NOAEL Studies
Cosmetic Ingredient
3-Benzylidene Camphor NOAEL Studies
INCI: 3-BENZYLIDENE CAMPHOR
CAS: 15087-24-8
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
SCCS_vision_codex 48 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =0.21 | mg/kg bw | rat | oral | - | NOAEL study | {"dose":"Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active...","effect":"e results need to be confirmed. 24 3.3.13. Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Effect Level (NOAEL) = 15 mg/kg bw/d 37 (teratogenicity study, maternal effects, oral, rat) 38 NOAEL corrected from bioavailability 50% (default) = 7.5 mg/kg bw/d 39 40 MOS NOAEL/SED = 36 41 42 43 * This is the highest value of two experiments in man, which gave values of 3.29 and 1.9% 44 45 3.3.14. Discussion 46 47 3-Benzylidene camphor is proposed for use in sunscreen products at levels up 2%. 48 49 General Toxicity 50 Various batches used for toxicity testing have not been identified with respect to their purity 51 a","page":24,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_010"} |
| SCCS_vision_codex | NOAEL | =0.21 | mg/kg bw | rat | oral | - | NOAEL study | {"dose":"Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active...","effect":"e results need to be confirmed. 24 3.3.13. Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Effect Level (NOAEL) = 15 mg/kg bw/d 37 (teratogenicity study, maternal effects, oral, rat) 38 NOAEL corrected from bioavailability 50% (default) = 7.5 mg/kg bw/d 39 40 MOS NOAEL/SED = 36 41 42 43 * This is the highest value of two experiments in man, which gave values of 3.29 and 1.9% 44 45 3.3.14. Discussion 46 47 3-Benzylidene camphor is proposed for use in sunscreen products at levels up 2%. 48 49 General Toxicity 50 Various batches used for toxicity testing have not been identified with respect to their purity 51 a","page":24,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_010"} |
| SCCS_vision_codex | NOAEL | =0.21 | mg/kg bw | rat | oral | - | NOAEL study | {"dose":"Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active...","effect":"e results need to be confirmed. 24 3.3.13. Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Effect Level (NOAEL) = 15 mg/kg bw/d 37 (teratogenicity study, maternal effects, oral, rat) 38 NOAEL corrected from bioavailability 50% (default) = 7.5 mg/kg bw/d 39 40 MOS NOAEL/SED = 36 41 42 43 * This is the highest value of two experiments in man, which gave values of 3.29 and 1.9% 44 45 3.3.14. Discussion 46 47 3-Benzylidene camphor is proposed for use in sunscreen products at levels up 2%. 48 49 General Toxicity 50 Various batches used for toxicity testing have not been identified with respect to their purity 51 a","page":24,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_010"} |
| SCCS_vision_codex | NOAEL | =0.21 | mg/kg bw | rat | oral | - | NOAEL study | {"dose":"Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active...","effect":"e results need to be confirmed. 24 3.3.13. Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Effect Level (NOAEL) = 15 mg/kg bw/d 37 (teratogenicity study, maternal effects, oral, rat) 38 NOAEL corrected from bioavailability 50% (default) = 7.5 mg/kg bw/d 39 40 MOS NOAEL/SED = 36 41 42 43 * This is the highest value of two experiments in man, which gave values of 3.29 and 1.9% 44 45 3.3.14. Discussion 46 47 3-Benzylidene camphor is proposed for use in sunscreen products at levels up 2%. 48 49 General Toxicity 50 Various batches used for toxicity testing have not been identified with respect to their purity 51 a","page":24,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_010"} |
| SCCS_vision_codex | NOAEL | =2 | % | rat | - | - | NOAEL study | {"effect":"ulation of the MOS but as supportive studies for risk assessment of 3-BC. 16 17 SCCS comment on studies on endocrine activity 18 Concerning the potential endocrine disruptor properties of 3-BC, multiple hormonal activities 19 of 3-BC have been reported in vitro: estrogenic and anti-estrogenic effects as well 20 antiandrogenic activities. In vivo, the expression of target genes (ERα, ERβ, SRC-1 and PR 21 (progesterone receptor)) has been shown to be altered in both males and females rats at 22 doses lower than the NOAEL used to calculate the MoS. Due to some shortcomings in the 23 studies, the results need to be confirmed. 24 3.3.13. Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x","page":24,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_009"} |
| SCCS_vision_codex | NOAEL | =2 | % | rat | - | - | NOAEL study | {"effect":"ulation of the MOS but as supportive studies for risk assessment of 3-BC. 16 17 SCCS comment on studies on endocrine activity 18 Concerning the potential endocrine disruptor properties of 3-BC, multiple hormonal activities 19 of 3-BC have been reported in vitro: estrogenic and anti-estrogenic effects as well 20 antiandrogenic activities. In vivo, the expression of target genes (ERα, ERβ, SRC-1 and PR 21 (progesterone receptor)) has been shown to be altered in both males and females rats at 22 doses lower than the NOAEL used to calculate the MoS. Due to some shortcomings in the 23 studies, the results need to be confirmed. 24 3.3.13. Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x","page":24,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_009"} |
| SCCS_vision_codex | NOAEL | =2 | % | rat | - | - | NOAEL study | {"effect":"ulation of the MOS but as supportive studies for risk assessment of 3-BC. 16 17 SCCS comment on studies on endocrine activity 18 Concerning the potential endocrine disruptor properties of 3-BC, multiple hormonal activities 19 of 3-BC have been reported in vitro: estrogenic and anti-estrogenic effects as well 20 antiandrogenic activities. In vivo, the expression of target genes (ERα, ERβ, SRC-1 and PR 21 (progesterone receptor)) has been shown to be altered in both males and females rats at 22 doses lower than the NOAEL used to calculate the MoS. Due to some shortcomings in the 23 studies, the results need to be confirmed. 24 3.3.13. Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x","page":24,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_009"} |
| SCCS_vision_codex | NOAEL | =2 | % | rat | - | - | NOAEL study | {"effect":"ulation of the MOS but as supportive studies for risk assessment of 3-BC. 16 17 SCCS comment on studies on endocrine activity 18 Concerning the potential endocrine disruptor properties of 3-BC, multiple hormonal activities 19 of 3-BC have been reported in vitro: estrogenic and anti-estrogenic effects as well 20 antiandrogenic activities. In vivo, the expression of target genes (ERα, ERβ, SRC-1 and PR 21 (progesterone receptor)) has been shown to be altered in both males and females rats at 22 doses lower than the NOAEL used to calculate the MoS. Due to some shortcomings in the 23 studies, the results need to be confirmed. 24 3.3.13. Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x","page":24,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_009"} |
| SCCS_vision_codex | NOAEL | =7.5 | mg/kg bw/d | rat | oral | - | NOAEL study | {"dose":"18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Ef...","effect":"18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Effect Level (NOAEL) = 15 mg/kg bw/d 37 (teratogenicity study, maternal effects, oral, rat) 38 NOAEL corrected from bioavailability 50% (default) = 7.5 mg/kg bw/d 39 40 MOS NOAEL/SED = 36 41 42 43 * This is the highest value of two experiments in man, which gave values of 3.29 and 1.9% 44 45 3.3.14. Discussion 46 47 3-Benzylidene camphor is proposed for use in sunscreen products at levels up 2%. 48 49 General Toxicity 50 Various batches used for toxicity testing have not been identified with respect to their purity 51 and impurity. The homogeneity and stability of test solutions/suspensions have not been 52 documented. Quantitative data on solubility in various solvents of 3-BC was no","page":24,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_013"} |
| SCCS_vision_codex | NOAEL | =7.5 | mg/kg bw/d | rat | oral | - | NOAEL study | {"dose":"18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Ef...","effect":"18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Effect Level (NOAEL) = 15 mg/kg bw/d 37 (teratogenicity study, maternal effects, oral, rat) 38 NOAEL corrected from bioavailability 50% (default) = 7.5 mg/kg bw/d 39 40 MOS NOAEL/SED = 36 41 42 43 * This is the highest value of two experiments in man, which gave values of 3.29 and 1.9% 44 45 3.3.14. Discussion 46 47 3-Benzylidene camphor is proposed for use in sunscreen products at levels up 2%. 48 49 General Toxicity 50 Various batches used for toxicity testing have not been identified with respect to their purity 51 and impurity. The homogeneity and stability of test solutions/suspensions have not been 52 documented. Quantitative data on solubility in various solvents of 3-BC was no","page":24,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_013"} |
| SCCS_vision_codex | NOAEL | =7.5 | mg/kg bw/d | rat | oral | - | NOAEL study | {"dose":"18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Ef...","effect":"18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Effect Level (NOAEL) = 15 mg/kg bw/d 37 (teratogenicity study, maternal effects, oral, rat) 38 NOAEL corrected from bioavailability 50% (default) = 7.5 mg/kg bw/d 39 40 MOS NOAEL/SED = 36 41 42 43 * This is the highest value of two experiments in man, which gave values of 3.29 and 1.9% 44 45 3.3.14. Discussion 46 47 3-Benzylidene camphor is proposed for use in sunscreen products at levels up 2%. 48 49 General Toxicity 50 Various batches used for toxicity testing have not been identified with respect to their purity 51 and impurity. The homogeneity and stability of test solutions/suspensions have not been 52 documented. Quantitative data on solubility in various solvents of 3-BC was no","page":24,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_013"} |
| SCCS_vision_codex | NOAEL | =7.5 | mg/kg bw/d | rat | oral | - | NOAEL study | {"dose":"18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Ef...","effect":"18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Effect Level (NOAEL) = 15 mg/kg bw/d 37 (teratogenicity study, maternal effects, oral, rat) 38 NOAEL corrected from bioavailability 50% (default) = 7.5 mg/kg bw/d 39 40 MOS NOAEL/SED = 36 41 42 43 * This is the highest value of two experiments in man, which gave values of 3.29 and 1.9% 44 45 3.3.14. Discussion 46 47 3-Benzylidene camphor is proposed for use in sunscreen products at levels up 2%. 48 49 General Toxicity 50 Various batches used for toxicity testing have not been identified with respect to their purity 51 and impurity. The homogeneity and stability of test solutions/suspensions have not been 52 documented. Quantitative data on solubility in various solvents of 3-BC was no","page":24,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_013"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/day | mouse | oral | 56 day | NOAEL study | {"citation":"Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline","dose":"present at 50 mg/kg bw/day).","effect":"present at 50 mg/kg bw/day). 35 The NOAEL for maternal toxicity and embryo-toxicity in this study is 15 mg/kg bw/day. In 36 an appendix a method for the estimation of the blood levels by HPLC is given, but no figures 37 for these values are provided. 38 Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline. However 43 the protocol seems to be very similar of the OECD TG 414 except that the dams were 44 treated only until GD 15th (instead of GD 18th). A NOAEL of 15 mg/kg bw/day can then be 45 derived from this study, based on maternal and embryo toxicity. This NOAEL can be used 46 for risk assessment. 47 48 49 Mouse 50 51 52 A similar test to the above was carried out in cr1 CD1 (ICR) BR mice, in conformity with 53 GLP. 54 Groups of 25 to 26 animals were mated; the numbers pregnant in each group were 26, 25, 55 23, 24, 24. Dosing was by gavage at levels of 0, 15, 50, 100 and 250 mg/kg bw/day, from 56 day 6 to day 15 of pregnancy. 57","page":15,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_007"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/d | rat | oral | - | NOAEL study | {"dose":"Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active...","effect":"3.3.13. Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Effect Level (NOAEL) = 15 mg/kg bw/d 37 (teratogenicity study, maternal effects, oral, rat) 38 NOAEL corrected from bioavailability 50% (default) = 7.5 mg/kg bw/d 39 40 MOS NOAEL/SED = 36 41 42 43 * This is the highest value of two experiments in man, which gave values of 3.29 and 1.9% 44 45 3.3.14. Discussion 46 47 3-Benzylidene camphor is proposed for use in sunscreen products at levels up 2%. 48 49 General Toxicity 50 Various batches used for toxicity testing have not been identified with respect to their purity 51 and impu","page":24,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_011"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/day | mouse | oral | 56 day | NOAEL study | {"citation":"Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline","dose":"present at 50 mg/kg bw/day).","effect":"present at 50 mg/kg bw/day). 35 The NOAEL for maternal toxicity and embryo-toxicity in this study is 15 mg/kg bw/day. In 36 an appendix a method for the estimation of the blood levels by HPLC is given, but no figures 37 for these values are provided. 38 Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline. However 43 the protocol seems to be very similar of the OECD TG 414 except that the dams were 44 treated only until GD 15th (instead of GD 18th). A NOAEL of 15 mg/kg bw/day can then be 45 derived from this study, based on maternal and embryo toxicity. This NOAEL can be used 46 for risk assessment. 47 48 49 Mouse 50 51 52 A similar test to the above was carried out in cr1 CD1 (ICR) BR mice, in conformity with 53 GLP. 54 Groups of 25 to 26 animals were mated; the numbers pregnant in each group were 26, 25, 55 23, 24, 24. Dosing was by gavage at levels of 0, 15, 50, 100 and 250 mg/kg bw/day, from 56 day 6 to day 15 of pregnancy. 57","page":15,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_007"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/d | rat | oral | - | NOAEL study | {"dose":"Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active...","effect":"3.3.13. Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Effect Level (NOAEL) = 15 mg/kg bw/d 37 (teratogenicity study, maternal effects, oral, rat) 38 NOAEL corrected from bioavailability 50% (default) = 7.5 mg/kg bw/d 39 40 MOS NOAEL/SED = 36 41 42 43 * This is the highest value of two experiments in man, which gave values of 3.29 and 1.9% 44 45 3.3.14. Discussion 46 47 3-Benzylidene camphor is proposed for use in sunscreen products at levels up 2%. 48 49 General Toxicity 50 Various batches used for toxicity testing have not been identified with respect to their purity 51 and impu","page":24,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_011"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/day | mouse | oral | 56 day | NOAEL study | {"citation":"Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline","dose":"present at 50 mg/kg bw/day).","effect":"present at 50 mg/kg bw/day). 35 The NOAEL for maternal toxicity and embryo-toxicity in this study is 15 mg/kg bw/day. In 36 an appendix a method for the estimation of the blood levels by HPLC is given, but no figures 37 for these values are provided. 38 Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline. However 43 the protocol seems to be very similar of the OECD TG 414 except that the dams were 44 treated only until GD 15th (instead of GD 18th). A NOAEL of 15 mg/kg bw/day can then be 45 derived from this study, based on maternal and embryo toxicity. This NOAEL can be used 46 for risk assessment. 47 48 49 Mouse 50 51 52 A similar test to the above was carried out in cr1 CD1 (ICR) BR mice, in conformity with 53 GLP. 54 Groups of 25 to 26 animals were mated; the numbers pregnant in each group were 26, 25, 55 23, 24, 24. Dosing was by gavage at levels of 0, 15, 50, 100 and 250 mg/kg bw/day, from 56 day 6 to day 15 of pregnancy. 57","page":15,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_007"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/d | rat | oral | - | NOAEL study | {"dose":"Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active...","effect":"3.3.13. Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Effect Level (NOAEL) = 15 mg/kg bw/d 37 (teratogenicity study, maternal effects, oral, rat) 38 NOAEL corrected from bioavailability 50% (default) = 7.5 mg/kg bw/d 39 40 MOS NOAEL/SED = 36 41 42 43 * This is the highest value of two experiments in man, which gave values of 3.29 and 1.9% 44 45 3.3.14. Discussion 46 47 3-Benzylidene camphor is proposed for use in sunscreen products at levels up 2%. 48 49 General Toxicity 50 Various batches used for toxicity testing have not been identified with respect to their purity 51 and impu","page":24,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_011"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/day | mouse | oral | 56 day | NOAEL study | {"citation":"Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline","dose":"present at 50 mg/kg bw/day).","effect":"present at 50 mg/kg bw/day). 35 The NOAEL for maternal toxicity and embryo-toxicity in this study is 15 mg/kg bw/day. In 36 an appendix a method for the estimation of the blood levels by HPLC is given, but no figures 37 for these values are provided. 38 Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline. However 43 the protocol seems to be very similar of the OECD TG 414 except that the dams were 44 treated only until GD 15th (instead of GD 18th). A NOAEL of 15 mg/kg bw/day can then be 45 derived from this study, based on maternal and embryo toxicity. This NOAEL can be used 46 for risk assessment. 47 48 49 Mouse 50 51 52 A similar test to the above was carried out in cr1 CD1 (ICR) BR mice, in conformity with 53 GLP. 54 Groups of 25 to 26 animals were mated; the numbers pregnant in each group were 26, 25, 55 23, 24, 24. Dosing was by gavage at levels of 0, 15, 50, 100 and 250 mg/kg bw/day, from 56 day 6 to day 15 of pregnancy. 57","page":15,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_007"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/d | rat | oral | - | NOAEL study | {"dose":"Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active...","effect":"3.3.13. Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Effect Level (NOAEL) = 15 mg/kg bw/d 37 (teratogenicity study, maternal effects, oral, rat) 38 NOAEL corrected from bioavailability 50% (default) = 7.5 mg/kg bw/d 39 40 MOS NOAEL/SED = 36 41 42 43 * This is the highest value of two experiments in man, which gave values of 3.29 and 1.9% 44 45 3.3.14. Discussion 46 47 3-Benzylidene camphor is proposed for use in sunscreen products at levels up 2%. 48 49 General Toxicity 50 Various batches used for toxicity testing have not been identified with respect to their purity 51 and impu","page":24,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_011"} |
| SCCS_vision_codex | NOAEL | =18 | - | human | dermal | - | NOAEL study | {"effect":"adopted prohibits, as a safeguard measure in accordance 18 with the provisions of Article 12(2) of the Directive 76/768/EEC, the manufacture, import, 19 export, wholesale distribution, placing on the market free of charge or against payment, 20 holding with a view to sale or distribution free of charge and use of cosmetic products 21 containing 3-benzylidene camphor (CAS: 15087-24-8). 22 23 The AFSSAPS report states that the hazard characterisation for this substance is considered 24 incomplete. In addition, the no observed adverse effect level (NOAEL) and the cutaneous 25 absorption rate used by the AFSSAPS in connection with the risk assessment results in 26 insufficient margin of safety to ensure consumer safety in accordance with the SCCS’s notes 27 of guidance3. Finally, as endocrine disruption effects were observed in the studies published 28 in the scientific literature, in the current state of knowledge, the French authorities consider 29 that it is not possible to conclude that there is no risk to humans. 30 31 32 2. TERMS OF REFERENCE 33 34","page":5,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_001"} |
| SCCS_vision_codex | NOAEL | =18 | - | human | dermal | - | NOAEL study | {"effect":"adopted prohibits, as a safeguard measure in accordance 18 with the provisions of Article 12(2) of the Directive 76/768/EEC, the manufacture, import, 19 export, wholesale distribution, placing on the market free of charge or against payment, 20 holding with a view to sale or distribution free of charge and use of cosmetic products 21 containing 3-benzylidene camphor (CAS: 15087-24-8). 22 23 The AFSSAPS report states that the hazard characterisation for this substance is considered 24 incomplete. In addition, the no observed adverse effect level (NOAEL) and the cutaneous 25 absorption rate used by the AFSSAPS in connection with the risk assessment results in 26 insufficient margin of safety to ensure consumer safety in accordance with the SCCS’s notes 27 of guidance3. Finally, as endocrine disruption effects were observed in the studies published 28 in the scientific literature, in the current state of knowledge, the French authorities consider 29 that it is not possible to conclude that there is no risk to humans. 30 31 32 2. TERMS OF REFERENCE 33 34","page":5,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_001"} |
| SCCS_vision_codex | NOAEL | =18 | - | human | dermal | - | NOAEL study | {"effect":"adopted prohibits, as a safeguard measure in accordance 18 with the provisions of Article 12(2) of the Directive 76/768/EEC, the manufacture, import, 19 export, wholesale distribution, placing on the market free of charge or against payment, 20 holding with a view to sale or distribution free of charge and use of cosmetic products 21 containing 3-benzylidene camphor (CAS: 15087-24-8). 22 23 The AFSSAPS report states that the hazard characterisation for this substance is considered 24 incomplete. In addition, the no observed adverse effect level (NOAEL) and the cutaneous 25 absorption rate used by the AFSSAPS in connection with the risk assessment results in 26 insufficient margin of safety to ensure consumer safety in accordance with the SCCS’s notes 27 of guidance3. Finally, as endocrine disruption effects were observed in the studies published 28 in the scientific literature, in the current state of knowledge, the French authorities consider 29 that it is not possible to conclude that there is no risk to humans. 30 31 32 2. TERMS OF REFERENCE 33 34","page":5,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_001"} |
| SCCS_vision_codex | NOAEL | =18 | - | human | dermal | - | NOAEL study | {"effect":"adopted prohibits, as a safeguard measure in accordance 18 with the provisions of Article 12(2) of the Directive 76/768/EEC, the manufacture, import, 19 export, wholesale distribution, placing on the market free of charge or against payment, 20 holding with a view to sale or distribution free of charge and use of cosmetic products 21 containing 3-benzylidene camphor (CAS: 15087-24-8). 22 23 The AFSSAPS report states that the hazard characterisation for this substance is considered 24 incomplete. In addition, the no observed adverse effect level (NOAEL) and the cutaneous 25 absorption rate used by the AFSSAPS in connection with the risk assessment results in 26 insufficient margin of safety to ensure consumer safety in accordance with the SCCS’s notes 27 of guidance3. Finally, as endocrine disruption effects were observed in the studies published 28 in the scientific literature, in the current state of knowledge, the French authorities consider 29 that it is not possible to conclude that there is no risk to humans. 30 31 32 2. TERMS OF REFERENCE 33 34","page":5,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_001"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/day | rat | oral | 6 week | reproductive toxicity | {"dose":"e toxicity 26 One 6 week oral study in the rat showed dose related increases in plasma triiodothyronine 27 in males, significant at 50 mg/kg bw/day, and in plasma thyroxine in females, significant at 28 25 and 50 mg/kg bw/day.","effect":"e toxicity 26 One 6 week oral study in the rat showed dose related increases in plasma triiodothyronine 27 in males, significant at 50 mg/kg bw/day, and in plasma thyroxine in females, significant at 28 25 and 50 mg/kg bw/day. 29 In two 90 day oral toxicity studies in the rat, elevated plasma lipids were observed in 30 female rats at doses as low as 20 mg/kg bw/day, although this was not statistically 31 significant at this dose. 32 The results of the two 90 day studies are scarcely reported in submission I. 33 No NOAEL can be derived from these experiments. 34 35 Mutagenicity / Genotoxicity 36 A test for chromosomal aberration in vitro was positive, but the Ames test and an in vivo 37 micronucleus test were negative. Based on the poor quality of the available tests, a firm 38 conclusion on mutagenicity cannot be drawn. 39 40 Reproductive toxicity 41 In a teratogenicity study in rats, embryo-toxicity was observed at 50 mg/kg bw/day and 42 above was observed. The observed major external/visceral abnormalities (at 100 and 150 43","page":25,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_014"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/day | rat | oral | 6 week | reproductive toxicity | {"dose":"e toxicity 26 One 6 week oral study in the rat showed dose related increases in plasma triiodothyronine 27 in males, significant at 50 mg/kg bw/day, and in plasma thyroxine in females, significant at 28 25 and 50 mg/kg bw/day.","effect":"e toxicity 26 One 6 week oral study in the rat showed dose related increases in plasma triiodothyronine 27 in males, significant at 50 mg/kg bw/day, and in plasma thyroxine in females, significant at 28 25 and 50 mg/kg bw/day. 29 In two 90 day oral toxicity studies in the rat, elevated plasma lipids were observed in 30 female rats at doses as low as 20 mg/kg bw/day, although this was not statistically 31 significant at this dose. 32 The results of the two 90 day studies are scarcely reported in submission I. 33 No NOAEL can be derived from these experiments. 34 35 Mutagenicity / Genotoxicity 36 A test for chromosomal aberration in vitro was positive, but the Ames test and an in vivo 37 micronucleus test were negative. Based on the poor quality of the available tests, a firm 38 conclusion on mutagenicity cannot be drawn. 39 40 Reproductive toxicity 41 In a teratogenicity study in rats, embryo-toxicity was observed at 50 mg/kg bw/day and 42 above was observed. The observed major external/visceral abnormalities (at 100 and 150 43","page":25,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_014"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/day | rat | oral | 6 week | reproductive toxicity | {"dose":"e toxicity 26 One 6 week oral study in the rat showed dose related increases in plasma triiodothyronine 27 in males, significant at 50 mg/kg bw/day, and in plasma thyroxine in females, significant at 28 25 and 50 mg/kg bw/day.","effect":"e toxicity 26 One 6 week oral study in the rat showed dose related increases in plasma triiodothyronine 27 in males, significant at 50 mg/kg bw/day, and in plasma thyroxine in females, significant at 28 25 and 50 mg/kg bw/day. 29 In two 90 day oral toxicity studies in the rat, elevated plasma lipids were observed in 30 female rats at doses as low as 20 mg/kg bw/day, although this was not statistically 31 significant at this dose. 32 The results of the two 90 day studies are scarcely reported in submission I. 33 No NOAEL can be derived from these experiments. 34 35 Mutagenicity / Genotoxicity 36 A test for chromosomal aberration in vitro was positive, but the Ames test and an in vivo 37 micronucleus test were negative. Based on the poor quality of the available tests, a firm 38 conclusion on mutagenicity cannot be drawn. 39 40 Reproductive toxicity 41 In a teratogenicity study in rats, embryo-toxicity was observed at 50 mg/kg bw/day and 42 above was observed. The observed major external/visceral abnormalities (at 100 and 150 43","page":25,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_014"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/day | rat | oral | 6 week | reproductive toxicity | {"dose":"e toxicity 26 One 6 week oral study in the rat showed dose related increases in plasma triiodothyronine 27 in males, significant at 50 mg/kg bw/day, and in plasma thyroxine in females, significant at 28 25 and 50 mg/kg bw/day.","effect":"e toxicity 26 One 6 week oral study in the rat showed dose related increases in plasma triiodothyronine 27 in males, significant at 50 mg/kg bw/day, and in plasma thyroxine in females, significant at 28 25 and 50 mg/kg bw/day. 29 In two 90 day oral toxicity studies in the rat, elevated plasma lipids were observed in 30 female rats at doses as low as 20 mg/kg bw/day, although this was not statistically 31 significant at this dose. 32 The results of the two 90 day studies are scarcely reported in submission I. 33 No NOAEL can be derived from these experiments. 34 35 Mutagenicity / Genotoxicity 36 A test for chromosomal aberration in vitro was positive, but the Ames test and an in vivo 37 micronucleus test were negative. Based on the poor quality of the available tests, a firm 38 conclusion on mutagenicity cannot be drawn. 39 40 Reproductive toxicity 41 In a teratogenicity study in rats, embryo-toxicity was observed at 50 mg/kg bw/day and 42 above was observed. The observed major external/visceral abnormalities (at 100 and 150 43","page":25,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_014"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg bw/d | guinea pig | oral | 15 days | NOAEL study | {"citation":"Ref.: 15 13 14 15 Guinea pig 16 17 18 Female animals only, of the Dunkin Hartley strain, were used in this study","dose":"ivers and spleens showed some increase, but although this was 1 statistically significant, it was small and probably not biologically significant (no dose given).","effect":"ivers and spleens showed some increase, but although this was 1 statistically significant, it was small and probably not biologically significant (no dose given). 2 A similar observation applies to the adrenal glands. 3 4 Microscopic examinations indicated a follicular and epithelial thyroid hyperplasia and a 5 hypertrophy of the fasciculated zone in adrenals from the treated female groups. 6 Ophthalmological examinations at sacrifice showed no differences between control and 7 treated animals. 8 9 Apparently, a NOAEL (which would be lower than 25 mg/kg bw/d) has not been established 10 from that study. 11 12 Ref.: 15 13 14 15 Guinea pig 16 17 18 Female animals only, of the Dunkin Hartley strain, were used in this study. In a preliminary 19 experiment, one animal was treated by gavage with 500 and one with 1000 mg/kg bw/day 20 for 15 days. No abnormality was found, and the dose of 500 mg/kg bw/day was chosen for 21 the main study. 22 23 Two experiments were conducted in parallel, in accordance with GLP. In one, groups of","page":12,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_004"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg bw/d | guinea pig | oral | 15 days | NOAEL study | {"citation":"Ref.: 15 13 14 15 Guinea pig 16 17 18 Female animals only, of the Dunkin Hartley strain, were used in this study","dose":"ivers and spleens showed some increase, but although this was 1 statistically significant, it was small and probably not biologically significant (no dose given).","effect":"ivers and spleens showed some increase, but although this was 1 statistically significant, it was small and probably not biologically significant (no dose given). 2 A similar observation applies to the adrenal glands. 3 4 Microscopic examinations indicated a follicular and epithelial thyroid hyperplasia and a 5 hypertrophy of the fasciculated zone in adrenals from the treated female groups. 6 Ophthalmological examinations at sacrifice showed no differences between control and 7 treated animals. 8 9 Apparently, a NOAEL (which would be lower than 25 mg/kg bw/d) has not been established 10 from that study. 11 12 Ref.: 15 13 14 15 Guinea pig 16 17 18 Female animals only, of the Dunkin Hartley strain, were used in this study. In a preliminary 19 experiment, one animal was treated by gavage with 500 and one with 1000 mg/kg bw/day 20 for 15 days. No abnormality was found, and the dose of 500 mg/kg bw/day was chosen for 21 the main study. 22 23 Two experiments were conducted in parallel, in accordance with GLP. In one, groups of","page":12,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_004"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg bw/d | guinea pig | oral | 15 days | NOAEL study | {"citation":"Ref.: 15 13 14 15 Guinea pig 16 17 18 Female animals only, of the Dunkin Hartley strain, were used in this study","dose":"ivers and spleens showed some increase, but although this was 1 statistically significant, it was small and probably not biologically significant (no dose given).","effect":"ivers and spleens showed some increase, but although this was 1 statistically significant, it was small and probably not biologically significant (no dose given). 2 A similar observation applies to the adrenal glands. 3 4 Microscopic examinations indicated a follicular and epithelial thyroid hyperplasia and a 5 hypertrophy of the fasciculated zone in adrenals from the treated female groups. 6 Ophthalmological examinations at sacrifice showed no differences between control and 7 treated animals. 8 9 Apparently, a NOAEL (which would be lower than 25 mg/kg bw/d) has not been established 10 from that study. 11 12 Ref.: 15 13 14 15 Guinea pig 16 17 18 Female animals only, of the Dunkin Hartley strain, were used in this study. In a preliminary 19 experiment, one animal was treated by gavage with 500 and one with 1000 mg/kg bw/day 20 for 15 days. No abnormality was found, and the dose of 500 mg/kg bw/day was chosen for 21 the main study. 22 23 Two experiments were conducted in parallel, in accordance with GLP. In one, groups of","page":12,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_004"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg bw/d | guinea pig | oral | 15 days | NOAEL study | {"citation":"Ref.: 15 13 14 15 Guinea pig 16 17 18 Female animals only, of the Dunkin Hartley strain, were used in this study","dose":"ivers and spleens showed some increase, but although this was 1 statistically significant, it was small and probably not biologically significant (no dose given).","effect":"ivers and spleens showed some increase, but although this was 1 statistically significant, it was small and probably not biologically significant (no dose given). 2 A similar observation applies to the adrenal glands. 3 4 Microscopic examinations indicated a follicular and epithelial thyroid hyperplasia and a 5 hypertrophy of the fasciculated zone in adrenals from the treated female groups. 6 Ophthalmological examinations at sacrifice showed no differences between control and 7 treated animals. 8 9 Apparently, a NOAEL (which would be lower than 25 mg/kg bw/d) has not been established 10 from that study. 11 12 Ref.: 15 13 14 15 Guinea pig 16 17 18 Female animals only, of the Dunkin Hartley strain, were used in this study. In a preliminary 19 experiment, one animal was treated by gavage with 500 and one with 1000 mg/kg bw/day 20 for 15 days. No abnormality was found, and the dose of 500 mg/kg bw/day was chosen for 21 the main study. 22 23 Two experiments were conducted in parallel, in accordance with GLP. In one, groups of","page":12,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_004"} |
| SCCS_vision_codex | NOAEL | =40 | mg/kg bw/day | - | - | 38 weeks | genotoxicity | {"citation":"Ref.: 3 bis 35 36 SCCS comments 37 The results of these two studies are scarcely reported in submission I report","dose":"the increase at the lower dose was not 31 significant.","effect":"the increase at the lower dose was not 31 significant. The no adverse effect level is probably 20 mg/kg bw/day. 32 33 34 Ref.: 3 bis 35 36 SCCS comments 37 The results of these two studies are scarcely reported in submission I report. In the 6 38 weeks toxicity study described above, effects were observed at the doses of 25 and 50 39 mg/kg bw/day. In the second study, based on the submission file, no change of biological 40 relevance was seen in animals treated and 40 mg/kg bw/day could be considered as the 41 NOAEL. 42 43 3.3.5.3. Chronic (> 12 months) toxicity 44 45 No data submitted 46 47 3.3.6. Mutagenicity / Genotoxicity 48 Taken from previous opinion 1374/98 49 50 3.3.6.1 Mutagenicity / Genotoxicity in vitro 51 52 An Ames test was carried out according to GLP, using strains TA 1525, TA 1537, TA 98 and 53 TA 100. Toxicity experiments were not carried out; in strain TA 100 there was a decrease in 54","page":13,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_005"} |
| SCCS_vision_codex | NOAEL | =40 | mg/kg bw/day | - | - | 38 weeks | genotoxicity | {"citation":"Ref.: 3 bis 35 36 SCCS comments 37 The results of these two studies are scarcely reported in submission I report","dose":"the increase at the lower dose was not 31 significant.","effect":"the increase at the lower dose was not 31 significant. The no adverse effect level is probably 20 mg/kg bw/day. 32 33 34 Ref.: 3 bis 35 36 SCCS comments 37 The results of these two studies are scarcely reported in submission I report. In the 6 38 weeks toxicity study described above, effects were observed at the doses of 25 and 50 39 mg/kg bw/day. In the second study, based on the submission file, no change of biological 40 relevance was seen in animals treated and 40 mg/kg bw/day could be considered as the 41 NOAEL. 42 43 3.3.5.3. Chronic (> 12 months) toxicity 44 45 No data submitted 46 47 3.3.6. Mutagenicity / Genotoxicity 48 Taken from previous opinion 1374/98 49 50 3.3.6.1 Mutagenicity / Genotoxicity in vitro 51 52 An Ames test was carried out according to GLP, using strains TA 1525, TA 1537, TA 98 and 53 TA 100. Toxicity experiments were not carried out; in strain TA 100 there was a decrease in 54","page":13,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_005"} |
| SCCS_vision_codex | NOAEL | =40 | mg/kg bw/day | - | - | 38 weeks | genotoxicity | {"citation":"Ref.: 3 bis 35 36 SCCS comments 37 The results of these two studies are scarcely reported in submission I report","dose":"the increase at the lower dose was not 31 significant.","effect":"the increase at the lower dose was not 31 significant. The no adverse effect level is probably 20 mg/kg bw/day. 32 33 34 Ref.: 3 bis 35 36 SCCS comments 37 The results of these two studies are scarcely reported in submission I report. In the 6 38 weeks toxicity study described above, effects were observed at the doses of 25 and 50 39 mg/kg bw/day. In the second study, based on the submission file, no change of biological 40 relevance was seen in animals treated and 40 mg/kg bw/day could be considered as the 41 NOAEL. 42 43 3.3.5.3. Chronic (> 12 months) toxicity 44 45 No data submitted 46 47 3.3.6. Mutagenicity / Genotoxicity 48 Taken from previous opinion 1374/98 49 50 3.3.6.1 Mutagenicity / Genotoxicity in vitro 51 52 An Ames test was carried out according to GLP, using strains TA 1525, TA 1537, TA 98 and 53 TA 100. Toxicity experiments were not carried out; in strain TA 100 there was a decrease in 54","page":13,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_005"} |
| SCCS_vision_codex | NOAEL | =40 | mg/kg bw/day | - | - | 38 weeks | genotoxicity | {"citation":"Ref.: 3 bis 35 36 SCCS comments 37 The results of these two studies are scarcely reported in submission I report","dose":"the increase at the lower dose was not 31 significant.","effect":"the increase at the lower dose was not 31 significant. The no adverse effect level is probably 20 mg/kg bw/day. 32 33 34 Ref.: 3 bis 35 36 SCCS comments 37 The results of these two studies are scarcely reported in submission I report. In the 6 38 weeks toxicity study described above, effects were observed at the doses of 25 and 50 39 mg/kg bw/day. In the second study, based on the submission file, no change of biological 40 relevance was seen in animals treated and 40 mg/kg bw/day could be considered as the 41 NOAEL. 42 43 3.3.5.3. Chronic (> 12 months) toxicity 44 45 No data submitted 46 47 3.3.6. Mutagenicity / Genotoxicity 48 Taken from previous opinion 1374/98 49 50 3.3.6.1 Mutagenicity / Genotoxicity in vitro 51 52 An Ames test was carried out according to GLP, using strains TA 1525, TA 1537, TA 98 and 53 TA 100. Toxicity experiments were not carried out; in strain TA 100 there was a decrease in 54","page":13,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_005"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/day | - | - | 45 d | NOAEL study | {"citation":"Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline","dose":"e been a well conducted study, and is fully reported; there is clear 30 evidence of embryo-toxicity at 50 mg/kg bw/day and above.","effect":"e been a well conducted study, and is fully reported; there is clear 30 evidence of embryo-toxicity at 50 mg/kg bw/day and above. The observed major 31 external/visceral abnormalities (at 100 and 150 mg/kg bw/day), most plausibly result from 32 retarded development and in utero pressure (the finding of retarded ossification is in line 33 with this hypothesis). The development of these effects may be associated with the 34 maternal toxicity (note that maternal toxicity is already present at 50 mg/kg bw/day). 35 The NOAEL for maternal toxicity and embryo-toxicity in this study is 15 mg/kg bw/day. In 36 an appendix a method for the estimation of the blood levels by HPLC is given, but no figures 37 for these values are provided. 38 Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline. However 43 the protocol seems to be very similar of the OECD TG 414 except that the dams were 44 treated only until GD 15th (instead of GD 18th). A NOAEL of 15 mg/kg bw/day can then be 45 d","page":15,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_006"} |
| SCCS_vision_codex | NOAEL | =50 | % | rat | oral | - | NOAEL study | {"dose":"OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35...","effect":"OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Effect Level (NOAEL) = 15 mg/kg bw/d 37 (teratogenicity study, maternal effects, oral, rat) 38 NOAEL corrected from bioavailability 50% (default) = 7.5 mg/kg bw/d 39 40 MOS NOAEL/SED = 36 41 42 43 * This is the highest value of two experiments in man, which gave values of 3.29 and 1.9% 44 45 3.3.14. Discussion 46 47 3-Benzylidene camphor is proposed for use in sunscreen products at levels up 2%. 48 49 General Toxicity 50 Various batches used for toxicity testing have not been identified with respect to their purity 51 and impurity. The homogeneity and stability of test solutions/suspensions have not been 5","page":24,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_012"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/day | - | - | 45 d | NOAEL study | {"citation":"Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline","dose":"e been a well conducted study, and is fully reported; there is clear 30 evidence of embryo-toxicity at 50 mg/kg bw/day and above.","effect":"e been a well conducted study, and is fully reported; there is clear 30 evidence of embryo-toxicity at 50 mg/kg bw/day and above. The observed major 31 external/visceral abnormalities (at 100 and 150 mg/kg bw/day), most plausibly result from 32 retarded development and in utero pressure (the finding of retarded ossification is in line 33 with this hypothesis). The development of these effects may be associated with the 34 maternal toxicity (note that maternal toxicity is already present at 50 mg/kg bw/day). 35 The NOAEL for maternal toxicity and embryo-toxicity in this study is 15 mg/kg bw/day. In 36 an appendix a method for the estimation of the blood levels by HPLC is given, but no figures 37 for these values are provided. 38 Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline. However 43 the protocol seems to be very similar of the OECD TG 414 except that the dams were 44 treated only until GD 15th (instead of GD 18th). A NOAEL of 15 mg/kg bw/day can then be 45 d","page":15,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_006"} |
| SCCS_vision_codex | NOAEL | =50 | % | rat | oral | - | NOAEL study | {"dose":"OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35...","effect":"OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Effect Level (NOAEL) = 15 mg/kg bw/d 37 (teratogenicity study, maternal effects, oral, rat) 38 NOAEL corrected from bioavailability 50% (default) = 7.5 mg/kg bw/d 39 40 MOS NOAEL/SED = 36 41 42 43 * This is the highest value of two experiments in man, which gave values of 3.29 and 1.9% 44 45 3.3.14. Discussion 46 47 3-Benzylidene camphor is proposed for use in sunscreen products at levels up 2%. 48 49 General Toxicity 50 Various batches used for toxicity testing have not been identified with respect to their purity 51 and impurity. The homogeneity and stability of test solutions/suspensions have not been 5","page":24,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_012"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/day | - | - | 45 d | NOAEL study | {"citation":"Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline","dose":"e been a well conducted study, and is fully reported; there is clear 30 evidence of embryo-toxicity at 50 mg/kg bw/day and above.","effect":"e been a well conducted study, and is fully reported; there is clear 30 evidence of embryo-toxicity at 50 mg/kg bw/day and above. The observed major 31 external/visceral abnormalities (at 100 and 150 mg/kg bw/day), most plausibly result from 32 retarded development and in utero pressure (the finding of retarded ossification is in line 33 with this hypothesis). The development of these effects may be associated with the 34 maternal toxicity (note that maternal toxicity is already present at 50 mg/kg bw/day). 35 The NOAEL for maternal toxicity and embryo-toxicity in this study is 15 mg/kg bw/day. In 36 an appendix a method for the estimation of the blood levels by HPLC is given, but no figures 37 for these values are provided. 38 Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline. However 43 the protocol seems to be very similar of the OECD TG 414 except that the dams were 44 treated only until GD 15th (instead of GD 18th). A NOAEL of 15 mg/kg bw/day can then be 45 d","page":15,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_006"} |
| SCCS_vision_codex | NOAEL | =50 | % | rat | oral | - | NOAEL study | {"dose":"OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35...","effect":"OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Effect Level (NOAEL) = 15 mg/kg bw/d 37 (teratogenicity study, maternal effects, oral, rat) 38 NOAEL corrected from bioavailability 50% (default) = 7.5 mg/kg bw/d 39 40 MOS NOAEL/SED = 36 41 42 43 * This is the highest value of two experiments in man, which gave values of 3.29 and 1.9% 44 45 3.3.14. Discussion 46 47 3-Benzylidene camphor is proposed for use in sunscreen products at levels up 2%. 48 49 General Toxicity 50 Various batches used for toxicity testing have not been identified with respect to their purity 51 and impurity. The homogeneity and stability of test solutions/suspensions have not been 5","page":24,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_012"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/day | - | - | 45 d | NOAEL study | {"citation":"Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline","dose":"e been a well conducted study, and is fully reported; there is clear 30 evidence of embryo-toxicity at 50 mg/kg bw/day and above.","effect":"e been a well conducted study, and is fully reported; there is clear 30 evidence of embryo-toxicity at 50 mg/kg bw/day and above. The observed major 31 external/visceral abnormalities (at 100 and 150 mg/kg bw/day), most plausibly result from 32 retarded development and in utero pressure (the finding of retarded ossification is in line 33 with this hypothesis). The development of these effects may be associated with the 34 maternal toxicity (note that maternal toxicity is already present at 50 mg/kg bw/day). 35 The NOAEL for maternal toxicity and embryo-toxicity in this study is 15 mg/kg bw/day. In 36 an appendix a method for the estimation of the blood levels by HPLC is given, but no figures 37 for these values are provided. 38 Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline. However 43 the protocol seems to be very similar of the OECD TG 414 except that the dams were 44 treated only until GD 15th (instead of GD 18th). A NOAEL of 15 mg/kg bw/day can then be 45 d","page":15,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_006"} |
| SCCS_vision_codex | NOAEL | =50 | % | rat | oral | - | NOAEL study | {"dose":"OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35...","effect":"OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Effect Level (NOAEL) = 15 mg/kg bw/d 37 (teratogenicity study, maternal effects, oral, rat) 38 NOAEL corrected from bioavailability 50% (default) = 7.5 mg/kg bw/d 39 40 MOS NOAEL/SED = 36 41 42 43 * This is the highest value of two experiments in man, which gave values of 3.29 and 1.9% 44 45 3.3.14. Discussion 46 47 3-Benzylidene camphor is proposed for use in sunscreen products at levels up 2%. 48 49 General Toxicity 50 Various batches used for toxicity testing have not been identified with respect to their purity 51 and impurity. The homogeneity and stability of test solutions/suspensions have not been 5","page":24,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_012"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/d | rat | oral | sub-chronic | repeated dose toxicity | {"citation":"Ref.: 2 16 17 Rat 18 19 20 Groups of 10 male and 10 female SD rats were given doses of a","dose":"In male animals, bilirubin 8 was reduced in a dose related manner, and protein was somewhat increased.","effect":"a very striking reduction of cholesterol levels 7 in all dosed groups (cf. Results from sub-chronic toxicity, infra). In male animals, bilirubin 8 was reduced in a dose related manner, and protein was somewhat increased. In female 9 animals glucose, protein and alkaline phosphatase levels were all very significantly 10 increased in all dosed groups, but the increases did not seem to be dose related. Lipids do 11 not seem to have been measured. Examination of the urine revealed no abnormality. 12 13 Apparently, a NOAEL (which would be lower than 250 mg/kg bw/d) has not been 14 established from that study. 15 Ref.: 2 16 17 Rat 18 19 20 Groups of 10 male and 10 female SD rats were given doses of a.i. of 0, 25 and 50 mg/kg 21 bw/day by gavage for 6 weeks. The study was conducted according to GLP. 22 23 There were no deaths. The chief clinical finding was alopecia chiefly in females at the high 24 dose. 25 26 Body weight and body weight gain were unaffected. There were some falls in food 27 consumption in female animals in two","page":11,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_003"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/d | rat | oral | sub-chronic | repeated dose toxicity | {"citation":"Ref.: 2 16 17 Rat 18 19 20 Groups of 10 male and 10 female SD rats were given doses of a","dose":"In male animals, bilirubin 8 was reduced in a dose related manner, and protein was somewhat increased.","effect":"a very striking reduction of cholesterol levels 7 in all dosed groups (cf. Results from sub-chronic toxicity, infra). In male animals, bilirubin 8 was reduced in a dose related manner, and protein was somewhat increased. In female 9 animals glucose, protein and alkaline phosphatase levels were all very significantly 10 increased in all dosed groups, but the increases did not seem to be dose related. Lipids do 11 not seem to have been measured. Examination of the urine revealed no abnormality. 12 13 Apparently, a NOAEL (which would be lower than 250 mg/kg bw/d) has not been 14 established from that study. 15 Ref.: 2 16 17 Rat 18 19 20 Groups of 10 male and 10 female SD rats were given doses of a.i. of 0, 25 and 50 mg/kg 21 bw/day by gavage for 6 weeks. The study was conducted according to GLP. 22 23 There were no deaths. The chief clinical finding was alopecia chiefly in females at the high 24 dose. 25 26 Body weight and body weight gain were unaffected. There were some falls in food 27 consumption in female animals in two","page":11,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_003"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/d | rat | oral | sub-chronic | repeated dose toxicity | {"citation":"Ref.: 2 16 17 Rat 18 19 20 Groups of 10 male and 10 female SD rats were given doses of a","dose":"In male animals, bilirubin 8 was reduced in a dose related manner, and protein was somewhat increased.","effect":"a very striking reduction of cholesterol levels 7 in all dosed groups (cf. Results from sub-chronic toxicity, infra). In male animals, bilirubin 8 was reduced in a dose related manner, and protein was somewhat increased. In female 9 animals glucose, protein and alkaline phosphatase levels were all very significantly 10 increased in all dosed groups, but the increases did not seem to be dose related. Lipids do 11 not seem to have been measured. Examination of the urine revealed no abnormality. 12 13 Apparently, a NOAEL (which would be lower than 250 mg/kg bw/d) has not been 14 established from that study. 15 Ref.: 2 16 17 Rat 18 19 20 Groups of 10 male and 10 female SD rats were given doses of a.i. of 0, 25 and 50 mg/kg 21 bw/day by gavage for 6 weeks. The study was conducted according to GLP. 22 23 There were no deaths. The chief clinical finding was alopecia chiefly in females at the high 24 dose. 25 26 Body weight and body weight gain were unaffected. There were some falls in food 27 consumption in female animals in two","page":11,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_003"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/d | rat | oral | sub-chronic | repeated dose toxicity | {"citation":"Ref.: 2 16 17 Rat 18 19 20 Groups of 10 male and 10 female SD rats were given doses of a","dose":"In male animals, bilirubin 8 was reduced in a dose related manner, and protein was somewhat increased.","effect":"a very striking reduction of cholesterol levels 7 in all dosed groups (cf. Results from sub-chronic toxicity, infra). In male animals, bilirubin 8 was reduced in a dose related manner, and protein was somewhat increased. In female 9 animals glucose, protein and alkaline phosphatase levels were all very significantly 10 increased in all dosed groups, but the increases did not seem to be dose related. Lipids do 11 not seem to have been measured. Examination of the urine revealed no abnormality. 12 13 Apparently, a NOAEL (which would be lower than 250 mg/kg bw/d) has not been 14 established from that study. 15 Ref.: 2 16 17 Rat 18 19 20 Groups of 10 male and 10 female SD rats were given doses of a.i. of 0, 25 and 50 mg/kg 21 bw/day by gavage for 6 weeks. The study was conducted according to GLP. 22 23 There were no deaths. The chief clinical finding was alopecia chiefly in females at the high 24 dose. 25 26 Body weight and body weight gain were unaffected. There were some falls in food 27 consumption in female animals in two","page":11,"pdf":"sccs_o_134.pdf","row_type":"noael_study","study_id":"sccs_o_134_noael_003"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 16 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | =0.21 | mg/kg bw | rat | oral | - | - | SOURCE_SUBDIR=sccs_o_134; REPORT_TITLE=OPINION ON 3-Benzylidene camphor COLIPA n° S61 References are cited in a different way in the opinion compared to the submissions; OPINION_NUMBER=SCCS/1513/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 0.21; DOSE=Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active...; EFFECT=e results need to be confirmed. 24 3.3.13. Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Effect Level (NOAEL) = 15 mg/kg bw/d 37 (teratogenicity study, maternal effects, oral, rat) 38 NOAEL corrected from bioavailability 50% (default) = 7.5 mg/kg bw/d 39 40 MOS NOAEL/SED = 36 41 42 43 * This is the highest value of two experiments in man, which gave values of 3.29 and 1.9% 44 45 3.3.14. Discussion 46 47 3-Benzylidene camphor is proposed for use in sunscreen products at levels up 2%. 48 49 General Toxicity 50 Various batches used for toxicity testing have not been identified with respect to their purity 51 a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"15087-24-8","citation":"","dose":"Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active...","duration":"","effect":"e results need to be confirmed. 24 3.3.13. Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Effect Level (NOAEL) = 15 mg/kg bw/d 37 (teratogenicity study, maternal effects, oral, rat) 38 NOAEL corrected from bioavailability 50% (default) = 7.5 mg/kg bw/d 39 40 MOS NOAEL/SED = 36 41 42 43 * This is the highest value of two experiments in man, which gave values of 3.29 and 1.9% 44 45 3.3.14. Discussion 46 47 3-Benzylidene camphor is proposed for use in sunscreen products at levels up 2%. 48 49 General Toxicity 50 Various batches used for toxicity testing have not been identified with respect to their purity 51 a","endpoint":"","ingredient":"3-Benzylidene camphor","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.21","page":24,"route":"oral","species":"rat","study_id":"sccs_o_134_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | =2 | % | rat | - | - | - | SOURCE_SUBDIR=sccs_o_134; REPORT_TITLE=OPINION ON 3-Benzylidene camphor COLIPA n° S61 References are cited in a different way in the opinion compared to the submissions; OPINION_NUMBER=SCCS/1513/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 2; EFFECT=ulation of the MOS but as supportive studies for risk assessment of 3-BC. 16 17 SCCS comment on studies on endocrine activity 18 Concerning the potential endocrine disruptor properties of 3-BC, multiple hormonal activities 19 of 3-BC have been reported in vitro: estrogenic and anti-estrogenic effects as well 20 antiandrogenic activities. In vivo, the expression of target genes (ERα, ERβ, SRC-1 and PR 21 (progesterone receptor)) has been shown to be altered in both males and females rats at 22 doses lower than the NOAEL used to calculate the MoS. Due to some shortcomings in the 23 studies, the results need to be confirmed. 24 3.3.13. Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"15087-24-8","citation":"","dose":"","duration":"","effect":"ulation of the MOS but as supportive studies for risk assessment of 3-BC. 16 17 SCCS comment on studies on endocrine activity 18 Concerning the potential endocrine disruptor properties of 3-BC, multiple hormonal activities 19 of 3-BC have been reported in vitro: estrogenic and anti-estrogenic effects as well 20 antiandrogenic activities. In vivo, the expression of target genes (ERα, ERβ, SRC-1 and PR 21 (progesterone receptor)) has been shown to be altered in both males and females rats at 22 doses lower than the NOAEL used to calculate the MoS. Due to some shortcomings in the 23 studies, the results need to be confirmed. 24 3.3.13. Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x","endpoint":"","ingredient":"3-Benzylidene camphor","loael_value":"","noael_unit":"%","noael_value":"= 2","page":24,"route":"","species":"rat","study_id":"sccs_o_134_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 2 | % | rat | oral | 4 week | - | SOURCE_SUBDIR=sccs_o_134; REPORT_TITLE=OPINION ON 3-Benzylidene camphor COLIPA n° S61 References are cited in a different way in the opinion compared to the submissions; OPINION_NUMBER=SCCS/1513/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=2.0; EFFECT=ers that the use of 3-benzylidene-camphor as a UV-filter 20 in cosmetic products in a concentration up 2.0% is not safe. 21 22 Concerning the potential endocrine disruptor properties of 3-BC, multiple hormonal activities 23 of 3-BC have been reported in vitro: estrogenic and anti-estrogenic effects as well anti- 24 androgenic activities. In vivo, the expression of target genes (ERα, ERβ, SRC-1 and PR 25 (progesterone receptor)) has been shown to be altered in both males and females rats at 26 doses lower than the NOAEL used to calculate the MoS. Due to some shortcomings in the 27 studies, the results need to be confirmed. 28 29 30 5. MINORITY OPINION 31 - 32 33 6. REFERENCES 34 35 36 1. Fournier P.E. (1981) Unité de pharmacologie Clinique, Hopital Fernand Widal, 200 rue 37 du Faubourg St. Denis 75010 Paris. 38 2. Monnot G. (1987) Mexoryl SD- 4 week oral toxicity study in rat-Report n° 611534- 39 Hazleton-IFT, Les Oncins, 69210 St. Germain-sur-l'Arbresle. 40 3. Fournier P.E. (1982) Mexoryl SD -13 week oral toxicity study in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"15087-24-8","citation":"","dose":"","duration":"4 week","effect":"ers that the use of 3-benzylidene-camphor as a UV-filter 20 in cosmetic products in a concentration up 2.0% is not safe. 21 22 Concerning the potential endocrine disruptor properties of 3-BC, multiple hormonal activities 23 of 3-BC have been reported in vitro: estrogenic and anti-estrogenic effects as well anti- 24 androgenic activities. In vivo, the expression of target genes (ERα, ERβ, SRC-1 and PR 25 (progesterone receptor)) has been shown to be altered in both males and females rats at 26 doses lower than the NOAEL used to calculate the MoS. Due to some shortcomings in the 27 studies, the results need to be confirmed. 28 29 30 5. MINORITY OPINION 31 - 32 33 6. REFERENCES 34 35 36 1. Fournier P.E. (1981) Unité de pharmacologie Clinique, Hopital Fernand Widal, 200 rue 37 du Faubourg St. Denis 75010 Paris. 38 2. Monnot G. (1987) Mexoryl SD- 4 week oral toxicity study in rat-Report n° 611534- 39 Hazleton-IFT, Les Oncins, 69210 St. Germain-sur-l'Arbresle. 40 3. Fournier P.E. (1982) Mexoryl SD -13 week oral toxicity study in","endpoint":"","ingredient":"3-Benzylidene camphor","loael_value":"","noael_unit":"%","noael_value":"2.0","page":26,"route":"oral","species":"rat","study_id":"sccs_o_134_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | =7.5 | mg/kg bw/d | rat | oral | - | - | SOURCE_SUBDIR=sccs_o_134; REPORT_TITLE=OPINION ON 3-Benzylidene camphor COLIPA n° S61 References are cited in a different way in the opinion compared to the submissions; OPINION_NUMBER=SCCS/1513/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 7.5; DOSE=18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Ef...; EFFECT=18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Effect Level (NOAEL) = 15 mg/kg bw/d 37 (teratogenicity study, maternal effects, oral, rat) 38 NOAEL corrected from bioavailability 50% (default) = 7.5 mg/kg bw/d 39 40 MOS NOAEL/SED = 36 41 42 43 * This is the highest value of two experiments in man, which gave values of 3.29 and 1.9% 44 45 3.3.14. Discussion 46 47 3-Benzylidene camphor is proposed for use in sunscreen products at levels up 2%. 48 49 General Toxicity 50 Various batches used for toxicity testing have not been identified with respect to their purity 51 and impurity. The homogeneity and stability of test solutions/suspensions have not been 52 documented. Quantitative data on solubility in various solvents of 3-BC was no; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"15087-24-8","citation":"","dose":"18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Ef...","duration":"","effect":"18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Effect Level (NOAEL) = 15 mg/kg bw/d 37 (teratogenicity study, maternal effects, oral, rat) 38 NOAEL corrected from bioavailability 50% (default) = 7.5 mg/kg bw/d 39 40 MOS NOAEL/SED = 36 41 42 43 * This is the highest value of two experiments in man, which gave values of 3.29 and 1.9% 44 45 3.3.14. Discussion 46 47 3-Benzylidene camphor is proposed for use in sunscreen products at levels up 2%. 48 49 General Toxicity 50 Various batches used for toxicity testing have not been identified with respect to their purity 51 and impurity. The homogeneity and stability of test solutions/suspensions have not been 52 documented. Quantitative data on solubility in various solvents of 3-BC was no","endpoint":"","ingredient":"3-Benzylidene camphor","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 7.5","page":24,"route":"oral","species":"rat","study_id":"sccs_o_134_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 15 | mg/kg bw/day | mouse | oral | 56 day | - | SOURCE_SUBDIR=sccs_o_134; REPORT_TITLE=OPINION ON 3-Benzylidene camphor COLIPA n° S61 References are cited in a different way in the opinion compared to the submissions; OPINION_NUMBER=SCCS/1513/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=15; DOSE=present at 50 mg/kg bw/day).; EFFECT=present at 50 mg/kg bw/day). 35 The NOAEL for maternal toxicity and embryo-toxicity in this study is 15 mg/kg bw/day. In 36 an appendix a method for the estimation of the blood levels by HPLC is given, but no figures 37 for these values are provided. 38 Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline. However 43 the protocol seems to be very similar of the OECD TG 414 except that the dams were 44 treated only until GD 15th (instead of GD 18th). A NOAEL of 15 mg/kg bw/day can then be 45 derived from this study, based on maternal and embryo toxicity. This NOAEL can be used 46 for risk assessment. 47 48 49 Mouse 50 51 52 A similar test to the above was carried out in cr1 CD1 (ICR) BR mice, in conformity with 53 GLP. 54 Groups of 25 to 26 animals were mated; the numbers pregnant in each group were 26, 25, 55 23, 24, 24. Dosing was by gavage at levels of 0, 15, 50, 100 and 250 mg/kg bw/day, from 56 day 6 to day 15 of pregnancy. 57; CITATION=Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline; CITATION_NUMBERS=[18,39,40,41,42]; REFERENCE=Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline; DETAILS_JSON={"cas_number":"15087-24-8","citation":"Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline","dose":"present at 50 mg/kg bw/day).","duration":"56 day","effect":"present at 50 mg/kg bw/day). 35 The NOAEL for maternal toxicity and embryo-toxicity in this study is 15 mg/kg bw/day. In 36 an appendix a method for the estimation of the blood levels by HPLC is given, but no figures 37 for these values are provided. 38 Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline. However 43 the protocol seems to be very similar of the OECD TG 414 except that the dams were 44 treated only until GD 15th (instead of GD 18th). A NOAEL of 15 mg/kg bw/day can then be 45 derived from this study, based on maternal and embryo toxicity. This NOAEL can be used 46 for risk assessment. 47 48 49 Mouse 50 51 52 A similar test to the above was carried out in cr1 CD1 (ICR) BR mice, in conformity with 53 GLP. 54 Groups of 25 to 26 animals were mated; the numbers pregnant in each group were 26, 25, 55 23, 24, 24. Dosing was by gavage at levels of 0, 15, 50, 100 and 250 mg/kg bw/day, from 56 day 6 to day 15 of pregnancy. 57","endpoint":"","ingredient":"3-Benzylidene camphor","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"15","page":15,"route":"oral","species":"mouse","study_id":"sccs_o_134_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 15 | mg/kg bw/day | mouse | oral | 56 day | - | SOURCE_SUBDIR=sccs_o_134; REPORT_TITLE=OPINION ON 3-Benzylidene camphor COLIPA n° S61 References are cited in a different way in the opinion compared to the submissions; OPINION_NUMBER=SCCS/1513/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=15; DOSE=However 43 the protocol seems to be very similar of the OECD TG 414 except that the dams were 44 treated only until GD 15th (instead of GD 18th).; EFFECT=bw/day. In 36 an appendix a method for the estimation of the blood levels by HPLC is given, but no figures 37 for these values are provided. 38 Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline. However 43 the protocol seems to be very similar of the OECD TG 414 except that the dams were 44 treated only until GD 15th (instead of GD 18th). A NOAEL of 15 mg/kg bw/day can then be 45 derived from this study, based on maternal and embryo toxicity. This NOAEL can be used 46 for risk assessment. 47 48 49 Mouse 50 51 52 A similar test to the above was carried out in cr1 CD1 (ICR) BR mice, in conformity with 53 GLP. 54 Groups of 25 to 26 animals were mated; the numbers pregnant in each group were 26, 25, 55 23, 24, 24. Dosing was by gavage at levels of 0, 15, 50, 100 and 250 mg/kg bw/day, from 56 day 6 to day 15 of pregnancy. 57; CITATION=Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline; CITATION_NUMBERS=[18,39,40,41,42]; REFERENCE=Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline; DETAILS_JSON={"cas_number":"15087-24-8","citation":"Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline","dose":"However 43 the protocol seems to be very similar of the OECD TG 414 except that the dams were 44 treated only until GD 15th (instead of GD 18th).","duration":"56 day","effect":"bw/day. In 36 an appendix a method for the estimation of the blood levels by HPLC is given, but no figures 37 for these values are provided. 38 Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline. However 43 the protocol seems to be very similar of the OECD TG 414 except that the dams were 44 treated only until GD 15th (instead of GD 18th). A NOAEL of 15 mg/kg bw/day can then be 45 derived from this study, based on maternal and embryo toxicity. This NOAEL can be used 46 for risk assessment. 47 48 49 Mouse 50 51 52 A similar test to the above was carried out in cr1 CD1 (ICR) BR mice, in conformity with 53 GLP. 54 Groups of 25 to 26 animals were mated; the numbers pregnant in each group were 26, 25, 55 23, 24, 24. Dosing was by gavage at levels of 0, 15, 50, 100 and 250 mg/kg bw/day, from 56 day 6 to day 15 of pregnancy. 57","endpoint":"","ingredient":"3-Benzylidene camphor","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"15","page":15,"route":"oral","species":"mouse","study_id":"sccs_o_134_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | =15 | mg/kg bw/d | rat | oral | - | - | SOURCE_SUBDIR=sccs_o_134; REPORT_TITLE=OPINION ON 3-Benzylidene camphor COLIPA n° S61 References are cited in a different way in the opinion compared to the submissions; OPINION_NUMBER=SCCS/1513/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 15; DOSE=Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active...; EFFECT=3.3.13. Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Effect Level (NOAEL) = 15 mg/kg bw/d 37 (teratogenicity study, maternal effects, oral, rat) 38 NOAEL corrected from bioavailability 50% (default) = 7.5 mg/kg bw/d 39 40 MOS NOAEL/SED = 36 41 42 43 * This is the highest value of two experiments in man, which gave values of 3.29 and 1.9% 44 45 3.3.14. Discussion 46 47 3-Benzylidene camphor is proposed for use in sunscreen products at levels up 2%. 48 49 General Toxicity 50 Various batches used for toxicity testing have not been identified with respect to their purity 51 and impu; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"15087-24-8","citation":"","dose":"Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active...","duration":"","effect":"3.3.13. Safety evaluation (including calculation of the MoS) 25 26 CALCULATION OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Effect Level (NOAEL) = 15 mg/kg bw/d 37 (teratogenicity study, maternal effects, oral, rat) 38 NOAEL corrected from bioavailability 50% (default) = 7.5 mg/kg bw/d 39 40 MOS NOAEL/SED = 36 41 42 43 * This is the highest value of two experiments in man, which gave values of 3.29 and 1.9% 44 45 3.3.14. Discussion 46 47 3-Benzylidene camphor is proposed for use in sunscreen products at levels up 2%. 48 49 General Toxicity 50 Various batches used for toxicity testing have not been identified with respect to their purity 51 and impu","endpoint":"","ingredient":"3-Benzylidene camphor","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 15","page":24,"route":"oral","species":"rat","study_id":"sccs_o_134_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 18 | - | human | dermal | - | - | SOURCE_SUBDIR=sccs_o_134; REPORT_TITLE=OPINION ON 3-Benzylidene camphor COLIPA n° S61 References are cited in a different way in the opinion compared to the submissions; OPINION_NUMBER=SCCS/1513/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=unclear:adopted prohibits, as a safeguard measure in accordance 18 with the provisions of Article 12(2) of the Directive 76/768/EEC, the manufacture, import, 19 export, wholesale distribution, placing on the market free of charge or against payment, 20 holding with a view to sale or distribution free of charge and use of cosmetic products 21 containing 3-benzylidene camphor (CAS: 15087-24-8). 22 23 The AFSSAPS report states that the hazard characterisation for this substance is considered 24 incomplete. In addition, the no observed adverse effect level (NOAEL) and the cutaneous 25 absorption rate used by the AFSSAPS in connection with the risk assessment results in 26 insufficient margin of safety to ensure consumer safety in accordance with the SCCS’s notes 27 of guidance3. Finally, as endocrine disruption effects were observed in the studies published 28 in the scientific literature, in the current state of knowledge, the French authorities consider 29 that it is not possible to conclude that there is no risk to humans. 30 31 32 2. TERMS OF REFERENCE 33 34; EFFECT=adopted prohibits, as a safeguard measure in accordance 18 with the provisions of Article 12(2) of the Directive 76/768/EEC, the manufacture, import, 19 export, wholesale distribution, placing on the market free of charge or against payment, 20 holding with a view to sale or distribution free of charge and use of cosmetic products 21 containing 3-benzylidene camphor (CAS: 15087-24-8). 22 23 The AFSSAPS report states that the hazard characterisation for this substance is considered 24 incomplete. In addition, the no observed adverse effect level (NOAEL) and the cutaneous 25 absorption rate used by the AFSSAPS in connection with the risk assessment results in 26 insufficient margin of safety to ensure consumer safety in accordance with the SCCS’s notes 27 of guidance3. Finally, as endocrine disruption effects were observed in the studies published 28 in the scientific literature, in the current state of knowledge, the French authorities consider 29 that it is not possible to conclude that there is no risk to humans. 30 31 32 2. TERMS OF REFERENCE 33 34; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"15087-24-8","citation":"","dose":"","duration":"","effect":"adopted prohibits, as a safeguard measure in accordance 18 with the provisions of Article 12(2) of the Directive 76/768/EEC, the manufacture, import, 19 export, wholesale distribution, placing on the market free of charge or against payment, 20 holding with a view to sale or distribution free of charge and use of cosmetic products 21 containing 3-benzylidene camphor (CAS: 15087-24-8). 22 23 The AFSSAPS report states that the hazard characterisation for this substance is considered 24 incomplete. In addition, the no observed adverse effect level (NOAEL) and the cutaneous 25 absorption rate used by the AFSSAPS in connection with the risk assessment results in 26 insufficient margin of safety to ensure consumer safety in accordance with the SCCS’s notes 27 of guidance3. Finally, as endocrine disruption effects were observed in the studies published 28 in the scientific literature, in the current state of knowledge, the French authorities consider 29 that it is not possible to conclude that there is no risk to humans. 30 31 32 2. TERMS OF REFERENCE 33 34","endpoint":"","ingredient":"3-Benzylidene camphor","loael_value":"","noael_unit":"","noael_value":"unclear:adopted prohibits, as a safeguard measure in accordance 18 with the provisions of Article 12(2) of the Directive 76/768/EEC, the manufacture, import, 19 export, wholesale distribution, placing on the market free of charge or against payment, 20 holding with a view to sale or distribution free of charge and use of cosmetic products 21 containing 3-benzylidene camphor (CAS: 15087-24-8). 22 23 The AFSSAPS report states that the hazard characterisation for this substance is considered 24 incomplete. In addition, the no observed adverse effect level (NOAEL) and the cutaneous 25 absorption rate used by the AFSSAPS in connection with the risk assessment results in 26 insufficient margin of safety to ensure consumer safety in accordance with the SCCS’s notes 27 of guidance3. Finally, as endocrine disruption effects were observed in the studies published 28 in the scientific literature, in the current state of knowledge, the French authorities consider 29 that it is not possible to conclude that there is no risk to humans. 30 31 32 2. TERMS OF REFERENCE 33 34","page":5,"route":"dermal","species":"human","study_id":"sccs_o_134_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 18 | - | human | dermal | - | - | SOURCE_SUBDIR=sccs_o_134; REPORT_TITLE=OPINION ON 3-Benzylidene camphor COLIPA n° S61 References are cited in a different way in the opinion compared to the submissions; OPINION_NUMBER=SCCS/1513/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=unclear:measure in accordance 18 with the provisions of Article 12(2) of the Directive 76/768/EEC, the manufacture, import, 19 export, wholesale distribution, placing on the market free of charge or against payment, 20 holding with a view to sale or distribution free of charge and use of cosmetic products 21 containing 3-benzylidene camphor (CAS: 15087-24-8). 22 23 The AFSSAPS report states that the hazard characterisation for this substance is considered 24 incomplete. In addition, the no observed adverse effect level (NOAEL) and the cutaneous 25 absorption rate used by the AFSSAPS in connection with the risk assessment results in 26 insufficient margin of safety to ensure consumer safety in accordance with the SCCS’s notes 27 of guidance3. Finally, as endocrine disruption effects were observed in the studies published 28 in the scientific literature, in the current state of knowledge, the French authorities consider 29 that it is not possible to conclude that there is no risk to humans. 30 31 32 2. TERMS OF REFERENCE 33 34 1. Does; EFFECT=measure in accordance 18 with the provisions of Article 12(2) of the Directive 76/768/EEC, the manufacture, import, 19 export, wholesale distribution, placing on the market free of charge or against payment, 20 holding with a view to sale or distribution free of charge and use of cosmetic products 21 containing 3-benzylidene camphor (CAS: 15087-24-8). 22 23 The AFSSAPS report states that the hazard characterisation for this substance is considered 24 incomplete. In addition, the no observed adverse effect level (NOAEL) and the cutaneous 25 absorption rate used by the AFSSAPS in connection with the risk assessment results in 26 insufficient margin of safety to ensure consumer safety in accordance with the SCCS’s notes 27 of guidance3. Finally, as endocrine disruption effects were observed in the studies published 28 in the scientific literature, in the current state of knowledge, the French authorities consider 29 that it is not possible to conclude that there is no risk to humans. 30 31 32 2. TERMS OF REFERENCE 33 34 1. Does; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"15087-24-8","citation":"","dose":"","duration":"","effect":"measure in accordance 18 with the provisions of Article 12(2) of the Directive 76/768/EEC, the manufacture, import, 19 export, wholesale distribution, placing on the market free of charge or against payment, 20 holding with a view to sale or distribution free of charge and use of cosmetic products 21 containing 3-benzylidene camphor (CAS: 15087-24-8). 22 23 The AFSSAPS report states that the hazard characterisation for this substance is considered 24 incomplete. In addition, the no observed adverse effect level (NOAEL) and the cutaneous 25 absorption rate used by the AFSSAPS in connection with the risk assessment results in 26 insufficient margin of safety to ensure consumer safety in accordance with the SCCS’s notes 27 of guidance3. Finally, as endocrine disruption effects were observed in the studies published 28 in the scientific literature, in the current state of knowledge, the French authorities consider 29 that it is not possible to conclude that there is no risk to humans. 30 31 32 2. TERMS OF REFERENCE 33 34 1. Does","endpoint":"","ingredient":"3-Benzylidene camphor","loael_value":"","noael_unit":"","noael_value":"unclear:measure in accordance 18 with the provisions of Article 12(2) of the Directive 76/768/EEC, the manufacture, import, 19 export, wholesale distribution, placing on the market free of charge or against payment, 20 holding with a view to sale or distribution free of charge and use of cosmetic products 21 containing 3-benzylidene camphor (CAS: 15087-24-8). 22 23 The AFSSAPS report states that the hazard characterisation for this substance is considered 24 incomplete. In addition, the no observed adverse effect level (NOAEL) and the cutaneous 25 absorption rate used by the AFSSAPS in connection with the risk assessment results in 26 insufficient margin of safety to ensure consumer safety in accordance with the SCCS’s notes 27 of guidance3. Finally, as endocrine disruption effects were observed in the studies published 28 in the scientific literature, in the current state of knowledge, the French authorities consider 29 that it is not possible to conclude that there is no risk to humans. 30 31 32 2. TERMS OF REFERENCE 33 34 1. Does","page":5,"route":"dermal","species":"human","study_id":"sccs_o_134_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | mg/kg bw/d | guinea pig | oral | 15 days | - | SOURCE_SUBDIR=sccs_o_134; REPORT_TITLE=OPINION ON 3-Benzylidene camphor COLIPA n° S61 References are cited in a different way in the opinion compared to the submissions; OPINION_NUMBER=SCCS/1513/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=25; DOSE=ivers and spleens showed some increase, but although this was 1 statistically significant, it was small and probably not biologically significant (no dose given).; EFFECT=ivers and spleens showed some increase, but although this was 1 statistically significant, it was small and probably not biologically significant (no dose given). 2 A similar observation applies to the adrenal glands. 3 4 Microscopic examinations indicated a follicular and epithelial thyroid hyperplasia and a 5 hypertrophy of the fasciculated zone in adrenals from the treated female groups. 6 Ophthalmological examinations at sacrifice showed no differences between control and 7 treated animals. 8 9 Apparently, a NOAEL (which would be lower than 25 mg/kg bw/d) has not been established 10 from that study. 11 12 Ref.: 15 13 14 15 Guinea pig 16 17 18 Female animals only, of the Dunkin Hartley strain, were used in this study. In a preliminary 19 experiment, one animal was treated by gavage with 500 and one with 1000 mg/kg bw/day 20 for 15 days. No abnormality was found, and the dose of 500 mg/kg bw/day was chosen for 21 the main study. 22 23 Two experiments were conducted in parallel, in accordance with GLP. In one, groups of; CITATION=Ref.: 15 13 14 15 Guinea pig 16 17 18 Female animals only, of the Dunkin Hartley strain, were used in this study; CITATION_NUMBERS=[15,13,14,16,17,18]; REFERENCE=Ref.: 15 13 14 15 Guinea pig 16 17 18 Female animals only, of the Dunkin Hartley strain, were used in this study; DETAILS_JSON={"cas_number":"15087-24-8","citation":"Ref.: 15 13 14 15 Guinea pig 16 17 18 Female animals only, of the Dunkin Hartley strain, were used in this study","dose":"ivers and spleens showed some increase, but although this was 1 statistically significant, it was small and probably not biologically significant (no dose given).","duration":"15 days","effect":"ivers and spleens showed some increase, but although this was 1 statistically significant, it was small and probably not biologically significant (no dose given). 2 A similar observation applies to the adrenal glands. 3 4 Microscopic examinations indicated a follicular and epithelial thyroid hyperplasia and a 5 hypertrophy of the fasciculated zone in adrenals from the treated female groups. 6 Ophthalmological examinations at sacrifice showed no differences between control and 7 treated animals. 8 9 Apparently, a NOAEL (which would be lower than 25 mg/kg bw/d) has not been established 10 from that study. 11 12 Ref.: 15 13 14 15 Guinea pig 16 17 18 Female animals only, of the Dunkin Hartley strain, were used in this study. In a preliminary 19 experiment, one animal was treated by gavage with 500 and one with 1000 mg/kg bw/day 20 for 15 days. No abnormality was found, and the dose of 500 mg/kg bw/day was chosen for 21 the main study. 22 23 Two experiments were conducted in parallel, in accordance with GLP. In one, groups of","endpoint":"","ingredient":"3-Benzylidene camphor","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"25","page":12,"route":"oral","species":"guinea pig","study_id":"sccs_o_134_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 50 | mg/kg bw/day | - | - | 45 d | - | SOURCE_SUBDIR=sccs_o_134; REPORT_TITLE=OPINION ON 3-Benzylidene camphor COLIPA n° S61 References are cited in a different way in the opinion compared to the submissions; OPINION_NUMBER=SCCS/1513/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=50; DOSE=e been a well conducted study, and is fully reported; there is clear 30 evidence of embryo-toxicity at 50 mg/kg bw/day and above.; EFFECT=e been a well conducted study, and is fully reported; there is clear 30 evidence of embryo-toxicity at 50 mg/kg bw/day and above. The observed major 31 external/visceral abnormalities (at 100 and 150 mg/kg bw/day), most plausibly result from 32 retarded development and in utero pressure (the finding of retarded ossification is in line 33 with this hypothesis). The development of these effects may be associated with the 34 maternal toxicity (note that maternal toxicity is already present at 50 mg/kg bw/day). 35 The NOAEL for maternal toxicity and embryo-toxicity in this study is 15 mg/kg bw/day. In 36 an appendix a method for the estimation of the blood levels by HPLC is given, but no figures 37 for these values are provided. 38 Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline. However 43 the protocol seems to be very similar of the OECD TG 414 except that the dams were 44 treated only until GD 15th (instead of GD 18th). A NOAEL of 15 mg/kg bw/day can then be 45 d; CITATION=Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline; CITATION_NUMBERS=[18,39,40,41,42]; REFERENCE=Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline; DETAILS_JSON={"cas_number":"15087-24-8","citation":"Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline","dose":"e been a well conducted study, and is fully reported; there is clear 30 evidence of embryo-toxicity at 50 mg/kg bw/day and above.","duration":"45 d","effect":"e been a well conducted study, and is fully reported; there is clear 30 evidence of embryo-toxicity at 50 mg/kg bw/day and above. The observed major 31 external/visceral abnormalities (at 100 and 150 mg/kg bw/day), most plausibly result from 32 retarded development and in utero pressure (the finding of retarded ossification is in line 33 with this hypothesis). The development of these effects may be associated with the 34 maternal toxicity (note that maternal toxicity is already present at 50 mg/kg bw/day). 35 The NOAEL for maternal toxicity and embryo-toxicity in this study is 15 mg/kg bw/day. In 36 an appendix a method for the estimation of the blood levels by HPLC is given, but no figures 37 for these values are provided. 38 Ref.: 18 39 40 41 SCCS comments 42 As reported in the Afssaps report, this study does not follow an OECD guideline. However 43 the protocol seems to be very similar of the OECD TG 414 except that the dams were 44 treated only until GD 15th (instead of GD 18th). A NOAEL of 15 mg/kg bw/day can then be 45 d","endpoint":"","ingredient":"3-Benzylidene camphor","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":15,"route":"","species":"","study_id":"sccs_o_134_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 50 | % | rat | oral | - | - | SOURCE_SUBDIR=sccs_o_134; REPORT_TITLE=OPINION ON 3-Benzylidene camphor COLIPA n° S61 References are cited in a different way in the opinion compared to the submissions; OPINION_NUMBER=SCCS/1513/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=50; DOSE=OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35...; EFFECT=OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Effect Level (NOAEL) = 15 mg/kg bw/d 37 (teratogenicity study, maternal effects, oral, rat) 38 NOAEL corrected from bioavailability 50% (default) = 7.5 mg/kg bw/d 39 40 MOS NOAEL/SED = 36 41 42 43 * This is the highest value of two experiments in man, which gave values of 3.29 and 1.9% 44 45 3.3.14. Discussion 46 47 3-Benzylidene camphor is proposed for use in sunscreen products at levels up 2%. 48 49 General Toxicity 50 Various batches used for toxicity testing have not been identified with respect to their purity 51 and impurity. The homogeneity and stability of test solutions/suspensions have not been 5; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"15087-24-8","citation":"","dose":"OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35...","duration":"","effect":"OF THE MARGIN OF SAFETY 27 28 29 Amount of cosmetic product applied daily F = 18000 mg 30 Concentration of ingredient in finished product C% = 2% 31 Total amount of active ingredient applied I=F x C/100 = 360 mg 32 Typical body weight of human = 60 kg 33 Absorption of active ingredient * A% = 3.29% 34 Total amount absorbed I x A/100 = 12.7 mg 35 Systemic exposure dose (SED) 9.8/60 = 0.21 mg/kg bw 36 No Observed Adverse Effect Level (NOAEL) = 15 mg/kg bw/d 37 (teratogenicity study, maternal effects, oral, rat) 38 NOAEL corrected from bioavailability 50% (default) = 7.5 mg/kg bw/d 39 40 MOS NOAEL/SED = 36 41 42 43 * This is the highest value of two experiments in man, which gave values of 3.29 and 1.9% 44 45 3.3.14. Discussion 46 47 3-Benzylidene camphor is proposed for use in sunscreen products at levels up 2%. 48 49 General Toxicity 50 Various batches used for toxicity testing have not been identified with respect to their purity 51 and impurity. The homogeneity and stability of test solutions/suspensions have not been 5","endpoint":"","ingredient":"3-Benzylidene camphor","loael_value":"","noael_unit":"%","noael_value":"50","page":24,"route":"oral","species":"rat","study_id":"sccs_o_134_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 40 | mg/kg bw/day | - | - | 38 weeks | genotoxicity | SOURCE_SUBDIR=sccs_o_134; REPORT_TITLE=OPINION ON 3-Benzylidene camphor COLIPA n° S61 References are cited in a different way in the opinion compared to the submissions; OPINION_NUMBER=SCCS/1513/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=40; DOSE=the increase at the lower dose was not 31 significant.; EFFECT=the increase at the lower dose was not 31 significant. The no adverse effect level is probably 20 mg/kg bw/day. 32 33 34 Ref.: 3 bis 35 36 SCCS comments 37 The results of these two studies are scarcely reported in submission I report. In the 6 38 weeks toxicity study described above, effects were observed at the doses of 25 and 50 39 mg/kg bw/day. In the second study, based on the submission file, no change of biological 40 relevance was seen in animals treated and 40 mg/kg bw/day could be considered as the 41 NOAEL. 42 43 3.3.5.3. Chronic (> 12 months) toxicity 44 45 No data submitted 46 47 3.3.6. Mutagenicity / Genotoxicity 48 Taken from previous opinion 1374/98 49 50 3.3.6.1 Mutagenicity / Genotoxicity in vitro 51 52 An Ames test was carried out according to GLP, using strains TA 1525, TA 1537, TA 98 and 53 TA 100. Toxicity experiments were not carried out; in strain TA 100 there was a decrease in 54; CITATION=Ref.: 3 bis 35 36 SCCS comments 37 The results of these two studies are scarcely reported in submission I report; CITATION_NUMBERS=[3,35,36,37]; REFERENCE=Ref.: 3 bis 35 36 SCCS comments 37 The results of these two studies are scarcely reported in submission I report; DETAILS_JSON={"cas_number":"15087-24-8","citation":"Ref.: 3 bis 35 36 SCCS comments 37 The results of these two studies are scarcely reported in submission I report","dose":"the increase at the lower dose was not 31 significant.","duration":"38 weeks","effect":"the increase at the lower dose was not 31 significant. The no adverse effect level is probably 20 mg/kg bw/day. 32 33 34 Ref.: 3 bis 35 36 SCCS comments 37 The results of these two studies are scarcely reported in submission I report. In the 6 38 weeks toxicity study described above, effects were observed at the doses of 25 and 50 39 mg/kg bw/day. In the second study, based on the submission file, no change of biological 40 relevance was seen in animals treated and 40 mg/kg bw/day could be considered as the 41 NOAEL. 42 43 3.3.5.3. Chronic (> 12 months) toxicity 44 45 No data submitted 46 47 3.3.6. Mutagenicity / Genotoxicity 48 Taken from previous opinion 1374/98 49 50 3.3.6.1 Mutagenicity / Genotoxicity in vitro 51 52 An Ames test was carried out according to GLP, using strains TA 1525, TA 1537, TA 98 and 53 TA 100. Toxicity experiments were not carried out; in strain TA 100 there was a decrease in 54","endpoint":"genotoxicity","ingredient":"3-Benzylidene camphor","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"40","page":13,"route":"","species":"","study_id":"sccs_o_134_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 250 | mg/kg bw/d | rat | oral | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_134; REPORT_TITLE=OPINION ON 3-Benzylidene camphor COLIPA n° S61 References are cited in a different way in the opinion compared to the submissions; OPINION_NUMBER=SCCS/1513/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=250; DOSE=In male animals, bilirubin 8 was reduced in a dose related manner, and protein was somewhat increased.; EFFECT=a very striking reduction of cholesterol levels 7 in all dosed groups (cf. Results from sub-chronic toxicity, infra). In male animals, bilirubin 8 was reduced in a dose related manner, and protein was somewhat increased. In female 9 animals glucose, protein and alkaline phosphatase levels were all very significantly 10 increased in all dosed groups, but the increases did not seem to be dose related. Lipids do 11 not seem to have been measured. Examination of the urine revealed no abnormality. 12 13 Apparently, a NOAEL (which would be lower than 250 mg/kg bw/d) has not been 14 established from that study. 15 Ref.: 2 16 17 Rat 18 19 20 Groups of 10 male and 10 female SD rats were given doses of a.i. of 0, 25 and 50 mg/kg 21 bw/day by gavage for 6 weeks. The study was conducted according to GLP. 22 23 There were no deaths. The chief clinical finding was alopecia chiefly in females at the high 24 dose. 25 26 Body weight and body weight gain were unaffected. There were some falls in food 27 consumption in female animals in two; CITATION=Ref.: 2 16 17 Rat 18 19 20 Groups of 10 male and 10 female SD rats were given doses of a; CITATION_NUMBERS=[2,16,17,18,19,20,10]; REFERENCE=Ref.: 2 16 17 Rat 18 19 20 Groups of 10 male and 10 female SD rats were given doses of a; DETAILS_JSON={"cas_number":"15087-24-8","citation":"Ref.: 2 16 17 Rat 18 19 20 Groups of 10 male and 10 female SD rats were given doses of a","dose":"In male animals, bilirubin 8 was reduced in a dose related manner, and protein was somewhat increased.","duration":"sub-chronic","effect":"a very striking reduction of cholesterol levels 7 in all dosed groups (cf. Results from sub-chronic toxicity, infra). In male animals, bilirubin 8 was reduced in a dose related manner, and protein was somewhat increased. In female 9 animals glucose, protein and alkaline phosphatase levels were all very significantly 10 increased in all dosed groups, but the increases did not seem to be dose related. Lipids do 11 not seem to have been measured. Examination of the urine revealed no abnormality. 12 13 Apparently, a NOAEL (which would be lower than 250 mg/kg bw/d) has not been 14 established from that study. 15 Ref.: 2 16 17 Rat 18 19 20 Groups of 10 male and 10 female SD rats were given doses of a.i. of 0, 25 and 50 mg/kg 21 bw/day by gavage for 6 weeks. The study was conducted according to GLP. 22 23 There were no deaths. The chief clinical finding was alopecia chiefly in females at the high 24 dose. 25 26 Body weight and body weight gain were unaffected. There were some falls in food 27 consumption in female animals in two","endpoint":"repeated dose toxicity","ingredient":"3-Benzylidene camphor","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"250","page":11,"route":"oral","species":"rat","study_id":"sccs_o_134_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 15 | mg/kg bw/day | rat | - | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_134; REPORT_TITLE=OPINION ON 3-Benzylidene camphor COLIPA n° S61 References are cited in a different way in the opinion compared to the submissions; OPINION_NUMBER=SCCS/1513/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=15; DOSE=39 40 Reproductive toxicity 41 In a teratogenicity study in rats, embryo-toxicity was observed at 50 mg/kg bw/day and 42 above was observed.; EFFECT=tests, a firm 38 conclusion on mutagenicity cannot be drawn. 39 40 Reproductive toxicity 41 In a teratogenicity study in rats, embryo-toxicity was observed at 50 mg/kg bw/day and 42 above was observed. The observed major external/visceral abnormalities (at 100 and 150 43 mg/kg bw/day), most plausibly result from retarded development and in utero pressure (the 44 finding of retarded ossification is in line with this hypothesis). The development of these 45 effects may be associated with the maternal toxicity. The NOAEL for maternal toxicity and 46 embryo-toxicity in this study is 15 mg/kg bw/day. This value was used for the MOS 47 calculation. 48 49 Endocrine activity 50 In some recent studies, effect of 3-BC on rats sexual behaviour and oestrous cycle at low 51 doses (2.4 and 7 mg/kg body weight/day) were reported. These effects may be due to 52 endocrine activity of 3-BC. Multiple hormonal activities of 3-BC have indeed been reported 53 in vitro: estrogenic and anti-estrogenic effects as well as anti-androgenic activities. 3-; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"15087-24-8","citation":"","dose":"39 40 Reproductive toxicity 41 In a teratogenicity study in rats, embryo-toxicity was observed at 50 mg/kg bw/day and 42 above was observed.","duration":"","effect":"tests, a firm 38 conclusion on mutagenicity cannot be drawn. 39 40 Reproductive toxicity 41 In a teratogenicity study in rats, embryo-toxicity was observed at 50 mg/kg bw/day and 42 above was observed. The observed major external/visceral abnormalities (at 100 and 150 43 mg/kg bw/day), most plausibly result from retarded development and in utero pressure (the 44 finding of retarded ossification is in line with this hypothesis). The development of these 45 effects may be associated with the maternal toxicity. The NOAEL for maternal toxicity and 46 embryo-toxicity in this study is 15 mg/kg bw/day. This value was used for the MOS 47 calculation. 48 49 Endocrine activity 50 In some recent studies, effect of 3-BC on rats sexual behaviour and oestrous cycle at low 51 doses (2.4 and 7 mg/kg body weight/day) were reported. These effects may be due to 52 endocrine activity of 3-BC. Multiple hormonal activities of 3-BC have indeed been reported 53 in vitro: estrogenic and anti-estrogenic effects as well as anti-androgenic activities. 3-","endpoint":"reproductive toxicity","ingredient":"3-Benzylidene camphor","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"15","page":25,"route":"","species":"rat","study_id":"sccs_o_134_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 20 | mg/kg bw/day | rat | oral | 6 week | reproductive toxicity | SOURCE_SUBDIR=sccs_o_134; REPORT_TITLE=OPINION ON 3-Benzylidene camphor COLIPA n° S61 References are cited in a different way in the opinion compared to the submissions; OPINION_NUMBER=SCCS/1513/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=20; DOSE=e toxicity 26 One 6 week oral study in the rat showed dose related increases in plasma triiodothyronine 27 in males, significant at 50 mg/kg bw/day, and in plasma thyroxine in females, significant at 28 25 and 50 mg/kg bw/day.; EFFECT=e toxicity 26 One 6 week oral study in the rat showed dose related increases in plasma triiodothyronine 27 in males, significant at 50 mg/kg bw/day, and in plasma thyroxine in females, significant at 28 25 and 50 mg/kg bw/day. 29 In two 90 day oral toxicity studies in the rat, elevated plasma lipids were observed in 30 female rats at doses as low as 20 mg/kg bw/day, although this was not statistically 31 significant at this dose. 32 The results of the two 90 day studies are scarcely reported in submission I. 33 No NOAEL can be derived from these experiments. 34 35 Mutagenicity / Genotoxicity 36 A test for chromosomal aberration in vitro was positive, but the Ames test and an in vivo 37 micronucleus test were negative. Based on the poor quality of the available tests, a firm 38 conclusion on mutagenicity cannot be drawn. 39 40 Reproductive toxicity 41 In a teratogenicity study in rats, embryo-toxicity was observed at 50 mg/kg bw/day and 42 above was observed. The observed major external/visceral abnormalities (at 100 and 150 43; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"15087-24-8","citation":"","dose":"e toxicity 26 One 6 week oral study in the rat showed dose related increases in plasma triiodothyronine 27 in males, significant at 50 mg/kg bw/day, and in plasma thyroxine in females, significant at 28 25 and 50 mg/kg bw/day.","duration":"6 week","effect":"e toxicity 26 One 6 week oral study in the rat showed dose related increases in plasma triiodothyronine 27 in males, significant at 50 mg/kg bw/day, and in plasma thyroxine in females, significant at 28 25 and 50 mg/kg bw/day. 29 In two 90 day oral toxicity studies in the rat, elevated plasma lipids were observed in 30 female rats at doses as low as 20 mg/kg bw/day, although this was not statistically 31 significant at this dose. 32 The results of the two 90 day studies are scarcely reported in submission I. 33 No NOAEL can be derived from these experiments. 34 35 Mutagenicity / Genotoxicity 36 A test for chromosomal aberration in vitro was positive, but the Ames test and an in vivo 37 micronucleus test were negative. Based on the poor quality of the available tests, a firm 38 conclusion on mutagenicity cannot be drawn. 39 40 Reproductive toxicity 41 In a teratogenicity study in rats, embryo-toxicity was observed at 50 mg/kg bw/day and 42 above was observed. The observed major external/visceral abnormalities (at 100 and 150 43","endpoint":"reproductive toxicity","ingredient":"3-Benzylidene camphor","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":25,"route":"oral","species":"rat","study_id":"sccs_o_134_noael_014"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 2F60H204CM | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C17H20O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"2F60H204CM"} |
| openFDA substances | FDA UNII substance identifier | 2F60H204CM | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C17H20O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"2F60H204CM"} |
| openFDA substances | FDA UNII substance identifier | 2F60H204CM | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C17H20O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"2F60H204CM"} |
| openFDA substances | FDA UNII substance identifier | 2F60H204CM | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C17H20O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"2F60H204CM"} |