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Key value for chemical safety assessment

Effects on fertility

Additional information
Short description of key information:
There are no data available concerning effects on fertility.

Effects on developmental toxicity

Description of key information
OECD 414, rat, oral (gavage): NOAEL maternal and developmental effects = 1000 mg/kg/d
Additional information

In the key study (BASF SE, 2010), that was performed according to OECD guideline 414 in compliance with GLP, Adamantyltrimethylammoniumhydroxide 20% was administered to pregnant Wistar rats daily by gavage from implantation to one day prior to the expected day of parturition (GD 6 - 19). Analyses confirmed the correctness of the prepared concentrations and the stability of the test substance.

There were no test substance-related effects on the dams concerning mortality, food consumption, body weight, body weight gain, gestational parameters, uterine and placental weights, as well as necropsy observations up to and including a dose of 1000 mg/kg bw/day. The high-dose (1000 mg/kg bw/d) caused transient (for a few minutes) salivation directly after treatment, which was likely to be induced by the bad taste of the test substance or by local irritation in the upper digestive tract of dams. It is not considered to be a sign of systemic toxicity. Salivation was not observed after treatment with lower doses.

Fetal examinations revealed no influence of the test compound on sex distribution of the fetuses and fetal body weights. Adamantyltrimethylammoniumhydroxide 20% shows no direct and specific effect on fetal morphological structures.

In conclusion, the no observed adverse effect level (NOAEL) of Adamantyltrimethylammoniumhydroxide 20% for maternal and prenatal developmental toxicity was determined to be 1000 mg/kg bw/day.

Justification for classification or non-classification

EU classification according to Annex VI of Directive 67/548/EEC:

- Effects on fertility: No classification due to lacking data - Developmental toxicity/teratogenicity: Conclusive, but not sufficient for classification

GHS classification according toAnnex I 1272/2008 CLP (EU GHS):

- Effects on fertility: No classification due to lacking data

- Developmental toxicity/teratogenicity: Conclusive, but not sufficient for classification

Additional information

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