Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Results 'read across' from study on N,N', N''-nitrilotriethanol, propoxylated, as permitted by Annex XI para 1.5, based on the justification in the report from Paul Illing Consultancy Services Ltd and Marlin Consultancy (Illing and Barratt, 2007, revised 2009). The report identifies that N,N',N''-nitrilotriethanol, propoxylated is the most bioavailable of the NLP polyols linked by an ether group. The lack of toxicity seen for propoxylated sucrose, propoxylated glycerol, and for the components (sucrose, glycerol, oleic/linoleic acid and propane-1,2-diol) of the test substance should be considered representative of the lack of toxicity of the ether linked polyol. Thus, on animal welfare grounds this test should not be undertaken on Reaction product of Saccharose, Glycerine, biodiesel propoxylated. For further details concerning the grouping, consult Illing and Barratt, 2007.

Toxicity to reproduction of Nitrilotriethanol, propoxylated was investigated in an OECD 421 screening study. 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. Femalse of the 1000 m/kg dose group showed body weight loss during lactation for which treatment relationship, although unlikely, 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 body weight 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.

The reported NOAEL (reporduction/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.

The NLP polyols linked by an ether linkage (category 1), 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. Sufficient data exist to permit robust conclusions that the substances are not reproductive toxins and that no further testing is required (Illing and Barratt, 2009).

Short description of key information:
NOAEL >=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.

The NLP polyols linked by an ether linkage (category 1), nitrilotriethanol, propoxylated, propylidynetrimethanol, ethoxylated 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 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

On the basis of ´read across´ from2,2´,2´´-nitrilotriethanol, propoxylated the findings in the available studies do not warrant classification of sucrose, propoxylated according to EU criteria,