Registration Dossier
Registration Dossier
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EC number: 441-100-8 | CAS number: 351197-46-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
According to Annex IX 8.7.3 a two-generation reproductive toxicity study has to be conducted for one species, male and female, for the most appropriate route of administration, having regard to the likely route of human exposure, if the 28-day or 90-day study indicates adverse effects on reproductive organs or tissues. In the 28 day repeated oral dose study, epididymides, mammary gland, ovaries, prostate gland, seminal vesicles, testes, urinary bladder, uterus and vagina had been examined by macroscopy and microscopy and the organ weights of ovaries, testes and epididymides had been determined. There were no specific adverse effects observed on these tissues or reproductive organs. Therefore further testing for reproductive toxicity was not concerned to be necessary in terms of animal welfare.
Effects on developmental toxicity
Additional information
Directive 86/609/EEC stipulates that it is necessary to replace, reduce or refine testing on vertebrate animals. Regulation (EC) No. 1907/2006, Article 25, § 1 reinforces this by stating that the duplication of tests on vertebrates should be limited in particular with reference to the protection and welfare of animals. Hence, considering that the tonnage band of UAX-1179 is expected to increase in the near future from 10-100 t to 100-1000 t and in accordance also with Annex I § 0.5 (last paragraph), we consider that further information other than the 28d screening according to OECD guideline 421 study is necessary for producing an accurate chemical safety report with a accurately derived DNEL, which is sustainable for the higher tonnage levels (REGULATION (EC) No 1907/2006, Annex IX). This information can only be obtained by performing tests in accordance with Annex IX, thus it is proposed to perform a prenatal developmental toxicity study according to OECD guideline 414 rather than the 28 d screening study for reproductive/developmental toxicity (OECD 421). In the mean time interim risk management measures had been considered to manage the risks in relation to this endpoint.
Justification for classification or non-classification
According to DSD (67/548/EEC) and CLP (1272/2008/EC) UAX-1179 does not need meet the criteria to be classified regarding this endpoint.
Additional information
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