Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

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.

Link to relevant study records
Reference
Endpoint:
screening for reproductive / 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
Qualifier:
according to
Guideline:
other: See attached documentation
GLP compliance:
yes
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
water
Key result
Dose descriptor:
NOAEL
Remarks on result:
other: Not determined
Key result
Critical effects observed:
no
Key result
Dose descriptor:
NOAEL
Generation:
F1
Remarks on result:
other: Not determined
Key result
Critical effects observed:
not specified
Key result
Reproductive effects observed:
not specified
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.
Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available (further information necessary)

Effects on developmental toxicity

Description of key information

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.

Link to relevant study records
Reference
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
Qualifier:
according to
Guideline:
other: See attache ddocumentation
GLP compliance:
yes
Limit test:
no
Species:
rat
Strain:
Wistar
Route of administration:
oral: capsule
Key result
Dose descriptor:
NOAEL
Remarks on result:
other: Not determined
Key result
Abnormalities:
not specified
Key result
Dose descriptor:
NOAEL
Remarks on result:
other: Not determined
Key result
Abnormalities:
not specified
Key result
Developmental effects observed:
not specified
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.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available (further information necessary)

Justification for classification or non-classification

Based on the absence of relevant information (data lacking), DBI is not classified for reproduction and developmental toxicity according to Regulation EC (No.) 1272/2008 (CLP).