Registration Dossier

Administrative data

Description of key information

Pursuant to ECHA Decision TPE-D-2114465594-39-01/F (issued 4 July 2019) a subchronic toxicity study (90-day), oral route, in rats according to OECD guideline 408 is currently being performed. The deadline for submitting the requested information in an updated registration dossier set in the decision is 11 January 2021. Based on the results of the subchronic toxicity study (90-day), the hazard assessment with respect to repeated dose toxicity will be updated.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
sub-chronic toxicity: oral
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available (further information necessary)

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No data on repeated dose toxicity with the registered substance are available. Pursuant to ECHA Decision TPE-D-2114465594-39-01/F (issued 4 July 2019) a subchronic toxicity study (90-day), oral route, in rats according to OECD guideline 408 is currently being performed. The hazard assessment of propylidentrimethanol, propoxylated with respect to repeated dose toxicity will be updated in due course when the results of the study are available.

Justification for classification or non-classification

No data on repeated dose toxicity with the registered substance are available but a subchronic toxicity study (90-day), oral route, in rats according to OECD guideline 408 is currently ongoing. However, as a first indication on effects of the registered substance after repeated dose administration, results of a pre-natal developmental toxicity study in the rat (oral route) according to OECD guideline 414 can be considered (rel 1-key, rat, gavage, OECD 414, Charles River, 2020, 490529). Pregnant Han Wistar rats were treated with the test substance in doses of 100, 300 and 1000 mg/kg bw/day between Day 6 and 20 of gestation. No biologically relevant effects on maternal toxicity were observed in this study. The No-Observed-Adverse-Effect-Level (NOAEL) was determined to be 1000 mg/kg bw/day.

The data currently available provide not sufficient evidence that would imply a classification for repeated dose toxicity according to the CLP Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification. However, since a subchronic toxicity study (90-day) is currently ongoing, the overall conclusion for classification of propylidentrimethanol, propoxylated regarding repeated dose toxicity needs to be re-assessed once reliable study results are available.