Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

Toxicity to reproduction of propylidynetrimethaol, ethoxylated was investigated in an OECD 421 screening study.

The NOAEL (no observed adverse effect level) for reproductive performance and fertility is 1000 mg/kg body weight/day for the F0 parental rats. The NOAEL for general, systemic toxicity of the test substance was 1000 mg/kg body weight/day for the F0 parental animals. The NOAEL for developmental toxicity in the F1 progeny of the test-substance treated groups was found to be 1000 mg/kg body weight/day.

Adequate testing has been undertaken on a sufficient number of the core substances and repeating units. None of the tested core substances and none of the repeating units is classifiable as a reproductive toxin. Hence it would be anticipated that the NLP polyols, as a category, would also not be reproductive toxins. The NLP polyols, nitrilotriethanol, propoxylated and propylidynetrimethanol, ethoxylated were tested to fulfil the requirements of Annex VIII (>10 tonnes/y). The results from these screening reproductive tests confirmed the pre-existing information. The NLP polyols are not reproductive or developmental toxins. Furthermore, a range of studies has been conducted on core substances and repeating units and screening tests have been conducted on most substances in the NLP polyol categories. It is possible to ‘read across’ the results from all of these sources to all substances in these categories. Sufficient data exist to permit robust conclusions that the substances are not reproductive or developmental toxins and that no further testing is required (Illing and Barratt, 2009).


Short description of key information:
NOAEL (reproduction/developmental toxicity, OECD 421) >=1000 mg/kg bw/day.

Effects on developmental toxicity

Description of key information
NOAEL (development) >= 1000 mg/kg bw (on the basis from ´read across´from ethane-1,2-diol, propoxylated)
Additional information

Results ´read across´from ethane-1,2 -diol, propoxylated, as permitted by Annex XI para 1.5, based on the justification in the report by Paul Illing Consultancy Services Ltd and Marlin Consultancy (Illing and Barratt, 2007, revised 2009).

 A developmental toxicity study was performed with ethane-1,2 -diole, propoxylated according to OECD TG 414. Female Wistar rats each were treated daily orally bygavage with 0, 100, 300, and 1000 mg/kg body weight in deminaralized water from day 6 to day 20 p.c. Summarizing and evaluating all data investigated the following no-observed-adverse-effect levels (NOAELs) were determined: for maternal toxicity 1000 mg/kg bw, for developmental toxicity 1000 mg/kg bw.

 

Adequate testing has been undertaken on the core substances and repeating units. None of the tested core substances and none of the repeating units is classifiable as a reproductive toxin. Hence it would be anticipated that the NLP polyols, as a category, would also not be reproductive toxins.

The NLP polyols, nitrilotriethanol, propoxylated, propylidynetrimethanol, ethoxylatedand and ethane-1,2 -diol, propoxylated were tested to fulfil the requirements of Annex VIII (>10 tonnes/y). The results from these screening reproductive tests and the result from the developmental toxicity study confirmed the pre-existing information. Sufficient data exist to permit robust conclusions that the substances are not developmental toxins and that no further testing is required (Illing and Barratt, 2009).

Justification for classification or non-classification

The findings from testing reproduction toxicity screening do not warrant classification.

Additional information