Registration Dossier
Registration Dossier
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EC number: 224-618-7 | CAS number: 4430-18-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on developmental toxicity
Description of key information
According to the results of the two availables key studies (GLP, Klimisch 1, Following OECD guideline 414 method) and the CLP regulation, the registered substance Jarocol Violet 43 was considered to have a No Observe Adverse Effect Level for developmental toxicity (NOAEL) at 800 mg/kg/day (test material) by oral gavage routes (studies performed on rats).
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 800 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 800 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
Two studies were available for teratogenicity of registered substance assessment. They were considered as key studies. These two studies are teratogenicity studies performed on two different rat strains according the OECD guideline 414 method :
- The first key study (Klimisch 1, GLP, OECD 414, 1994) was performed on Sprague Dawley female rats which were exposed orally by gavage to 0, 50, 200 and 800 mg/kg/day of substance in water during day 6 to 15 of gestation period.
-The second key study (Klimisch 1, GLP, OECD 414, 2000) was performed on Wistar female rats which were exposed orally by gavage to 0, 100, 300 and 1000 mg/kg/day of substance in 1% carboxymethyl cellulose during day 6 to 17 of gestation period.
In the two studies, no adverse effect was observed in the fetuses or the pregnant rats. No abnormality or malformation was noted in both key studies. The NOAEL values were respectively defined as high dose level used in each study (respectively 800 and 1000 mg/kg bw/day).
Justification for classification or non-classification
In the two studies, no adverse effect was observed in the fetuses or the pregnant rats. No abnormality or malformation was noted in both key studies. The NOAELs were respectively defined as 800 and 1000 mg/kg/day in each study.
According to the results of the two availables key studies (GLP, Klimisch 1, Following OECD guideline 414 method) and the CLP regulation, the test substance was considered to have a No Observe Adverse Effect Level (NOAEL) for developmental toxicity at 800 mg/kg/day (test material) by gavage route (studies performed on rats).
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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