Polysilicone 15

SOURCE_SUBDIR=sccs_o_024; REPORT_TITLE=OPINION ON Polysilicone-15 COLIPA n° S74; OPINION_NUMBER=SCCS/1346/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 June 2010; VALUE_TEXT== 0.6; DOSE=Safety evaluation (including calculation of the MoS) Taken from SCCNFP/0079/98 Benzylidene malonate polysiloxane (UV Filter) Based on a usage volume of 18 ml, containing at maximum 10 % Maximum amount of ingredient applied I (mg) = 1800 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 2% Dermal absorption per trea...; EFFECT=oint 3.3.10.1 Photo-allergy 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) Taken from SCCNFP/0079/98 Benzylidene malonate polysiloxane (UV Filter) Based on a usage volume of 18 ml, containing at maximum 10 % Maximum amount of ingredient applied I (mg) = 1800 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 2% Dermal absorption per treatment I x A = 36 mg Systemic exposure dose (SED) I x A / 60 kg = 0.6 mg/kg bw/d No observed adverse effect level NOAEL = 1000 mg/kg bw/d (rat, oral 90 day study) Margin of Safety NOAEL / SED = 1600 For the Margin of Safety after inhalation exposure, see 3.3.14 3.3.14. Discussion In the present mandate, the SCCS was asked to take the recent acute inhalation data that lead to the classification of Polysilicone-15 as toxic by inhalation into account for the safety assessment. The safety of the substance for dermal application has been assessed in opinion SCCNFP/0079/98. The discussion in this section only refers to the safe; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"207574-74-1","citation":"","dose":"Safety evaluation (including calculation of the MoS) Taken from SCCNFP/0079/98 Benzylidene malonate polysiloxane (UV Filter) Based on a usage volume of 18 ml, containing at maximum 10 % Maximum amount of ingredient applied I (mg) = 1800 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 2% Dermal absorption per trea...","duration":"90 day","effect":"oint 3.3.10.1 Photo-allergy 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) Taken from SCCNFP/0079/98 Benzylidene malonate polysiloxane (UV Filter) Based on a usage volume of 18 ml, containing at maximum 10 % Maximum amount of ingredient applied I (mg) = 1800 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 2% Dermal absorption per treatment I x A = 36 mg Systemic exposure dose (SED) I x A / 60 kg = 0.6 mg/kg bw/d No observed adverse effect level NOAEL = 1000 mg/kg bw/d (rat, oral 90 day study) Margin of Safety NOAEL / SED = 1600 For the Margin of Safety after inhalation exposure, see 3.3.14 3.3.14. Discussion In the present mandate, the SCCS was asked to take the recent acute inhalation data that lead to the classification of Polysilicone-15 as toxic by inhalation into account for the safety assessment. The safety of the substance for dermal application has been assessed in opinion SCCNFP/0079/98. The discussion in this section only refers to the safe","endpoint":"dermal absorption","ingredient":"Polysilicone-15","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.6","page":22,"route":"oral","species":"rat","study_id":"sccs_o_024_noael_002"}

sccs_o_024.pdf

SOURCE_SUBDIR=sccs_o_024; REPORT_TITLE=OPINION ON Polysilicone-15 COLIPA n° S74; OPINION_NUMBER=SCCS/1346/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 June 2010; VALUE_TEXT== 1000; DOSE=Safety evaluation (including calculation of the MoS) Taken from SCCNFP/0079/98 Benzylidene malonate polysiloxane (UV Filter) Based on a usage volume of 18 ml, containing at maximum 10 % Maximum amount of ingredient applied I (mg) = 1800 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 2% Dermal absorption per trea...; EFFECT=12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) Taken from SCCNFP/0079/98 Benzylidene malonate polysiloxane (UV Filter) Based on a usage volume of 18 ml, containing at maximum 10 % Maximum amount of ingredient applied I (mg) = 1800 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 2% Dermal absorption per treatment I x A = 36 mg Systemic exposure dose (SED) I x A / 60 kg = 0.6 mg/kg bw/d No observed adverse effect level NOAEL = 1000 mg/kg bw/d (rat, oral 90 day study) Margin of Safety NOAEL / SED = 1600 For the Margin of Safety after inhalation exposure, see 3.3.14 3.3.14. Discussion In the present mandate, the SCCS was asked to take the recent acute inhalation data that lead to the classification of Polysilicone-15 as toxic by inhalation into account for the safety assessment. The safety of the substance for dermal application has been assessed in opinion SCCNFP/0079/98. The discussion in this section only refers to the safety ass; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"207574-74-1","citation":"","dose":"Safety evaluation (including calculation of the MoS) Taken from SCCNFP/0079/98 Benzylidene malonate polysiloxane (UV Filter) Based on a usage volume of 18 ml, containing at maximum 10 % Maximum amount of ingredient applied I (mg) = 1800 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 2% Dermal absorption per trea...","duration":"90 day","effect":"12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) Taken from SCCNFP/0079/98 Benzylidene malonate polysiloxane (UV Filter) Based on a usage volume of 18 ml, containing at maximum 10 % Maximum amount of ingredient applied I (mg) = 1800 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 2% Dermal absorption per treatment I x A = 36 mg Systemic exposure dose (SED) I x A / 60 kg = 0.6 mg/kg bw/d No observed adverse effect level NOAEL = 1000 mg/kg bw/d (rat, oral 90 day study) Margin of Safety NOAEL / SED = 1600 For the Margin of Safety after inhalation exposure, see 3.3.14 3.3.14. Discussion In the present mandate, the SCCS was asked to take the recent acute inhalation data that lead to the classification of Polysilicone-15 as toxic by inhalation into account for the safety assessment. The safety of the substance for dermal application has been assessed in opinion SCCNFP/0079/98. The discussion in this section only refers to the safety ass","endpoint":"dermal absorption","ingredient":"Polysilicone-15","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 1000","page":22,"route":"oral","species":"rat","study_id":"sccs_o_024_noael_003"}

sccs_o_024.pdf

SOURCE_SUBDIR=sccs_o_024; REPORT_TITLE=OPINION ON Polysilicone-15 COLIPA n° S74; OPINION_NUMBER=SCCS/1346/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 June 2010; VALUE_TEXT== 1000; DOSE=ation (including calculation of the MoS) Taken from SCCNFP/0079/98 Benzylidene malonate polysiloxane (UV Filter) Based on a usage volume of 18 ml, containing at maximum 10 % Maximum amount of ingredient applied I (mg) = 1800 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 2% Dermal absorption per treatment I x A...; EFFECT=ation (including calculation of the MoS) Taken from SCCNFP/0079/98 Benzylidene malonate polysiloxane (UV Filter) Based on a usage volume of 18 ml, containing at maximum 10 % Maximum amount of ingredient applied I (mg) = 1800 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 2% Dermal absorption per treatment I x A = 36 mg Systemic exposure dose (SED) I x A / 60 kg = 0.6 mg/kg bw/d No observed adverse effect level NOAEL = 1000 mg/kg bw/d (rat, oral 90 day study) Margin of Safety NOAEL / SED = 1600 For the Margin of Safety after inhalation exposure, see 3.3.14 3.3.14. Discussion In the present mandate, the SCCS was asked to take the recent acute inhalation data that lead to the classification of Polysilicone-15 as toxic by inhalation into account for the safety assessment. The safety of the substance for dermal application has been assessed in opinion SCCNFP/0079/98. The discussion in this section only refers to the safety assessment of the inhalation exposure. Currently, in the SCCP/SCCS No; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"207574-74-1","citation":"","dose":"ation (including calculation of the MoS) Taken from SCCNFP/0079/98 Benzylidene malonate polysiloxane (UV Filter) Based on a usage volume of 18 ml, containing at maximum 10 % Maximum amount of ingredient applied I (mg) = 1800 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 2% Dermal absorption per treatment I x A...","duration":"90 day","effect":"ation (including calculation of the MoS) Taken from SCCNFP/0079/98 Benzylidene malonate polysiloxane (UV Filter) Based on a usage volume of 18 ml, containing at maximum 10 % Maximum amount of ingredient applied I (mg) = 1800 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 2% Dermal absorption per treatment I x A = 36 mg Systemic exposure dose (SED) I x A / 60 kg = 0.6 mg/kg bw/d No observed adverse effect level NOAEL = 1000 mg/kg bw/d (rat, oral 90 day study) Margin of Safety NOAEL / SED = 1600 For the Margin of Safety after inhalation exposure, see 3.3.14 3.3.14. Discussion In the present mandate, the SCCS was asked to take the recent acute inhalation data that lead to the classification of Polysilicone-15 as toxic by inhalation into account for the safety assessment. The safety of the substance for dermal application has been assessed in opinion SCCNFP/0079/98. The discussion in this section only refers to the safety assessment of the inhalation exposure. Currently, in the SCCP/SCCS No","endpoint":"dermal absorption","ingredient":"Polysilicone-15","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 1000","page":22,"route":"oral","species":"rat","study_id":"sccs_o_024_noael_004"}

sccs_o_024.pdf

SOURCE_SUBDIR=sccs_o_024; REPORT_TITLE=OPINION ON Polysilicone-15 COLIPA n° S74; OPINION_NUMBER=SCCS/1346/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 June 2010; VALUE_TEXT=1000; DOSE=Necropsy did not show any dose related organ changes.; EFFECT=se groups, both male and female; this was attributed to the increased metabolic load in these animals. Again, statistical data are not supplied in the tables. Necropsy did not show any dose related organ changes. Histological examination did not show any dose related changes. In the case of mid dose animals in the main study, and of recovery animals, organs were examined histologically only if changes had been found in the organs of the high dose groups. The study seems to have been carefully carried out, and the NOAEL is put at 1000 mg/kg bw/day. Ref.: 6 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0079/98 Reverse mutation assay Two versions were used, viz. standard plate incorporation assay pre-incubation assay; CITATION=Ref.: 6 3; CITATION_NUMBERS=[6,3]; REFERENCE=Ref.: 6 3; DETAILS_JSON={"cas_number":"207574-74-1","citation":"Ref.: 6 3","dose":"Necropsy did not show any dose related organ changes.","duration":"Chronic","effect":"se groups, both male and female; this was attributed to the increased metabolic load in these animals. Again, statistical data are not supplied in the tables. Necropsy did not show any dose related organ changes. Histological examination did not show any dose related changes. In the case of mid dose animals in the main study, and of recovery animals, organs were examined histologically only if changes had been found in the organs of the high dose groups. The study seems to have been carefully carried out, and the NOAEL is put at 1000 mg/kg bw/day. Ref.: 6 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0079/98 Reverse mutation assay Two versions were used, viz. standard plate incorporation assay pre-incubation assay","endpoint":"genotoxicity","ingredient":"Polysilicone-15","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":15,"route":"","species":"","study_id":"sccs_o_024_noael_001"}

sccs_o_024.pdf