Registration Dossier

Administrative data

Description of key information

Pursuant to ECHA decision CCH-D-2114394004-54-01/F (issued 22 March 2018) a sub-acute oral repeated dose toxicity study (combined repeated dose toxicity study with the reproduction/developmental toxicity screening test) according to OECD guideline 422 and a sub-chronic oral repeated dose toxicity study (90-day) according to OECD guideline 408 are currently being performed. Based on the results of the sub-acute and sub-chronic toxicity studies (28 and 90 days), 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

Referenceopen allclose all

Endpoint:
short-term repeated dose toxicity: oral
Data waiving:
other justification
Justification for data waiving:
other:
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 CCH-D-2114394004-54-01/F (issued 22 March 2018) a sub-acute oral repeated dose toxicity study (combined repeated dose toxicity study with the reproduction/developmental toxicity screening test) according to OECD guideline 422 and a sub-chronic oral repeated dose toxicity study (90-day) according to OECD guideline 408 are currently being performed.

The hazard assessment of Ethanesulfonic acid, 2 -(methylamino)-, N-coco acyl derivs., sodium salts with respect to repeated dose toxicity will be updated in due course when the results of the studies are available.

Justification for classification or non-classification

No data on repeated dose toxicity with the registered substance are available but a sub-acute oral repeated dose toxicity study according to OECD guideline 422 and a sub-chronic oral repeated dose toxicity study (90-days) according to OECD guideline 408 are currently ongoing. 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 appropriate studies with repeated administration are currently ongoing, the overall conclusion for classification and labelling regarding repeated dose toxicity needs to be re-assessed once reliable study results are available.