, and this warrants further, 2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005., Benzophenone-3

SOURCE_SUBDIR=sccs_o_247; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzophenone-3 (CAS No 131-57-7, EC No 205-031-5); OPINION_NUMBER=SCCS/1625/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=unclear:SCCS/1625/20 Final Opinion Opinion on Benzophenone-3 (CAS No 131-57-7, EC No 205-031-5) _________________________________________________________________________________________________________________ 48 were 0. 187 µg/ml in females and 0.238 µg/mL in males. Twenty-four hours after the first application, the median BP-3 levels in plasma were 0.047 µg/ml in females and 0.041 µg/ml in males. This clearly shows that the levels of BP-3 had exceeded the concentration measured in rats at the NOAEL. 3.6 DISCUSSION The 2008 SCCP Opinion (SCCP/1201/08) had noted a number of shortcomings in the data provided as part of the dossier assessed in an earlier Opinion (SCCP/1069/06). Despite this, the SCS agrees with the SCCP Opinion (2008) that the submission provides a reasonably well- structured overview of the available test descriptions and publications. Physicochemical properties BP-3is a widely used UV filter in cosmetic products. It is an off-white to light-yellow powder with a melting point of 62°C to 65°; EFFECT=SCCS/1625/20 Final Opinion Opinion on Benzophenone-3 (CAS No 131-57-7, EC No 205-031-5) _________________________________________________________________________________________________________________ 48 were 0. 187 µg/ml in females and 0.238 µg/mL in males. Twenty-four hours after the first application, the median BP-3 levels in plasma were 0.047 µg/ml in females and 0.041 µg/ml in males. This clearly shows that the levels of BP-3 had exceeded the concentration measured in rats at the NOAEL. 3.6 DISCUSSION The 2008 SCCP Opinion (SCCP/1201/08) had noted a number of shortcomings in the data provided as part of the dossier assessed in an earlier Opinion (SCCP/1069/06). Despite this, the SCS agrees with the SCCP Opinion (2008) that the submission provides a reasonably well- structured overview of the available test descriptions and publications. Physicochemical properties BP-3is a widely used UV filter in cosmetic products. It is an off-white to light-yellow powder with a melting point of 62°C to 65°; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"","duration":"","effect":"SCCS/1625/20 Final Opinion Opinion on Benzophenone-3 (CAS No 131-57-7, EC No 205-031-5) _________________________________________________________________________________________________________________ 48 were 0. 187 µg/ml in females and 0.238 µg/mL in males. Twenty-four hours after the first application, the median BP-3 levels in plasma were 0.047 µg/ml in females and 0.041 µg/ml in males. This clearly shows that the levels of BP-3 had exceeded the concentration measured in rats at the NOAEL. 3.6 DISCUSSION The 2008 SCCP Opinion (SCCP/1201/08) had noted a number of shortcomings in the data provided as part of the dossier assessed in an earlier Opinion (SCCP/1069/06). Despite this, the SCS agrees with the SCCP Opinion (2008) that the submission provides a reasonably well- structured overview of the available test descriptions and publications. Physicochemical properties BP-3is a widely used UV filter in cosmetic products. It is an off-white to light-yellow powder with a melting point of 62°C to 65°","endpoint":"","ingredient":", and this warrants further","loael_value":"","noael_unit":"","noael_value":"unclear:SCCS/1625/20 Final Opinion Opinion on Benzophenone-3 (CAS No 131-57-7, EC No 205-031-5) _________________________________________________________________________________________________________________ 48 were 0. 187 µg/ml in females and 0.238 µg/mL in males. Twenty-four hours after the first application, the median BP-3 levels in plasma were 0.047 µg/ml in females and 0.041 µg/ml in males. This clearly shows that the levels of BP-3 had exceeded the concentration measured in rats at the NOAEL. 3.6 DISCUSSION The 2008 SCCP Opinion (SCCP/1201/08) had noted a number of shortcomings in the data provided as part of the dossier assessed in an earlier Opinion (SCCP/1069/06). Despite this, the SCS agrees with the SCCP Opinion (2008) that the submission provides a reasonably well- structured overview of the available test descriptions and publications. Physicochemical properties BP-3is a widely used UV filter in cosmetic products. It is an off-white to light-yellow powder with a melting point of 62°C to 65°","page":48,"route":"","species":"rat","study_id":"sccs_o_247_noael_013"}

sccs_o_247.pdf

{"absorption_percent":"3.1%; 6%","basis":"The 2008 SCCP Opinion (SCCP/1201/08) concluded that: ‘The major shortcoming in the dossier [assessed in SCCP/1069/06] was the absence of a sound dermal absorption study, allowing the calculation of the Margin of Safety for the UV- filter. The newly provided in vitro dermal absorption study is considered scientifically acceptable and shows a mean dermal absorption level of 19.3 µg/cm² or 3.1% of the applied dose for a sunscreen (o/w or w/o) containing the maximum requested BP-3 concentration of 6%.’","concentration_tested":"The newly provided in vitro dermal absorption study is considered scientifically acceptable and shows a mean dermal absorption level of 19.3 µg/cm² or 3.1% of the applied dose for a sunscreen (o/w or w/o) containing the maximum requested BP-3 concentration...","page":12,"pdf":"sccs_o_247.pdf","row_type":"dermal_absorption_study"}

sccs_o_247.pdf

{"absorption_percent":"3.1%; 6%","basis":"The 2008 SCCP Opinion (SCCP/1201/08) concluded that: ‘The major shortcoming in the dossier [assessed in SCCP/1069/06] was the absence of a sound dermal absorption study, allowing the calculation of the Margin of Safety for the UV- filter. The newly provided in vitro dermal absorption study is considered scientifically acceptable and shows a mean dermal absorption level of 19.3 µg/cm² or 3.1% of the applied dose for a sunscreen (o/w or w/o) containing the maximum requested BP-3 concentration of 6%.’","concentration_tested":"The newly provided in vitro dermal absorption study is considered scientifically acceptable and shows a mean dermal absorption level of 19.3 µg/cm² or 3.1% of the applied dose for a sunscreen (o/w or w/o) containing the maximum requested BP-3 concentration...","page":12,"pdf":"sccs_o_247.pdf","row_type":"dermal_absorption_study"}

sccs_o_247.pdf

{"absorption_percent":"3.1%; 6%","basis":"The 2008 SCCP Opinion (SCCP/1201/08) concluded that: ‘The major shortcoming in the dossier [assessed in SCCP/1069/06] was the absence of a sound dermal absorption study, allowing the calculation of the Margin of Safety for the UV- filter. The newly provided in vitro dermal absorption study is considered scientifically acceptable and shows a mean dermal absorption level of 19.3 µg/cm² or 3.1% of the applied dose for a sunscreen (o/w or w/o) containing the maximum requested BP-3 concentration of 6%.’","concentration_tested":"The newly provided in vitro dermal absorption study is considered scientifically acceptable and shows a mean dermal absorption level of 19.3 µg/cm² or 3.1% of the applied dose for a sunscreen (o/w or w/o) containing the maximum requested BP-3 concentration...","page":12,"pdf":"sccs_o_247.pdf","row_type":"dermal_absorption_study"}

sccs_o_247.pdf

{"effect":"SCCS/1625/20 Final Opinion Opinion on Benzophenone-3 (CAS No 131-57-7, EC No 205-031-5) _________________________________________________________________________________________________________________ 48 were 0. 187 µg/ml in females and 0.238 µg/mL in males. Twenty-four hours after the first application, the median BP-3 levels in plasma were 0.047 µg/ml in females and 0.041 µg/ml in males. This clearly shows that the levels of BP-3 had exceeded the concentration measured in rats at the NOAEL. 3.6 DISCUSSION The 2008 SCCP Opinion (SCCP/1201/08) had noted a number of shortcomings in the data provided as part of the dossier assessed in an earlier Opinion (SCCP/1069/06). Despite this, the SCS agrees with the SCCP Opinion (2008) that the submission provides a reasonably well- structured overview of the available test descriptions and publications. Physicochemical properties BP-3is a widely used UV filter in cosmetic products. It is an off-white to light-yellow powder with a melting point of 62°C to 65°","page":48,"pdf":"sccs_o_247.pdf","row_type":"noael_study","study_id":"sccs_o_247_noael_013"}

sccs_o_247.pdf

{"effect":"SCCS/1625/20 Final Opinion Opinion on Benzophenone-3 (CAS No 131-57-7, EC No 205-031-5) _________________________________________________________________________________________________________________ 48 were 0. 187 µg/ml in females and 0.238 µg/mL in males. Twenty-four hours after the first application, the median BP-3 levels in plasma were 0.047 µg/ml in females and 0.041 µg/ml in males. This clearly shows that the levels of BP-3 had exceeded the concentration measured in rats at the NOAEL. 3.6 DISCUSSION The 2008 SCCP Opinion (SCCP/1201/08) had noted a number of shortcomings in the data provided as part of the dossier assessed in an earlier Opinion (SCCP/1069/06). Despite this, the SCS agrees with the SCCP Opinion (2008) that the submission provides a reasonably well- structured overview of the available test descriptions and publications. Physicochemical properties BP-3is a widely used UV filter in cosmetic products. It is an off-white to light-yellow powder with a melting point of 62°C to 65°","page":48,"pdf":"sccs_o_247.pdf","row_type":"noael_study","study_id":"sccs_o_247_noael_013"}

sccs_o_247.pdf

{"effect":"SCCS/1625/20 Final Opinion Opinion on Benzophenone-3 (CAS No 131-57-7, EC No 205-031-5) _________________________________________________________________________________________________________________ 48 were 0. 187 µg/ml in females and 0.238 µg/mL in males. Twenty-four hours after the first application, the median BP-3 levels in plasma were 0.047 µg/ml in females and 0.041 µg/ml in males. This clearly shows that the levels of BP-3 had exceeded the concentration measured in rats at the NOAEL. 3.6 DISCUSSION The 2008 SCCP Opinion (SCCP/1201/08) had noted a number of shortcomings in the data provided as part of the dossier assessed in an earlier Opinion (SCCP/1069/06). Despite this, the SCS agrees with the SCCP Opinion (2008) that the submission provides a reasonably well- structured overview of the available test descriptions and publications. Physicochemical properties BP-3is a widely used UV filter in cosmetic products. It is an off-white to light-yellow powder with a melting point of 62°C to 65°","page":48,"pdf":"sccs_o_247.pdf","row_type":"noael_study","study_id":"sccs_o_247_noael_013"}

sccs_o_247.pdf

{"effect":"SCCS/1625/20 Final Opinion Opinion on Benzophenone-3 (CAS No 131-57-7, EC No 205-031-5) _________________________________________________________________________________________________________________ 48 were 0. 187 µg/ml in females and 0.238 µg/mL in males. Twenty-four hours after the first application, the median BP-3 levels in plasma were 0.047 µg/ml in females and 0.041 µg/ml in males. This clearly shows that the levels of BP-3 had exceeded the concentration measured in rats at the NOAEL. 3.6 DISCUSSION The 2008 SCCP Opinion (SCCP/1201/08) had noted a number of shortcomings in the data provided as part of the dossier assessed in an earlier Opinion (SCCP/1069/06). Despite this, the SCS agrees with the SCCP Opinion (2008) that the submission provides a reasonably well- structured overview of the available test descriptions and publications. Physicochemical properties BP-3is a widely used UV filter in cosmetic products. It is an off-white to light-yellow powder with a melting point of 62°C to 65°","page":48,"pdf":"sccs_o_247.pdf","row_type":"noael_study","study_id":"sccs_o_247_noael_013"}

sccs_o_247.pdf

SOURCE_SUBDIR=sccs_o_247; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzophenone-3 (CAS No 131-57-7, EC No 205-031-5); OPINION_NUMBER=SCCS/1625/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=200; DOSE=The NOAEL-value for maternal and developmental toxicity was 200 mg/kg bw/day.; EFFECT=ved relative liver weight increase. Analysis of a subset of estrogen-responsive genes showed no change in response to BP-3. Reproductive toxicity The 2008 SCCP Opinion (SCCP/1201/08) noted that the studies provided as part of the dossier assessed in the earlier Opinion (SCCP/1069/06) had indicated that: ‘A teratogenicity study in rats showed BP-3 to be non-teratogenic under the conditions of the test. Only at the highest dosage level, which also caused maternal toxicity, some skeletal aberrations were noted. The NOAEL-value for maternal and developmental toxicity was 200 mg/kg bw/day. A NOAEL value of 400 mg/kg bw/day for reproductive toxicity was extracted from subchronic toxicity studies involving additional reproductive toxicity parameter measurements.’ A more recent NTP modified one-generation study found that gestation body weights of dams receiving 10,000 ppm BP-3 in the diet were slightly lower (~3%) than those of the control group and showed statistically significant differences. Dams receiving 3,000 or 10,000 ppm BP-3; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"The NOAEL-value for maternal and developmental toxicity was 200 mg/kg bw/day.","duration":"developmental","effect":"ved relative liver weight increase. Analysis of a subset of estrogen-responsive genes showed no change in response to BP-3. Reproductive toxicity The 2008 SCCP Opinion (SCCP/1201/08) noted that the studies provided as part of the dossier assessed in the earlier Opinion (SCCP/1069/06) had indicated that: ‘A teratogenicity study in rats showed BP-3 to be non-teratogenic under the conditions of the test. Only at the highest dosage level, which also caused maternal toxicity, some skeletal aberrations were noted. The NOAEL-value for maternal and developmental toxicity was 200 mg/kg bw/day. A NOAEL value of 400 mg/kg bw/day for reproductive toxicity was extracted from subchronic toxicity studies involving additional reproductive toxicity parameter measurements.’ A more recent NTP modified one-generation study found that gestation body weights of dams receiving 10,000 ppm BP-3 in the diet were slightly lower (~3%) than those of the control group and showed statistically significant differences. Dams receiving 3,000 or 10,000 ppm BP-3","endpoint":"repeated dose toxicity","ingredient":", and this warrants further","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":50,"route":"oral","species":"rat","study_id":"sccs_o_247_noael_014"}

sccs_o_247.pdf

SOURCE_SUBDIR=sccs_o_247; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzophenone-3 (CAS No 131-57-7, EC No 205-031-5); OPINION_NUMBER=SCCS/1625/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=200; DOSE=The NOAEL-value for maternal and developmental toxicity was 200 mg/kg bw/day.; EFFECT=ive genes showed no change in response to BP-3. Reproductive toxicity The 2008 SCCP Opinion (SCCP/1201/08) noted that the studies provided as part of the dossier assessed in the earlier Opinion (SCCP/1069/06) had indicated that: ‘A teratogenicity study in rats showed BP-3 to be non-teratogenic under the conditions of the test. Only at the highest dosage level, which also caused maternal toxicity, some skeletal aberrations were noted. The NOAEL-value for maternal and developmental toxicity was 200 mg/kg bw/day. A NOAEL value of 400 mg/kg bw/day for reproductive toxicity was extracted from subchronic toxicity studies involving additional reproductive toxicity parameter measurements.’ A more recent NTP modified one-generation study found that gestation body weights of dams receiving 10,000 ppm BP-3 in the diet were slightly lower (~3%) than those of the control group and showed statistically significant differences. Dams receiving 3,000 or 10,000 ppm BP-3 in the diet displayed slight decreases in GD 6–21 body weight gain (~10%) r; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"The NOAEL-value for maternal and developmental toxicity was 200 mg/kg bw/day.","duration":"developmental","effect":"ive genes showed no change in response to BP-3. Reproductive toxicity The 2008 SCCP Opinion (SCCP/1201/08) noted that the studies provided as part of the dossier assessed in the earlier Opinion (SCCP/1069/06) had indicated that: ‘A teratogenicity study in rats showed BP-3 to be non-teratogenic under the conditions of the test. Only at the highest dosage level, which also caused maternal toxicity, some skeletal aberrations were noted. The NOAEL-value for maternal and developmental toxicity was 200 mg/kg bw/day. A NOAEL value of 400 mg/kg bw/day for reproductive toxicity was extracted from subchronic toxicity studies involving additional reproductive toxicity parameter measurements.’ A more recent NTP modified one-generation study found that gestation body weights of dams receiving 10,000 ppm BP-3 in the diet were slightly lower (~3%) than those of the control group and showed statistically significant differences. Dams receiving 3,000 or 10,000 ppm BP-3 in the diet displayed slight decreases in GD 6–21 body weight gain (~10%) r","endpoint":"repeated dose toxicity","ingredient":", and this warrants further","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":50,"route":"oral","species":"rat","study_id":"sccs_o_247_noael_015"}

sccs_o_247.pdf

SOURCE_SUBDIR=sccs_o_247; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzophenone-3 (CAS No 131-57-7, EC No 205-031-5); OPINION_NUMBER=SCCS/1625/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=200; DOSE=study male rat livers from the 10,000 ppm and control groups.; EFFECT=study male rat livers from the 10,000 ppm and control groups. The observed effects on transcription were consistent with a mild induction of xenobiotic metabolism-related processes that is likely related to the observed relative liver weight increase. Analysis of a subset of estrogen-responsive genes showed no change in response to BP-3. 3.4.4.3 Chronic (> 12 months) toxicity / 3.4.5 Reproductive toxicity The 2008 SCCP Opinion (SCCP/1201/08) noted that ‘the available teratogenicity study in the rat generated a NOAEL-value for maternal and developmental toxicity of 200 mg/kg bw/day, which was used to calculate the MoS ‘. The NOAEL value is derived from a 2005 prenatal developmental toxicity study (https://echa.europa.eu/el/registration-dossier/-/registered- dossier/5515/7/9/3). Other reprotoxicity studies have been published since the release of the previous SCCS opinion. The more informative studies are described below and summarised in Annex-1. The study from Nakamura et al. (2015) brings information of the reprotoxicity of; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"study male rat livers from the 10,000 ppm and control groups.","duration":"Chronic","effect":"study male rat livers from the 10,000 ppm and control groups. The observed effects on transcription were consistent with a mild induction of xenobiotic metabolism-related processes that is likely related to the observed relative liver weight increase. Analysis of a subset of estrogen-responsive genes showed no change in response to BP-3. 3.4.4.3 Chronic (> 12 months) toxicity / 3.4.5 Reproductive toxicity The 2008 SCCP Opinion (SCCP/1201/08) noted that ‘the available teratogenicity study in the rat generated a NOAEL-value for maternal and developmental toxicity of 200 mg/kg bw/day, which was used to calculate the MoS ‘. The NOAEL value is derived from a 2005 prenatal developmental toxicity study (https://echa.europa.eu/el/registration-dossier/-/registered- dossier/5515/7/9/3). Other reprotoxicity studies have been published since the release of the previous SCCS opinion. The more informative studies are described below and summarised in Annex-1. The study from Nakamura et al. (2015) brings information of the reprotoxicity of","endpoint":"reproductive toxicity","ingredient":", and this warrants further","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":26,"route":"","species":"rat","study_id":"sccs_o_247_noael_003"}

sccs_o_247.pdf

SOURCE_SUBDIR=sccs_o_247; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzophenone-3 (CAS No 131-57-7, EC No 205-031-5); OPINION_NUMBER=SCCS/1625/20; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=31 March 2021; VALUE_TEXT=200; DOSE=3.4.4.3 Chronic (> 12 months) toxicity / 3.4.5 Reproductive toxicity The 2008 SCCP Opinion (SCCP/1201/08) noted that ‘the available teratogenicity study in the rat generated a NOAEL-value for maternal and developmental toxicity of 200 mg/kg bw/day, which was used to calculate the MoS ‘.; EFFECT=with a mild induction of xenobiotic metabolism-related processes that is likely related to the observed relative liver weight increase. Analysis of a subset of estrogen-responsive genes showed no change in response to BP-3. 3.4.4.3 Chronic (> 12 months) toxicity / 3.4.5 Reproductive toxicity The 2008 SCCP Opinion (SCCP/1201/08) noted that ‘the available teratogenicity study in the rat generated a NOAEL-value for maternal and developmental toxicity of 200 mg/kg bw/day, which was used to calculate the MoS ‘. The NOAEL value is derived from a 2005 prenatal developmental toxicity study (https://echa.europa.eu/el/registration-dossier/-/registered- dossier/5515/7/9/3). Other reprotoxicity studies have been published since the release of the previous SCCS opinion. The more informative studies are described below and summarised in Annex-1. The study from Nakamura et al. (2015) brings information of the reprotoxicity of BP-3 and also on some ED properties. This study is therefore described in this section and also in more detail in th; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"3.4.4.3 Chronic (> 12 months) toxicity / 3.4.5 Reproductive toxicity The 2008 SCCP Opinion (SCCP/1201/08) noted that ‘the available teratogenicity study in the rat generated a NOAEL-value for maternal and developmental toxicity of 200 mg/kg bw/day, which was used to calculate the MoS ‘.","duration":"Chronic","effect":"with a mild induction of xenobiotic metabolism-related processes that is likely related to the observed relative liver weight increase. Analysis of a subset of estrogen-responsive genes showed no change in response to BP-3. 3.4.4.3 Chronic (> 12 months) toxicity / 3.4.5 Reproductive toxicity The 2008 SCCP Opinion (SCCP/1201/08) noted that ‘the available teratogenicity study in the rat generated a NOAEL-value for maternal and developmental toxicity of 200 mg/kg bw/day, which was used to calculate the MoS ‘. The NOAEL value is derived from a 2005 prenatal developmental toxicity study (https://echa.europa.eu/el/registration-dossier/-/registered- dossier/5515/7/9/3). Other reprotoxicity studies have been published since the release of the previous SCCS opinion. The more informative studies are described below and summarised in Annex-1. The study from Nakamura et al. (2015) brings information of the reprotoxicity of BP-3 and also on some ED properties. This study is therefore described in this section and also in more detail in th","endpoint":"reproductive toxicity","ingredient":", and this warrants further","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":26,"route":"","species":"rat","study_id":"sccs_o_247_noael_004"}

sccs_o_247.pdf

SOURCE_SUBDIR=sccp_o_159; REPORT_TITLE=OPINION ON Benzophenone-3 COLIPA n° S38; OPINION_NUMBER=SCCP/1201/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=The SCCP was unable to calculate the Margin of Safety for BP-3 as no scientifically; EFFECT=Unlabeled table on page 7: The SCCP was unable to calculate the Margin of Safety for BP-3 as no scientifically; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 7: The SCCP was unable to calculate the Margin of Safety for BP-3 as no scientifically","endpoint":"","ingredient":"2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005.","loael_value":"","noael_unit":"","noael_value":"The SCCP was unable to calculate the Margin of Safety for BP-3 as no scientifically","page":7,"route":"","species":"","study_id":"sccp_o_159_noael_015"}

sccp_o_159.pdf

SOURCE_SUBDIR=sccp_o_159; REPORT_TITLE=OPINION ON Benzophenone-3 COLIPA n° S38; OPINION_NUMBER=SCCP/1201/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=0.5; EFFECT=Unlabeled table on page 13: protect formulations up to 0.5% in all types of cosmetics), the MoS of BP-3 is above 100.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 13: protect formulations up to 0.5% in all types of cosmetics), the MoS of BP-3 is above 100.","endpoint":"","ingredient":"2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005.","loael_value":"","noael_unit":"%","noael_value":"0.5","page":13,"route":"","species":"","study_id":"sccp_o_159_noael_023"}

sccp_o_159.pdf

SOURCE_SUBDIR=sccp_o_159; REPORT_TITLE=OPINION ON Benzophenone-3 COLIPA n° S38; OPINION_NUMBER=SCCP/1201/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=3.2 DATA INTRODUCED; EFFECT=Unlabeled table on page 7: 3.2 DATA INTRODUCED; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 7: 3.2 DATA INTRODUCED","endpoint":"","ingredient":"2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005.","loael_value":"","noael_unit":"","noael_value":"3.2 DATA INTRODUCED","page":7,"route":"","species":"","study_id":"sccp_o_159_noael_016"}

sccp_o_159.pdf

SOURCE_SUBDIR=sccp_o_159; REPORT_TITLE=OPINION ON Benzophenone-3 COLIPA n° S38; OPINION_NUMBER=SCCP/1201/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=section 3.2.4.; EFFECT=Unlabeled table on page 13: section 3.2.4.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 13: section 3.2.4.","endpoint":"","ingredient":"2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005.","loael_value":"","noael_unit":"","noael_value":"section 3.2.4.","page":13,"route":"","species":"","study_id":"sccp_o_159_noael_021"}

sccp_o_159.pdf

SOURCE_SUBDIR=sccp_o_159; REPORT_TITLE=OPINION ON Benzophenone-3 COLIPA n° S38; OPINION_NUMBER=SCCP/1201/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=under 3.2.3, support the statements of SCCP/1069/06 and do not introduce new discussion; EFFECT=Unlabeled table on page 13: under 3.2.3, support the statements of SCCP/1069/06 and do not introduce new discussion; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 13: under 3.2.3, support the statements of SCCP/1069/06 and do not introduce new discussion","endpoint":"","ingredient":"2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005.","loael_value":"","noael_unit":"","noael_value":"under 3.2.3, support the statements of SCCP/1069/06 and do not introduce new discussion","page":13,"route":"","species":"","study_id":"sccp_o_159_noael_024"}

sccp_o_159.pdf

SOURCE_SUBDIR=sccp_o_159; REPORT_TITLE=OPINION ON Benzophenone-3 COLIPA n° S38; OPINION_NUMBER=SCCP/1201/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=unclear:Unlabeled table on page 6: reversible. Therefore, according to the 2005-submission, the oral NOAEL corresponded to; EFFECT=Unlabeled table on page 6: reversible. Therefore, according to the 2005-submission, the oral NOAEL corresponded to; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 6: reversible. Therefore, according to the 2005-submission, the oral NOAEL corresponded to","endpoint":"","ingredient":"2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005.","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 6: reversible. Therefore, according to the 2005-submission, the oral NOAEL corresponded to","page":6,"route":"oral","species":"","study_id":"sccp_o_159_noael_009"}

sccp_o_159.pdf

SOURCE_SUBDIR=sccp_o_159; REPORT_TITLE=OPINION ON Benzophenone-3 COLIPA n° S38; OPINION_NUMBER=SCCP/1201/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=6; EFFECT=Unlabeled table on page 13: sunscreen (o/w or w/o) containing the maximum requested BP-3 concentration of 6%.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 13: sunscreen (o/w or w/o) containing the maximum requested BP-3 concentration of 6%.","endpoint":"","ingredient":"2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005.","loael_value":"","noael_unit":"%","noael_value":"6","page":13,"route":"","species":"","study_id":"sccp_o_159_noael_019"}

sccp_o_159.pdf

SOURCE_SUBDIR=sccp_o_159; REPORT_TITLE=OPINION ON Benzophenone-3 COLIPA n° S38; OPINION_NUMBER=SCCP/1201/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=6; EFFECT=Unlabeled table on page 13: For both requested use patterns (as a UV filter up to 6% in sunscreens and as a UV filter to; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 13: For both requested use patterns (as a UV filter up to 6% in sunscreens and as a UV filter to","endpoint":"","ingredient":"2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005.","loael_value":"","noael_unit":"%","noael_value":"6","page":13,"route":"","species":"","study_id":"sccp_o_159_noael_022"}

sccp_o_159.pdf

SOURCE_SUBDIR=sccp_o_159; REPORT_TITLE=OPINION ON Benzophenone-3 COLIPA n° S38; OPINION_NUMBER=SCCP/1201/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=unclear:Unlabeled table on page 13: The available teratogenicity study in the rat generated a NOAEL-value for maternal and; EFFECT=Unlabeled table on page 13: The available teratogenicity study in the rat generated a NOAEL-value for maternal and; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 13: The available teratogenicity study in the rat generated a NOAEL-value for maternal and","endpoint":"","ingredient":"2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005.","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 13: The available teratogenicity study in the rat generated a NOAEL-value for maternal and","page":13,"route":"","species":"rat","study_id":"sccp_o_159_noael_017"}

sccp_o_159.pdf

SOURCE_SUBDIR=sccp_o_159; REPORT_TITLE=OPINION ON Benzophenone-3 COLIPA n° S38; OPINION_NUMBER=SCCP/1201/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=(cid:56) Toxicokinetic studies indicated that BP-3 was readily biotransformed into its three major; EFFECT=Unlabeled table on page 7: (cid:56) Toxicokinetic studies indicated that BP-3 was readily biotransformed into its three major; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 7: (cid:56) Toxicokinetic studies indicated that BP-3 was readily biotransformed into its three major","endpoint":"","ingredient":"2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005.","loael_value":"","noael_unit":"","noael_value":"(cid:56) Toxicokinetic studies indicated that BP-3 was readily biotransformed into its three major","page":7,"route":"","species":"","study_id":"sccp_o_159_noael_013"}

sccp_o_159.pdf

SOURCE_SUBDIR=sccp_o_159; REPORT_TITLE=OPINION ON Benzophenone-3 COLIPA n° S38; OPINION_NUMBER=SCCP/1201/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=(cid:56) As far as the (photo)mutagenic/(photo)genotoxic potential of BP-3 was concerned, the; EFFECT=Unlabeled table on page 7: (cid:56) As far as the (photo)mutagenic/(photo)genotoxic potential of BP-3 was concerned, the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 7: (cid:56) As far as the (photo)mutagenic/(photo)genotoxic potential of BP-3 was concerned, the","endpoint":"","ingredient":"2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005.","loael_value":"","noael_unit":"","noael_value":"(cid:56) As far as the (photo)mutagenic/(photo)genotoxic potential of BP-3 was concerned, the","page":7,"route":"","species":"","study_id":"sccp_o_159_noael_014"}

sccp_o_159.pdf

SOURCE_SUBDIR=sccp_o_159; REPORT_TITLE=OPINION ON Benzophenone-3 COLIPA n° S38; OPINION_NUMBER=SCCP/1201/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=200; DOSE=Unlabeled table on page 6: dermal NOAEL of 200 mg/kg bw/day was put forward, on the assumption that deviations; EFFECT=Unlabeled table on page 6: dermal NOAEL of 200 mg/kg bw/day was put forward, on the assumption that deviations; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"Unlabeled table on page 6: dermal NOAEL of 200 mg/kg bw/day was put forward, on the assumption that deviations","duration":"","effect":"Unlabeled table on page 6: dermal NOAEL of 200 mg/kg bw/day was put forward, on the assumption that deviations","endpoint":"","ingredient":"2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005.","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":6,"route":"dermal","species":"","study_id":"sccp_o_159_noael_010"}

sccp_o_159.pdf

{"dose":"9.9% [mean (3.1%) + 2 SD (2*3.4%)] Applied dose (sunscreen):","effect":"SCCP/1201/08 Opinion on benzophenone-3 13 3.2.4 Safety evaluation (including calculation of the MoS) BP-3 as a UV-filter in sunscreens up to 6% Dermal absorption (6% formulation): 9.9% [mean (3.1%) + 2 SD (2*3.4%)] Applied dose (sunscreen): 18 g/day Typical human body weight: 60 kg No observed effect level NOAEL (terato-rat): 200 mg/kg bw/day Systemic exposure dose (SED) = (18.103 mg/day * 6/100 * 9.9/100) / 60 kg = 1.78 mg/kg bw/day MoS = NOAEL / SED = 112 BP-3 as a UV-filter at 0.5% to protect cosmetic formulations against sunlight Dermal absorption (2% formulation): 8.0% [mean (4.0%) + 2 SD (2*2.0%)] Applied dose (all cosmetic products): 17.79 g/day Typical human body weight: 60 kg No observed effect level NOAEL (terato-rat): 200 mg/kg bw/day Systemic exposure dose (SED) = (17.79.103 mg/day * 0.5/100 * 8.0/100) / 60 kg = 0.119 mg/kg bw/day MoS = NOAEL / SED = 1686 3.2.5 Discussion A detailed discussion on the general toxicological profile of B","page":13,"pdf":"sccp_o_159.pdf","row_type":"noael_study","study_id":"sccp_o_159_noael_005"}

sccp_o_159.pdf

{"dose":"9.9% [mean (3.1%) + 2 SD (2*3.4%)] Applied dose (sunscreen):","effect":"SCCP/1201/08 Opinion on benzophenone-3 13 3.2.4 Safety evaluation (including calculation of the MoS) BP-3 as a UV-filter in sunscreens up to 6% Dermal absorption (6% formulation): 9.9% [mean (3.1%) + 2 SD (2*3.4%)] Applied dose (sunscreen): 18 g/day Typical human body weight: 60 kg No observed effect level NOAEL (terato-rat): 200 mg/kg bw/day Systemic exposure dose (SED) = (18.103 mg/day * 6/100 * 9.9/100) / 60 kg = 1.78 mg/kg bw/day MoS = NOAEL / SED = 112 BP-3 as a UV-filter at 0.5% to protect cosmetic formulations against sunlight Dermal absorption (2% formulation): 8.0% [mean (4.0%) + 2 SD (2*2.0%)] Applied dose (all cosmetic products): 17.79 g/day Typical human body weight: 60 kg No observed effect level NOAEL (terato-rat): 200 mg/kg bw/day Systemic exposure dose (SED) = (17.79.103 mg/day * 0.5/100 * 8.0/100) / 60 kg = 0.119 mg/kg bw/day MoS = NOAEL / SED = 1686 3.2.5 Discussion A detailed discussion on the general toxicological profile of B","page":13,"pdf":"sccp_o_159.pdf","row_type":"noael_study","study_id":"sccp_o_159_noael_005"}

sccp_o_159.pdf

{"dose":"9.9% [mean (3.1%) + 2 SD (2*3.4%)] Applied dose (sunscreen):","effect":"SCCP/1201/08 Opinion on benzophenone-3 13 3.2.4 Safety evaluation (including calculation of the MoS) BP-3 as a UV-filter in sunscreens up to 6% Dermal absorption (6% formulation): 9.9% [mean (3.1%) + 2 SD (2*3.4%)] Applied dose (sunscreen): 18 g/day Typical human body weight: 60 kg No observed effect level NOAEL (terato-rat): 200 mg/kg bw/day Systemic exposure dose (SED) = (18.103 mg/day * 6/100 * 9.9/100) / 60 kg = 1.78 mg/kg bw/day MoS = NOAEL / SED = 112 BP-3 as a UV-filter at 0.5% to protect cosmetic formulations against sunlight Dermal absorption (2% formulation): 8.0% [mean (4.0%) + 2 SD (2*2.0%)] Applied dose (all cosmetic products): 17.79 g/day Typical human body weight: 60 kg No observed effect level NOAEL (terato-rat): 200 mg/kg bw/day Systemic exposure dose (SED) = (17.79.103 mg/day * 0.5/100 * 8.0/100) / 60 kg = 0.119 mg/kg bw/day MoS = NOAEL / SED = 1686 3.2.5 Discussion A detailed discussion on the general toxicological profile of B","page":13,"pdf":"sccp_o_159.pdf","row_type":"noael_study","study_id":"sccp_o_159_noael_005"}

sccp_o_159.pdf

{"dose":"9.9% [mean (3.1%) + 2 SD (2*3.4%)] Applied dose (sunscreen):","effect":"SCCP/1201/08 Opinion on benzophenone-3 13 3.2.4 Safety evaluation (including calculation of the MoS) BP-3 as a UV-filter in sunscreens up to 6% Dermal absorption (6% formulation): 9.9% [mean (3.1%) + 2 SD (2*3.4%)] Applied dose (sunscreen): 18 g/day Typical human body weight: 60 kg No observed effect level NOAEL (terato-rat): 200 mg/kg bw/day Systemic exposure dose (SED) = (18.103 mg/day * 6/100 * 9.9/100) / 60 kg = 1.78 mg/kg bw/day MoS = NOAEL / SED = 112 BP-3 as a UV-filter at 0.5% to protect cosmetic formulations against sunlight Dermal absorption (2% formulation): 8.0% [mean (4.0%) + 2 SD (2*2.0%)] Applied dose (all cosmetic products): 17.79 g/day Typical human body weight: 60 kg No observed effect level NOAEL (terato-rat): 200 mg/kg bw/day Systemic exposure dose (SED) = (17.79.103 mg/day * 0.5/100 * 8.0/100) / 60 kg = 0.119 mg/kg bw/day MoS = NOAEL / SED = 1686 3.2.5 Discussion A detailed discussion on the general toxicological profile of B","page":13,"pdf":"sccp_o_159.pdf","row_type":"noael_study","study_id":"sccp_o_159_noael_005"}

sccp_o_159.pdf

SOURCE_SUBDIR=sccp_o_159; REPORT_TITLE=OPINION ON Benzophenone-3 COLIPA n° S38; OPINION_NUMBER=SCCP/1201/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT== 0.119; DOSE=temic exposure dose (SED) = (18.103 mg/day * 6/100 * 9.9/100) / 60 kg = 1.78 mg/kg bw/day MoS = NOAEL / SED = 112 BP-3 as a UV-filter at 0.5% to protect cosmetic formulations against sunlight Dermal absorption (2% formulation):; EFFECT=temic exposure dose (SED) = (18.103 mg/day * 6/100 * 9.9/100) / 60 kg = 1.78 mg/kg bw/day MoS = NOAEL / SED = 112 BP-3 as a UV-filter at 0.5% to protect cosmetic formulations against sunlight Dermal absorption (2% formulation): 8.0% [mean (4.0%) + 2 SD (2*2.0%)] Applied dose (all cosmetic products): 17.79 g/day Typical human body weight: 60 kg No observed effect level NOAEL (terato-rat): 200 mg/kg bw/day Systemic exposure dose (SED) = (17.79.103 mg/day * 0.5/100 * 8.0/100) / 60 kg = 0.119 mg/kg bw/day MoS = NOAEL / SED = 1686 3.2.5 Discussion A detailed discussion on the general toxicological profile of BP-3 was given in SCCP/1069/06 and taken over under section 3.1 of the current opinion. The major shortcoming in the dossier was the absence of a sound dermal absorption study, allowing the calculation of the Margin of Safety for the UV-filter. The newly provided in vitro dermal absorption study is considered scientifically acceptable and shows a mean dermal absorption level of 19.3 µg/cm² or 3.1% of the applied dose fo; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"temic exposure dose (SED) = (18.103 mg/day * 6/100 * 9.9/100) / 60 kg = 1.78 mg/kg bw/day MoS = NOAEL / SED = 112 BP-3 as a UV-filter at 0.5% to protect cosmetic formulations against sunlight Dermal absorption (2% formulation):","duration":"","effect":"temic exposure dose (SED) = (18.103 mg/day * 6/100 * 9.9/100) / 60 kg = 1.78 mg/kg bw/day MoS = NOAEL / SED = 112 BP-3 as a UV-filter at 0.5% to protect cosmetic formulations against sunlight Dermal absorption (2% formulation): 8.0% [mean (4.0%) + 2 SD (2*2.0%)] Applied dose (all cosmetic products): 17.79 g/day Typical human body weight: 60 kg No observed effect level NOAEL (terato-rat): 200 mg/kg bw/day Systemic exposure dose (SED) = (17.79.103 mg/day * 0.5/100 * 8.0/100) / 60 kg = 0.119 mg/kg bw/day MoS = NOAEL / SED = 1686 3.2.5 Discussion A detailed discussion on the general toxicological profile of BP-3 was given in SCCP/1069/06 and taken over under section 3.1 of the current opinion. The major shortcoming in the dossier was the absence of a sound dermal absorption study, allowing the calculation of the Margin of Safety for the UV-filter. The newly provided in vitro dermal absorption study is considered scientifically acceptable and shows a mean dermal absorption level of 19.3 µg/cm² or 3.1% of the applied dose fo","endpoint":"dermal absorption","ingredient":"2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005.","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 0.119","page":13,"route":"dermal","species":"rat","study_id":"sccp_o_159_noael_007"}

sccp_o_159.pdf

SOURCE_SUBDIR=sccp_o_159; REPORT_TITLE=OPINION ON Benzophenone-3 COLIPA n° S38; OPINION_NUMBER=SCCP/1201/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT== 1.78; DOSE=9.9% [mean (3.1%) + 2 SD (2*3.4%)] Applied dose (sunscreen):; EFFECT=SCCP/1201/08 Opinion on benzophenone-3 13 3.2.4 Safety evaluation (including calculation of the MoS) BP-3 as a UV-filter in sunscreens up to 6% Dermal absorption (6% formulation): 9.9% [mean (3.1%) + 2 SD (2*3.4%)] Applied dose (sunscreen): 18 g/day Typical human body weight: 60 kg No observed effect level NOAEL (terato-rat): 200 mg/kg bw/day Systemic exposure dose (SED) = (18.103 mg/day * 6/100 * 9.9/100) / 60 kg = 1.78 mg/kg bw/day MoS = NOAEL / SED = 112 BP-3 as a UV-filter at 0.5% to protect cosmetic formulations against sunlight Dermal absorption (2% formulation): 8.0% [mean (4.0%) + 2 SD (2*2.0%)] Applied dose (all cosmetic products): 17.79 g/day Typical human body weight: 60 kg No observed effect level NOAEL (terato-rat): 200 mg/kg bw/day Systemic exposure dose (SED) = (17.79.103 mg/day * 0.5/100 * 8.0/100) / 60 kg = 0.119 mg/kg bw/day MoS = NOAEL / SED = 1686 3.2.5 Discussion A detailed discussion on the general toxicological profile of B; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"9.9% [mean (3.1%) + 2 SD (2*3.4%)] Applied dose (sunscreen):","duration":"","effect":"SCCP/1201/08 Opinion on benzophenone-3 13 3.2.4 Safety evaluation (including calculation of the MoS) BP-3 as a UV-filter in sunscreens up to 6% Dermal absorption (6% formulation): 9.9% [mean (3.1%) + 2 SD (2*3.4%)] Applied dose (sunscreen): 18 g/day Typical human body weight: 60 kg No observed effect level NOAEL (terato-rat): 200 mg/kg bw/day Systemic exposure dose (SED) = (18.103 mg/day * 6/100 * 9.9/100) / 60 kg = 1.78 mg/kg bw/day MoS = NOAEL / SED = 112 BP-3 as a UV-filter at 0.5% to protect cosmetic formulations against sunlight Dermal absorption (2% formulation): 8.0% [mean (4.0%) + 2 SD (2*2.0%)] Applied dose (all cosmetic products): 17.79 g/day Typical human body weight: 60 kg No observed effect level NOAEL (terato-rat): 200 mg/kg bw/day Systemic exposure dose (SED) = (17.79.103 mg/day * 0.5/100 * 8.0/100) / 60 kg = 0.119 mg/kg bw/day MoS = NOAEL / SED = 1686 3.2.5 Discussion A detailed discussion on the general toxicological profile of B","endpoint":"dermal absorption","ingredient":"2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005.","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 1.78","page":13,"route":"dermal","species":"rat","study_id":"sccp_o_159_noael_005"}

sccp_o_159.pdf

SOURCE_SUBDIR=sccp_o_159; REPORT_TITLE=OPINION ON Benzophenone-3 COLIPA n° S38; OPINION_NUMBER=SCCP/1201/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=19.3; DOSE=Unlabeled table on page 13: and shows a mean dermal absorption level of 19.3 µg/cm² or 3.1% of the applied dose for a; EFFECT=Unlabeled table on page 13: and shows a mean dermal absorption level of 19.3 µg/cm² or 3.1% of the applied dose for a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"Unlabeled table on page 13: and shows a mean dermal absorption level of 19.3 µg/cm² or 3.1% of the applied dose for a","duration":"","effect":"Unlabeled table on page 13: and shows a mean dermal absorption level of 19.3 µg/cm² or 3.1% of the applied dose for a","endpoint":"dermal absorption","ingredient":"2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005.","loael_value":"","noael_unit":"µg/cm","noael_value":"19.3","page":13,"route":"dermal","species":"","study_id":"sccp_o_159_noael_018"}

sccp_o_159.pdf

SOURCE_SUBDIR=sccp_o_159; REPORT_TITLE=OPINION ON Benzophenone-3 COLIPA n° S38; OPINION_NUMBER=SCCP/1201/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=200; DOSE=9.9% [mean (3.1%) + 2 SD (2*3.4%)] Applied dose (sunscreen):; EFFECT=SCCP/1201/08 Opinion on benzophenone-3 13 3.2.4 Safety evaluation (including calculation of the MoS) BP-3 as a UV-filter in sunscreens up to 6% Dermal absorption (6% formulation): 9.9% [mean (3.1%) + 2 SD (2*3.4%)] Applied dose (sunscreen): 18 g/day Typical human body weight: 60 kg No observed effect level NOAEL (terato-rat): 200 mg/kg bw/day Systemic exposure dose (SED) = (18.103 mg/day * 6/100 * 9.9/100) / 60 kg = 1.78 mg/kg bw/day MoS = NOAEL / SED = 112 BP-3 as a UV-filter at 0.5% to protect cosmetic formulations against sunlight Dermal absorption (2% formulation): 8.0% [mean (4.0%) + 2 SD (2*2.0%)] Applied dose (all cosmetic products): 17.79 g/day Typical human body weight: 60 kg No observed effect level NOAEL (terato-rat): 200 mg/kg bw/day Systemic exposure dose (SED) = (17.79.103 mg/day * 0.5/100 * 8.0/100); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"9.9% [mean (3.1%) + 2 SD (2*3.4%)] Applied dose (sunscreen):","duration":"","effect":"SCCP/1201/08 Opinion on benzophenone-3 13 3.2.4 Safety evaluation (including calculation of the MoS) BP-3 as a UV-filter in sunscreens up to 6% Dermal absorption (6% formulation): 9.9% [mean (3.1%) + 2 SD (2*3.4%)] Applied dose (sunscreen): 18 g/day Typical human body weight: 60 kg No observed effect level NOAEL (terato-rat): 200 mg/kg bw/day Systemic exposure dose (SED) = (18.103 mg/day * 6/100 * 9.9/100) / 60 kg = 1.78 mg/kg bw/day MoS = NOAEL / SED = 112 BP-3 as a UV-filter at 0.5% to protect cosmetic formulations against sunlight Dermal absorption (2% formulation): 8.0% [mean (4.0%) + 2 SD (2*2.0%)] Applied dose (all cosmetic products): 17.79 g/day Typical human body weight: 60 kg No observed effect level NOAEL (terato-rat): 200 mg/kg bw/day Systemic exposure dose (SED) = (17.79.103 mg/day * 0.5/100 * 8.0/100)","endpoint":"dermal absorption","ingredient":"2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005.","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":13,"route":"dermal","species":"rat","study_id":"sccp_o_159_noael_004"}

sccp_o_159.pdf

SOURCE_SUBDIR=sccp_o_159; REPORT_TITLE=OPINION ON Benzophenone-3 COLIPA n° S38; OPINION_NUMBER=SCCP/1201/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=200; DOSE=(2*3.4%)] Applied dose (sunscreen):; EFFECT=(2*3.4%)] Applied dose (sunscreen): 18 g/day Typical human body weight: 60 kg No observed effect level NOAEL (terato-rat): 200 mg/kg bw/day Systemic exposure dose (SED) = (18.103 mg/day * 6/100 * 9.9/100) / 60 kg = 1.78 mg/kg bw/day MoS = NOAEL / SED = 112 BP-3 as a UV-filter at 0.5% to protect cosmetic formulations against sunlight Dermal absorption (2% formulation): 8.0% [mean (4.0%) + 2 SD (2*2.0%)] Applied dose (all cosmetic products): 17.79 g/day Typical human body weight: 60 kg No observed effect level NOAEL (terato-rat): 200 mg/kg bw/day Systemic exposure dose (SED) = (17.79.103 mg/day * 0.5/100 * 8.0/100) / 60 kg = 0.119 mg/kg bw/day MoS = NOAEL / SED = 1686 3.2.5 Discussion A detailed discussion on the general toxicological profile of BP-3 was given in SCCP/1069/06 and taken over under section 3.1 of the current opinion. The major shortcoming in the dossier was the absence of a sound dermal absorption study, allowing the calculation of the Margin of Safety for the UV-filter. The newly provided in vitro dermal; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"(2*3.4%)] Applied dose (sunscreen):","duration":"","effect":"(2*3.4%)] Applied dose (sunscreen): 18 g/day Typical human body weight: 60 kg No observed effect level NOAEL (terato-rat): 200 mg/kg bw/day Systemic exposure dose (SED) = (18.103 mg/day * 6/100 * 9.9/100) / 60 kg = 1.78 mg/kg bw/day MoS = NOAEL / SED = 112 BP-3 as a UV-filter at 0.5% to protect cosmetic formulations against sunlight Dermal absorption (2% formulation): 8.0% [mean (4.0%) + 2 SD (2*2.0%)] Applied dose (all cosmetic products): 17.79 g/day Typical human body weight: 60 kg No observed effect level NOAEL (terato-rat): 200 mg/kg bw/day Systemic exposure dose (SED) = (17.79.103 mg/day * 0.5/100 * 8.0/100) / 60 kg = 0.119 mg/kg bw/day MoS = NOAEL / SED = 1686 3.2.5 Discussion A detailed discussion on the general toxicological profile of BP-3 was given in SCCP/1069/06 and taken over under section 3.1 of the current opinion. The major shortcoming in the dossier was the absence of a sound dermal absorption study, allowing the calculation of the Margin of Safety for the UV-filter. The newly provided in vitro dermal","endpoint":"dermal absorption","ingredient":"2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005.","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":13,"route":"dermal","species":"rat","study_id":"sccp_o_159_noael_006"}

sccp_o_159.pdf

SOURCE_SUBDIR=sccp_o_159; REPORT_TITLE=OPINION ON Benzophenone-3 COLIPA n° S38; OPINION_NUMBER=SCCP/1201/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=unclear:Unlabeled table on page 7: skeletal aberrations were noted. The NOAEL-value for maternal and developmental; EFFECT=Unlabeled table on page 7: skeletal aberrations were noted. The NOAEL-value for maternal and developmental; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"","duration":"developmental","effect":"Unlabeled table on page 7: skeletal aberrations were noted. The NOAEL-value for maternal and developmental","endpoint":"developmental toxicity","ingredient":"2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005.","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 7: skeletal aberrations were noted. The NOAEL-value for maternal and developmental","page":7,"route":"","species":"","study_id":"sccp_o_159_noael_011"}

sccp_o_159.pdf

SOURCE_SUBDIR=sccp_o_159; REPORT_TITLE=OPINION ON Benzophenone-3 COLIPA n° S38; OPINION_NUMBER=SCCP/1201/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=200; DOSE=The newly provided in vitro dermal absorption study is considered scientifically acceptable and shows a mean dermal absorption level of 19.3 µg/cm² or 3.1% of the applied dose for a sunscreen (o/w or w/o) containing the maximum requested BP-3 concentration of 6%.; EFFECT=der section 3.1 of the current opinion. The major shortcoming in the dossier was the absence of a sound dermal absorption study, allowing the calculation of the Margin of Safety for the UV-filter. The newly provided in vitro dermal absorption study is considered scientifically acceptable and shows a mean dermal absorption level of 19.3 µg/cm² or 3.1% of the applied dose for a sunscreen (o/w or w/o) containing the maximum requested BP-3 concentration of 6%. The available teratogenicity study in the rat generated a NOAEL-value for maternal and developmental toxicity of 200 mg/kg bw/day, which was used to calculate the MoS under section 3.2.4. For both requested use patterns (as a UV filter up to 6% in sunscreens and as a UV filter to protect formulations up to 0.5% in all types of cosmetics), the MoS of BP-3 is above 100. The additional literature references provided in the most recent submission and summarized under 3.2.3, support the statements of SCCP/1069/06 and do not introduce new discussion points.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"The newly provided in vitro dermal absorption study is considered scientifically acceptable and shows a mean dermal absorption level of 19.3 µg/cm² or 3.1% of the applied dose for a sunscreen (o/w or w/o) containing the maximum requested BP-3 concentration of 6%.","duration":"developmental","effect":"der section 3.1 of the current opinion. The major shortcoming in the dossier was the absence of a sound dermal absorption study, allowing the calculation of the Margin of Safety for the UV-filter. The newly provided in vitro dermal absorption study is considered scientifically acceptable and shows a mean dermal absorption level of 19.3 µg/cm² or 3.1% of the applied dose for a sunscreen (o/w or w/o) containing the maximum requested BP-3 concentration of 6%. The available teratogenicity study in the rat generated a NOAEL-value for maternal and developmental toxicity of 200 mg/kg bw/day, which was used to calculate the MoS under section 3.2.4. For both requested use patterns (as a UV filter up to 6% in sunscreens and as a UV filter to protect formulations up to 0.5% in all types of cosmetics), the MoS of BP-3 is above 100. The additional literature references provided in the most recent submission and summarized under 3.2.3, support the statements of SCCP/1069/06 and do not introduce new discussion points.","endpoint":"developmental toxicity","ingredient":"2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005.","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":13,"route":"dermal","species":"rat","study_id":"sccp_o_159_noael_008"}

sccp_o_159.pdf

SOURCE_SUBDIR=sccp_o_159; REPORT_TITLE=OPINION ON Benzophenone-3 COLIPA n° S38; OPINION_NUMBER=SCCP/1201/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=200; DOSE=Unlabeled table on page 13: developmental toxicity of 200 mg/kg bw/day, which was used to calculate the MoS under; EFFECT=Unlabeled table on page 13: developmental toxicity of 200 mg/kg bw/day, which was used to calculate the MoS under; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"Unlabeled table on page 13: developmental toxicity of 200 mg/kg bw/day, which was used to calculate the MoS under","duration":"developmental","effect":"Unlabeled table on page 13: developmental toxicity of 200 mg/kg bw/day, which was used to calculate the MoS under","endpoint":"developmental toxicity","ingredient":"2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005.","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":13,"route":"","species":"","study_id":"sccp_o_159_noael_020"}

sccp_o_159.pdf

SOURCE_SUBDIR=sccp_o_159; REPORT_TITLE=OPINION ON Benzophenone-3 COLIPA n° S38; OPINION_NUMBER=SCCP/1201/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=200; DOSE=Therefore, according to the 2005-submission, the oral NOAEL corresponded to 411 mg/kg bw/day.; EFFECT=SCCS-rejected applicant NOAEL: ciated with changes in clinical chemistry. Very often the most susceptible parameter was the increase in liver weight. The latter, however, without any histopathological correlate, is not considered by the submission authors to reflect an adverse effect per se but should be considered as an adaptive metabolic response which is known to be reversible. Therefore, according to the 2005-submission, the oral NOAEL corresponded to 411 mg/kg bw/day. With regard to the results of the dermal repeated dose studies, a dermal NOAEL of 200 mg/kg bw/day was put forward, on the assumption that deviations without dose-response relationship and without correlated histopathological findings (e.g. the decreased reticulocyte count, increased relative kidney weight, increased platelet count and whole blood cell count in the 90d dermal study in rat) should not be taken into account. 8 A teratogenicity study in rat showed BP-3 to be non-teratogenic under the conditions of the test. Only at the highest dosage level, which also caused maternal toxicity,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"Therefore, according to the 2005-submission, the oral NOAEL corresponded to 411 mg/kg bw/day.","duration":"90d","effect":"SCCS-rejected applicant NOAEL: ciated with changes in clinical chemistry. Very often the most susceptible parameter was the increase in liver weight. The latter, however, without any histopathological correlate, is not considered by the submission authors to reflect an adverse effect per se but should be considered as an adaptive metabolic response which is known to be reversible. Therefore, according to the 2005-submission, the oral NOAEL corresponded to 411 mg/kg bw/day. With regard to the results of the dermal repeated dose studies, a dermal NOAEL of 200 mg/kg bw/day was put forward, on the assumption that deviations without dose-response relationship and without correlated histopathological findings (e.g. the decreased reticulocyte count, increased relative kidney weight, increased platelet count and whole blood cell count in the 90d dermal study in rat) should not be taken into account. 8 A teratogenicity study in rat showed BP-3 to be non-teratogenic under the conditions of the test. Only at the highest dosage level, which also caused maternal toxicity,","endpoint":"repeated dose toxicity","ingredient":"2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005.","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":6,"route":"oral","species":"rat","study_id":"sccp_o_159_noael_002"}

sccp_o_159.pdf

SOURCE_SUBDIR=sccp_o_159; REPORT_TITLE=OPINION ON Benzophenone-3 COLIPA n° S38; OPINION_NUMBER=SCCP/1201/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=200; DOSE=The NOAEL-value for maternal and developmental toxicity was 200 mg/kg bw/day.; EFFECT=SCCP/1201/08 Opinion on benzophenone-3 7 skeletal aberrations were noted. The NOAEL-value for maternal and developmental toxicity was 200 mg/kg bw/day. A NOAEL value of 400 mg/kg bw/day for reproductive toxicity was extracted from subchronic toxicity studies involving additional reproductive toxicity parameter measurements. 8 Toxicokinetic studies indicated that BP-3 was readily biotransformed into its three major metabolites and that excretion in the rat primarily occurs via the urine, while in the mouse the faecal route appears to be equally important. 8 As far as the (photo)mutagenic/(photo); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"The NOAEL-value for maternal and developmental toxicity was 200 mg/kg bw/day.","duration":"developmental","effect":"SCCP/1201/08 Opinion on benzophenone-3 7 skeletal aberrations were noted. The NOAEL-value for maternal and developmental toxicity was 200 mg/kg bw/day. A NOAEL value of 400 mg/kg bw/day for reproductive toxicity was extracted from subchronic toxicity studies involving additional reproductive toxicity parameter measurements. 8 Toxicokinetic studies indicated that BP-3 was readily biotransformed into its three major metabolites and that excretion in the rat primarily occurs via the urine, while in the mouse the faecal route appears to be equally important. 8 As far as the (photo)mutagenic/(photo)","endpoint":"repeated dose toxicity","ingredient":"2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005.","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":7,"route":"","species":"rat","study_id":"sccp_o_159_noael_003"}

sccp_o_159.pdf

SOURCE_SUBDIR=sccp_o_159; REPORT_TITLE=OPINION ON Benzophenone-3 COLIPA n° S38; OPINION_NUMBER=SCCP/1201/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=411; DOSE=Therefore, according to the 2005-submission, the oral NOAEL corresponded to 411 mg/kg bw/day.; EFFECT=SCCS-rejected applicant NOAEL: ether with effects on the identified target organs being the kidney and the liver. These effects were partly associated with changes in clinical chemistry. Very often the most susceptible parameter was the increase in liver weight. The latter, however, without any histopathological correlate, is not considered by the submission authors to reflect an adverse effect per se but should be considered as an adaptive metabolic response which is known to be reversible. Therefore, according to the 2005-submission, the oral NOAEL corresponded to 411 mg/kg bw/day. With regard to the results of the dermal repeated dose studies, a dermal NOAEL of 200 mg/kg bw/day was put forward, on the assumption that deviations without dose-response relationship and without correlated histopathological findings (e.g. the decreased reticulocyte count, increased relative kidney weight, increased platelet count and whole blood cell count in the 90d dermal study in rat) should not be taken into account. 8 A teratogenicity study in rat showed BP-3 to be non-ter; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"Therefore, according to the 2005-submission, the oral NOAEL corresponded to 411 mg/kg bw/day.","duration":"90d","effect":"SCCS-rejected applicant NOAEL: ether with effects on the identified target organs being the kidney and the liver. These effects were partly associated with changes in clinical chemistry. Very often the most susceptible parameter was the increase in liver weight. The latter, however, without any histopathological correlate, is not considered by the submission authors to reflect an adverse effect per se but should be considered as an adaptive metabolic response which is known to be reversible. Therefore, according to the 2005-submission, the oral NOAEL corresponded to 411 mg/kg bw/day. With regard to the results of the dermal repeated dose studies, a dermal NOAEL of 200 mg/kg bw/day was put forward, on the assumption that deviations without dose-response relationship and without correlated histopathological findings (e.g. the decreased reticulocyte count, increased relative kidney weight, increased platelet count and whole blood cell count in the 90d dermal study in rat) should not be taken into account. 8 A teratogenicity study in rat showed BP-3 to be non-ter","endpoint":"repeated dose toxicity","ingredient":"2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005.","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"411","page":6,"route":"oral","species":"rat","study_id":"sccp_o_159_noael_001"}

sccp_o_159.pdf

SOURCE_SUBDIR=sccp_o_159; REPORT_TITLE=OPINION ON Benzophenone-3 COLIPA n° S38; OPINION_NUMBER=SCCP/1201/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=200; DOSE=Unlabeled table on page 7: toxicity was 200 mg/kg bw/day.; EFFECT=Unlabeled table on page 7: toxicity was 200 mg/kg bw/day. A NOAEL value of 400 mg/kg bw/day for reproductive; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"131-57-7","citation":"","dose":"Unlabeled table on page 7: toxicity was 200 mg/kg bw/day.","duration":"","effect":"Unlabeled table on page 7: toxicity was 200 mg/kg bw/day. A NOAEL value of 400 mg/kg bw/day for reproductive","endpoint":"reproductive toxicity","ingredient":"2-hydroxy-4-methoxybenzophenone was submitted by COLIPA1 in December 2005.","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":7,"route":"","species":"","study_id":"sccp_o_159_noael_012"}

sccp_o_159.pdf