Registration Dossier
Registration Dossier
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EC number: 419-370-3 | CAS number: 84632-66-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- valid without restrictions
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The potential of the test item to induce toxicity to reproduction was not examined. Reliable data on a structural analogue are available. Both substances are pigments and share high similarity in structure and are of low solubilitx in water (< 0.1 mg/l). The analogue has a slightly higher molecular weight which gives an additional safety margin.
Based on available toxicity data of the main component (NOAEL = 1000 mg/kg bw/day, 28 days). The dose levels for this reproduction/developmental toxicity screening test were selected to be 100, 300 and 1000 mg/kg bw/day. The study was based on the guideline OECD 421, Reproduction/Developmental Toxicity Screening Test, July 1995 and GLP. After acclimatization, four groups of ten male and ten female Wistar Han rats were exposed by oral gavage to the test substance at 0, 100, 300 and 1000 mg/kg bw/day. Males were exposed for 29 days, i.e. 2 weeks prior to mating, during mating, and up to termination. Females were exposed for 40-45 days, i.e. during 2 weeks prior to mating, during mating, during post-coitum, and during at least 4 days of lactation.
The following observations and examinations were evaluated: mortality / viability, clinical signs (daily), body weight and food consumption (at least at weekly intervals), haematology and clotting tests (Week 4, males only), macroscopy at termination, organ weights and histopathology on a selection of tissues, and reproduction/developmental parameters, consisting of mating, fertility and conception indices, precoital time, number of corpora lutea and implantation sites, gestation index and duration, parturition, maternal care, sex ratio and early postnatal pup development (mortality, clinical signs, body weights and macroscopy). Formulations were analyzed once during the study to assess accuracy, homogeneity and stability.
Accuracy, homogeneity and stability of formulations were demonstrated by analyses. No parental, reproduction and developmental toxicity was observed up to the highest dose level tested (1000 mg/kg bw/day).
Short description of key information:
The substance did not cause toxicity to reproduction in rat at the screening information level at the limit dose (OECD 421, GLP) (BASF 2012).
Justification for selection of Effect on fertility via oral route:
only study available.
Effects on developmental toxicity
Description of key information
No indication of developmental toxicity in rats was observed in a screening study (OECD 421, GLP) at the limit dose of 1000 mg/kg bw (BASF 2012).
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- valid, but screening study.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no adverse effect observed
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The potential of the test item to influence fertility and development was not examined. Reliable data on a structural analogue are available. Both substances are pigments and share high similarity in structure and are of low solubilitx in water (< 0.1 mg/l). The analogue has a slightly higher molecular weight which gives an additional safety margin.
Based on available toxicity data of the main component (NOAEL = 1000 mg/kg bw/day, 28 days). The dose levels for this reproduction/developmental toxicity screening test were selected to be 100, 300 and 1000 mg/kg bw/day. The study was based on the guideline OECD 421, Reproduction/Developmental Toxicity Screening Test, July 1995 and GLP. After acclimatization, four groups of ten male and ten female Wistar Han rats were exposed by oral gavage to the test substance at 0, 100, 300 and 1000 mg/kg bw/day. Males were exposed for 29 days, i.e. 2 weeks prior to mating, during mating, and up to termination. Females were exposed for 40-45 days, i.e. during 2 weeks prior to mating, during mating, during post-coitum, and during at least 4 days of lactation.
The following observations and examinations were evaluated: mortality / viability, clinical signs (daily), body weight and food consumption (at least at weekly intervals), haematology and clotting tests (Week 4, males only), macroscopy at termination, organ weights and histopathology on a selection of tissues, and reproduction/developmental parameters, consisting of mating, fertility and conception indices, precoital time, number of corpora lutea and implantation sites, gestation index and duration, parturition, maternal care, sex ratio and early postnatal pup development (mortality, clinical signs, body weights and macroscopy). Formulations were analyzed once during the study to assess accuracy, homogeneity and stability.
Accuracy, homogeneity and stability of formulations were demonstrated by analyses. No parental, reproduction and developmental toxicity was observed up to the highest dose level tested (1000 mg/kg bw/day).
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available screening study is considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for fertility or developmental toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EG.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available screening study is reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for fertility or developmental toxicity under Regulation (EC) No. 1272/2008, as amended for the third time in Directive (EC 618/2012).
During the four days covered in the screening study, no effects via lactation were observed.
Additional information
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