, the SCCS has considered it appropriate to use the same dermal absorption values as for BP-4 - the closest analogue of BP5 - for safety assessment of BP-5. In regard to dermal absorption, the values estimated by EPI DERMWIN model (v2.02) within EPISUITE platform also indicate a comparable profile for both BP-4 and BP-5 (5.22 µg/cm2 and 7.32 µg/cm2, respectively). Therefore, the SCCS used the same dermal absorption values for BP-5 as for BP-4, for which an OECD Test Guideline 428 in vitro skin penetration study from 2021 on human skin is available (SCCS /1660/23). The study reported that topical application of 2 mg/cm2 radiolabelled BP-4 at 5% in a standard sunscreen application formula base resulted in a dermal delivery of 0.20 + 0.13% (Mean + 1SD) after 24h exposure. From this skin absorption study, the SCCS had used 0.46% (Mean + 2SD) for the calculation of SED for BP-4. This value will also be applie...","page":17,"pdf":"sccs_o_301.pdf","row_type":"dermal_absorption_study"}

sccs_o_301.pdf

{"absorption_percent":"5%; 0.13%; 0.46%; 5.22 µg/cm2; 7.32 µg/cm2","basis":"As explained in section 3.2, in the absence of data on dermal absorption of BP-5, the SCCS has considered it appropriate to use the same dermal absorption values as for BP-4 - the closest analogue of BP5 - for safety assessment of BP-5. In regard to dermal absorption, the values estimated by EPI DERMWIN model (v2.02) within EPISUITE platform also indicate a comparable profile for both BP-4 and BP-5 (5.22 µg/cm2 and 7.32 µg/cm2, respectively). Therefore, the SCCS used the same dermal absorption values for BP-5 as for BP-4, for which an OECD Test Guideline 428 in vitro skin penetration study from 2021 on human skin is available (SCCS /1660/23). The study reported that topical application of 2 mg/cm2 radiolabelled BP-4 at 5% in a standard sunscreen application formula base resulted in a dermal delivery of 0.20 + 0.13% (Mean + 1SD) after 24h exposure. From this skin absorption study, the SCCS had used 0.46% (Mean + 2SD) for the calculation of SED for BP-4. This value will also be applie...","page":17,"pdf":"sccs_o_301.pdf","row_type":"dermal_absorption_study"}

sccs_o_301.pdf

{"absorption_percent":"5%; 0.13%; 0.46%; 5.22 µg/cm2; 7.32 µg/cm2","basis":"As explained in section 3.2, in the absence of data on dermal absorption of BP-5, the SCCS has considered it appropriate to use the same dermal absorption values as for BP-4 - the closest analogue of BP5 - for safety assessment of BP-5. In regard to dermal absorption, the values estimated by EPI DERMWIN model (v2.02) within EPISUITE platform also indicate a comparable profile for both BP-4 and BP-5 (5.22 µg/cm2 and 7.32 µg/cm2, respectively). Therefore, the SCCS used the same dermal absorption values for BP-5 as for BP-4, for which an OECD Test Guideline 428 in vitro skin penetration study from 2021 on human skin is available (SCCS /1660/23). The study reported that topical application of 2 mg/cm2 radiolabelled BP-4 at 5% in a standard sunscreen application formula base resulted in a dermal delivery of 0.20 + 0.13% (Mean + 1SD) after 24h exposure. From this skin absorption study, the SCCS had used 0.46% (Mean + 2SD) for the calculation of SED for BP-4. This value will also be applie...","page":17,"pdf":"sccs_o_301.pdf","row_type":"dermal_absorption_study"}

sccs_o_301.pdf

{"dose":"The calculation of the systemic exposure dose (SED), the margin of safety (MOS), and the selection of Point of Departure (PoD) for BP-5 are therefore the taken as the same for BP-4, which has already been assessed in the SCCS Opinion (SCCS/1660/23).","effect":"iders it appropriate to use the available toxicological data on BP-4 for read-across to BP-5. The calculation of the systemic exposure dose (SED), the margin of safety (MOS), and the selection of Point of Departure (PoD) for BP-5 are therefore the taken as the same for BP-4, which has already been assessed in the SCCS Opinion (SCCS/1660/23). Table 7: Margins of Safety (MoS) calculation for benzophenone-5 based on read-across from BP-4 when used in cosmetic products at 5%. Product type SED (mg/kg bw/day) Adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face cream* 0.006 620 103333 Hand cream* 0.008 620 77500 Oral exposure: Lip stick* 0.045 620 13778 Inhalatory exposure: Sunscreen propellant spray* 0.088 620 7046 Sunscreen pump spray 0.001 620 620000 Overall aggregate* (deterministic) 0.147 620 4218 *Aggregate exposure has been calculated from face cream, hand cream, lipstick and sunscreen propellant spray (only one sunscreen was considered for the worst-case scenario) The calculation","page":39,"pdf":"sccs_o_301.pdf","row_type":"noael_study","study_id":"sccs_o_301_noael_002"}

sccs_o_301.pdf

{"dose":"The calculation of the systemic exposure dose (SED), the margin of safety (MOS), and the selection of Point of Departure (PoD) for BP-5 are therefore the taken as the same for BP-4, which has already been assessed in the SCCS Opinion (SCCS/1660/23).","effect":"iders it appropriate to use the available toxicological data on BP-4 for read-across to BP-5. The calculation of the systemic exposure dose (SED), the margin of safety (MOS), and the selection of Point of Departure (PoD) for BP-5 are therefore the taken as the same for BP-4, which has already been assessed in the SCCS Opinion (SCCS/1660/23). Table 7: Margins of Safety (MoS) calculation for benzophenone-5 based on read-across from BP-4 when used in cosmetic products at 5%. Product type SED (mg/kg bw/day) Adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face cream* 0.006 620 103333 Hand cream* 0.008 620 77500 Oral exposure: Lip stick* 0.045 620 13778 Inhalatory exposure: Sunscreen propellant spray* 0.088 620 7046 Sunscreen pump spray 0.001 620 620000 Overall aggregate* (deterministic) 0.147 620 4218 *Aggregate exposure has been calculated from face cream, hand cream, lipstick and sunscreen propellant spray (only one sunscreen was considered for the worst-case scenario) The calculation","page":39,"pdf":"sccs_o_301.pdf","row_type":"noael_study","study_id":"sccs_o_301_noael_002"}

sccs_o_301.pdf

{"dose":"The calculation of the systemic exposure dose (SED), the margin of safety (MOS), and the selection of Point of Departure (PoD) for BP-5 are therefore the taken as the same for BP-4, which has already been assessed in the SCCS Opinion (SCCS/1660/23).","effect":"iders it appropriate to use the available toxicological data on BP-4 for read-across to BP-5. The calculation of the systemic exposure dose (SED), the margin of safety (MOS), and the selection of Point of Departure (PoD) for BP-5 are therefore the taken as the same for BP-4, which has already been assessed in the SCCS Opinion (SCCS/1660/23). Table 7: Margins of Safety (MoS) calculation for benzophenone-5 based on read-across from BP-4 when used in cosmetic products at 5%. Product type SED (mg/kg bw/day) Adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face cream* 0.006 620 103333 Hand cream* 0.008 620 77500 Oral exposure: Lip stick* 0.045 620 13778 Inhalatory exposure: Sunscreen propellant spray* 0.088 620 7046 Sunscreen pump spray 0.001 620 620000 Overall aggregate* (deterministic) 0.147 620 4218 *Aggregate exposure has been calculated from face cream, hand cream, lipstick and sunscreen propellant spray (only one sunscreen was considered for the worst-case scenario) The calculation","page":39,"pdf":"sccs_o_301.pdf","row_type":"noael_study","study_id":"sccs_o_301_noael_002"}

sccs_o_301.pdf

{"dose":"The calculation of the systemic exposure dose (SED), the margin of safety (MOS), and the selection of Point of Departure (PoD) for BP-5 are therefore the taken as the same for BP-4, which has already been assessed in the SCCS Opinion (SCCS/1660/23).","effect":"iders it appropriate to use the available toxicological data on BP-4 for read-across to BP-5. The calculation of the systemic exposure dose (SED), the margin of safety (MOS), and the selection of Point of Departure (PoD) for BP-5 are therefore the taken as the same for BP-4, which has already been assessed in the SCCS Opinion (SCCS/1660/23). Table 7: Margins of Safety (MoS) calculation for benzophenone-5 based on read-across from BP-4 when used in cosmetic products at 5%. Product type SED (mg/kg bw/day) Adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face cream* 0.006 620 103333 Hand cream* 0.008 620 77500 Oral exposure: Lip stick* 0.045 620 13778 Inhalatory exposure: Sunscreen propellant spray* 0.088 620 7046 Sunscreen pump spray 0.001 620 620000 Overall aggregate* (deterministic) 0.147 620 4218 *Aggregate exposure has been calculated from face cream, hand cream, lipstick and sunscreen propellant spray (only one sunscreen was considered for the worst-case scenario) The calculation","page":39,"pdf":"sccs_o_301.pdf","row_type":"noael_study","study_id":"sccs_o_301_noael_002"}

sccs_o_301.pdf

{"dose":"3.6.5 Repeated dose toxicity From the 90-day repeat dose oral toxicity study in rats, referred to in the SCCS Opinion (SCCS/1660/23) a NOAEL of 1239 mg/kg bw/day could be derived for BP-4.","effect":"sensitisation potential to BP-4, the risk of sensitisation to humans can be regarded as very low. 3.6.4 Acute toxicity The studies referred to in the SCCS Opinion (SCCS/1660/23) pointed to low or no acute toxicity of benzophenone-4 in animals. However, as indicated in the SCCS Notes of Guidance, acute toxicity studies are not mandatory for risk assessment of cosmetic ingredients. 3.6.5 Repeated dose toxicity From the 90-day repeat dose oral toxicity study in rats, referred to in the SCCS Opinion (SCCS/1660/23) a NOAEL of 1239 mg/kg bw/day could be derived for BP-4. 3.6.6 Reproductive toxicity The OECD TG 422 study, referred to in the SCCS Opinion (SCCS/1660/23) for BP-4, showed no treatment related changes up to 1250 mg/kg bw /day. 3.6.7 Mutagenicity / genotoxicity Benzophenone-4 has no in vitro genotoxic potential. 3.6.8 Carcinogenicity No data available. 3.6.9 Photo-induced toxicity Benzophenone-4 is not phototoxic, not photosensitising, not photomutagenic and not photoclastogenic. 3.6.10 Human data Considering the avail","page":38,"pdf":"sccs_o_301.pdf","row_type":"noael_study","study_id":"sccs_o_301_noael_001"}

sccs_o_301.pdf

{"dose":"3.6.5 Repeated dose toxicity From the 90-day repeat dose oral toxicity study in rats, referred to in the SCCS Opinion (SCCS/1660/23) a NOAEL of 1239 mg/kg bw/day could be derived for BP-4.","effect":"sensitisation potential to BP-4, the risk of sensitisation to humans can be regarded as very low. 3.6.4 Acute toxicity The studies referred to in the SCCS Opinion (SCCS/1660/23) pointed to low or no acute toxicity of benzophenone-4 in animals. However, as indicated in the SCCS Notes of Guidance, acute toxicity studies are not mandatory for risk assessment of cosmetic ingredients. 3.6.5 Repeated dose toxicity From the 90-day repeat dose oral toxicity study in rats, referred to in the SCCS Opinion (SCCS/1660/23) a NOAEL of 1239 mg/kg bw/day could be derived for BP-4. 3.6.6 Reproductive toxicity The OECD TG 422 study, referred to in the SCCS Opinion (SCCS/1660/23) for BP-4, showed no treatment related changes up to 1250 mg/kg bw /day. 3.6.7 Mutagenicity / genotoxicity Benzophenone-4 has no in vitro genotoxic potential. 3.6.8 Carcinogenicity No data available. 3.6.9 Photo-induced toxicity Benzophenone-4 is not phototoxic, not photosensitising, not photomutagenic and not photoclastogenic. 3.6.10 Human data Considering the avail","page":38,"pdf":"sccs_o_301.pdf","row_type":"noael_study","study_id":"sccs_o_301_noael_001"}

sccs_o_301.pdf

{"dose":"3.6.5 Repeated dose toxicity From the 90-day repeat dose oral toxicity study in rats, referred to in the SCCS Opinion (SCCS/1660/23) a NOAEL of 1239 mg/kg bw/day could be derived for BP-4.","effect":"sensitisation potential to BP-4, the risk of sensitisation to humans can be regarded as very low. 3.6.4 Acute toxicity The studies referred to in the SCCS Opinion (SCCS/1660/23) pointed to low or no acute toxicity of benzophenone-4 in animals. However, as indicated in the SCCS Notes of Guidance, acute toxicity studies are not mandatory for risk assessment of cosmetic ingredients. 3.6.5 Repeated dose toxicity From the 90-day repeat dose oral toxicity study in rats, referred to in the SCCS Opinion (SCCS/1660/23) a NOAEL of 1239 mg/kg bw/day could be derived for BP-4. 3.6.6 Reproductive toxicity The OECD TG 422 study, referred to in the SCCS Opinion (SCCS/1660/23) for BP-4, showed no treatment related changes up to 1250 mg/kg bw /day. 3.6.7 Mutagenicity / genotoxicity Benzophenone-4 has no in vitro genotoxic potential. 3.6.8 Carcinogenicity No data available. 3.6.9 Photo-induced toxicity Benzophenone-4 is not phototoxic, not photosensitising, not photomutagenic and not photoclastogenic. 3.6.10 Human data Considering the avail","page":38,"pdf":"sccs_o_301.pdf","row_type":"noael_study","study_id":"sccs_o_301_noael_001"}

sccs_o_301.pdf

{"dose":"3.6.5 Repeated dose toxicity From the 90-day repeat dose oral toxicity study in rats, referred to in the SCCS Opinion (SCCS/1660/23) a NOAEL of 1239 mg/kg bw/day could be derived for BP-4.","effect":"sensitisation potential to BP-4, the risk of sensitisation to humans can be regarded as very low. 3.6.4 Acute toxicity The studies referred to in the SCCS Opinion (SCCS/1660/23) pointed to low or no acute toxicity of benzophenone-4 in animals. However, as indicated in the SCCS Notes of Guidance, acute toxicity studies are not mandatory for risk assessment of cosmetic ingredients. 3.6.5 Repeated dose toxicity From the 90-day repeat dose oral toxicity study in rats, referred to in the SCCS Opinion (SCCS/1660/23) a NOAEL of 1239 mg/kg bw/day could be derived for BP-4. 3.6.6 Reproductive toxicity The OECD TG 422 study, referred to in the SCCS Opinion (SCCS/1660/23) for BP-4, showed no treatment related changes up to 1250 mg/kg bw /day. 3.6.7 Mutagenicity / genotoxicity Benzophenone-4 has no in vitro genotoxic potential. 3.6.8 Carcinogenicity No data available. 3.6.9 Photo-induced toxicity Benzophenone-4 is not phototoxic, not photosensitising, not photomutagenic and not photoclastogenic. 3.6.10 Human data Considering the avail","page":38,"pdf":"sccs_o_301.pdf","row_type":"noael_study","study_id":"sccs_o_301_noael_001"}

sccs_o_301.pdf

SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=unclear:Unlabeled table on page 59: Product type | SED (mg/kg bw/day) | adjusted NOAEL (mg/kg bw/day) | MoS; DOSE=Product type | SED (mg/kg bw/day) | adjusted NOAEL (mg/kg bw/day) | MoS; EFFECT=Unlabeled table on page 59: Product type | SED (mg/kg bw/day) | adjusted NOAEL (mg/kg bw/day) | MoS; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"Product type | SED (mg/kg bw/day) | adjusted NOAEL (mg/kg bw/day) | MoS","duration":"","effect":"Unlabeled table on page 59: Product type | SED (mg/kg bw/day) | adjusted NOAEL (mg/kg bw/day) | MoS","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 59: Product type | SED (mg/kg bw/day) | adjusted NOAEL (mg/kg bw/day) | MoS","page":59,"route":"","species":"","study_id":"sccs_o_283_noael_008"}

sccs_o_283.pdf

SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=620; EFFECT=Unlabeled table on page 59: Sunscreen lotion | 0.069 | 620 | 8986; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 59: Sunscreen lotion | 0.069 | 620 | 8986","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"620","page":59,"route":"","species":"","study_id":"sccs_o_283_noael_009"}

sccs_o_283.pdf

SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=620; EFFECT=Unlabeled table on page 59: Face cream* | 0.006 | 620 | 103333; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 59: Face cream* | 0.006 | 620 | 103333","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"620","page":59,"route":"","species":"","study_id":"sccs_o_283_noael_010"}

sccs_o_283.pdf

SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=620; EFFECT=Unlabeled table on page 59: Hand cream* | 0.008 | 620 | 77500; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 59: Hand cream* | 0.008 | 620 | 77500","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"620","page":59,"route":"","species":"","study_id":"sccs_o_283_noael_011"}

sccs_o_283.pdf

SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=620; EFFECT=Unlabeled table on page 59: Dermal aggregate for leave-on and rinse-off products | 0.067 | 620 | 9254; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 59: Dermal aggregate for leave-on and rinse-off products | 0.067 | 620 | 9254","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"620","page":59,"route":"dermal","species":"","study_id":"sccs_o_283_noael_012"}

sccs_o_283.pdf

SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=620; EFFECT=Unlabeled table on page 59: Lip stick* | 0.045 | 620 | 13778; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 59: Lip stick* | 0.045 | 620 | 13778","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"620","page":59,"route":"","species":"","study_id":"sccs_o_283_noael_013"}

sccs_o_283.pdf

SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=620; EFFECT=Unlabeled table on page 59: Sunscreen propellant spray* | 0.088 | 620 | 7046; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 59: Sunscreen propellant spray* | 0.088 | 620 | 7046","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"620","page":59,"route":"","species":"","study_id":"sccs_o_283_noael_014"}

sccs_o_283.pdf

SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=620; EFFECT=Unlabeled table on page 59: Sunscreen pump spray | 0.001 | 620 | 620000; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 59: Sunscreen pump spray | 0.001 | 620 | 620000","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"620","page":59,"route":"","species":"","study_id":"sccs_o_283_noael_015"}

sccs_o_283.pdf

SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=1239; DOSE=rats exposed to the highest dose showed a decrease in body and liver weight, while female rats exposed to the middle dose showed an increase in adrenal gland weight.; EFFECT=rats exposed to the highest dose showed a decrease in body and liver weight, while female rats exposed to the middle dose showed an increase in adrenal gland weight. However, these changes were not associated with any adverse gross or histopathological findings. Overall, the study concluded that benzophenone-4 did not have significant toxic effects on the rats, as there were no adverse findings in the clinical examination or histopathological analysis. Therefore, the highest dose of 1239 mg/kg/day was taken as the NOAEL. (BASF AG 1996) SCCS comment Original study reports were not provided with the first submission, but the original study report of the 90-day repeat dose toxicity study was requested and received. A NOAEL of 1239 mg/kg/day was derived. The study report was not signed.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"rats exposed to the highest dose showed a decrease in body and liver weight, while female rats exposed to the middle dose showed an increase in adrenal gland weight.","duration":"90-day","effect":"rats exposed to the highest dose showed a decrease in body and liver weight, while female rats exposed to the middle dose showed an increase in adrenal gland weight. However, these changes were not associated with any adverse gross or histopathological findings. Overall, the study concluded that benzophenone-4 did not have significant toxic effects on the rats, as there were no adverse findings in the clinical examination or histopathological analysis. Therefore, the highest dose of 1239 mg/kg/day was taken as the NOAEL. (BASF AG 1996) SCCS comment Original study reports were not provided with the first submission, but the original study report of the 90-day repeat dose toxicity study was requested and received. A NOAEL of 1239 mg/kg/day was derived. The study report was not signed.","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1239","page":37,"route":"","species":"rat","study_id":"sccs_o_283_noael_001"}

sccs_o_283.pdf

SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=1239; DOSE=Therefore, the highest dose of 1239 mg/kg/day was taken as the NOAEL.; EFFECT=ed with any adverse gross or histopathological findings. Overall, the study concluded that benzophenone-4 did not have significant toxic effects on the rats, as there were no adverse findings in the clinical examination or histopathological analysis. Therefore, the highest dose of 1239 mg/kg/day was taken as the NOAEL. (BASF AG 1996) SCCS comment Original study reports were not provided with the first submission, but the original study report of the 90-day repeat dose toxicity study was requested and received. A NOAEL of 1239 mg/kg/day was derived. The study report was not signed.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"Therefore, the highest dose of 1239 mg/kg/day was taken as the NOAEL.","duration":"90-day","effect":"ed with any adverse gross or histopathological findings. Overall, the study concluded that benzophenone-4 did not have significant toxic effects on the rats, as there were no adverse findings in the clinical examination or histopathological analysis. Therefore, the highest dose of 1239 mg/kg/day was taken as the NOAEL. (BASF AG 1996) SCCS comment Original study reports were not provided with the first submission, but the original study report of the 90-day repeat dose toxicity study was requested and received. A NOAEL of 1239 mg/kg/day was derived. The study report was not signed.","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1239","page":37,"route":"","species":"rat","study_id":"sccs_o_283_noael_002"}

sccs_o_283.pdf

SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=1250; DOSE=Based on the results reported, a NOAEL of 1250 mg/kg/day for male and female rats was considered.; EFFECT=l data showed no significant effects on T4, TSH, testosterone(males) and estradiol (females). No notable effects on organs or blood chemistry parameters were observed. Pregnancy rates, gestation length and litter size were not affected by treatment. No significant effects were seen on the number of live births, pup weight, pup survival or sex ratio. No test substance abnormalities were seen in pups. Special investigations on thyroid and parathyroid glands revealed no abnormalities. Based on the results reported, a NOAEL of 1250 mg/kg/day for male and female rats was considered. (Sustainability Support Services (Europe) AB 2018) SCCS comment The original study report was not provided with the initial submission, but was sent upon request. A number of deviations from OECD TG 422 were observed: - the study employed a dose volume of 2 ml/100g body weight, while the recommended guideline suggested using only 1 mg/100g body weight (with 2 ml being acceptable for aqueous solutions). Here corn oil has been used. - the report did not in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"Based on the results reported, a NOAEL of 1250 mg/kg/day for male and female rats was considered.","duration":"","effect":"l data showed no significant effects on T4, TSH, testosterone(males) and estradiol (females). No notable effects on organs or blood chemistry parameters were observed. Pregnancy rates, gestation length and litter size were not affected by treatment. No significant effects were seen on the number of live births, pup weight, pup survival or sex ratio. No test substance abnormalities were seen in pups. Special investigations on thyroid and parathyroid glands revealed no abnormalities. Based on the results reported, a NOAEL of 1250 mg/kg/day for male and female rats was considered. (Sustainability Support Services (Europe) AB 2018) SCCS comment The original study report was not provided with the initial submission, but was sent upon request. A number of deviations from OECD TG 422 were observed: - the study employed a dose volume of 2 ml/100g body weight, while the recommended guideline suggested using only 1 mg/100g body weight (with 2 ml being acceptable for aqueous solutions). Here corn oil has been used. - the report did not in","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1250","page":38,"route":"","species":"rat","study_id":"sccs_o_283_noael_003"}

sccs_o_283.pdf

SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=620; DOSE=LUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4.; EFFECT=LUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4. As point of departure for 24 risk assessment, a NOAEL of 1239 mg/kg bw/day, based on a 90-day oral repeated dose rat 25 study is used (see section 3.4.4.2). As no good oral absorption study for benzophenone-4 is 26 available, the default value of 50 % is used for the oral absorption, resulting in an adjusted 27 NOAEL of 620 mg/kg bw/day. Following MoS calculations for separate product types and 28 aggregated exposure can be calculated: 29 30 31 Product type SED (mg/kg bw/day) adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face cream* 0.006 620 103333 Hand cream* 0.008 620 77500 Dermal aggregate for leave-on and rinse-off products 0.067 620 9254 Oral exposure: Lip stick* 0.045 620 13778 Inhalatory exposure: Sunscreen propellant spray* 0.088 620 7046 Sunscreen pump spray 0.001 620 6; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"LUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4.","duration":"90-day","effect":"LUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4. As point of departure for 24 risk assessment, a NOAEL of 1239 mg/kg bw/day, based on a 90-day oral repeated dose rat 25 study is used (see section 3.4.4.2). As no good oral absorption study for benzophenone-4 is 26 available, the default value of 50 % is used for the oral absorption, resulting in an adjusted 27 NOAEL of 620 mg/kg bw/day. Following MoS calculations for separate product types and 28 aggregated exposure can be calculated: 29 30 31 Product type SED (mg/kg bw/day) adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face cream* 0.006 620 103333 Hand cream* 0.008 620 77500 Dermal aggregate for leave-on and rinse-off products 0.067 620 9254 Oral exposure: Lip stick* 0.045 620 13778 Inhalatory exposure: Sunscreen propellant spray* 0.088 620 7046 Sunscreen pump spray 0.001 620 6","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"620","page":59,"route":"oral","species":"rat","study_id":"sccs_o_283_noael_005"}

sccs_o_283.pdf

SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=620; DOSE=As point of departure for 24 risk assessment, a NOAEL of 1239 mg/kg bw/day, based on a 90-day oral repeated dose rat 25 study is used (see section 3.4.4.2).; EFFECT=described in section 3.2.4. As point of departure for 24 risk assessment, a NOAEL of 1239 mg/kg bw/day, based on a 90-day oral repeated dose rat 25 study is used (see section 3.4.4.2). As no good oral absorption study for benzophenone-4 is 26 available, the default value of 50 % is used for the oral absorption, resulting in an adjusted 27 NOAEL of 620 mg/kg bw/day. Following MoS calculations for separate product types and 28 aggregated exposure can be calculated: 29 30 31 Product type SED (mg/kg bw/day) adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face cream* 0.006 620 103333 Hand cream* 0.008 620 77500 Dermal aggregate for leave-on and rinse-off products 0.067 620 9254 Oral exposure: Lip stick* 0.045 620 13778 Inhalatory exposure: Sunscreen propellant spray* 0.088 620 7046 Sunscreen pump spray 0.001 620 620000 Overall aggregate* (deterministic) 0.147 620 4218 32 33 Considering the different cosmetic products either directly applied on the skin or by spray, at 34 the maximum conc; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"As point of departure for 24 risk assessment, a NOAEL of 1239 mg/kg bw/day, based on a 90-day oral repeated dose rat 25 study is used (see section 3.4.4.2).","duration":"90-day","effect":"described in section 3.2.4. As point of departure for 24 risk assessment, a NOAEL of 1239 mg/kg bw/day, based on a 90-day oral repeated dose rat 25 study is used (see section 3.4.4.2). As no good oral absorption study for benzophenone-4 is 26 available, the default value of 50 % is used for the oral absorption, resulting in an adjusted 27 NOAEL of 620 mg/kg bw/day. Following MoS calculations for separate product types and 28 aggregated exposure can be calculated: 29 30 31 Product type SED (mg/kg bw/day) adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face cream* 0.006 620 103333 Hand cream* 0.008 620 77500 Dermal aggregate for leave-on and rinse-off products 0.067 620 9254 Oral exposure: Lip stick* 0.045 620 13778 Inhalatory exposure: Sunscreen propellant spray* 0.088 620 7046 Sunscreen pump spray 0.001 620 620000 Overall aggregate* (deterministic) 0.147 620 4218 32 33 Considering the different cosmetic products either directly applied on the skin or by spray, at 34 the maximum conc","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"620","page":59,"route":"oral","species":"rat","study_id":"sccs_o_283_noael_006"}

sccs_o_283.pdf

SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=1239; DOSE=19 20 21 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4.; EFFECT=11 12 3.4.10.4 In vivo adverse effects on endocrine relevant endpoints 13 14 / 15 16 SCCS comment 17 Based on the various studies provided, it can be concluded that benzophenone-4 does not 18 demonstrate endocrine-disrupting properties. 19 20 21 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4. As point of departure for 24 risk assessment, a NOAEL of 1239 mg/kg bw/day, based on a 90-day oral repeated dose rat 25 study is used (see section 3.4.4.2). As no good oral absorption study for benzophenone-4 is 26 available, the default value of 50 % is used for the oral absorption, resulting in an adjusted 27 NOAEL of 620 mg/kg bw/day. Following MoS calculations for separate product types and 28 aggregated exposure can be calculated: 29 30 31 Product type SED (mg/kg bw/day) adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"19 20 21 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4.","duration":"90-day","effect":"11 12 3.4.10.4 In vivo adverse effects on endocrine relevant endpoints 13 14 / 15 16 SCCS comment 17 Based on the various studies provided, it can be concluded that benzophenone-4 does not 18 demonstrate endocrine-disrupting properties. 19 20 21 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) 22 The calculation of the systemic exposure dose (SED) was carried out using data from an in 23 vitro percutaneous absorption study, as described in section 3.2.4. As point of departure for 24 risk assessment, a NOAEL of 1239 mg/kg bw/day, based on a 90-day oral repeated dose rat 25 study is used (see section 3.4.4.2). As no good oral absorption study for benzophenone-4 is 26 available, the default value of 50 % is used for the oral absorption, resulting in an adjusted 27 NOAEL of 620 mg/kg bw/day. Following MoS calculations for separate product types and 28 aggregated exposure can be calculated: 29 30 31 Product type SED (mg/kg bw/day) adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1239","page":59,"route":"oral","species":"rat","study_id":"sccs_o_283_noael_004"}

sccs_o_283.pdf

SOURCE_SUBDIR=sccs_o_283; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on benzophenone - 4 (CAS No. 4065-45-6, EC No. 223-772-2); OPINION_NUMBER=SCCS/1660/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 27 March 2024; VALUE_TEXT=1239; DOSE=223-772-2) _________________________________________________________________________________ ___________________________________________________________________________________________ 61 1 Repeated dose toxicity 2 From the 90-day repeat dose oral toxicity study in rats, a NOAEL of 1239 mg/kg bw/day could 3 be derived.; EFFECT=SCCS/1660/23 Final Opinion Opinion on benzophenone – 4 (CAS No. 4065-45-6, EC No. 223-772-2) _________________________________________________________________________________ ___________________________________________________________________________________________ 61 1 Repeated dose toxicity 2 From the 90-day repeat dose oral toxicity study in rats, a NOAEL of 1239 mg/kg bw/day could 3 be derived. 4 5 Reproductive toxicity 6 Subject to change whether a typo is present or not in the report of the conducted OECD TG 7 422 study, no treatment related changes were noted up to 1250 mg/kg bw /day. 8 9 Mutagenicity / genotoxicity 10 Benzophenone-4 has no in vitro genotoxic potential. 11 12 Carcinogenicity 13 No data. 14 15 Photo-induced toxicity 16 Benzophenone-4 is not phototoxic, not photosensitising, not photomutagenic and not 17 photoclastogenic. 18 19 Human data 20; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"4065-45-6","citation":"","dose":"223-772-2) _________________________________________________________________________________ ___________________________________________________________________________________________ 61 1 Repeated dose toxicity 2 From the 90-day repeat dose oral toxicity study in rats, a NOAEL of 1239 mg/kg bw/day could 3 be derived.","duration":"90-day","effect":"SCCS/1660/23 Final Opinion Opinion on benzophenone – 4 (CAS No. 4065-45-6, EC No. 223-772-2) _________________________________________________________________________________ ___________________________________________________________________________________________ 61 1 Repeated dose toxicity 2 From the 90-day repeat dose oral toxicity study in rats, a NOAEL of 1239 mg/kg bw/day could 3 be derived. 4 5 Reproductive toxicity 6 Subject to change whether a typo is present or not in the report of the conducted OECD TG 7 422 study, no treatment related changes were noted up to 1250 mg/kg bw /day. 8 9 Mutagenicity / genotoxicity 10 Benzophenone-4 has no in vitro genotoxic potential. 11 12 Carcinogenicity 13 No data. 14 15 Photo-induced toxicity 16 Benzophenone-4 is not phototoxic, not photosensitising, not photomutagenic and not 17 photoclastogenic. 18 19 Human data 20","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1239","page":61,"route":"oral","species":"rat","study_id":"sccs_o_283_noael_007"}

sccs_o_283.pdf