Registration Dossier
Registration Dossier
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EC number: 218-451-9 | CAS number: 2155-60-4
Toxicity to reproduction
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: See attached documentation
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Dibutyl itaconate
- EC Number:
- 218-451-9
- EC Name:
- Dibutyl itaconate
- Cas Number:
- 2155-60-4
- Molecular formula:
- C13H22O4
- IUPAC Name:
- 1,4-dibutyl 2-methylidenebutanedioate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
Results and discussion
Results: P1 (second parental generation)
Effect levels (P1)
- Key result
- Dose descriptor:
- NOAEL
- Remarks on result:
- other: Not determined
Target system / organ toxicity (P1)
- Key result
- Critical effects observed:
- no
Results: F1 generation
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Remarks on result:
- other: Not determined
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- not specified
Overall reproductive toxicity
- Key result
- Reproductive 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
