Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

Toxicity to reproduction of 2,2’,2’’-Nitrilotriethanol, propoxylated was investigated in an OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test). Treatment with 2,2',2''-Nitrilotriethanol, propoxylated resulted in increased incidence of salivation at the 1000 mg/kg dose in both genders and possibly transiently in females at 300 mg/kg dose group. Females of the 1000 mg/kg dose group showed body weight loss during lactation for which treatment relationship could not be completely excluded.

The reported NOAEL for male (general toxicity) 1000 mg/kg bw/day

The reported NOAEL for female (general toxicity): 300 mg/kg bw/day

The registrant considers the mild bodyweight loss observed with females at the highest dose group (1000 mg/kg bw/day) as non adverse treatment related effect as it follows a statistically significant increased body weight gain, as compared to control, in the premating phase. Possible minor effects on bodyweight do not constitute 'serious damage', the requirement relevant to classification.

The No Adverse Effect Level is therefore concluded to be >=1000 mg/kg bw/day.

There were no detectable effects in offspring. Thus the reported NOAEL (reproduction/developmental toxicity) >= 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.


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

Effects on developmental toxicity

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

The findings from testing reproduction toxicity screening of 2,2’,2’’-Nitrilotriethanol, propoxylated do not warrant classification. Possible minor effects on bodyweight do not constitute 'serious damage', the requirement relevant to classification.