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EC number: 701-186-2 | CAS number: -
Read-across from analogue:
Reproductive/Developmental toxicity screening test:
Key study. Study with 12 male/ 12 female rats at doses of 100, 300, 1000 mg/kg/day, according to OECD Test Guideline 422. The result was as follows: fertility/reproductive toxicity NOAEL = 1000 mg/kg bw /day
Two-generation reproductive toxicity study:
In accordance with column 2 of REACH Annex IX, the two-generation reproductive toxicity study ( required in section 8.7.3) does not need to be conducted as the 28-day and 90-day study results do not indicate adverse effects on reproductive organs or tissues.
The analogue approach covers the substance Ultramarine Blue (CAS 57455-37-5) and the substance Ultramarine Violet (CAS 12769-96-9).
The analogue Ultramarine Blue shares the same functional group with the substance Ultramarine Violet. Therefore, they are expected to be toxicologically equivalent.
Based on the experimental results obtained with the analogue, the read-across approach is applied and the NOAELs for the substance Ultramarine Violet are:
-NOAEL maternal toxicity >= 300 mg/kg bw /day
-NOAEL reproductive toxicity>= 1000 mg/kg bw/day
-NOAEL offspring development >= 1000 mg/kg bw/day
Key study. Study with 12 female rats at doses of 100, 300, 1000 mg/kg/day, according to OECD Test Guideline 422. The result was as follows: developmental toxicity NOAEL = 1000 mg/kg bw /day
Pre-natal developmental toxicity study:
The study does not need to be conducted since based on the available data from the reproduction/developmental toxicity screening test, the test material did not cause any adverse effects.
The study was performed to assess the teratogenic activity of the test material according to a method similar to OECD guideline 414). It was given an oral administration of the test material mixed in their diet at four different dose levels (10, 100, 1000, 10000 mg/kg bw) to 5 different groups of 12 female rats in each (a total of 60) during 7 days prior to mating. No maternal deaths and no teratogenical effects were observed. Results of the investigations confirm that the test material has not teratogenic activity.
The NOAEL maternal toxicity is > 100 mg/kg bw per day
The NOAEL teratogenicity is > 10000 mg/kg bw per day
Based on the available information:
fertility/reproductive toxicity NOAEL = 1000 mg/kg bw /day
developmental toxicity NOAEL = 1000 mg/kg bw /day
the substance is not classified.
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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