Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

Pursuant to ECHA decision CCH-D-2114394004-54-01/F (issued 22 March 2018) a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test according to OECD guideline 422 is currently being performed. Based on the results of the study, the hazard assessment with respect to toxicity to reproduction will be updated.

Link to relevant study records
Reference
Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
other justification
Justification for data waiving:
other:
Effect on fertility: via oral route
Endpoint conclusion:
no study available (further information necessary)
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

No data on repeated dose toxicity with the registered substance is available. Pursuant to ECHA Decision CCH-D-2114394004-54-01/F (issued 22 March 2018) a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test according to OECD guideline 422 is currently being performed. The hazard assessment of Ethanesulfonic acid, 2 -(methylamino)-, N-coco acyl derivs., sodium salt with respect to toxicity to reproduction will be updated in due course when the results of the study are available.

Effects on developmental toxicity

Description of key information

Pursuant to ECHA decision CCH-D-2114394004-54-01/F (issued 22 March 2018) a prenatal developmental toxicity study according to OECD guideline 414 is currently being performed. Based on the results of the prenatal developmental toxicity study, the hazard assessment with respect to developmental toxicity will be updated..

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Data waiving:
other justification
Justification for data waiving:
other:
Species:
rat
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available (further information necessary)
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

No data on prenatal developmental toxicity with the registered substance are available. Pursuant to ECHA decision CCH-D-2114394004-54-01/F (issued 22 March 2018) a prenatal developmental toxicity study according to OECD guideline 414 is currently being performed. The hazard assessment of Ethanesulfonic acid, 2 -(methylamino)-, N-coco acyl derivs., sodium salt with respect to developmental toxicity will be updated in due course when the results of the study are available.

Justification for classification or non-classification

No data on toxicity to reproduction / developmental toxicity with the registered substance are available but a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test according to OECD guideline 422 and a prenatal developmental toxicity study according to OECD guideline 414 are currently ongoing. The data currently available provide not sufficient evidence that would imply a classification for reproductive or developmental toxicity according to the CLP Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification. However, since appropriate studies are currently ongoing, the overall conclusion for classification and labelling regarding toxicity to reproduction and developmental toxicity needs to be re-assessed once reliable study results are available.