Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
developmental toxicity
Data waiving:
other justification
Justification for data waiving:
other:
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study planned
Remarks:
In accordance with Annex IX of REACH, the registrant must submit a proposal and a time schedule for fulfilling the information requirements of this Annex in accordance with Article 12(1)(d).
Study period:
A study will be placed after the final decision for this testing proposal is received from the European Chemicals Agency.
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out:
1,2-diacetoxybut-3-ene; EC: 421-720-5; CAS: 18085-02-4
- Name of the substance for which the testing proposal will be used [if different from tested substance] not required

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
- Available GLP studies:
A GLP compliant sub-acute repeated dose toxicity study conducted in accordance with OECD TG 407 is available. However, this study is not suitable to fulfil the REACH Annex IX requirements for a 'Sub-chronic toxicity study (90-day), one species, rodent, male and female, most appropriate route of administration, having regard to the likely route of human exposure' (point 8.6.2). No sub-chronic (90-day) repeated dose toxicity studies or chronic repeated dose toxicity are available.
- Available non-GLP studies
None available which are able to meet the requirements of the above endpoint.
- Historical human/control data
None available which are able to meet the requirements of the above
endpoint.
- (Q)SAR
QSAR modelling is not suitable to meet the requirements of this endpoint.
- In vitro methods
None suitable which are able to meet the requirements of the above endpoint.
- Weight of evidence
No relevant data is available to make use of this approach.
- Grouping and read-across
No suitable alternative substance with data available for read-across purposes has been identified.
- Substance-tailored exposure driven testing [if applicable]. This study is being proposed to support exposure-based adaptation in accordance with Annex XI of REACH for other information requirement endpoints to minimise vertebrate testing.
- Approaches in addition to above [if applicable] n.a.
- Other reasons [if applicable] n.a.

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- The specific adaptations described in Column 2 (adaptation from column 1) are unfortunately not applicable to this substance based on its data available. The general rules for adaptation of the standard testing regime set out in Annexes VII to X have been considered but cannot be used based on the data available on the substance.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]
The proposed study design is in accordance with the OECD TG 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents). The oral route of exposure is selected as this was used in the OECD TG 407 and TG 421 studies and based on the physicochemical properties of the substance this the most appropriate route of exposure for risk characterisation purposes.
Qualifier:
according to guideline
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)

Data source

Materials and methods

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion

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