Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: See attache ddocumentation
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar

Administration / exposure

Route of administration:
oral: capsule

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Key result
Dose descriptor:
NOAEL
Remarks on result:
other: Not determined

Maternal abnormalities

Key result
Abnormalities:
not specified

Results (fetuses)

Effect levels (fetuses)

Key result
Dose descriptor:
NOAEL
Remarks on result:
other: Not determined

Fetal abnormalities

Key result
Abnormalities:
not specified

Overall developmental toxicity

Key result
Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
No information on effects of repeated exposure to DBI are available. Data on analogues have been sought and evaluated, but were found not adequate to address this endpoint for the registered substance. Upon registration of Annex VIII, the registrant will update without delay to Annex IX. This dossier will be updated with a test proposal for a 90-day study combined with a screening study for developmental/ reproduction effects.