Registration Dossier
Registration Dossier
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EC number: 415-430-8 | CAS number: 86403-32-9 CYASORB UV-3853 LIGHT STABILIZER; DASTIB 845; SANDUVOR 845
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
Additional information
This substance has been tested in a 2-generation reproductive toxicity assay, with the key findings of no alterations in live birth rates in either the F1 or F2 generations, and no functional decrements. Fertility indices were examined in the F1 adults, again with no findings suggestive of reproductive toxicity. The NOAEL is greater than 250 mg/kg bw/d, which was the highest dose tested in the 2-generation reproductive toxicity test. The doses selected for investigation in the reproductive toxicity studies are lower than those chosen in a 28 -day repeated dose oral toxicity test in rats, and this should not suggest that the animals have a lower NOAEL for developmental toxicity than for systemic toxicity.
Short description of key information:
There is no evidence that this substance adversely affected mammalian fertility from a 2-generation reproductive toxicity study in rats.
Effects on developmental toxicity
Description of key information
There is no evidence that this substance adversely affected mammalian development from a 2-generation reproductive toxicity study in rats.
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
Additional information
This substance has been well tested in a teratology assay and a 2-generation reproductive toxicity assay. As noted earlier, the maximal dose administered to rats in the 2-generation test was 250 mg/kg bw/d, with no adverse effects noted in the offspring (with the exception of one instance of hydrocephalus in an F2 pup of the low dose group). In the older teratology study (OECD 414), doses ranged from 100 to 400 during days 6 -15 of pregnancy in ICR mice. Neonatal mice displayed minor variations which were not considered abnormalities or evidence of teratogenic effects. No evidence of fetolethality was noted. These data lead to the conclusion that the substance is not a reproductive toxicant at doses up to the maximal tested. The NOAEL is greater than 250 mg/kg bw/d in rats and 400 mg/kg bw/d in mice. The doses selected for investigation in the reproductive toxicity studies are lower than those tested in a 28 -day repeated dose oral toxicity test in rats, and this should not suggest that the animals have a lower NOAEL for developmental toxicity than for systemic toxicity.
Justification for classification or non-classification
There is no evidence that this substance adversely affects mammalian fertility or development in a 2-generation reproductive toxicity study, and so it is not classified as a reproductive toxicant.
Additional information
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