NOAEL Studies
Cosmetic Ingredient
Disperse Violet 1 NOAEL Studies
INCI: DISPERSE VIOLET 1
CAS: 128-95-0
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
CIR Safety Assessment 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| CIR Safety Assessment | DERMAL_ABSORPTION | =3 | % | Not stated (anesthetized animals) | dermal | 10% solution | Cutaneous absorption study; thick layer of 10% solution applied to shaved area of abdomen for 3 h | {"absorption_percent":"No indications that this ingredient was absorbed after 3 h","basis":"No indications that this ingredient was absorbed after 3 h","citation":"20","concentration_tested":"10% solution","page":5,"pdf":"pr126.pdf","row_type":"dermal_absorption_study"} |
| CIR Safety Assessment | DERMAL_ABSORPTION | =3 | % | Not stated (anesthetized animals) | dermal | 10% solution | Cutaneous absorption study; thick layer of 10% solution applied to shaved area of abdomen for 3 h | {"absorption_percent":"No indications that this ingredient was absorbed after 3 h","basis":"No indications that this ingredient was absorbed after 3 h","citation":"20","concentration_tested":"10% solution","page":5,"pdf":"pr126.pdf","row_type":"dermal_absorption_study"} |
| CIR Safety Assessment | DERMAL_ABSORPTION | =3 | % | Not stated (anesthetized animals) | dermal | 10% solution | Cutaneous absorption study; thick layer of 10% solution applied to shaved area of abdomen for 3 h | {"absorption_percent":"No indications that this ingredient was absorbed after 3 h","basis":"No indications that this ingredient was absorbed after 3 h","citation":"20","concentration_tested":"10% solution","page":5,"pdf":"pr126.pdf","row_type":"dermal_absorption_study"} |
COSMOS DB 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS DB | LOAEL | 2 | mg/kg bw/day | rat | oral | 90 day | Subchronic | SCCS; van Otterdijk, F. M. 90-day oral toxicity study with Disperse Violet 1/18588/ bydaily gavage in the rat; NOTOX, the Netherlands. Project 397755, 6 June 2005 |
| COSMOS DB | NOAEL | 0.25 | mg/kg bw/day | rat | oral | 90 day | Subchronic | SCCS; van Otterdijk, F. M. 90-day oral toxicity study with Disperse Violet 1/18588/ bydaily gavage in the rat; NOTOX, the Netherlands. Project 397755, 6 June 2005 |
NTP ICE acute oral 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP ICE acute oral | LD50 | =5790 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM ChemIDplus TEST (undated); record_id=acute_oral_2129; row=4722; data_type=In Vivo; mixture=Chemical; chemical_name=1,4-Diaminoanthraquinone; preferred_name=1,4-Diaminoanthraquinone; dtxsid=DTXSID2041252; url=https://chem.nlm.nih.gov/chemidplus/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2041252; source_file=acute_oral.xlsx |
NTP ICE endocrine 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP ICE endocrine | AC50 | 8.20890019925237 | uM | - | - | - | ARPathway2016; AR Pathway Model, Antagonist | sheet=Integrated_approaches; excel_row=813; RecordID=ARPathway2016_349; DatasetName=ARPathway2016; DTXSID=DTXSID2041252; Assay=AR Pathway Model, Antagonist; Endpoint=AC50; Response=8.20890019925237; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2041252 |
| NTP ICE endocrine | ACC | 62.33937348 | uM | - | - | - | ARPathway2016; AR Pathway Model, Antagonist | sheet=Integrated_approaches; excel_row=812; RecordID=ARPathway2016_349; DatasetName=ARPathway2016; DTXSID=DTXSID2041252; Assay=AR Pathway Model, Antagonist; Endpoint=ACC; Response=62.33937348; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2041252 |
| NTP ICE endocrine | Model Score | 0 | unitless | - | - | - | ARPathway2016; AR Pathway Model, Antagonist | sheet=Integrated_approaches; excel_row=814; RecordID=ARPathway2016_349; DatasetName=ARPathway2016; DTXSID=DTXSID2041252; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2041252 |
| NTP ICE endocrine | Model Score | 0.0102 | unitless | - | - | - | ARPathway2016; AR Pathway Model, Agonist | sheet=Integrated_approaches; excel_row=815; RecordID=ARPathway2016_349; DatasetName=ARPathway2016; DTXSID=DTXSID2041252; Assay=AR Pathway Model, Agonist; Endpoint=Model Score; Response=0.0102; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2041252 |
SCCNFP Opinion 12 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP Opinion | NOAEL | =1.21 | mg/kg | guinea pig | - | - | irritation | {"citation":"Ref. : 15 2","dose":"ical (red cell and white cell count) and biochemical parameters (alkaline phosphatase), these data were not dose and time related, they were considered incidental by investigators.","effect":"ical (red cell and white cell count) and biochemical parameters (alkaline phosphatase), these data were not dose and time related, they were considered incidental by investigators. Liver weights were increased in male high and mid group and in female high group. Kidney weights were increased in male high group. These data were considered test article related. Concerning macroscopic and histopathological observations, the results were within the normal range of variation for this strain. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) was established to be 1.21 mg/kg (1.14 – 1.28) for 1,4-Diamino-anthraquinone and 0.19 mg/kg (0.18-0.20) for 1- Hydroxy-4-amino-anthraquinone. Ref. : 15 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD guideline 404 (1981) Species/strain : Pirbright albino guinea pigs","page":7,"pdf":"out160_en.pdf","row_type":"noael_study","study_id":"out160_en_noael_001"} |
| SCCNFP Opinion | NOAEL | =1.21 | mg/kg/day | rat | oral | sub-chronic | repeated dose toxicity | {"dose":"In view of the low concentration, this may not be important. * The allergenicity of the compounds cannot be assessed due to inadequate data. * From the sub-chronic studies conducted by oral route in the rat, a NOAEL of 1.21 mg/kg/day for Disperse Violet 1 and of 0.19 mg/kg/day for Disperse Red 15 was obtained. * The percutaneous absorption study...","effect":"e preparation per application, the maximum amount applied would be close to 700 mg. * Disperse Violet 1 is neither irritant to the skin nor to the eye. After repeated topical applications of Disperse Violet 1, no adverse effects were noted. No data is available on irritant potential of Disperse Red 15 (C61). In view of the low concentration, this may not be important. * The allergenicity of the compounds cannot be assessed due to inadequate data. * From the sub-chronic studies conducted by oral route in the rat, a NOAEL of 1.21 mg/kg/day for Disperse Violet 1 and of 0.19 mg/kg/day for Disperse Red 15 was obtained. * The percutaneous absorption study is considered inadequate * The evaluation of the mutagenic potential of Disperse Violet 1 is not possible at present since no adequate data has been produced. Disperse Red 15 of unknown purity has been found positive in the bacterial gene mutation assay and for the induction of chromosome aberration in","page":21,"pdf":"out160_en.pdf","row_type":"noael_study","study_id":"out160_en_noael_006"} |
| SCCNFP Opinion | NOAEL | =1.21 | mg/kg | guinea pig | - | - | irritation | {"citation":"Ref. : 15 2","dose":"ical (red cell and white cell count) and biochemical parameters (alkaline phosphatase), these data were not dose and time related, they were considered incidental by investigators.","effect":"ical (red cell and white cell count) and biochemical parameters (alkaline phosphatase), these data were not dose and time related, they were considered incidental by investigators. Liver weights were increased in male high and mid group and in female high group. Kidney weights were increased in male high group. These data were considered test article related. Concerning macroscopic and histopathological observations, the results were within the normal range of variation for this strain. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) was established to be 1.21 mg/kg (1.14 – 1.28) for 1,4-Diamino-anthraquinone and 0.19 mg/kg (0.18-0.20) for 1- Hydroxy-4-amino-anthraquinone. Ref. : 15 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD guideline 404 (1981) Species/strain : Pirbright albino guinea pigs","page":7,"pdf":"out160_en.pdf","row_type":"noael_study","study_id":"out160_en_noael_001"} |
| SCCNFP Opinion | NOAEL | =1.21 | mg/kg/day | rat | oral | sub-chronic | repeated dose toxicity | {"dose":"In view of the low concentration, this may not be important. * The allergenicity of the compounds cannot be assessed due to inadequate data. * From the sub-chronic studies conducted by oral route in the rat, a NOAEL of 1.21 mg/kg/day for Disperse Violet 1 and of 0.19 mg/kg/day for Disperse Red 15 was obtained. * The percutaneous absorption study...","effect":"e preparation per application, the maximum amount applied would be close to 700 mg. * Disperse Violet 1 is neither irritant to the skin nor to the eye. After repeated topical applications of Disperse Violet 1, no adverse effects were noted. No data is available on irritant potential of Disperse Red 15 (C61). In view of the low concentration, this may not be important. * The allergenicity of the compounds cannot be assessed due to inadequate data. * From the sub-chronic studies conducted by oral route in the rat, a NOAEL of 1.21 mg/kg/day for Disperse Violet 1 and of 0.19 mg/kg/day for Disperse Red 15 was obtained. * The percutaneous absorption study is considered inadequate * The evaluation of the mutagenic potential of Disperse Violet 1 is not possible at present since no adequate data has been produced. Disperse Red 15 of unknown purity has been found positive in the bacterial gene mutation assay and for the induction of chromosome aberration in","page":21,"pdf":"out160_en.pdf","row_type":"noael_study","study_id":"out160_en_noael_006"} |
| SCCNFP Opinion | NOAEL | =1.21 | mg/kg | guinea pig | - | - | irritation | {"citation":"Ref. : 15 2","dose":"ical (red cell and white cell count) and biochemical parameters (alkaline phosphatase), these data were not dose and time related, they were considered incidental by investigators.","effect":"ical (red cell and white cell count) and biochemical parameters (alkaline phosphatase), these data were not dose and time related, they were considered incidental by investigators. Liver weights were increased in male high and mid group and in female high group. Kidney weights were increased in male high group. These data were considered test article related. Concerning macroscopic and histopathological observations, the results were within the normal range of variation for this strain. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) was established to be 1.21 mg/kg (1.14 – 1.28) for 1,4-Diamino-anthraquinone and 0.19 mg/kg (0.18-0.20) for 1- Hydroxy-4-amino-anthraquinone. Ref. : 15 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD guideline 404 (1981) Species/strain : Pirbright albino guinea pigs","page":7,"pdf":"out160_en.pdf","row_type":"noael_study","study_id":"out160_en_noael_001"} |
| SCCNFP Opinion | NOAEL | =1.21 | mg/kg/day | rat | oral | sub-chronic | repeated dose toxicity | {"dose":"In view of the low concentration, this may not be important. * The allergenicity of the compounds cannot be assessed due to inadequate data. * From the sub-chronic studies conducted by oral route in the rat, a NOAEL of 1.21 mg/kg/day for Disperse Violet 1 and of 0.19 mg/kg/day for Disperse Red 15 was obtained. * The percutaneous absorption study...","effect":"e preparation per application, the maximum amount applied would be close to 700 mg. * Disperse Violet 1 is neither irritant to the skin nor to the eye. After repeated topical applications of Disperse Violet 1, no adverse effects were noted. No data is available on irritant potential of Disperse Red 15 (C61). In view of the low concentration, this may not be important. * The allergenicity of the compounds cannot be assessed due to inadequate data. * From the sub-chronic studies conducted by oral route in the rat, a NOAEL of 1.21 mg/kg/day for Disperse Violet 1 and of 0.19 mg/kg/day for Disperse Red 15 was obtained. * The percutaneous absorption study is considered inadequate * The evaluation of the mutagenic potential of Disperse Violet 1 is not possible at present since no adequate data has been produced. Disperse Red 15 of unknown purity has been found positive in the bacterial gene mutation assay and for the induction of chromosome aberration in","page":21,"pdf":"out160_en.pdf","row_type":"noael_study","study_id":"out160_en_noael_006"} |
| SCCNFP Opinion | NOAEL | =1.21 | mg/kg | guinea pig | - | - | irritation | {"citation":"Ref. : 15 2","dose":"ical (red cell and white cell count) and biochemical parameters (alkaline phosphatase), these data were not dose and time related, they were considered incidental by investigators.","effect":"ical (red cell and white cell count) and biochemical parameters (alkaline phosphatase), these data were not dose and time related, they were considered incidental by investigators. Liver weights were increased in male high and mid group and in female high group. Kidney weights were increased in male high group. These data were considered test article related. Concerning macroscopic and histopathological observations, the results were within the normal range of variation for this strain. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) was established to be 1.21 mg/kg (1.14 – 1.28) for 1,4-Diamino-anthraquinone and 0.19 mg/kg (0.18-0.20) for 1- Hydroxy-4-amino-anthraquinone. Ref. : 15 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD guideline 404 (1981) Species/strain : Pirbright albino guinea pigs","page":7,"pdf":"out160_en.pdf","row_type":"noael_study","study_id":"out160_en_noael_001"} |
| SCCNFP Opinion | NOAEL | =1.21 | mg/kg/day | rat | oral | sub-chronic | repeated dose toxicity | {"dose":"In view of the low concentration, this may not be important. * The allergenicity of the compounds cannot be assessed due to inadequate data. * From the sub-chronic studies conducted by oral route in the rat, a NOAEL of 1.21 mg/kg/day for Disperse Violet 1 and of 0.19 mg/kg/day for Disperse Red 15 was obtained. * The percutaneous absorption study...","effect":"e preparation per application, the maximum amount applied would be close to 700 mg. * Disperse Violet 1 is neither irritant to the skin nor to the eye. After repeated topical applications of Disperse Violet 1, no adverse effects were noted. No data is available on irritant potential of Disperse Red 15 (C61). In view of the low concentration, this may not be important. * The allergenicity of the compounds cannot be assessed due to inadequate data. * From the sub-chronic studies conducted by oral route in the rat, a NOAEL of 1.21 mg/kg/day for Disperse Violet 1 and of 0.19 mg/kg/day for Disperse Red 15 was obtained. * The percutaneous absorption study is considered inadequate * The evaluation of the mutagenic potential of Disperse Violet 1 is not possible at present since no adequate data has been produced. Disperse Red 15 of unknown purity has been found positive in the bacterial gene mutation assay and for the induction of chromosome aberration in","page":21,"pdf":"out160_en.pdf","row_type":"noael_study","study_id":"out160_en_noael_006"} |
| SCCNFP Opinion | NOAEL | =2 | % | human | dermal | - | irritation | {"dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Based on a usage volume of x ml, containing at maximum x % Highest penetration PA (\u0001g/cm2) = Typical body weight of human = 60 kg Exposed area (scalp) = 700 cm2 Systemic exposure PA x 700 cm2 = mg Systemic exposure dose (SED) PA x 700/ 60 x = mg/kg bw No observed adverse effect level (mg/kg)...","effect":"SCCNFP/0504/01, final Evaluation and opinion on : Disperse Violet 1 impurified with Disperse Red 15 ____________________________________________________________________________________________ 21 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Based on a usage volume of x ml, containing at maximum x % Highest penetration PA (\u0001g/cm2) = Typical body weight of human = 60 kg Exposed area (scalp) = 700 cm2 Systemic exposure PA x 700 cm2 = mg Systemic exposure dose (SED) PA x 700/ 60 x = mg/kg bw No observed adverse effect level (mg/kg) NOAEL = mg/kg bw (species, route of application) Margin of Safety NOAEL / SED = 2.12. Conclusions Disperse Violet 1 (C 64) is a compound impurified with Disperse Red 15 (C 61) and intended to be used in colour setting lotions at a maximal concentration of 2 %. Basing on a usage volume of 35 ml of hair dye preparation per application, the maximum amount applied would be close to 700 mg. * Disperse Violet 1 is neither irritant to the skin nor to the eye. After repeated topical applications of Disperse Violet","page":21,"pdf":"out160_en.pdf","row_type":"noael_study","study_id":"out160_en_noael_003"} |
| SCCNFP Opinion | NOAEL | =2 | % | human | dermal | - | irritation | {"dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Based on a usage volume of x ml, containing at maximum x % Highest penetration PA (\u0001g/cm2) = Typical body weight of human = 60 kg Exposed area (scalp) = 700 cm2 Systemic exposure PA x 700 cm2 = mg Systemic exposure dose (SED) PA x 700/ 60 x = mg/kg bw No observed adverse effect level (mg/kg)...","effect":"SCCNFP/0504/01, final Evaluation and opinion on : Disperse Violet 1 impurified with Disperse Red 15 ____________________________________________________________________________________________ 21 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Based on a usage volume of x ml, containing at maximum x % Highest penetration PA (\u0001g/cm2) = Typical body weight of human = 60 kg Exposed area (scalp) = 700 cm2 Systemic exposure PA x 700 cm2 = mg Systemic exposure dose (SED) PA x 700/ 60 x = mg/kg bw No observed adverse effect level (mg/kg) NOAEL = mg/kg bw (species, route of application) Margin of Safety NOAEL / SED = 2.12. Conclusions Disperse Violet 1 (C 64) is a compound impurified with Disperse Red 15 (C 61) and intended to be used in colour setting lotions at a maximal concentration of 2 %. Basing on a usage volume of 35 ml of hair dye preparation per application, the maximum amount applied would be close to 700 mg. * Disperse Violet 1 is neither irritant to the skin nor to the eye. After repeated topical applications of Disperse Violet","page":21,"pdf":"out160_en.pdf","row_type":"noael_study","study_id":"out160_en_noael_003"} |
| SCCNFP Opinion | NOAEL | =2 | % | human | dermal | - | irritation | {"dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Based on a usage volume of x ml, containing at maximum x % Highest penetration PA (\u0001g/cm2) = Typical body weight of human = 60 kg Exposed area (scalp) = 700 cm2 Systemic exposure PA x 700 cm2 = mg Systemic exposure dose (SED) PA x 700/ 60 x = mg/kg bw No observed adverse effect level (mg/kg)...","effect":"SCCNFP/0504/01, final Evaluation and opinion on : Disperse Violet 1 impurified with Disperse Red 15 ____________________________________________________________________________________________ 21 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Based on a usage volume of x ml, containing at maximum x % Highest penetration PA (\u0001g/cm2) = Typical body weight of human = 60 kg Exposed area (scalp) = 700 cm2 Systemic exposure PA x 700 cm2 = mg Systemic exposure dose (SED) PA x 700/ 60 x = mg/kg bw No observed adverse effect level (mg/kg) NOAEL = mg/kg bw (species, route of application) Margin of Safety NOAEL / SED = 2.12. Conclusions Disperse Violet 1 (C 64) is a compound impurified with Disperse Red 15 (C 61) and intended to be used in colour setting lotions at a maximal concentration of 2 %. Basing on a usage volume of 35 ml of hair dye preparation per application, the maximum amount applied would be close to 700 mg. * Disperse Violet 1 is neither irritant to the skin nor to the eye. After repeated topical applications of Disperse Violet","page":21,"pdf":"out160_en.pdf","row_type":"noael_study","study_id":"out160_en_noael_003"} |
| SCCNFP Opinion | NOAEL | =2 | % | human | dermal | - | irritation | {"dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Based on a usage volume of x ml, containing at maximum x % Highest penetration PA (\u0001g/cm2) = Typical body weight of human = 60 kg Exposed area (scalp) = 700 cm2 Systemic exposure PA x 700 cm2 = mg Systemic exposure dose (SED) PA x 700/ 60 x = mg/kg bw No observed adverse effect level (mg/kg)...","effect":"SCCNFP/0504/01, final Evaluation and opinion on : Disperse Violet 1 impurified with Disperse Red 15 ____________________________________________________________________________________________ 21 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Based on a usage volume of x ml, containing at maximum x % Highest penetration PA (\u0001g/cm2) = Typical body weight of human = 60 kg Exposed area (scalp) = 700 cm2 Systemic exposure PA x 700 cm2 = mg Systemic exposure dose (SED) PA x 700/ 60 x = mg/kg bw No observed adverse effect level (mg/kg) NOAEL = mg/kg bw (species, route of application) Margin of Safety NOAEL / SED = 2.12. Conclusions Disperse Violet 1 (C 64) is a compound impurified with Disperse Red 15 (C 61) and intended to be used in colour setting lotions at a maximal concentration of 2 %. Basing on a usage volume of 35 ml of hair dye preparation per application, the maximum amount applied would be close to 700 mg. * Disperse Violet 1 is neither irritant to the skin nor to the eye. After repeated topical applications of Disperse Violet","page":21,"pdf":"out160_en.pdf","row_type":"noael_study","study_id":"out160_en_noael_003"} |
SCCS Opinion 24 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS Opinion | NOAEL | =0.003 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"citation":"Ref.: 31 (Subm","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) S...","effect":"e guinea pigs. Ref.: 31 (Subm. II) 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw No observed adverse effect level NOAEL = 2.0 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 667 3.3.14. Discussion Physico-chemical properties Disperse Violet 1 is used as a hair colour in semi-permanent hair dye formulations at a maximum on-head concentration of 0.5%. Characterisation of several batches of test material was insufficient or incomplete, but the test batches used for the main studies for safety evaluation, in this opinion, were fully characterised. The stability of Disperse Violet 1 in typical hair dye formulati","page":25,"pdf":"sccs_o_028.pdf","row_type":"noael_study","study_id":"sccs_o_028_noael_003"} |
| SCCS Opinion | NOAEL | =0.003 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"citation":"Ref.: 31 (Subm","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) S...","effect":"e guinea pigs. Ref.: 31 (Subm. II) 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw No observed adverse effect level NOAEL = 2.0 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 667 3.3.14. Discussion Physico-chemical properties Disperse Violet 1 is used as a hair colour in semi-permanent hair dye formulations at a maximum on-head concentration of 0.5%. Characterisation of several batches of test material was insufficient or incomplete, but the test batches used for the main studies for safety evaluation, in this opinion, were fully characterised. The stability of Disperse Violet 1 in typical hair dye formulati","page":25,"pdf":"sccs_o_028.pdf","row_type":"noael_study","study_id":"sccs_o_028_noael_003"} |
| SCCS Opinion | NOAEL | =0.003 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"citation":"Ref.: 31 (Subm","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) S...","effect":"e guinea pigs. Ref.: 31 (Subm. II) 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw No observed adverse effect level NOAEL = 2.0 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 667 3.3.14. Discussion Physico-chemical properties Disperse Violet 1 is used as a hair colour in semi-permanent hair dye formulations at a maximum on-head concentration of 0.5%. Characterisation of several batches of test material was insufficient or incomplete, but the test batches used for the main studies for safety evaluation, in this opinion, were fully characterised. The stability of Disperse Violet 1 in typical hair dye formulati","page":25,"pdf":"sccs_o_028.pdf","row_type":"noael_study","study_id":"sccs_o_028_noael_003"} |
| SCCS Opinion | NOAEL | =0.003 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"citation":"Ref.: 31 (Subm","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) S...","effect":"e guinea pigs. Ref.: 31 (Subm. II) 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw No observed adverse effect level NOAEL = 2.0 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 667 3.3.14. Discussion Physico-chemical properties Disperse Violet 1 is used as a hair colour in semi-permanent hair dye formulations at a maximum on-head concentration of 0.5%. Characterisation of several batches of test material was insufficient or incomplete, but the test batches used for the main studies for safety evaluation, in this opinion, were fully characterised. The stability of Disperse Violet 1 in typical hair dye formulati","page":25,"pdf":"sccs_o_028.pdf","row_type":"noael_study","study_id":"sccs_o_028_noael_003"} |
| SCCS Opinion | NOAEL | =2 | mg/kg/day | - | - | Chronic | genotoxicity | {"citation":"Ref.: 23 (subm","dose":"Some slight changes in haematological parameters were observed at this dose in males including lower erythrocyte counts, haemoglobin and haematocrit levels and lower relative eosinophil counts and were considered to be of no toxicological significance.","effect":"Some slight changes in haematological parameters were observed at this dose in males including lower erythrocyte counts, haemoglobin and haematocrit levels and lower relative eosinophil counts and were considered to be of no toxicological significance. At 2 mg/kg bw/day no signs of toxicity were observed, only purple discolouration of urine and staining of the body. Some alterations in the biochemistry were considered of no toxicological significance due to the absence of a dose-related distribution. Conclusion A NOAEL of 2 mg/kg/day was established for this study. Ref.: 23 (subm. II) 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 Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: triplicate plates in 2 independent experiments Test substance: Disperse Violet 1 Batch: MB002 Purity: 100 area% (HPLC, 548 nm), 99.3 area% (HPLC, 254 nm), 94.6","page":16,"pdf":"sccs_o_028.pdf","row_type":"noael_study","study_id":"sccs_o_028_noael_001"} |
| SCCS Opinion | NOAEL | =2 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) S...","effect":") 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw No observed adverse effect level NOAEL = 2.0 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 667 3.3.14. Discussion Physico-chemical properties Disperse Violet 1 is used as a hair colour in semi-permanent hair dye formulations at a maximum on-head concentration of 0.5%. Characterisation of several batches of test material was insufficient or incomplete, but the test batches used for the main studies for safety evaluation, in this opinion, were fully characterised. The stability of Disperse Violet 1 in typical hair dye formulations is","page":25,"pdf":"sccs_o_028.pdf","row_type":"noael_study","study_id":"sccs_o_028_noael_004"} |
| SCCS Opinion | NOAEL | =2 | mg/kg/day | - | - | Chronic | genotoxicity | {"citation":"Ref.: 23 (subm","dose":"Some slight changes in haematological parameters were observed at this dose in males including lower erythrocyte counts, haemoglobin and haematocrit levels and lower relative eosinophil counts and were considered to be of no toxicological significance.","effect":"Some slight changes in haematological parameters were observed at this dose in males including lower erythrocyte counts, haemoglobin and haematocrit levels and lower relative eosinophil counts and were considered to be of no toxicological significance. At 2 mg/kg bw/day no signs of toxicity were observed, only purple discolouration of urine and staining of the body. Some alterations in the biochemistry were considered of no toxicological significance due to the absence of a dose-related distribution. Conclusion A NOAEL of 2 mg/kg/day was established for this study. Ref.: 23 (subm. II) 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 Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: triplicate plates in 2 independent experiments Test substance: Disperse Violet 1 Batch: MB002 Purity: 100 area% (HPLC, 548 nm), 99.3 area% (HPLC, 254 nm), 94.6","page":16,"pdf":"sccs_o_028.pdf","row_type":"noael_study","study_id":"sccs_o_028_noael_001"} |
| SCCS Opinion | NOAEL | =2 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) S...","effect":") 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw No observed adverse effect level NOAEL = 2.0 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 667 3.3.14. Discussion Physico-chemical properties Disperse Violet 1 is used as a hair colour in semi-permanent hair dye formulations at a maximum on-head concentration of 0.5%. Characterisation of several batches of test material was insufficient or incomplete, but the test batches used for the main studies for safety evaluation, in this opinion, were fully characterised. The stability of Disperse Violet 1 in typical hair dye formulations is","page":25,"pdf":"sccs_o_028.pdf","row_type":"noael_study","study_id":"sccs_o_028_noael_004"} |
| SCCS Opinion | NOAEL | =2 | mg/kg/day | - | - | Chronic | genotoxicity | {"citation":"Ref.: 23 (subm","dose":"Some slight changes in haematological parameters were observed at this dose in males including lower erythrocyte counts, haemoglobin and haematocrit levels and lower relative eosinophil counts and were considered to be of no toxicological significance.","effect":"Some slight changes in haematological parameters were observed at this dose in males including lower erythrocyte counts, haemoglobin and haematocrit levels and lower relative eosinophil counts and were considered to be of no toxicological significance. At 2 mg/kg bw/day no signs of toxicity were observed, only purple discolouration of urine and staining of the body. Some alterations in the biochemistry were considered of no toxicological significance due to the absence of a dose-related distribution. Conclusion A NOAEL of 2 mg/kg/day was established for this study. Ref.: 23 (subm. II) 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 Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: triplicate plates in 2 independent experiments Test substance: Disperse Violet 1 Batch: MB002 Purity: 100 area% (HPLC, 548 nm), 99.3 area% (HPLC, 254 nm), 94.6","page":16,"pdf":"sccs_o_028.pdf","row_type":"noael_study","study_id":"sccs_o_028_noael_001"} |
| SCCS Opinion | NOAEL | =2 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) S...","effect":") 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw No observed adverse effect level NOAEL = 2.0 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 667 3.3.14. Discussion Physico-chemical properties Disperse Violet 1 is used as a hair colour in semi-permanent hair dye formulations at a maximum on-head concentration of 0.5%. Characterisation of several batches of test material was insufficient or incomplete, but the test batches used for the main studies for safety evaluation, in this opinion, were fully characterised. The stability of Disperse Violet 1 in typical hair dye formulations is","page":25,"pdf":"sccs_o_028.pdf","row_type":"noael_study","study_id":"sccs_o_028_noael_004"} |
| SCCS Opinion | NOAEL | =2 | mg/kg/day | - | - | Chronic | genotoxicity | {"citation":"Ref.: 23 (subm","dose":"Some slight changes in haematological parameters were observed at this dose in males including lower erythrocyte counts, haemoglobin and haematocrit levels and lower relative eosinophil counts and were considered to be of no toxicological significance.","effect":"Some slight changes in haematological parameters were observed at this dose in males including lower erythrocyte counts, haemoglobin and haematocrit levels and lower relative eosinophil counts and were considered to be of no toxicological significance. At 2 mg/kg bw/day no signs of toxicity were observed, only purple discolouration of urine and staining of the body. Some alterations in the biochemistry were considered of no toxicological significance due to the absence of a dose-related distribution. Conclusion A NOAEL of 2 mg/kg/day was established for this study. Ref.: 23 (subm. II) 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 Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: triplicate plates in 2 independent experiments Test substance: Disperse Violet 1 Batch: MB002 Purity: 100 area% (HPLC, 548 nm), 99.3 area% (HPLC, 254 nm), 94.6","page":16,"pdf":"sccs_o_028.pdf","row_type":"noael_study","study_id":"sccs_o_028_noael_001"} |
| SCCS Opinion | NOAEL | =2 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) S...","effect":") 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw No observed adverse effect level NOAEL = 2.0 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 667 3.3.14. Discussion Physico-chemical properties Disperse Violet 1 is used as a hair colour in semi-permanent hair dye formulations at a maximum on-head concentration of 0.5%. Characterisation of several batches of test material was insufficient or incomplete, but the test batches used for the main studies for safety evaluation, in this opinion, were fully characterised. The stability of Disperse Violet 1 in typical hair dye formulations is","page":25,"pdf":"sccs_o_028.pdf","row_type":"noael_study","study_id":"sccs_o_028_noael_004"} |
| SCCS Opinion | NOAEL | =40 | mg/kg bw | human | - | - | developmental toxicity | {"citation":"Ref.: 28 (Subm","dose":"t the visceral examination, severe general subcutaneous oedema with corresponding hydrocephalus and diaphragmatic herniation in foetuses of high dose group were observed.","effect":"t the visceral examination, severe general subcutaneous oedema with corresponding hydrocephalus and diaphragmatic herniation in foetuses of high dose group were observed. These observations were not considered by investigators to be a teratogenic effect but secondary to maternal toxicity. None of the effects recorded were considered as teratogenic. Conclusion Based on the findings noted in dams (reduced food intake and body weight gain) and foetuses (subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw for both maternal and fetal toxicity was deduced from this study. Ref.: 28 (Subm. II) 3.3.9. Toxicokinetics Guideline: / Species/strain: human intestinal epithelial cell line TC-7 Replicates: two independent experiments Test substance: Disperse Violet 1 Batch: MB002 Purity: 98.9 area% (HPLC, 254 nm), 99.2 area% (HPLC, 548 nm) Concentration: 10 µM in HBSS (Hank's balanced salt solution), 1% DMSO GLP: not in compliance Study period: 4 April – 2 May 2005 The bioavailability of Disperse Violet 1 acr","page":23,"pdf":"sccs_o_028.pdf","row_type":"noael_study","study_id":"sccs_o_028_noael_002"} |
| SCCS Opinion | NOAEL | =40 | mg/kg bw/d | rat | dermal | sub-chronic | repeated dose toxicity | {"dose":"SCCS/1232/09 Opinion on Disperse Violet 1 ___________________________________________________________________________________________ 26 General toxicity In the sub-chronic toxicity study in rats, the NOAEL is 2 mg/kg bw/d.","effect":"SCCS/1232/09 Opinion on Disperse Violet 1 ___________________________________________________________________________________________ 26 General toxicity In the sub-chronic toxicity study in rats, the NOAEL is 2 mg/kg bw/d. In the teratogenicity study in rats, based on the findings noted in dams (reduced food intake and body weight gain) and foetuses (subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw/d for both maternal and foetal toxicity was deduced. No two generation reproduction study was submitted. Irritation / sensitisation Disperse Violet 1 was as non-irritating to guinea pig skin at a concentration of 1% in water. It was a mild irritant when applied as aqueous slurry to New Zealand white rabbit skin. The test substance at 1% in water was classified as non-irritant in the rabbit eye irritation test. Disperse Violet 1 is a moderate sensitiser. Dermal absorption The two experiments res","page":26,"pdf":"sccs_o_028.pdf","row_type":"noael_study","study_id":"sccs_o_028_noael_007"} |
| SCCS Opinion | NOAEL | =40 | mg/kg bw | human | - | - | developmental toxicity | {"citation":"Ref.: 28 (Subm","dose":"t the visceral examination, severe general subcutaneous oedema with corresponding hydrocephalus and diaphragmatic herniation in foetuses of high dose group were observed.","effect":"t the visceral examination, severe general subcutaneous oedema with corresponding hydrocephalus and diaphragmatic herniation in foetuses of high dose group were observed. These observations were not considered by investigators to be a teratogenic effect but secondary to maternal toxicity. None of the effects recorded were considered as teratogenic. Conclusion Based on the findings noted in dams (reduced food intake and body weight gain) and foetuses (subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw for both maternal and fetal toxicity was deduced from this study. Ref.: 28 (Subm. II) 3.3.9. Toxicokinetics Guideline: / Species/strain: human intestinal epithelial cell line TC-7 Replicates: two independent experiments Test substance: Disperse Violet 1 Batch: MB002 Purity: 98.9 area% (HPLC, 254 nm), 99.2 area% (HPLC, 548 nm) Concentration: 10 µM in HBSS (Hank's balanced salt solution), 1% DMSO GLP: not in compliance Study period: 4 April – 2 May 2005 The bioavailability of Disperse Violet 1 acr","page":23,"pdf":"sccs_o_028.pdf","row_type":"noael_study","study_id":"sccs_o_028_noael_002"} |
| SCCS Opinion | NOAEL | =40 | mg/kg bw/d | rat | dermal | sub-chronic | repeated dose toxicity | {"dose":"SCCS/1232/09 Opinion on Disperse Violet 1 ___________________________________________________________________________________________ 26 General toxicity In the sub-chronic toxicity study in rats, the NOAEL is 2 mg/kg bw/d.","effect":"SCCS/1232/09 Opinion on Disperse Violet 1 ___________________________________________________________________________________________ 26 General toxicity In the sub-chronic toxicity study in rats, the NOAEL is 2 mg/kg bw/d. In the teratogenicity study in rats, based on the findings noted in dams (reduced food intake and body weight gain) and foetuses (subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw/d for both maternal and foetal toxicity was deduced. No two generation reproduction study was submitted. Irritation / sensitisation Disperse Violet 1 was as non-irritating to guinea pig skin at a concentration of 1% in water. It was a mild irritant when applied as aqueous slurry to New Zealand white rabbit skin. The test substance at 1% in water was classified as non-irritant in the rabbit eye irritation test. Disperse Violet 1 is a moderate sensitiser. Dermal absorption The two experiments res","page":26,"pdf":"sccs_o_028.pdf","row_type":"noael_study","study_id":"sccs_o_028_noael_007"} |
| SCCS Opinion | NOAEL | =40 | mg/kg bw | human | - | - | developmental toxicity | {"citation":"Ref.: 28 (Subm","dose":"t the visceral examination, severe general subcutaneous oedema with corresponding hydrocephalus and diaphragmatic herniation in foetuses of high dose group were observed.","effect":"t the visceral examination, severe general subcutaneous oedema with corresponding hydrocephalus and diaphragmatic herniation in foetuses of high dose group were observed. These observations were not considered by investigators to be a teratogenic effect but secondary to maternal toxicity. None of the effects recorded were considered as teratogenic. Conclusion Based on the findings noted in dams (reduced food intake and body weight gain) and foetuses (subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw for both maternal and fetal toxicity was deduced from this study. Ref.: 28 (Subm. II) 3.3.9. Toxicokinetics Guideline: / Species/strain: human intestinal epithelial cell line TC-7 Replicates: two independent experiments Test substance: Disperse Violet 1 Batch: MB002 Purity: 98.9 area% (HPLC, 254 nm), 99.2 area% (HPLC, 548 nm) Concentration: 10 µM in HBSS (Hank's balanced salt solution), 1% DMSO GLP: not in compliance Study period: 4 April – 2 May 2005 The bioavailability of Disperse Violet 1 acr","page":23,"pdf":"sccs_o_028.pdf","row_type":"noael_study","study_id":"sccs_o_028_noael_002"} |
| SCCS Opinion | NOAEL | =40 | mg/kg bw/d | rat | dermal | sub-chronic | repeated dose toxicity | {"dose":"SCCS/1232/09 Opinion on Disperse Violet 1 ___________________________________________________________________________________________ 26 General toxicity In the sub-chronic toxicity study in rats, the NOAEL is 2 mg/kg bw/d.","effect":"SCCS/1232/09 Opinion on Disperse Violet 1 ___________________________________________________________________________________________ 26 General toxicity In the sub-chronic toxicity study in rats, the NOAEL is 2 mg/kg bw/d. In the teratogenicity study in rats, based on the findings noted in dams (reduced food intake and body weight gain) and foetuses (subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw/d for both maternal and foetal toxicity was deduced. No two generation reproduction study was submitted. Irritation / sensitisation Disperse Violet 1 was as non-irritating to guinea pig skin at a concentration of 1% in water. It was a mild irritant when applied as aqueous slurry to New Zealand white rabbit skin. The test substance at 1% in water was classified as non-irritant in the rabbit eye irritation test. Disperse Violet 1 is a moderate sensitiser. Dermal absorption The two experiments res","page":26,"pdf":"sccs_o_028.pdf","row_type":"noael_study","study_id":"sccs_o_028_noael_007"} |
| SCCS Opinion | NOAEL | =40 | mg/kg bw | human | - | - | developmental toxicity | {"citation":"Ref.: 28 (Subm","dose":"t the visceral examination, severe general subcutaneous oedema with corresponding hydrocephalus and diaphragmatic herniation in foetuses of high dose group were observed.","effect":"t the visceral examination, severe general subcutaneous oedema with corresponding hydrocephalus and diaphragmatic herniation in foetuses of high dose group were observed. These observations were not considered by investigators to be a teratogenic effect but secondary to maternal toxicity. None of the effects recorded were considered as teratogenic. Conclusion Based on the findings noted in dams (reduced food intake and body weight gain) and foetuses (subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw for both maternal and fetal toxicity was deduced from this study. Ref.: 28 (Subm. II) 3.3.9. Toxicokinetics Guideline: / Species/strain: human intestinal epithelial cell line TC-7 Replicates: two independent experiments Test substance: Disperse Violet 1 Batch: MB002 Purity: 98.9 area% (HPLC, 254 nm), 99.2 area% (HPLC, 548 nm) Concentration: 10 µM in HBSS (Hank's balanced salt solution), 1% DMSO GLP: not in compliance Study period: 4 April – 2 May 2005 The bioavailability of Disperse Violet 1 acr","page":23,"pdf":"sccs_o_028.pdf","row_type":"noael_study","study_id":"sccs_o_028_noael_002"} |
| SCCS Opinion | NOAEL | =40 | mg/kg bw/d | rat | dermal | sub-chronic | repeated dose toxicity | {"dose":"SCCS/1232/09 Opinion on Disperse Violet 1 ___________________________________________________________________________________________ 26 General toxicity In the sub-chronic toxicity study in rats, the NOAEL is 2 mg/kg bw/d.","effect":"SCCS/1232/09 Opinion on Disperse Violet 1 ___________________________________________________________________________________________ 26 General toxicity In the sub-chronic toxicity study in rats, the NOAEL is 2 mg/kg bw/d. In the teratogenicity study in rats, based on the findings noted in dams (reduced food intake and body weight gain) and foetuses (subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw/d for both maternal and foetal toxicity was deduced. No two generation reproduction study was submitted. Irritation / sensitisation Disperse Violet 1 was as non-irritating to guinea pig skin at a concentration of 1% in water. It was a mild irritant when applied as aqueous slurry to New Zealand white rabbit skin. The test substance at 1% in water was classified as non-irritant in the rabbit eye irritation test. Disperse Violet 1 is a moderate sensitiser. Dermal absorption The two experiments res","page":26,"pdf":"sccs_o_028.pdf","row_type":"noael_study","study_id":"sccs_o_028_noael_007"} |
| SCCS Opinion | NOAEL | =160 | mg/kg bw | - | - | - | NOAEL study | {"dose":"(subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw","effect":"Unlabeled table on page 23: (subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw","page":23,"pdf":"sccs_o_028.pdf","row_type":"noael_study","study_id":"sccs_o_028_noael_008"} |
| SCCS Opinion | NOAEL | =160 | mg/kg bw | - | - | - | NOAEL study | {"dose":"(subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw","effect":"Unlabeled table on page 23: (subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw","page":23,"pdf":"sccs_o_028.pdf","row_type":"noael_study","study_id":"sccs_o_028_noael_008"} |
| SCCS Opinion | NOAEL | =160 | mg/kg bw | - | - | - | NOAEL study | {"dose":"(subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw","effect":"Unlabeled table on page 23: (subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw","page":23,"pdf":"sccs_o_028.pdf","row_type":"noael_study","study_id":"sccs_o_028_noael_008"} |
| SCCS Opinion | NOAEL | =160 | mg/kg bw | - | - | - | NOAEL study | {"dose":"(subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw","effect":"Unlabeled table on page 23: (subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw","page":23,"pdf":"sccs_o_028.pdf","row_type":"noael_study","study_id":"sccs_o_028_noael_008"} |
Regulatory source 17 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| Regulatory source | irritation | 1.21 | mg/kg | guinea pig | - | - | irritation | SOURCE_SUBDIR=out160_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING DISPERSE VIOLET 1 IMPURIFIED WITH DISPERSE RED 15 Colipa n° C64 & C61; OPINION_NUMBER=SCCNFP/0504/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=1.21; DOSE=ical (red cell and white cell count) and biochemical parameters (alkaline phosphatase), these data were not dose and time related, they were considered incidental by investigators.; EFFECT=ical (red cell and white cell count) and biochemical parameters (alkaline phosphatase), these data were not dose and time related, they were considered incidental by investigators. Liver weights were increased in male high and mid group and in female high group. Kidney weights were increased in male high group. These data were considered test article related. Concerning macroscopic and histopathological observations, the results were within the normal range of variation for this strain. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) was established to be 1.21 mg/kg (1.14 – 1.28) for 1,4-Diamino-anthraquinone and 0.19 mg/kg (0.18-0.20) for 1- Hydroxy-4-amino-anthraquinone. Ref. : 15 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD guideline 404 (1981) Species/strain : Pirbright albino guinea pigs; CITATION=Ref. : 15 2; CITATION_NUMBERS=[15,2]; REFERENCE=Ref. : 15 2; DETAILS_JSON={"cas_number":"128-95-0","citation":"Ref. : 15 2","dose":"ical (red cell and white cell count) and biochemical parameters (alkaline phosphatase), these data were not dose and time related, they were considered incidental by investigators.","duration":"","effect":"ical (red cell and white cell count) and biochemical parameters (alkaline phosphatase), these data were not dose and time related, they were considered incidental by investigators. Liver weights were increased in male high and mid group and in female high group. Kidney weights were increased in male high group. These data were considered test article related. Concerning macroscopic and histopathological observations, the results were within the normal range of variation for this strain. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) was established to be 1.21 mg/kg (1.14 – 1.28) for 1,4-Diamino-anthraquinone and 0.19 mg/kg (0.18-0.20) for 1- Hydroxy-4-amino-anthraquinone. Ref. : 15 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD guideline 404 (1981) Species/strain : Pirbright albino guinea pigs","endpoint":"irritation","ingredient":"s)","loael_value":"","noael_unit":"mg/kg","noael_value":"1.21","page":7,"route":"","species":"guinea pig","study_id":"out160_en_noael_001"} |
| Regulatory source | irritation | 1.21 | mg/kg | guinea pig | - | - | irritation | SOURCE_SUBDIR=out160_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING DISPERSE VIOLET 1 IMPURIFIED WITH DISPERSE RED 15 Colipa n° C64 & C61; OPINION_NUMBER=SCCNFP/0504/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=1.21; DOSE=ed cell and white cell count) and biochemical parameters (alkaline phosphatase), these data were not dose and time related, they were considered incidental by investigators.; EFFECT=ed cell and white cell count) and biochemical parameters (alkaline phosphatase), these data were not dose and time related, they were considered incidental by investigators. Liver weights were increased in male high and mid group and in female high group. Kidney weights were increased in male high group. These data were considered test article related. Concerning macroscopic and histopathological observations, the results were within the normal range of variation for this strain. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) was established to be 1.21 mg/kg (1.14 – 1.28) for 1,4-Diamino-anthraquinone and 0.19 mg/kg (0.18-0.20) for 1- Hydroxy-4-amino-anthraquinone. Ref. : 15 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD guideline 404 (1981) Species/strain : Pirbright albino guinea pigs; CITATION=Ref. : 15 2; CITATION_NUMBERS=[15,2]; REFERENCE=Ref. : 15 2; DETAILS_JSON={"cas_number":"128-95-0","citation":"Ref. : 15 2","dose":"ed cell and white cell count) and biochemical parameters (alkaline phosphatase), these data were not dose and time related, they were considered incidental by investigators.","duration":"","effect":"ed cell and white cell count) and biochemical parameters (alkaline phosphatase), these data were not dose and time related, they were considered incidental by investigators. Liver weights were increased in male high and mid group and in female high group. Kidney weights were increased in male high group. These data were considered test article related. Concerning macroscopic and histopathological observations, the results were within the normal range of variation for this strain. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) was established to be 1.21 mg/kg (1.14 – 1.28) for 1,4-Diamino-anthraquinone and 0.19 mg/kg (0.18-0.20) for 1- Hydroxy-4-amino-anthraquinone. Ref. : 15 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD guideline 404 (1981) Species/strain : Pirbright albino guinea pigs","endpoint":"irritation","ingredient":"s)","loael_value":"","noael_unit":"mg/kg","noael_value":"1.21","page":7,"route":"","species":"guinea pig","study_id":"out160_en_noael_002"} |
| Regulatory source | irritation | 2 | % | human | dermal | - | irritation | SOURCE_SUBDIR=out160_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING DISPERSE VIOLET 1 IMPURIFIED WITH DISPERSE RED 15 Colipa n° C64 & C61; OPINION_NUMBER=SCCNFP/0504/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=2; DOSE=Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Based on a usage volume of x ml, containing at maximum x % Highest penetration PA (g/cm2) = Typical body weight of human = 60 kg Exposed area (scalp) = 700 cm2 Systemic exposure PA x 700 cm2 = mg Systemic exposure dose (SED) PA x 700/ 60 x = mg/kg bw No observed adverse effect level (mg/kg)...; EFFECT=SCCNFP/0504/01, final Evaluation and opinion on : Disperse Violet 1 impurified with Disperse Red 15 ____________________________________________________________________________________________ 21 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Based on a usage volume of x ml, containing at maximum x % Highest penetration PA (g/cm2) = Typical body weight of human = 60 kg Exposed area (scalp) = 700 cm2 Systemic exposure PA x 700 cm2 = mg Systemic exposure dose (SED) PA x 700/ 60 x = mg/kg bw No observed adverse effect level (mg/kg) NOAEL = mg/kg bw (species, route of application) Margin of Safety NOAEL / SED = 2.12. Conclusions Disperse Violet 1 (C 64) is a compound impurified with Disperse Red 15 (C 61) and intended to be used in colour setting lotions at a maximal concentration of 2 %. Basing on a usage volume of 35 ml of hair dye preparation per application, the maximum amount applied would be close to 700 mg. * Disperse Violet 1 is neither irritant to the skin nor to the eye. After repeated topical applications of Disperse Violet; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-95-0","citation":"","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Based on a usage volume of x ml, containing at maximum x % Highest penetration PA (\u0001g/cm2) = Typical body weight of human = 60 kg Exposed area (scalp) = 700 cm2 Systemic exposure PA x 700 cm2 = mg Systemic exposure dose (SED) PA x 700/ 60 x = mg/kg bw No observed adverse effect level (mg/kg)...","duration":"","effect":"SCCNFP/0504/01, final Evaluation and opinion on : Disperse Violet 1 impurified with Disperse Red 15 ____________________________________________________________________________________________ 21 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Based on a usage volume of x ml, containing at maximum x % Highest penetration PA (\u0001g/cm2) = Typical body weight of human = 60 kg Exposed area (scalp) = 700 cm2 Systemic exposure PA x 700 cm2 = mg Systemic exposure dose (SED) PA x 700/ 60 x = mg/kg bw No observed adverse effect level (mg/kg) NOAEL = mg/kg bw (species, route of application) Margin of Safety NOAEL / SED = 2.12. Conclusions Disperse Violet 1 (C 64) is a compound impurified with Disperse Red 15 (C 61) and intended to be used in colour setting lotions at a maximal concentration of 2 %. Basing on a usage volume of 35 ml of hair dye preparation per application, the maximum amount applied would be close to 700 mg. * Disperse Violet 1 is neither irritant to the skin nor to the eye. After repeated topical applications of Disperse Violet","endpoint":"irritation","ingredient":"s)","loael_value":"","noael_unit":"%","noael_value":"2","page":21,"route":"dermal","species":"human","study_id":"out160_en_noael_003"} |
| Regulatory source | irritation | 2 | % | human | dermal | - | irritation | SOURCE_SUBDIR=out160_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING DISPERSE VIOLET 1 IMPURIFIED WITH DISPERSE RED 15 Colipa n° C64 & C61; OPINION_NUMBER=SCCNFP/0504/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=2; DOSE=Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Based on a usage volume of x ml, containing at maximum x % Highest penetration PA (g/cm2) = Typical body weight of human = 60 kg Exposed area (scalp) = 700 cm2 Systemic exposure PA x 700 cm2 = mg Systemic exposure dose (SED) PA x 700/ 60 x = mg/kg bw No observed adverse effect level (mg/kg)...; EFFECT=ion and opinion on : Disperse Violet 1 impurified with Disperse Red 15 ____________________________________________________________________________________________ 21 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Based on a usage volume of x ml, containing at maximum x % Highest penetration PA (g/cm2) = Typical body weight of human = 60 kg Exposed area (scalp) = 700 cm2 Systemic exposure PA x 700 cm2 = mg Systemic exposure dose (SED) PA x 700/ 60 x = mg/kg bw No observed adverse effect level (mg/kg) NOAEL = mg/kg bw (species, route of application) Margin of Safety NOAEL / SED = 2.12. Conclusions Disperse Violet 1 (C 64) is a compound impurified with Disperse Red 15 (C 61) and intended to be used in colour setting lotions at a maximal concentration of 2 %. Basing on a usage volume of 35 ml of hair dye preparation per application, the maximum amount applied would be close to 700 mg. * Disperse Violet 1 is neither irritant to the skin nor to the eye. After repeated topical applications of Disperse Violet 1, no adverse; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-95-0","citation":"","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Based on a usage volume of x ml, containing at maximum x % Highest penetration PA (\u0001g/cm2) = Typical body weight of human = 60 kg Exposed area (scalp) = 700 cm2 Systemic exposure PA x 700 cm2 = mg Systemic exposure dose (SED) PA x 700/ 60 x = mg/kg bw No observed adverse effect level (mg/kg)...","duration":"","effect":"ion and opinion on : Disperse Violet 1 impurified with Disperse Red 15 ____________________________________________________________________________________________ 21 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Based on a usage volume of x ml, containing at maximum x % Highest penetration PA (\u0001g/cm2) = Typical body weight of human = 60 kg Exposed area (scalp) = 700 cm2 Systemic exposure PA x 700 cm2 = mg Systemic exposure dose (SED) PA x 700/ 60 x = mg/kg bw No observed adverse effect level (mg/kg) NOAEL = mg/kg bw (species, route of application) Margin of Safety NOAEL / SED = 2.12. Conclusions Disperse Violet 1 (C 64) is a compound impurified with Disperse Red 15 (C 61) and intended to be used in colour setting lotions at a maximal concentration of 2 %. Basing on a usage volume of 35 ml of hair dye preparation per application, the maximum amount applied would be close to 700 mg. * Disperse Violet 1 is neither irritant to the skin nor to the eye. After repeated topical applications of Disperse Violet 1, no adverse","endpoint":"irritation","ingredient":"s)","loael_value":"","noael_unit":"%","noael_value":"2","page":21,"route":"dermal","species":"human","study_id":"out160_en_noael_004"} |
| Regulatory source | irritation | 2 | % | human | dermal | - | irritation | SOURCE_SUBDIR=out160_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING DISPERSE VIOLET 1 IMPURIFIED WITH DISPERSE RED 15 Colipa n° C64 & C61; OPINION_NUMBER=SCCNFP/0504/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=2; DOSE=Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Based on a usage volume of x ml, containing at maximum x % Highest penetration PA (g/cm2) = Typical body weight of human = 60 kg Exposed area (scalp) = 700 cm2 Systemic exposure PA x 700 cm2 = mg Systemic exposure dose (SED) PA x 700/ 60 x = mg/kg bw No observed adverse effect level (mg/kg)...; EFFECT=d 15 ____________________________________________________________________________________________ 21 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Based on a usage volume of x ml, containing at maximum x % Highest penetration PA (g/cm2) = Typical body weight of human = 60 kg Exposed area (scalp) = 700 cm2 Systemic exposure PA x 700 cm2 = mg Systemic exposure dose (SED) PA x 700/ 60 x = mg/kg bw No observed adverse effect level (mg/kg) NOAEL = mg/kg bw (species, route of application) Margin of Safety NOAEL / SED = 2.12. Conclusions Disperse Violet 1 (C 64) is a compound impurified with Disperse Red 15 (C 61) and intended to be used in colour setting lotions at a maximal concentration of 2 %. Basing on a usage volume of 35 ml of hair dye preparation per application, the maximum amount applied would be close to 700 mg. * Disperse Violet 1 is neither irritant to the skin nor to the eye. After repeated topical applications of Disperse Violet 1, no adverse effects were noted. No data is available on irritant potential of; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-95-0","citation":"","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Based on a usage volume of x ml, containing at maximum x % Highest penetration PA (\u0001g/cm2) = Typical body weight of human = 60 kg Exposed area (scalp) = 700 cm2 Systemic exposure PA x 700 cm2 = mg Systemic exposure dose (SED) PA x 700/ 60 x = mg/kg bw No observed adverse effect level (mg/kg)...","duration":"","effect":"d 15 ____________________________________________________________________________________________ 21 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY Based on a usage volume of x ml, containing at maximum x % Highest penetration PA (\u0001g/cm2) = Typical body weight of human = 60 kg Exposed area (scalp) = 700 cm2 Systemic exposure PA x 700 cm2 = mg Systemic exposure dose (SED) PA x 700/ 60 x = mg/kg bw No observed adverse effect level (mg/kg) NOAEL = mg/kg bw (species, route of application) Margin of Safety NOAEL / SED = 2.12. Conclusions Disperse Violet 1 (C 64) is a compound impurified with Disperse Red 15 (C 61) and intended to be used in colour setting lotions at a maximal concentration of 2 %. Basing on a usage volume of 35 ml of hair dye preparation per application, the maximum amount applied would be close to 700 mg. * Disperse Violet 1 is neither irritant to the skin nor to the eye. After repeated topical applications of Disperse Violet 1, no adverse effects were noted. No data is available on irritant potential of","endpoint":"irritation","ingredient":"s)","loael_value":"","noael_unit":"%","noael_value":"2","page":21,"route":"dermal","species":"human","study_id":"out160_en_noael_005"} |
| Regulatory source | repeated dose toxicity | 1.21 | mg/kg/day | rat | oral | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out160_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING DISPERSE VIOLET 1 IMPURIFIED WITH DISPERSE RED 15 Colipa n° C64 & C61; OPINION_NUMBER=SCCNFP/0504/01; COMMITTEE=SCCNFP; REPORT_DATE=27 February 2002; VALUE_TEXT=1.21; DOSE=In view of the low concentration, this may not be important. * The allergenicity of the compounds cannot be assessed due to inadequate data. * From the sub-chronic studies conducted by oral route in the rat, a NOAEL of 1.21 mg/kg/day for Disperse Violet 1 and of 0.19 mg/kg/day for Disperse Red 15 was obtained. * The percutaneous absorption study...; EFFECT=e preparation per application, the maximum amount applied would be close to 700 mg. * Disperse Violet 1 is neither irritant to the skin nor to the eye. After repeated topical applications of Disperse Violet 1, no adverse effects were noted. No data is available on irritant potential of Disperse Red 15 (C61). In view of the low concentration, this may not be important. * The allergenicity of the compounds cannot be assessed due to inadequate data. * From the sub-chronic studies conducted by oral route in the rat, a NOAEL of 1.21 mg/kg/day for Disperse Violet 1 and of 0.19 mg/kg/day for Disperse Red 15 was obtained. * The percutaneous absorption study is considered inadequate * The evaluation of the mutagenic potential of Disperse Violet 1 is not possible at present since no adequate data has been produced. Disperse Red 15 of unknown purity has been found positive in the bacterial gene mutation assay and for the induction of chromosome aberration in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-95-0","citation":"","dose":"In view of the low concentration, this may not be important. * The allergenicity of the compounds cannot be assessed due to inadequate data. * From the sub-chronic studies conducted by oral route in the rat, a NOAEL of 1.21 mg/kg/day for Disperse Violet 1 and of 0.19 mg/kg/day for Disperse Red 15 was obtained. * The percutaneous absorption study...","duration":"sub-chronic","effect":"e preparation per application, the maximum amount applied would be close to 700 mg. * Disperse Violet 1 is neither irritant to the skin nor to the eye. After repeated topical applications of Disperse Violet 1, no adverse effects were noted. No data is available on irritant potential of Disperse Red 15 (C61). In view of the low concentration, this may not be important. * The allergenicity of the compounds cannot be assessed due to inadequate data. * From the sub-chronic studies conducted by oral route in the rat, a NOAEL of 1.21 mg/kg/day for Disperse Violet 1 and of 0.19 mg/kg/day for Disperse Red 15 was obtained. * The percutaneous absorption study is considered inadequate * The evaluation of the mutagenic potential of Disperse Violet 1 is not possible at present since no adequate data has been produced. Disperse Red 15 of unknown purity has been found positive in the bacterial gene mutation assay and for the induction of chromosome aberration in","endpoint":"repeated dose toxicity","ingredient":"s)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1.21","page":21,"route":"oral","species":"rat","study_id":"out160_en_noael_006"} |
| Regulatory source | - | 40 | mg/kg bw/d | - | - | - | - | SOURCE_SUBDIR=sccs_o_028; REPORT_TITLE=OPINION ON Disperse Violet 1 COLIPA n° C64; OPINION_NUMBER=SCCS/1232/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 September 2010; VALUE_TEXT=40; DOSE=(NOAEL) of 40 mg/kg bw/d for both maternal and foetal toxicity was deduced.; EFFECT=Unlabeled table on page 26: (NOAEL) of 40 mg/kg bw/d for both maternal and foetal toxicity was deduced. No two; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-95-0","citation":"","dose":"(NOAEL) of 40 mg/kg bw/d for both maternal and foetal toxicity was deduced.","duration":"","effect":"Unlabeled table on page 26: (NOAEL) of 40 mg/kg bw/d for both maternal and foetal toxicity was deduced. No two","endpoint":"","ingredient":"1,4-Diaminoanthraquinone, was","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"40","page":26,"route":"","species":"","study_id":"sccs_o_028_noael_010"} |
| Regulatory source | - | 160 | mg/kg bw | - | - | - | - | SOURCE_SUBDIR=sccs_o_028; REPORT_TITLE=OPINION ON Disperse Violet 1 COLIPA n° C64; OPINION_NUMBER=SCCS/1232/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 September 2010; VALUE_TEXT=160; DOSE=(subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw; EFFECT=Unlabeled table on page 23: (subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-95-0","citation":"","dose":"(subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw","duration":"","effect":"Unlabeled table on page 23: (subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw","endpoint":"","ingredient":"1,4-Diaminoanthraquinone, was","loael_value":"","noael_unit":"mg/kg bw","noael_value":"160","page":23,"route":"","species":"","study_id":"sccs_o_028_noael_008"} |
| Regulatory source | - | 160 | mg/kg bw | - | - | - | - | SOURCE_SUBDIR=sccs_o_028; REPORT_TITLE=OPINION ON Disperse Violet 1 COLIPA n° C64; OPINION_NUMBER=SCCS/1232/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 September 2010; VALUE_TEXT=160; DOSE=Unlabeled table on page 26: gain) and foetuses (subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level; EFFECT=Unlabeled table on page 26: gain) and foetuses (subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-95-0","citation":"","dose":"Unlabeled table on page 26: gain) and foetuses (subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level","duration":"","effect":"Unlabeled table on page 26: gain) and foetuses (subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level","endpoint":"","ingredient":"1,4-Diaminoanthraquinone, was","loael_value":"","noael_unit":"mg/kg bw","noael_value":"160","page":26,"route":"","species":"","study_id":"sccs_o_028_noael_011"} |
| Regulatory source | dermal absorption | =0.003 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccs_o_028; REPORT_TITLE=OPINION ON Disperse Violet 1 COLIPA n° C64; OPINION_NUMBER=SCCS/1232/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 September 2010; VALUE_TEXT== 0.003; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) S...; EFFECT=e guinea pigs. Ref.: 31 (Subm. II) 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw No observed adverse effect level NOAEL = 2.0 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 667 3.3.14. Discussion Physico-chemical properties Disperse Violet 1 is used as a hair colour in semi-permanent hair dye formulations at a maximum on-head concentration of 0.5%. Characterisation of several batches of test material was insufficient or incomplete, but the test batches used for the main studies for safety evaluation, in this opinion, were fully characterised. The stability of Disperse Violet 1 in typical hair dye formulati; CITATION=Ref.: 31 (Subm; CITATION_NUMBERS=[31]; REFERENCE=Ref.: 31 (Subm; DETAILS_JSON={"cas_number":"128-95-0","citation":"Ref.: 31 (Subm","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) S...","duration":"90-day","effect":"e guinea pigs. Ref.: 31 (Subm. II) 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw No observed adverse effect level NOAEL = 2.0 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 667 3.3.14. Discussion Physico-chemical properties Disperse Violet 1 is used as a hair colour in semi-permanent hair dye formulations at a maximum on-head concentration of 0.5%. Characterisation of several batches of test material was insufficient or incomplete, but the test batches used for the main studies for safety evaluation, in this opinion, were fully characterised. The stability of Disperse Violet 1 in typical hair dye formulati","endpoint":"dermal absorption","ingredient":"1,4-Diaminoanthraquinone, was","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.003","page":25,"route":"oral","species":"rat","study_id":"sccs_o_028_noael_003"} |
| Regulatory source | dermal absorption | =2 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccs_o_028; REPORT_TITLE=OPINION ON Disperse Violet 1 COLIPA n° C64; OPINION_NUMBER=SCCS/1232/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 September 2010; VALUE_TEXT== 2.0; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) S...; EFFECT=) 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw No observed adverse effect level NOAEL = 2.0 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 667 3.3.14. Discussion Physico-chemical properties Disperse Violet 1 is used as a hair colour in semi-permanent hair dye formulations at a maximum on-head concentration of 0.5%. Characterisation of several batches of test material was insufficient or incomplete, but the test batches used for the main studies for safety evaluation, in this opinion, were fully characterised. The stability of Disperse Violet 1 in typical hair dye formulations is; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-95-0","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) S...","duration":"90-day","effect":") 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw No observed adverse effect level NOAEL = 2.0 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 667 3.3.14. Discussion Physico-chemical properties Disperse Violet 1 is used as a hair colour in semi-permanent hair dye formulations at a maximum on-head concentration of 0.5%. Characterisation of several batches of test material was insufficient or incomplete, but the test batches used for the main studies for safety evaluation, in this opinion, were fully characterised. The stability of Disperse Violet 1 in typical hair dye formulations is","endpoint":"dermal absorption","ingredient":"1,4-Diaminoanthraquinone, was","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 2.0","page":25,"route":"oral","species":"rat","study_id":"sccs_o_028_noael_004"} |
| Regulatory source | dermal absorption | =2 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccs_o_028; REPORT_TITLE=OPINION ON Disperse Violet 1 COLIPA n° C64; OPINION_NUMBER=SCCS/1232/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 September 2010; VALUE_TEXT== 2.0; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) S...; EFFECT=estigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw No observed adverse effect level NOAEL = 2.0 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 667 3.3.14. Discussion Physico-chemical properties Disperse Violet 1 is used as a hair colour in semi-permanent hair dye formulations at a maximum on-head concentration of 0.5%. Characterisation of several batches of test material was insufficient or incomplete, but the test batches used for the main studies for safety evaluation, in this opinion, were fully characterised. The stability of Disperse Violet 1 in typical hair dye formulations is not provided.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-95-0","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) S...","duration":"90-day","effect":"estigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Disperse Violet 1 (non-oxidative conditions) Absorption through the skin A (µg/cm2) = 0.36 µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.21 Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw No observed adverse effect level NOAEL = 2.0 mg/kg bw/d (90-day, oral, rat) Margin of Safety NOAEL / SED = 667 3.3.14. Discussion Physico-chemical properties Disperse Violet 1 is used as a hair colour in semi-permanent hair dye formulations at a maximum on-head concentration of 0.5%. Characterisation of several batches of test material was insufficient or incomplete, but the test batches used for the main studies for safety evaluation, in this opinion, were fully characterised. The stability of Disperse Violet 1 in typical hair dye formulations is not provided.","endpoint":"dermal absorption","ingredient":"1,4-Diaminoanthraquinone, was","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 2.0","page":25,"route":"oral","species":"rat","study_id":"sccs_o_028_noael_005"} |
| Regulatory source | developmental toxicity | 40 | mg/kg bw | human | - | - | developmental toxicity | SOURCE_SUBDIR=sccs_o_028; REPORT_TITLE=OPINION ON Disperse Violet 1 COLIPA n° C64; OPINION_NUMBER=SCCS/1232/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 September 2010; VALUE_TEXT=40; DOSE=t the visceral examination, severe general subcutaneous oedema with corresponding hydrocephalus and diaphragmatic herniation in foetuses of high dose group were observed.; EFFECT=t the visceral examination, severe general subcutaneous oedema with corresponding hydrocephalus and diaphragmatic herniation in foetuses of high dose group were observed. These observations were not considered by investigators to be a teratogenic effect but secondary to maternal toxicity. None of the effects recorded were considered as teratogenic. Conclusion Based on the findings noted in dams (reduced food intake and body weight gain) and foetuses (subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw for both maternal and fetal toxicity was deduced from this study. Ref.: 28 (Subm. II) 3.3.9. Toxicokinetics Guideline: / Species/strain: human intestinal epithelial cell line TC-7 Replicates: two independent experiments Test substance: Disperse Violet 1 Batch: MB002 Purity: 98.9 area% (HPLC, 254 nm), 99.2 area% (HPLC, 548 nm) Concentration: 10 µM in HBSS (Hank's balanced salt solution), 1% DMSO GLP: not in compliance Study period: 4 April – 2 May 2005 The bioavailability of Disperse Violet 1 acr; CITATION=Ref.: 28 (Subm; CITATION_NUMBERS=[28]; REFERENCE=Ref.: 28 (Subm; DETAILS_JSON={"cas_number":"128-95-0","citation":"Ref.: 28 (Subm","dose":"t the visceral examination, severe general subcutaneous oedema with corresponding hydrocephalus and diaphragmatic herniation in foetuses of high dose group were observed.","duration":"","effect":"t the visceral examination, severe general subcutaneous oedema with corresponding hydrocephalus and diaphragmatic herniation in foetuses of high dose group were observed. These observations were not considered by investigators to be a teratogenic effect but secondary to maternal toxicity. None of the effects recorded were considered as teratogenic. Conclusion Based on the findings noted in dams (reduced food intake and body weight gain) and foetuses (subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw for both maternal and fetal toxicity was deduced from this study. Ref.: 28 (Subm. II) 3.3.9. Toxicokinetics Guideline: / Species/strain: human intestinal epithelial cell line TC-7 Replicates: two independent experiments Test substance: Disperse Violet 1 Batch: MB002 Purity: 98.9 area% (HPLC, 254 nm), 99.2 area% (HPLC, 548 nm) Concentration: 10 µM in HBSS (Hank's balanced salt solution), 1% DMSO GLP: not in compliance Study period: 4 April – 2 May 2005 The bioavailability of Disperse Violet 1 acr","endpoint":"developmental toxicity","ingredient":"1,4-Diaminoanthraquinone, was","loael_value":"","noael_unit":"mg/kg bw","noael_value":"40","page":23,"route":"","species":"human","study_id":"sccs_o_028_noael_002"} |
| Regulatory source | genotoxicity | 2 | mg/kg/day | - | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccs_o_028; REPORT_TITLE=OPINION ON Disperse Violet 1 COLIPA n° C64; OPINION_NUMBER=SCCS/1232/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 September 2010; VALUE_TEXT=2; DOSE=Some slight changes in haematological parameters were observed at this dose in males including lower erythrocyte counts, haemoglobin and haematocrit levels and lower relative eosinophil counts and were considered to be of no toxicological significance.; EFFECT=Some slight changes in haematological parameters were observed at this dose in males including lower erythrocyte counts, haemoglobin and haematocrit levels and lower relative eosinophil counts and were considered to be of no toxicological significance. At 2 mg/kg bw/day no signs of toxicity were observed, only purple discolouration of urine and staining of the body. Some alterations in the biochemistry were considered of no toxicological significance due to the absence of a dose-related distribution. Conclusion A NOAEL of 2 mg/kg/day was established for this study. Ref.: 23 (subm. II) 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 Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: triplicate plates in 2 independent experiments Test substance: Disperse Violet 1 Batch: MB002 Purity: 100 area% (HPLC, 548 nm), 99.3 area% (HPLC, 254 nm), 94.6; CITATION=Ref.: 23 (subm; CITATION_NUMBERS=[23]; REFERENCE=Ref.: 23 (subm; DETAILS_JSON={"cas_number":"128-95-0","citation":"Ref.: 23 (subm","dose":"Some slight changes in haematological parameters were observed at this dose in males including lower erythrocyte counts, haemoglobin and haematocrit levels and lower relative eosinophil counts and were considered to be of no toxicological significance.","duration":"Chronic","effect":"Some slight changes in haematological parameters were observed at this dose in males including lower erythrocyte counts, haemoglobin and haematocrit levels and lower relative eosinophil counts and were considered to be of no toxicological significance. At 2 mg/kg bw/day no signs of toxicity were observed, only purple discolouration of urine and staining of the body. Some alterations in the biochemistry were considered of no toxicological significance due to the absence of a dose-related distribution. Conclusion A NOAEL of 2 mg/kg/day was established for this study. Ref.: 23 (subm. II) 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 Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: triplicate plates in 2 independent experiments Test substance: Disperse Violet 1 Batch: MB002 Purity: 100 area% (HPLC, 548 nm), 99.3 area% (HPLC, 254 nm), 94.6","endpoint":"genotoxicity","ingredient":"1,4-Diaminoanthraquinone, was","loael_value":"","noael_unit":"mg/kg/day","noael_value":"2","page":16,"route":"","species":"","study_id":"sccs_o_028_noael_001"} |
| Regulatory source | repeated dose toxicity | 2 | mg/kg bw/d | rat | - | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_028; REPORT_TITLE=OPINION ON Disperse Violet 1 COLIPA n° C64; OPINION_NUMBER=SCCS/1232/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 September 2010; VALUE_TEXT=2; DOSE=SCCS/1232/09 Opinion on Disperse Violet 1 ___________________________________________________________________________________________ 26 General toxicity In the sub-chronic toxicity study in rats, the NOAEL is 2 mg/kg bw/d.; EFFECT=SCCS/1232/09 Opinion on Disperse Violet 1 ___________________________________________________________________________________________ 26 General toxicity In the sub-chronic toxicity study in rats, the NOAEL is 2 mg/kg bw/d. In the teratogenicity study in rats, based on the findings noted in dams (reduced food intake and body weight gain) and foetuses (subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw/d for both maternal and foetal toxicity was deduced. No two generation reproduction study was submitted. Irritation / sensitisation Disperse Violet 1 was as non-irritating to guinea pig skin at a concentration of 1% in water. It was a mild irritant when applied as aqueous slurry to; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-95-0","citation":"","dose":"SCCS/1232/09 Opinion on Disperse Violet 1 ___________________________________________________________________________________________ 26 General toxicity In the sub-chronic toxicity study in rats, the NOAEL is 2 mg/kg bw/d.","duration":"sub-chronic","effect":"SCCS/1232/09 Opinion on Disperse Violet 1 ___________________________________________________________________________________________ 26 General toxicity In the sub-chronic toxicity study in rats, the NOAEL is 2 mg/kg bw/d. In the teratogenicity study in rats, based on the findings noted in dams (reduced food intake and body weight gain) and foetuses (subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw/d for both maternal and foetal toxicity was deduced. No two generation reproduction study was submitted. Irritation / sensitisation Disperse Violet 1 was as non-irritating to guinea pig skin at a concentration of 1% in water. It was a mild irritant when applied as aqueous slurry to","endpoint":"repeated dose toxicity","ingredient":"1,4-Diaminoanthraquinone, was","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"2","page":26,"route":"","species":"rat","study_id":"sccs_o_028_noael_006"} |
| Regulatory source | repeated dose toxicity | 2 | mg/kg bw/d | rat | - | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_028; REPORT_TITLE=OPINION ON Disperse Violet 1 COLIPA n° C64; OPINION_NUMBER=SCCS/1232/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 September 2010; VALUE_TEXT=2; DOSE=In the sub-chronic toxicity study in rats, the NOAEL is 2 mg/kg bw/d.; EFFECT=Unlabeled table on page 26: In the sub-chronic toxicity study in rats, the NOAEL is 2 mg/kg bw/d. In the teratogenicity; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-95-0","citation":"","dose":"In the sub-chronic toxicity study in rats, the NOAEL is 2 mg/kg bw/d.","duration":"sub-chronic","effect":"Unlabeled table on page 26: In the sub-chronic toxicity study in rats, the NOAEL is 2 mg/kg bw/d. In the teratogenicity","endpoint":"repeated dose toxicity","ingredient":"1,4-Diaminoanthraquinone, was","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"2","page":26,"route":"","species":"rat","study_id":"sccs_o_028_noael_009"} |
| Regulatory source | repeated dose toxicity | 40 | mg/kg bw/d | rat | dermal | sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_028; REPORT_TITLE=OPINION ON Disperse Violet 1 COLIPA n° C64; OPINION_NUMBER=SCCS/1232/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 September 2010; VALUE_TEXT=40; DOSE=SCCS/1232/09 Opinion on Disperse Violet 1 ___________________________________________________________________________________________ 26 General toxicity In the sub-chronic toxicity study in rats, the NOAEL is 2 mg/kg bw/d.; EFFECT=SCCS/1232/09 Opinion on Disperse Violet 1 ___________________________________________________________________________________________ 26 General toxicity In the sub-chronic toxicity study in rats, the NOAEL is 2 mg/kg bw/d. In the teratogenicity study in rats, based on the findings noted in dams (reduced food intake and body weight gain) and foetuses (subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw/d for both maternal and foetal toxicity was deduced. No two generation reproduction study was submitted. Irritation / sensitisation Disperse Violet 1 was as non-irritating to guinea pig skin at a concentration of 1% in water. It was a mild irritant when applied as aqueous slurry to New Zealand white rabbit skin. The test substance at 1% in water was classified as non-irritant in the rabbit eye irritation test. Disperse Violet 1 is a moderate sensitiser. Dermal absorption The two experiments res; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"128-95-0","citation":"","dose":"SCCS/1232/09 Opinion on Disperse Violet 1 ___________________________________________________________________________________________ 26 General toxicity In the sub-chronic toxicity study in rats, the NOAEL is 2 mg/kg bw/d.","duration":"sub-chronic","effect":"SCCS/1232/09 Opinion on Disperse Violet 1 ___________________________________________________________________________________________ 26 General toxicity In the sub-chronic toxicity study in rats, the NOAEL is 2 mg/kg bw/d. In the teratogenicity study in rats, based on the findings noted in dams (reduced food intake and body weight gain) and foetuses (subcutaneous oedema) at 160 mg/kg bw, a no adverse effect level (NOAEL) of 40 mg/kg bw/d for both maternal and foetal toxicity was deduced. No two generation reproduction study was submitted. Irritation / sensitisation Disperse Violet 1 was as non-irritating to guinea pig skin at a concentration of 1% in water. It was a mild irritant when applied as aqueous slurry to New Zealand white rabbit skin. The test substance at 1% in water was classified as non-irritant in the rabbit eye irritation test. Disperse Violet 1 is a moderate sensitiser. Dermal absorption The two experiments res","endpoint":"repeated dose toxicity","ingredient":"1,4-Diaminoanthraquinone, was","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"40","page":26,"route":"dermal","species":"rat","study_id":"sccs_o_028_noael_007"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | N21HDQ0TKN | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C14H10N2O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"N21HDQ0TKN"} |
| openFDA substances | FDA UNII substance identifier | N21HDQ0TKN | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C14H10N2O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"N21HDQ0TKN"} |
| openFDA substances | FDA UNII substance identifier | N21HDQ0TKN | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C14H10N2O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"N21HDQ0TKN"} |
| openFDA substances | FDA UNII substance identifier | N21HDQ0TKN | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C14H10N2O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"N21HDQ0TKN"} |