NOAEL Studies
Cosmetic Ingredient
4-Formyl-1-Methylquinolinium-P-Toluenesulfonate NOAEL Studies
INCI: 4-FORMYL-1-METHYLQUINOLINIUM-P-TOLUENESULFONATE
CAS: 223398-02-5
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 316 | mg/kg bw/day | rat | oral | 5-19 Gestation day | Developmental | SCCS; Amutha, S. (2002) Prenatal Developmental Toxicity Study of Moe-HM-6116-190 inRats by Oral Gavage. Jai Research Foundation, Department of Toxicology, Valvada,India, Study No. 3672. Henkel KGaA, Düsseldorf, Report No. R 0200657 |
| COSMOS_DB | NOAEL | 1000 | mg/kg bw/day | rat | oral | 91 day | Subchronic | SCCP; Mathews, M. (2003) Repeated Dose 90-Day Oral Toxicity Study of Moe-HM-6116-190in Rats Followed by a 4 Week Recovery Period (Vol. I - III). Jai Research Foundation, |
| COSMOS_DB | NOAEL | 100 | mg/kg bw/day | rat | oral | 5-19 Gestation day | Developmental | SCCS; Amutha, S. (2002) Prenatal Developmental Toxicity Study of Moe-HM-6116-190 inRats by Oral Gavage. Jai Research Foundation, Department of Toxicology, Valvada,India, Study No. 3672. Henkel KGaA, Düsseldorf, Report No. R 0200657 |
SCCS_vision_codex 32 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/day | - | oral | Chronic | genotoxicity | {"citation":"Ref.: 16 3","dose":"Changes in haematological parameters in high dose females were found reversible in the recovery group.","effect":"copy and histopathology was performed, on all animals. Results No mortality and no clinical signs of toxicity were observed and feed consumption and body weight was not affected. Ophthalmoscopy and neurobehavioural observations did not show substance-related toxicity and motor activity and sensory reactivity were comparable to controls. Changes in haematological parameters in high dose females were found reversible in the recovery group. Clinical chemistry and urinalysis showed no treatment related changes. The NOAEL is 250 mg/kg bw/day. Ref.: 16 3.3.5.3. Chronic (> 12 months) toxicity / 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535 and TA1537 Replicates: Two independent tests (plate incorporation assay) Test substance: COLIPA A 157 Batch No.: Moe-HM-6116-190 Concentrations: 33 - 5000 µg/plate without and with metabolic activation GLP: Quality Assurance Statement include","page":13,"pdf":"sccp_o_033.pdf","row_type":"noael_study","study_id":"sccp_o_033_noael_001"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw | - | oral | - | NOAEL study | {"citation":"Ref.: 17","dose":"Variations in pregnancy and litter data were not considered dose-related.","effect":"ng the study which may be of incidental nature. No maternal clinical signs of toxicity were reported, feed consumption and body weight gain change was not affected significantly. No gross pathological lesions were found on necropsy. Variations in pregnancy and litter data were not considered dose-related. A significant decrease in foetal weight was reported for the dose group 1000 mg/kg bw. Significant incidences of haemorrhage in the thymus and cerebral oedema were observed in the middle and high dose groups. The NOAEL of embryo/foetotoxicity was 100 mg/kg bw, for maternal toxicity the NOAEL was 1000 mg/kg bw. Ref.: 17","page":16,"pdf":"sccp_o_033.pdf","row_type":"noael_study","study_id":"sccp_o_033_noael_002"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw | - | oral | - | NOAEL study | {"citation":"Ref.: 17","dose":"Variations in pregnancy and litter data were not considered dose-related.","effect":"of toxicity were reported, feed consumption and body weight gain change was not affected significantly. No gross pathological lesions were found on necropsy. Variations in pregnancy and litter data were not considered dose-related. A significant decrease in foetal weight was reported for the dose group 1000 mg/kg bw. Significant incidences of haemorrhage in the thymus and cerebral oedema were observed in the middle and high dose groups. The NOAEL of embryo/foetotoxicity was 100 mg/kg bw, for maternal toxicity the NOAEL was 1000 mg/kg bw. Ref.: 17","page":16,"pdf":"sccp_o_033.pdf","row_type":"noael_study","study_id":"sccp_o_033_noael_003"} |
| SCCS_vision_codex | NOAEL | >2000 | mg/kg bw | rat | oral | 90 day | irritation | {"dose":"Toxicity The LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate is found to be >2000 mg/kg bw.","effect":"hair dye formulations up to a maximum concentration of 2.5% on scalp. Chemical analyses of the two batches of 4-Formyl-1- methylquinolinium-p-toluenesulfonate revealed that one of the batches contained an unknown impurity (12.8%), detected at 468 nm by HPLC. However, the applicant has made a declaration that the specification of the material used in products on the market excludes the presence of this impurity. Toxicity The LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate is found to be >2000 mg/kg bw. The NOAEL was set at 250 mg/kg bw (90 day oral rat). The NOAEL was set at 1000 mg/kg bw for maternal toxicity and at 100 mg/kg bw for embryo/foetotoxicity (teratogenicity study). Irritation, sensitisation 4-Formyl-1-methylquinolinium-p-toluenesulfonate is an irritant to rabbit skin and, at a concentration of 25%, to the ear dorsum of mice. It is an irritant to rabbit eye. The substance is a non-sensitiser in the Buehler test and the LLNA. However, the vehicle used may not be suitable.","page":17,"pdf":"sccp_o_033.pdf","row_type":"noael_study","study_id":"sccp_o_033_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.009 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) Oxidative Absorption through the skin A = 0.95 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.551mg Typical body weight of human = 60 k...","effect":"__________________________________________________________________________________________ 21 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) Oxidative Absorption through the skin A = 0.95 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.551mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.781 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0297 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% Bioavailability* 50 mg/kg bw/d MOS = 1685 * s","page":21,"pdf":"sccs_o_080.pdf","row_type":"noael_study","study_id":"sccs_o_080_noael_004"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) Oxidative Absorption through the skin A = 0.95 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.551mg Typical body weight of human = 60 k...","effect":"_________________________________________________________ 21 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) Oxidative Absorption through the skin A = 0.95 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.551mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.781 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0297 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% Bioavailability* 50 mg/kg bw/d MOS = 1685 * standar","page":21,"pdf":"sccs_o_080.pdf","row_type":"noael_study","study_id":"sccs_o_080_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.0297 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"A x 0.001 = 0.551mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 58...","effect":"A x 0.001 = 0.551mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.781 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0297 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% Bioavailability* 50 mg/kg bw/d MOS = 1685 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical specifications 4-Formyl-1-methylquinolinium-p-toluenesulfonate is used in hair dye formulations (used in the absence or presence of hydrogen peroxide) up to a maximum concentration of 2.5% on scalp. Chemical analyses of the two batches","page":21,"pdf":"sccs_o_080.pdf","row_type":"noael_study","study_id":"sccs_o_080_noael_006"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw | rat | oral | 90 day | NOAEL study | {"dose":"Toxicity The oral and dermal LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate were >2000 mg/kg bw.","effect":"ined 12.8% (HPLC peak area) of an unknown impurity, determined at its λmax 467 nm. However, the applicant has made a declaration that the specification of the material used in products on the market excludes the presence of this impurity. The stability of 4-Formyl-1-methylquinolinium-p- toluenesulfonate in typical hair dye formulations is not reported. Toxicity The oral and dermal LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate were >2000 mg/kg bw. The NOAEL was set at 250 mg/kg bw (90 day oral rat). The NOAEL was set at","page":21,"pdf":"sccs_o_080.pdf","row_type":"noael_study","study_id":"sccs_o_080_noael_009"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/day | - | oral | Chronic | genotoxicity | {"citation":"Ref.: 16 3","dose":"Changes in haematological parameters in high dose females were found reversible in the recovery group.","effect":"copy and histopathology was performed, on all animals. Results No mortality and no clinical signs of toxicity were observed and feed consumption and body weight was not affected. Ophthalmoscopy and neurobehavioural observations did not show substance-related toxicity and motor activity and sensory reactivity were comparable to controls. Changes in haematological parameters in high dose females were found reversible in the recovery group. Clinical chemistry and urinalysis showed no treatment related changes. The NOAEL is 250 mg/kg bw/day. Ref.: 16 3.3.5.3. Chronic (> 12 months) toxicity / 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535 and TA1537 Replicates: Two independent tests (plate incorporation assay) Test substance: COLIPA A 157 Batch No.: Moe-HM-6116-190 Concentrations: 33 - 5000 µg/plate without and with metabolic activation GLP: Quality Assurance Statement include","page":13,"pdf":"sccp_o_033.pdf","row_type":"noael_study","study_id":"sccp_o_033_noael_001"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw | - | oral | - | NOAEL study | {"citation":"Ref.: 17","dose":"Variations in pregnancy and litter data were not considered dose-related.","effect":"ng the study which may be of incidental nature. No maternal clinical signs of toxicity were reported, feed consumption and body weight gain change was not affected significantly. No gross pathological lesions were found on necropsy. Variations in pregnancy and litter data were not considered dose-related. A significant decrease in foetal weight was reported for the dose group 1000 mg/kg bw. Significant incidences of haemorrhage in the thymus and cerebral oedema were observed in the middle and high dose groups. The NOAEL of embryo/foetotoxicity was 100 mg/kg bw, for maternal toxicity the NOAEL was 1000 mg/kg bw. Ref.: 17","page":16,"pdf":"sccp_o_033.pdf","row_type":"noael_study","study_id":"sccp_o_033_noael_002"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw | - | oral | - | NOAEL study | {"citation":"Ref.: 17","dose":"Variations in pregnancy and litter data were not considered dose-related.","effect":"of toxicity were reported, feed consumption and body weight gain change was not affected significantly. No gross pathological lesions were found on necropsy. Variations in pregnancy and litter data were not considered dose-related. A significant decrease in foetal weight was reported for the dose group 1000 mg/kg bw. Significant incidences of haemorrhage in the thymus and cerebral oedema were observed in the middle and high dose groups. The NOAEL of embryo/foetotoxicity was 100 mg/kg bw, for maternal toxicity the NOAEL was 1000 mg/kg bw. Ref.: 17","page":16,"pdf":"sccp_o_033.pdf","row_type":"noael_study","study_id":"sccp_o_033_noael_003"} |
| SCCS_vision_codex | NOAEL | >2000 | mg/kg bw | rat | oral | 90 day | irritation | {"dose":"Toxicity The LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate is found to be >2000 mg/kg bw.","effect":"hair dye formulations up to a maximum concentration of 2.5% on scalp. Chemical analyses of the two batches of 4-Formyl-1- methylquinolinium-p-toluenesulfonate revealed that one of the batches contained an unknown impurity (12.8%), detected at 468 nm by HPLC. However, the applicant has made a declaration that the specification of the material used in products on the market excludes the presence of this impurity. Toxicity The LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate is found to be >2000 mg/kg bw. The NOAEL was set at 250 mg/kg bw (90 day oral rat). The NOAEL was set at 1000 mg/kg bw for maternal toxicity and at 100 mg/kg bw for embryo/foetotoxicity (teratogenicity study). Irritation, sensitisation 4-Formyl-1-methylquinolinium-p-toluenesulfonate is an irritant to rabbit skin and, at a concentration of 25%, to the ear dorsum of mice. It is an irritant to rabbit eye. The substance is a non-sensitiser in the Buehler test and the LLNA. However, the vehicle used may not be suitable.","page":17,"pdf":"sccp_o_033.pdf","row_type":"noael_study","study_id":"sccp_o_033_noael_004"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/day | - | oral | Chronic | genotoxicity | {"citation":"Ref.: 16 3","dose":"Changes in haematological parameters in high dose females were found reversible in the recovery group.","effect":"copy and histopathology was performed, on all animals. Results No mortality and no clinical signs of toxicity were observed and feed consumption and body weight was not affected. Ophthalmoscopy and neurobehavioural observations did not show substance-related toxicity and motor activity and sensory reactivity were comparable to controls. Changes in haematological parameters in high dose females were found reversible in the recovery group. Clinical chemistry and urinalysis showed no treatment related changes. The NOAEL is 250 mg/kg bw/day. Ref.: 16 3.3.5.3. Chronic (> 12 months) toxicity / 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535 and TA1537 Replicates: Two independent tests (plate incorporation assay) Test substance: COLIPA A 157 Batch No.: Moe-HM-6116-190 Concentrations: 33 - 5000 µg/plate without and with metabolic activation GLP: Quality Assurance Statement include","page":13,"pdf":"sccp_o_033.pdf","row_type":"noael_study","study_id":"sccp_o_033_noael_001"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw | - | oral | - | NOAEL study | {"citation":"Ref.: 17","dose":"Variations in pregnancy and litter data were not considered dose-related.","effect":"ng the study which may be of incidental nature. No maternal clinical signs of toxicity were reported, feed consumption and body weight gain change was not affected significantly. No gross pathological lesions were found on necropsy. Variations in pregnancy and litter data were not considered dose-related. A significant decrease in foetal weight was reported for the dose group 1000 mg/kg bw. Significant incidences of haemorrhage in the thymus and cerebral oedema were observed in the middle and high dose groups. The NOAEL of embryo/foetotoxicity was 100 mg/kg bw, for maternal toxicity the NOAEL was 1000 mg/kg bw. Ref.: 17","page":16,"pdf":"sccp_o_033.pdf","row_type":"noael_study","study_id":"sccp_o_033_noael_002"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw | - | oral | - | NOAEL study | {"citation":"Ref.: 17","dose":"Variations in pregnancy and litter data were not considered dose-related.","effect":"of toxicity were reported, feed consumption and body weight gain change was not affected significantly. No gross pathological lesions were found on necropsy. Variations in pregnancy and litter data were not considered dose-related. A significant decrease in foetal weight was reported for the dose group 1000 mg/kg bw. Significant incidences of haemorrhage in the thymus and cerebral oedema were observed in the middle and high dose groups. The NOAEL of embryo/foetotoxicity was 100 mg/kg bw, for maternal toxicity the NOAEL was 1000 mg/kg bw. Ref.: 17","page":16,"pdf":"sccp_o_033.pdf","row_type":"noael_study","study_id":"sccp_o_033_noael_003"} |
| SCCS_vision_codex | NOAEL | >2000 | mg/kg bw | rat | oral | 90 day | irritation | {"dose":"Toxicity The LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate is found to be >2000 mg/kg bw.","effect":"hair dye formulations up to a maximum concentration of 2.5% on scalp. Chemical analyses of the two batches of 4-Formyl-1- methylquinolinium-p-toluenesulfonate revealed that one of the batches contained an unknown impurity (12.8%), detected at 468 nm by HPLC. However, the applicant has made a declaration that the specification of the material used in products on the market excludes the presence of this impurity. Toxicity The LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate is found to be >2000 mg/kg bw. The NOAEL was set at 250 mg/kg bw (90 day oral rat). The NOAEL was set at 1000 mg/kg bw for maternal toxicity and at 100 mg/kg bw for embryo/foetotoxicity (teratogenicity study). Irritation, sensitisation 4-Formyl-1-methylquinolinium-p-toluenesulfonate is an irritant to rabbit skin and, at a concentration of 25%, to the ear dorsum of mice. It is an irritant to rabbit eye. The substance is a non-sensitiser in the Buehler test and the LLNA. However, the vehicle used may not be suitable.","page":17,"pdf":"sccp_o_033.pdf","row_type":"noael_study","study_id":"sccp_o_033_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.009 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) Oxidative Absorption through the skin A = 0.95 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.551mg Typical body weight of human = 60 k...","effect":"__________________________________________________________________________________________ 21 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) Oxidative Absorption through the skin A = 0.95 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.551mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.781 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0297 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% Bioavailability* 50 mg/kg bw/d MOS = 1685 * s","page":21,"pdf":"sccs_o_080.pdf","row_type":"noael_study","study_id":"sccs_o_080_noael_004"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) Oxidative Absorption through the skin A = 0.95 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.551mg Typical body weight of human = 60 k...","effect":"_________________________________________________________ 21 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) Oxidative Absorption through the skin A = 0.95 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.551mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.781 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0297 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% Bioavailability* 50 mg/kg bw/d MOS = 1685 * standar","page":21,"pdf":"sccs_o_080.pdf","row_type":"noael_study","study_id":"sccs_o_080_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.0297 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"A x 0.001 = 0.551mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 58...","effect":"A x 0.001 = 0.551mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.781 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0297 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% Bioavailability* 50 mg/kg bw/d MOS = 1685 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical specifications 4-Formyl-1-methylquinolinium-p-toluenesulfonate is used in hair dye formulations (used in the absence or presence of hydrogen peroxide) up to a maximum concentration of 2.5% on scalp. Chemical analyses of the two batches","page":21,"pdf":"sccs_o_080.pdf","row_type":"noael_study","study_id":"sccs_o_080_noael_006"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw | rat | oral | 90 day | NOAEL study | {"dose":"Toxicity The oral and dermal LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate were >2000 mg/kg bw.","effect":"ined 12.8% (HPLC peak area) of an unknown impurity, determined at its λmax 467 nm. However, the applicant has made a declaration that the specification of the material used in products on the market excludes the presence of this impurity. The stability of 4-Formyl-1-methylquinolinium-p- toluenesulfonate in typical hair dye formulations is not reported. Toxicity The oral and dermal LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate were >2000 mg/kg bw. The NOAEL was set at 250 mg/kg bw (90 day oral rat). The NOAEL was set at","page":21,"pdf":"sccs_o_080.pdf","row_type":"noael_study","study_id":"sccs_o_080_noael_009"} |
| SCCS_vision_codex | NOAEL | =0.009 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) Oxidative Absorption through the skin A = 0.95 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.551mg Typical body weight of human = 60 k...","effect":"__________________________________________________________________________________________ 21 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) Oxidative Absorption through the skin A = 0.95 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.551mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.781 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0297 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% Bioavailability* 50 mg/kg bw/d MOS = 1685 * s","page":21,"pdf":"sccs_o_080.pdf","row_type":"noael_study","study_id":"sccs_o_080_noael_004"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) Oxidative Absorption through the skin A = 0.95 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.551mg Typical body weight of human = 60 k...","effect":"_________________________________________________________ 21 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) Oxidative Absorption through the skin A = 0.95 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.551mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.781 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0297 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% Bioavailability* 50 mg/kg bw/d MOS = 1685 * standar","page":21,"pdf":"sccs_o_080.pdf","row_type":"noael_study","study_id":"sccs_o_080_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.0297 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"A x 0.001 = 0.551mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 58...","effect":"A x 0.001 = 0.551mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.781 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0297 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% Bioavailability* 50 mg/kg bw/d MOS = 1685 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical specifications 4-Formyl-1-methylquinolinium-p-toluenesulfonate is used in hair dye formulations (used in the absence or presence of hydrogen peroxide) up to a maximum concentration of 2.5% on scalp. Chemical analyses of the two batches","page":21,"pdf":"sccs_o_080.pdf","row_type":"noael_study","study_id":"sccs_o_080_noael_006"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw | rat | oral | 90 day | NOAEL study | {"dose":"Toxicity The oral and dermal LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate were >2000 mg/kg bw.","effect":"ined 12.8% (HPLC peak area) of an unknown impurity, determined at its λmax 467 nm. However, the applicant has made a declaration that the specification of the material used in products on the market excludes the presence of this impurity. The stability of 4-Formyl-1-methylquinolinium-p- toluenesulfonate in typical hair dye formulations is not reported. Toxicity The oral and dermal LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate were >2000 mg/kg bw. The NOAEL was set at 250 mg/kg bw (90 day oral rat). The NOAEL was set at","page":21,"pdf":"sccs_o_080.pdf","row_type":"noael_study","study_id":"sccs_o_080_noael_009"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/day | - | oral | Chronic | genotoxicity | {"citation":"Ref.: 16 3","dose":"Changes in haematological parameters in high dose females were found reversible in the recovery group.","effect":"copy and histopathology was performed, on all animals. Results No mortality and no clinical signs of toxicity were observed and feed consumption and body weight was not affected. Ophthalmoscopy and neurobehavioural observations did not show substance-related toxicity and motor activity and sensory reactivity were comparable to controls. Changes in haematological parameters in high dose females were found reversible in the recovery group. Clinical chemistry and urinalysis showed no treatment related changes. The NOAEL is 250 mg/kg bw/day. Ref.: 16 3.3.5.3. Chronic (> 12 months) toxicity / 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535 and TA1537 Replicates: Two independent tests (plate incorporation assay) Test substance: COLIPA A 157 Batch No.: Moe-HM-6116-190 Concentrations: 33 - 5000 µg/plate without and with metabolic activation GLP: Quality Assurance Statement include","page":13,"pdf":"sccp_o_033.pdf","row_type":"noael_study","study_id":"sccp_o_033_noael_001"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw | - | oral | - | NOAEL study | {"citation":"Ref.: 17","dose":"Variations in pregnancy and litter data were not considered dose-related.","effect":"ng the study which may be of incidental nature. No maternal clinical signs of toxicity were reported, feed consumption and body weight gain change was not affected significantly. No gross pathological lesions were found on necropsy. Variations in pregnancy and litter data were not considered dose-related. A significant decrease in foetal weight was reported for the dose group 1000 mg/kg bw. Significant incidences of haemorrhage in the thymus and cerebral oedema were observed in the middle and high dose groups. The NOAEL of embryo/foetotoxicity was 100 mg/kg bw, for maternal toxicity the NOAEL was 1000 mg/kg bw. Ref.: 17","page":16,"pdf":"sccp_o_033.pdf","row_type":"noael_study","study_id":"sccp_o_033_noael_002"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw | - | oral | - | NOAEL study | {"citation":"Ref.: 17","dose":"Variations in pregnancy and litter data were not considered dose-related.","effect":"of toxicity were reported, feed consumption and body weight gain change was not affected significantly. No gross pathological lesions were found on necropsy. Variations in pregnancy and litter data were not considered dose-related. A significant decrease in foetal weight was reported for the dose group 1000 mg/kg bw. Significant incidences of haemorrhage in the thymus and cerebral oedema were observed in the middle and high dose groups. The NOAEL of embryo/foetotoxicity was 100 mg/kg bw, for maternal toxicity the NOAEL was 1000 mg/kg bw. Ref.: 17","page":16,"pdf":"sccp_o_033.pdf","row_type":"noael_study","study_id":"sccp_o_033_noael_003"} |
| SCCS_vision_codex | NOAEL | >2000 | mg/kg bw | rat | oral | 90 day | irritation | {"dose":"Toxicity The LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate is found to be >2000 mg/kg bw.","effect":"hair dye formulations up to a maximum concentration of 2.5% on scalp. Chemical analyses of the two batches of 4-Formyl-1- methylquinolinium-p-toluenesulfonate revealed that one of the batches contained an unknown impurity (12.8%), detected at 468 nm by HPLC. However, the applicant has made a declaration that the specification of the material used in products on the market excludes the presence of this impurity. Toxicity The LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate is found to be >2000 mg/kg bw. The NOAEL was set at 250 mg/kg bw (90 day oral rat). The NOAEL was set at 1000 mg/kg bw for maternal toxicity and at 100 mg/kg bw for embryo/foetotoxicity (teratogenicity study). Irritation, sensitisation 4-Formyl-1-methylquinolinium-p-toluenesulfonate is an irritant to rabbit skin and, at a concentration of 25%, to the ear dorsum of mice. It is an irritant to rabbit eye. The substance is a non-sensitiser in the Buehler test and the LLNA. However, the vehicle used may not be suitable.","page":17,"pdf":"sccp_o_033.pdf","row_type":"noael_study","study_id":"sccp_o_033_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.009 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) Oxidative Absorption through the skin A = 0.95 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.551mg Typical body weight of human = 60 k...","effect":"__________________________________________________________________________________________ 21 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) Oxidative Absorption through the skin A = 0.95 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.551mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.781 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0297 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% Bioavailability* 50 mg/kg bw/d MOS = 1685 * s","page":21,"pdf":"sccs_o_080.pdf","row_type":"noael_study","study_id":"sccs_o_080_noael_004"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) Oxidative Absorption through the skin A = 0.95 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.551mg Typical body weight of human = 60 k...","effect":"_________________________________________________________ 21 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) Oxidative Absorption through the skin A = 0.95 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.551mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.781 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0297 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% Bioavailability* 50 mg/kg bw/d MOS = 1685 * standar","page":21,"pdf":"sccs_o_080.pdf","row_type":"noael_study","study_id":"sccs_o_080_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.0297 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"A x 0.001 = 0.551mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 58...","effect":"A x 0.001 = 0.551mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.781 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0297 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% Bioavailability* 50 mg/kg bw/d MOS = 1685 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical specifications 4-Formyl-1-methylquinolinium-p-toluenesulfonate is used in hair dye formulations (used in the absence or presence of hydrogen peroxide) up to a maximum concentration of 2.5% on scalp. Chemical analyses of the two batches","page":21,"pdf":"sccs_o_080.pdf","row_type":"noael_study","study_id":"sccs_o_080_noael_006"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw | rat | oral | 90 day | NOAEL study | {"dose":"Toxicity The oral and dermal LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate were >2000 mg/kg bw.","effect":"ined 12.8% (HPLC peak area) of an unknown impurity, determined at its λmax 467 nm. However, the applicant has made a declaration that the specification of the material used in products on the market excludes the presence of this impurity. The stability of 4-Formyl-1-methylquinolinium-p- toluenesulfonate in typical hair dye formulations is not reported. Toxicity The oral and dermal LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate were >2000 mg/kg bw. The NOAEL was set at 250 mg/kg bw (90 day oral rat). The NOAEL was set at","page":21,"pdf":"sccs_o_080.pdf","row_type":"noael_study","study_id":"sccs_o_080_noael_009"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 15 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 100 | mg/kg bw | - | oral | - | - | SOURCE_SUBDIR=sccp_o_033; REPORT_TITLE=Opinion on Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzenesulfonic acid (1:1) COLIPA N° A157; OPINION_NUMBER=SCCP/0923/05; COMMITTEE=SCCP; REPORT_DATE=13 December 2005; VALUE_TEXT=100; DOSE=Variations in pregnancy and litter data were not considered dose-related.; EFFECT=ng the study which may be of incidental nature. No maternal clinical signs of toxicity were reported, feed consumption and body weight gain change was not affected significantly. No gross pathological lesions were found on necropsy. Variations in pregnancy and litter data were not considered dose-related. A significant decrease in foetal weight was reported for the dose group 1000 mg/kg bw. Significant incidences of haemorrhage in the thymus and cerebral oedema were observed in the middle and high dose groups. The NOAEL of embryo/foetotoxicity was 100 mg/kg bw, for maternal toxicity the NOAEL was 1000 mg/kg bw. Ref.: 17; CITATION=Ref.: 17; CITATION_NUMBERS=[17]; REFERENCE=Ref.: 17; DETAILS_JSON={"cas_number":"223398-02-5","citation":"Ref.: 17","dose":"Variations in pregnancy and litter data were not considered dose-related.","duration":"","effect":"ng the study which may be of incidental nature. No maternal clinical signs of toxicity were reported, feed consumption and body weight gain change was not affected significantly. No gross pathological lesions were found on necropsy. Variations in pregnancy and litter data were not considered dose-related. A significant decrease in foetal weight was reported for the dose group 1000 mg/kg bw. Significant incidences of haemorrhage in the thymus and cerebral oedema were observed in the middle and high dose groups. The NOAEL of embryo/foetotoxicity was 100 mg/kg bw, for maternal toxicity the NOAEL was 1000 mg/kg bw. Ref.: 17","endpoint":"","ingredient":"Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzenesulfonic acid (1:1)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"100","page":16,"route":"oral","species":"","study_id":"sccp_o_033_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 1000 | mg/kg bw | - | oral | - | - | SOURCE_SUBDIR=sccp_o_033; REPORT_TITLE=Opinion on Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzenesulfonic acid (1:1) COLIPA N° A157; OPINION_NUMBER=SCCP/0923/05; COMMITTEE=SCCP; REPORT_DATE=13 December 2005; VALUE_TEXT=1000; DOSE=Variations in pregnancy and litter data were not considered dose-related.; EFFECT=of toxicity were reported, feed consumption and body weight gain change was not affected significantly. No gross pathological lesions were found on necropsy. Variations in pregnancy and litter data were not considered dose-related. A significant decrease in foetal weight was reported for the dose group 1000 mg/kg bw. Significant incidences of haemorrhage in the thymus and cerebral oedema were observed in the middle and high dose groups. The NOAEL of embryo/foetotoxicity was 100 mg/kg bw, for maternal toxicity the NOAEL was 1000 mg/kg bw. Ref.: 17; CITATION=Ref.: 17; CITATION_NUMBERS=[17]; REFERENCE=Ref.: 17; DETAILS_JSON={"cas_number":"223398-02-5","citation":"Ref.: 17","dose":"Variations in pregnancy and litter data were not considered dose-related.","duration":"","effect":"of toxicity were reported, feed consumption and body weight gain change was not affected significantly. No gross pathological lesions were found on necropsy. Variations in pregnancy and litter data were not considered dose-related. A significant decrease in foetal weight was reported for the dose group 1000 mg/kg bw. Significant incidences of haemorrhage in the thymus and cerebral oedema were observed in the middle and high dose groups. The NOAEL of embryo/foetotoxicity was 100 mg/kg bw, for maternal toxicity the NOAEL was 1000 mg/kg bw. Ref.: 17","endpoint":"","ingredient":"Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzenesulfonic acid (1:1)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1000","page":16,"route":"oral","species":"","study_id":"sccp_o_033_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 100 | mg/kg bw | - | oral | - | - | SOURCE_SUBDIR=sccs_o_080; REPORT_TITLE=OPINION ON Quinolinium, 4-formyl-1-methyl-, salt with 4- methylbenzene sulfonic acid (1:1) 4-Formyl-1-methylquinolinium-p-toluenesulfonate (INCI name) COLIPA n° A157; OPINION_NUMBER=SCCS/1435/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 13 December 2005; VALUE_TEXT=100; DOSE=Variations in pregnancy and litter data were not considered dose-related.; EFFECT=ng the study which may be of incidental nature. No maternal clinical signs of toxicity were reported, feed consumption and body weight gain change was not affected significantly. No gross pathological lesions were found on necropsy. Variations in pregnancy and litter data were not considered dose-related. A significant decrease in foetal weight was reported for the dose group 1000 mg/kg bw. Significant incidences of haemorrhage in the thymus and cerebral oedema were observed in the middle and high dose groups. The NOAEL of embryo/foetotoxicity was 100 mg/kg bw, for maternal toxicity the NOAEL was 1000 mg/kg bw. Ref.: 17; CITATION=Ref.: 17; CITATION_NUMBERS=[17]; REFERENCE=Ref.: 17; DETAILS_JSON={"cas_number":"223398-02-5","citation":"Ref.: 17","dose":"Variations in pregnancy and litter data were not considered dose-related.","duration":"","effect":"ng the study which may be of incidental nature. No maternal clinical signs of toxicity were reported, feed consumption and body weight gain change was not affected significantly. No gross pathological lesions were found on necropsy. Variations in pregnancy and litter data were not considered dose-related. A significant decrease in foetal weight was reported for the dose group 1000 mg/kg bw. Significant incidences of haemorrhage in the thymus and cerebral oedema were observed in the middle and high dose groups. The NOAEL of embryo/foetotoxicity was 100 mg/kg bw, for maternal toxicity the NOAEL was 1000 mg/kg bw. Ref.: 17","endpoint":"","ingredient":"Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzenesulfonic acid (1:1)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"100","page":19,"route":"oral","species":"","study_id":"sccs_o_080_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 1000 | mg/kg bw | - | oral | - | - | SOURCE_SUBDIR=sccs_o_080; REPORT_TITLE=OPINION ON Quinolinium, 4-formyl-1-methyl-, salt with 4- methylbenzene sulfonic acid (1:1) 4-Formyl-1-methylquinolinium-p-toluenesulfonate (INCI name) COLIPA n° A157; OPINION_NUMBER=SCCS/1435/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 13 December 2005; VALUE_TEXT=1000; DOSE=Variations in pregnancy and litter data were not considered dose-related.; EFFECT=of toxicity were reported, feed consumption and body weight gain change was not affected significantly. No gross pathological lesions were found on necropsy. Variations in pregnancy and litter data were not considered dose-related. A significant decrease in foetal weight was reported for the dose group 1000 mg/kg bw. Significant incidences of haemorrhage in the thymus and cerebral oedema were observed in the middle and high dose groups. The NOAEL of embryo/foetotoxicity was 100 mg/kg bw, for maternal toxicity the NOAEL was 1000 mg/kg bw. Ref.: 17; CITATION=Ref.: 17; CITATION_NUMBERS=[17]; REFERENCE=Ref.: 17; DETAILS_JSON={"cas_number":"223398-02-5","citation":"Ref.: 17","dose":"Variations in pregnancy and litter data were not considered dose-related.","duration":"","effect":"of toxicity were reported, feed consumption and body weight gain change was not affected significantly. No gross pathological lesions were found on necropsy. Variations in pregnancy and litter data were not considered dose-related. A significant decrease in foetal weight was reported for the dose group 1000 mg/kg bw. Significant incidences of haemorrhage in the thymus and cerebral oedema were observed in the middle and high dose groups. The NOAEL of embryo/foetotoxicity was 100 mg/kg bw, for maternal toxicity the NOAEL was 1000 mg/kg bw. Ref.: 17","endpoint":"","ingredient":"Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzenesulfonic acid (1:1)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1000","page":19,"route":"oral","species":"","study_id":"sccs_o_080_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | >2000 | mg/kg bw | rat | oral | 90 day | - | SOURCE_SUBDIR=sccs_o_080; REPORT_TITLE=OPINION ON Quinolinium, 4-formyl-1-methyl-, salt with 4- methylbenzene sulfonic acid (1:1) 4-Formyl-1-methylquinolinium-p-toluenesulfonate (INCI name) COLIPA n° A157; OPINION_NUMBER=SCCS/1435/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 13 December 2005; VALUE_TEXT=>2000; DOSE=Toxicity The oral and dermal LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate were >2000 mg/kg bw.; EFFECT=luenesulfonate revealed that one of the batches contained 12.8% (HPLC peak area) of an unknown impurity, determined at its λmax 467 nm. However, the applicant has made a declaration that the specification of the material used in products on the market excludes the presence of this impurity. The stability of 4-Formyl-1-methylquinolinium-p- toluenesulfonate in typical hair dye formulations is not reported. Toxicity The oral and dermal LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate were >2000 mg/kg bw. The NOAEL was set at 250 mg/kg bw (90 day oral rat). The NOAEL was set at; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"223398-02-5","citation":"","dose":"Toxicity The oral and dermal LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate were >2000 mg/kg bw.","duration":"90 day","effect":"luenesulfonate revealed that one of the batches contained 12.8% (HPLC peak area) of an unknown impurity, determined at its λmax 467 nm. However, the applicant has made a declaration that the specification of the material used in products on the market excludes the presence of this impurity. The stability of 4-Formyl-1-methylquinolinium-p- toluenesulfonate in typical hair dye formulations is not reported. Toxicity The oral and dermal LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate were >2000 mg/kg bw. The NOAEL was set at 250 mg/kg bw (90 day oral rat). The NOAEL was set at","endpoint":"","ingredient":"Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzenesulfonic acid (1:1)","loael_value":"","noael_unit":"mg/kg bw","noael_value":">2000","page":21,"route":"oral","species":"rat","study_id":"sccs_o_080_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 250 | mg/kg bw | rat | oral | 90 day | - | SOURCE_SUBDIR=sccs_o_080; REPORT_TITLE=OPINION ON Quinolinium, 4-formyl-1-methyl-, salt with 4- methylbenzene sulfonic acid (1:1) 4-Formyl-1-methylquinolinium-p-toluenesulfonate (INCI name) COLIPA n° A157; OPINION_NUMBER=SCCS/1435/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 13 December 2005; VALUE_TEXT=250; DOSE=Toxicity The oral and dermal LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate were >2000 mg/kg bw.; EFFECT=ined 12.8% (HPLC peak area) of an unknown impurity, determined at its λmax 467 nm. However, the applicant has made a declaration that the specification of the material used in products on the market excludes the presence of this impurity. The stability of 4-Formyl-1-methylquinolinium-p- toluenesulfonate in typical hair dye formulations is not reported. Toxicity The oral and dermal LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate were >2000 mg/kg bw. The NOAEL was set at 250 mg/kg bw (90 day oral rat). The NOAEL was set at; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"223398-02-5","citation":"","dose":"Toxicity The oral and dermal LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate were >2000 mg/kg bw.","duration":"90 day","effect":"ined 12.8% (HPLC peak area) of an unknown impurity, determined at its λmax 467 nm. However, the applicant has made a declaration that the specification of the material used in products on the market excludes the presence of this impurity. The stability of 4-Formyl-1-methylquinolinium-p- toluenesulfonate in typical hair dye formulations is not reported. Toxicity The oral and dermal LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate were >2000 mg/kg bw. The NOAEL was set at 250 mg/kg bw (90 day oral rat). The NOAEL was set at","endpoint":"","ingredient":"Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzenesulfonic acid (1:1)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"250","page":21,"route":"oral","species":"rat","study_id":"sccs_o_080_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.009 | mg/kg bw/d | rat | oral | - | dermal absorption | SOURCE_SUBDIR=sccs_o_080; REPORT_TITLE=OPINION ON Quinolinium, 4-formyl-1-methyl-, salt with 4- methylbenzene sulfonic acid (1:1) 4-Formyl-1-methylquinolinium-p-toluenesulfonate (INCI name) COLIPA n° A157; OPINION_NUMBER=SCCS/1435/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 13 December 2005; VALUE_TEXT== 0.009; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) Oxidative Absorption through the skin A = 0.95 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.551mg Typical body weight of human = 60 k...; EFFECT=__________________________________________________________________________________________ 21 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) Oxidative Absorption through the skin A = 0.95 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.551mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.781 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0297 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% Bioavailability* 50 mg/kg bw/d MOS = 1685 * s; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"223398-02-5","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) Oxidative Absorption through the skin A = 0.95 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.551mg Typical body weight of human = 60 k...","duration":"","effect":"__________________________________________________________________________________________ 21 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) Oxidative Absorption through the skin A = 0.95 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.551mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.781 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0297 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% Bioavailability* 50 mg/kg bw/d MOS = 1685 * s","endpoint":"dermal absorption","ingredient":"Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzenesulfonic acid (1:1)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.009","page":21,"route":"oral","species":"rat","study_id":"sccs_o_080_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =100 | mg/kg bw/d | rat | oral | - | dermal absorption | SOURCE_SUBDIR=sccs_o_080; REPORT_TITLE=OPINION ON Quinolinium, 4-formyl-1-methyl-, salt with 4- methylbenzene sulfonic acid (1:1) 4-Formyl-1-methylquinolinium-p-toluenesulfonate (INCI name) COLIPA n° A157; OPINION_NUMBER=SCCS/1435/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 13 December 2005; VALUE_TEXT== 100; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) Oxidative Absorption through the skin A = 0.95 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.551mg Typical body weight of human = 60 k...; EFFECT=_________________________________________________________ 21 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) Oxidative Absorption through the skin A = 0.95 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.551mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.781 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0297 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% Bioavailability* 50 mg/kg bw/d MOS = 1685 * standar; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"223398-02-5","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) Oxidative Absorption through the skin A = 0.95 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.551mg Typical body weight of human = 60 k...","duration":"","effect":"_________________________________________________________ 21 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) Oxidative Absorption through the skin A = 0.95 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.551mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.781 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0297 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% Bioavailability* 50 mg/kg bw/d MOS = 1685 * standar","endpoint":"dermal absorption","ingredient":"Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzenesulfonic acid (1:1)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 100","page":21,"route":"oral","species":"rat","study_id":"sccs_o_080_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.0297 | mg/kg bw/d | rat | oral | - | dermal absorption | SOURCE_SUBDIR=sccs_o_080; REPORT_TITLE=OPINION ON Quinolinium, 4-formyl-1-methyl-, salt with 4- methylbenzene sulfonic acid (1:1) 4-Formyl-1-methylquinolinium-p-toluenesulfonate (INCI name) COLIPA n° A157; OPINION_NUMBER=SCCS/1435/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 13 December 2005; VALUE_TEXT== 0.0297; DOSE=A x 0.001 = 0.551mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 58...; EFFECT=A x 0.001 = 0.551mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.781 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0297 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% Bioavailability* 50 mg/kg bw/d MOS = 1685 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical specifications 4-Formyl-1-methylquinolinium-p-toluenesulfonate is used in hair dye formulations (used in the absence or presence of hydrogen peroxide) up to a maximum concentration of 2.5% on scalp. Chemical analyses of the two batches; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"223398-02-5","citation":"","dose":"A x 0.001 = 0.551mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 58...","duration":"","effect":"A x 0.001 = 0.551mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.781 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0297 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% Bioavailability* 50 mg/kg bw/d MOS = 1685 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical specifications 4-Formyl-1-methylquinolinium-p-toluenesulfonate is used in hair dye formulations (used in the absence or presence of hydrogen peroxide) up to a maximum concentration of 2.5% on scalp. Chemical analyses of the two batches","endpoint":"dermal absorption","ingredient":"Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzenesulfonic acid (1:1)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.0297","page":21,"route":"oral","species":"rat","study_id":"sccs_o_080_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =100 | mg/kg bw/d | rat | oral | - | dermal absorption | SOURCE_SUBDIR=sccs_o_080; REPORT_TITLE=OPINION ON Quinolinium, 4-formyl-1-methyl-, salt with 4- methylbenzene sulfonic acid (1:1) 4-Formyl-1-methylquinolinium-p-toluenesulfonate (INCI name) COLIPA n° A157; OPINION_NUMBER=SCCS/1435/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 13 December 2005; VALUE_TEXT== 100; DOSE=weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treat...; EFFECT=weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.781 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0297 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% Bioavailability* 50 mg/kg bw/d MOS = 1685 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical specifications 4-Formyl-1-methylquinolinium-p-toluenesulfonate is used in hair dye formulations (used in the absence or presence of hydrogen peroxide) up to a maximum concentration of 2.5% on scalp. Chemical analyses of the two batches of 4-; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"223398-02-5","citation":"","dose":"weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treat...","duration":"","effect":"weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.009mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% bioavailablity* = 50 mg/kg bw/d MOS = 5555 Non-oxidative Absorption through the skin A = 3.07 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.781 mg Typical body weight of human = 60 kg Systemic exposure dose SAS x A x 0.001/60 = 0.0297 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 100 mg/kg bw/d (Teratogenicity, gavage, rat) Adjusted for 50% Bioavailability* 50 mg/kg bw/d MOS = 1685 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical specifications 4-Formyl-1-methylquinolinium-p-toluenesulfonate is used in hair dye formulations (used in the absence or presence of hydrogen peroxide) up to a maximum concentration of 2.5% on scalp. Chemical analyses of the two batches of 4-","endpoint":"dermal absorption","ingredient":"Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzenesulfonic acid (1:1)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 100","page":21,"route":"oral","species":"rat","study_id":"sccs_o_080_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | 100 | mg/kg bw | rabbit | dermal | - | dermal absorption | SOURCE_SUBDIR=sccs_o_080; REPORT_TITLE=OPINION ON Quinolinium, 4-formyl-1-methyl-, salt with 4- methylbenzene sulfonic acid (1:1) 4-Formyl-1-methylquinolinium-p-toluenesulfonate (INCI name) COLIPA n° A157; OPINION_NUMBER=SCCS/1435/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 13 December 2005; VALUE_TEXT=100; DOSE=SCCS/1435/11 Opinion on quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) ___________________________________________________________________________________________ 22 1000 mg/kg bw for maternal toxicity and at 100 mg/kg bw for embryo/foetotoxicity (teratogenicity study).; EFFECT=SCCS/1435/11 Opinion on quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) ___________________________________________________________________________________________ 22 1000 mg/kg bw for maternal toxicity and at 100 mg/kg bw for embryo/foetotoxicity (teratogenicity study). The NOAEL derived from embryo/foetotoxicity has been used for the calculation of MoS. No reproduction toxicity study was submitted. Irritation, sensitisation 4-Formyl-1-methylquinolinium-p-toluenesulfonate is an irritant to rabbit skin. It is an irritant to rabbit eye. The substance is a non-sensitiser in the Buehler test and the LLNA. Percutaneous absorption Dermal absorption of 4-formyl-1-methylquinolinium-p-toluenesulfonate solution as well as of two formulations, containing the test material with and without hydroge; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"223398-02-5","citation":"","dose":"SCCS/1435/11 Opinion on quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) ___________________________________________________________________________________________ 22 1000 mg/kg bw for maternal toxicity and at 100 mg/kg bw for embryo/foetotoxicity (teratogenicity study).","duration":"","effect":"SCCS/1435/11 Opinion on quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzene sulfonic acid (1:1) ___________________________________________________________________________________________ 22 1000 mg/kg bw for maternal toxicity and at 100 mg/kg bw for embryo/foetotoxicity (teratogenicity study). The NOAEL derived from embryo/foetotoxicity has been used for the calculation of MoS. No reproduction toxicity study was submitted. Irritation, sensitisation 4-Formyl-1-methylquinolinium-p-toluenesulfonate is an irritant to rabbit skin. It is an irritant to rabbit eye. The substance is a non-sensitiser in the Buehler test and the LLNA. Percutaneous absorption Dermal absorption of 4-formyl-1-methylquinolinium-p-toluenesulfonate solution as well as of two formulations, containing the test material with and without hydroge","endpoint":"dermal absorption","ingredient":"Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzenesulfonic acid (1:1)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"100","page":22,"route":"dermal","species":"rabbit","study_id":"sccs_o_080_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 250 | mg/kg bw/day | - | oral | Chronic | genotoxicity | SOURCE_SUBDIR=sccp_o_033; REPORT_TITLE=Opinion on Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzenesulfonic acid (1:1) COLIPA N° A157; OPINION_NUMBER=SCCP/0923/05; COMMITTEE=SCCP; REPORT_DATE=13 December 2005; VALUE_TEXT=250; DOSE=Changes in haematological parameters in high dose females were found reversible in the recovery group.; EFFECT=copy and histopathology was performed, on all animals. Results No mortality and no clinical signs of toxicity were observed and feed consumption and body weight was not affected. Ophthalmoscopy and neurobehavioural observations did not show substance-related toxicity and motor activity and sensory reactivity were comparable to controls. Changes in haematological parameters in high dose females were found reversible in the recovery group. Clinical chemistry and urinalysis showed no treatment related changes. The NOAEL is 250 mg/kg bw/day. Ref.: 16 3.3.5.3. Chronic (> 12 months) toxicity / 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535 and TA1537 Replicates: Two independent tests (plate incorporation assay) Test substance: COLIPA A 157 Batch No.: Moe-HM-6116-190 Concentrations: 33 - 5000 µg/plate without and with metabolic activation GLP: Quality Assurance Statement include; CITATION=Ref.: 16 3; CITATION_NUMBERS=[16,3]; REFERENCE=Ref.: 16 3; DETAILS_JSON={"cas_number":"223398-02-5","citation":"Ref.: 16 3","dose":"Changes in haematological parameters in high dose females were found reversible in the recovery group.","duration":"Chronic","effect":"copy and histopathology was performed, on all animals. Results No mortality and no clinical signs of toxicity were observed and feed consumption and body weight was not affected. Ophthalmoscopy and neurobehavioural observations did not show substance-related toxicity and motor activity and sensory reactivity were comparable to controls. Changes in haematological parameters in high dose females were found reversible in the recovery group. Clinical chemistry and urinalysis showed no treatment related changes. The NOAEL is 250 mg/kg bw/day. Ref.: 16 3.3.5.3. Chronic (> 12 months) toxicity / 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535 and TA1537 Replicates: Two independent tests (plate incorporation assay) Test substance: COLIPA A 157 Batch No.: Moe-HM-6116-190 Concentrations: 33 - 5000 µg/plate without and with metabolic activation GLP: Quality Assurance Statement include","endpoint":"genotoxicity","ingredient":"Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzenesulfonic acid (1:1)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":13,"route":"oral","species":"","study_id":"sccp_o_033_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 250 | mg/kg bw/day | - | oral | Chronic | genotoxicity | SOURCE_SUBDIR=sccs_o_080; REPORT_TITLE=OPINION ON Quinolinium, 4-formyl-1-methyl-, salt with 4- methylbenzene sulfonic acid (1:1) 4-Formyl-1-methylquinolinium-p-toluenesulfonate (INCI name) COLIPA n° A157; OPINION_NUMBER=SCCS/1435/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 13 December 2005; VALUE_TEXT=250; DOSE=Changes in haematological parameters in high dose females were found reversible in the recovery group.; EFFECT=copy and histopathology was performed, on all animals. Results No mortality and no clinical signs of toxicity were observed and feed consumption and body weight was not affected. Ophthalmoscopy and neurobehavioural observations did not show substance-related toxicity and motor activity and sensory reactivity were comparable to controls. Changes in haematological parameters in high dose females were found reversible in the recovery group. Clinical chemistry and urinalysis showed no treatment related changes. The NOAEL, according to the applicant, is 250 mg/kg bw/day. Ref.: 16 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535 and TA1537 Replicates: triplicate cultures Test substance: Moe-HM-6116-190 Batch: Moe-HM-6116-190 Purity: 97.9 % (HPLC); CITATION=Ref.: 16 3; CITATION_NUMBERS=[16,3]; REFERENCE=Ref.: 16 3; DETAILS_JSON={"cas_number":"223398-02-5","citation":"Ref.: 16 3","dose":"Changes in haematological parameters in high dose females were found reversible in the recovery group.","duration":"Chronic","effect":"copy and histopathology was performed, on all animals. Results No mortality and no clinical signs of toxicity were observed and feed consumption and body weight was not affected. Ophthalmoscopy and neurobehavioural observations did not show substance-related toxicity and motor activity and sensory reactivity were comparable to controls. Changes in haematological parameters in high dose females were found reversible in the recovery group. Clinical chemistry and urinalysis showed no treatment related changes. The NOAEL, according to the applicant, is 250 mg/kg bw/day. Ref.: 16 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535 and TA1537 Replicates: triplicate cultures Test substance: Moe-HM-6116-190 Batch: Moe-HM-6116-190 Purity: 97.9 % (HPLC)","endpoint":"genotoxicity","ingredient":"Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzenesulfonic acid (1:1)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":15,"route":"oral","species":"","study_id":"sccs_o_080_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | irritation | >2000 | mg/kg bw | rat | oral | 90 day | irritation | SOURCE_SUBDIR=sccp_o_033; REPORT_TITLE=Opinion on Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzenesulfonic acid (1:1) COLIPA N° A157; OPINION_NUMBER=SCCP/0923/05; COMMITTEE=SCCP; REPORT_DATE=13 December 2005; VALUE_TEXT=>2000; DOSE=Toxicity The LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate is found to be >2000 mg/kg bw.; EFFECT=hair dye formulations up to a maximum concentration of 2.5% on scalp. Chemical analyses of the two batches of 4-Formyl-1- methylquinolinium-p-toluenesulfonate revealed that one of the batches contained an unknown impurity (12.8%), detected at 468 nm by HPLC. However, the applicant has made a declaration that the specification of the material used in products on the market excludes the presence of this impurity. Toxicity The LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate is found to be >2000 mg/kg bw. The NOAEL was set at 250 mg/kg bw (90 day oral rat). The NOAEL was set at 1000 mg/kg bw for maternal toxicity and at 100 mg/kg bw for embryo/foetotoxicity (teratogenicity study). Irritation, sensitisation 4-Formyl-1-methylquinolinium-p-toluenesulfonate is an irritant to rabbit skin and, at a concentration of 25%, to the ear dorsum of mice. It is an irritant to rabbit eye. The substance is a non-sensitiser in the Buehler test and the LLNA. However, the vehicle used may not be suitable.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"223398-02-5","citation":"","dose":"Toxicity The LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate is found to be >2000 mg/kg bw.","duration":"90 day","effect":"hair dye formulations up to a maximum concentration of 2.5% on scalp. Chemical analyses of the two batches of 4-Formyl-1- methylquinolinium-p-toluenesulfonate revealed that one of the batches contained an unknown impurity (12.8%), detected at 468 nm by HPLC. However, the applicant has made a declaration that the specification of the material used in products on the market excludes the presence of this impurity. Toxicity The LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate is found to be >2000 mg/kg bw. The NOAEL was set at 250 mg/kg bw (90 day oral rat). The NOAEL was set at 1000 mg/kg bw for maternal toxicity and at 100 mg/kg bw for embryo/foetotoxicity (teratogenicity study). Irritation, sensitisation 4-Formyl-1-methylquinolinium-p-toluenesulfonate is an irritant to rabbit skin and, at a concentration of 25%, to the ear dorsum of mice. It is an irritant to rabbit eye. The substance is a non-sensitiser in the Buehler test and the LLNA. However, the vehicle used may not be suitable.","endpoint":"irritation","ingredient":"Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzenesulfonic acid (1:1)","loael_value":"","noael_unit":"mg/kg bw","noael_value":">2000","page":17,"route":"oral","species":"rat","study_id":"sccp_o_033_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | irritation | 1000 | mg/kg bw | rat | oral | 90 day | irritation | SOURCE_SUBDIR=sccp_o_033; REPORT_TITLE=Opinion on Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzenesulfonic acid (1:1) COLIPA N° A157; OPINION_NUMBER=SCCP/0923/05; COMMITTEE=SCCP; REPORT_DATE=13 December 2005; VALUE_TEXT=1000; DOSE=Toxicity The LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate is found to be >2000 mg/kg bw.; EFFECT=f 2.5% on scalp. Chemical analyses of the two batches of 4-Formyl-1- methylquinolinium-p-toluenesulfonate revealed that one of the batches contained an unknown impurity (12.8%), detected at 468 nm by HPLC. However, the applicant has made a declaration that the specification of the material used in products on the market excludes the presence of this impurity. Toxicity The LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate is found to be >2000 mg/kg bw. The NOAEL was set at 250 mg/kg bw (90 day oral rat). The NOAEL was set at 1000 mg/kg bw for maternal toxicity and at 100 mg/kg bw for embryo/foetotoxicity (teratogenicity study). Irritation, sensitisation 4-Formyl-1-methylquinolinium-p-toluenesulfonate is an irritant to rabbit skin and, at a concentration of 25%, to the ear dorsum of mice. It is an irritant to rabbit eye. The substance is a non-sensitiser in the Buehler test and the LLNA. However, the vehicle used may not be suitable.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"223398-02-5","citation":"","dose":"Toxicity The LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate is found to be >2000 mg/kg bw.","duration":"90 day","effect":"f 2.5% on scalp. Chemical analyses of the two batches of 4-Formyl-1- methylquinolinium-p-toluenesulfonate revealed that one of the batches contained an unknown impurity (12.8%), detected at 468 nm by HPLC. However, the applicant has made a declaration that the specification of the material used in products on the market excludes the presence of this impurity. Toxicity The LD50 of 4-formyl-1-methylquinolinium-p-toluenesulfonate is found to be >2000 mg/kg bw. The NOAEL was set at 250 mg/kg bw (90 day oral rat). The NOAEL was set at 1000 mg/kg bw for maternal toxicity and at 100 mg/kg bw for embryo/foetotoxicity (teratogenicity study). Irritation, sensitisation 4-Formyl-1-methylquinolinium-p-toluenesulfonate is an irritant to rabbit skin and, at a concentration of 25%, to the ear dorsum of mice. It is an irritant to rabbit eye. The substance is a non-sensitiser in the Buehler test and the LLNA. However, the vehicle used may not be suitable.","endpoint":"irritation","ingredient":"Quinolinium, 4-formyl-1-methyl-, salt with 4-methylbenzenesulfonic acid (1:1)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1000","page":17,"route":"oral","species":"rat","study_id":"sccp_o_033_noael_005"} |