Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study planned
Study period:
To be confirmed following approval by ECHA
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
CAPA 3050

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
- Available GLP studies: None available
- Available non-GLP studies: None avaialble
- Historical human data: None available
- (Q)SAR: not sufficiently reliable for the prediction of repeated dose toxicity
- In vitro methods: not sufficiently reliable for the prediction of repeated dose toxicity
- Weight of evidence: no data are available
- Grouping and read-across: A read-across proposal was previously rejected by ECHA
- Substance-tailored exposure driven testing: not applicable
- Approaches in addition to above: not applicable

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 provision of a 90-day study is a standard REACH requirement. It is not possible to meet this data requirement through any non-testing methods or any Column 2 or Annex XI adaptations.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
90-day rat oral toxicity study (OECD 408) with the submission substance

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
Principles of method if other than guideline:
A 90-day rat study is proposed for CAPA 3050 (OECD 408) using oral dosing

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): CAPA 3050
- Substance type: Oligomer
- Physical state: Liquid
- Analytical purity: 100%
- Lot/batch No.: WCB000999
- Expiration date of the lot/batch: 23th August 2015
- Stability under test conditions: Stable for the duration of the study
- Storage condition of test material: Ambient

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion