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Key value for chemical safety assessment

Effects on fertility

Description of key information

The NOAEL (reproduction/development, oral gavage - OECD 421) is >= 1000 mg/kg bw/day

 

Additional information

A reproduction toxicity screening study (oral gavage) following the OECD guideline 421 is available for the endpoint.

Survival rate of F0 animals was not reduced by treatment with ethylenediamine, ethoxylated and propoxylated at a dose level up to and including 1000 mg/kg bw/day. Salivation directly after the administration was observed in both genders at the 1000 mg/kg dose level but an adverse effect is not concluded from this finding. Body weight development was not affected to a toxicologically relevant extent in males at a dose level up to and including 1000 mg/kg. Females of the 1000 mg/kg group revealed a mild body weight gain depression during lactation.

The lowest-observed-effect-level (LOEL) and the no-observed-effect level (NOEL) for salivation after administration were as follows:

Males: LOEL: 1000 mg/kg bw/day; NOEL: 300 mg/kg bw/day

Females LOEL: 1000 mg/kg bw/day; NOEL: 300 mg/kg bw/day

 

There were no detectable effects in offspring. The NOAEL (reproduction/development) is >1000 mg/kg bw/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. Three of the NLP polyols, nitrilotriethanol, propoxylated, diaminotoluene, propoxylated and ethylenediamine, ethoxylated and propoxylated, 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.


Effects on developmental toxicity

Description of key information

The NOAEL (reproduction/development, oral gavage - OECD 421) is >= 1000 mg/kg bw/day

 

Additional information

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.

Three of the NLP polyols, nitrilotriethanol, propoxylated, diaminotoluene, propoxylated and ethylenediamine, ethoxylated and propoxylated, were tested to fulfil the requirements of Annex VIII (>10 tonnes/y). The results from these screening reproductive tests confirmed the pre-existing information. Sufficient data exist to permit robust conclusions that the substances are not reproductive or developmental toxins and that no further testing is required.

Justification for classification or non-classification

Possible minor effects on body weight and salivation do not constitute 'serious damage', the regulatory requirement relevant to classification.

Additional information