Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Remarks:
The audited draft report has been issued on 27 Septemer 2019. The report is currently in review prior to finalisation.
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The audited draft report has been issued on 27 Septemer 2019. The report is currently in review prior to finalisation.

Data source

Reference
Reference Type:
other: report in review prior to finalisation
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Remarks on result:
other: will be provided when available

Results (fetuses)

Effect levels (fetuses)

Remarks on result:
other: will be provided when available

Overall developmental toxicity

Developmental effects observed:
not specified
Treatment related:
not specified

Applicant's summary and conclusion