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Administrative data

Key value for chemical safety assessment

Effects on developmental toxicity

Description of key information
A study revealed no evidence of teratogenicity in rats: NOAEL = 1000 mg/kg bw/day (maternal and fetal toxicity). GLP-compliant OECD 414 studies (ETAD 1999 and 2000)
Additional information

A study on developmental toxicity and teratogenicity according to EPA Guideline OPPTS 870.3700 and under GLP conditions has been performed in rats with a close structural analogue (CAS 16470 -24 -9). In the study, 30 pregnant Sprague-Dawley rats per group were dosed with 100, 400 or 1000 mg/kg bw/day by oral gavage on gestation days 6-19. The only substance-related effect observed was discolored feces at 400 and 1000 mg/kg bw/day. At skeletal examination of fetuses, the incidence of misaligned sternebra was slightly increased in all dose groups but was well within historical control range and not dose-related and therefore not considered to be test substance related. The incidence of rudimentary ribs was slightly above the historical control range at 100 and 1000 mg/kg bw/day. As the difference from the concurrent control group was not statistically significant and the increase was not dose-related, these findings were not considered biologically significant or test substance-related. The number of vertebral malformations at 1000 mg/kg bw/day (litter incidence 7.1 %) was very slightly above the historical control range (0 - 7 %) and not statistically different from the vehicle controls. Therefore, this border finding too was considered to be within normal variation and unrelated to test substance administration. As there were no adverse maternal or developmental effects seen at any dose level, the NOAEL for both maternal and fetal

toxicity is the highest dose tested (1000 mg/kg bw/day) (ETAD 1999).

The test consistently yielded negative results indicating that the substance has no potential for teratogenicity. It is concluded that these negative findings can also be transferred to the substance CAS 133 -66 -4 which was not tested.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available 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 toxicity to reproduction, effects via lactation, developmental toxicity, and teratogenicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for toxicity to reproduction, effects via lactation, developmental toxicity, and teatogenicity under Regulation (EC) No. 1272/2008.

Additional information