Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Type of information:
experimental study planned
Study period:
To be confirmed following approval of the testing proposal 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: No adequate and reliable GLP studies addressing reproductive toxicity are available with the test substance or similar substance. A sub-chronic repeated dose oral toxicity study in the rat conducted according to OECD test guideline 408 has been proposed. If this study shows classifcation would be required for reproductive toxicity, then further testing to address this endpoint would not be necessary. A stepwise testing approach is therefore proposed.

- Available non-GLP studies: No adequate and reliable non-GLP studies addressing reproductive toxicity are available with the test substance or similar substance

- Historical human data: No data are available

- (Q)SAR: Currently available Q(SAR) methods are not applicable to assess the full scope of reproductive toxicity.

- In vitro methods: No validated in vitro methods to asess reproductive toxicity are available to date.

- Weight of evidence: There are no data to assess the reproductive toxicity of the test substance; a weight of evidence approach is therefore not appropriate.

- Grouping and read-across: There are no similar subtances which are considered to be acceptable for read-across; a read-across proposal was made previously, but this was rejected by ECHA.

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 generation of data to addess the toxicity to reproduction is a standard requirement under REACH at this tonnage band and cannot be adapted for this substance based on any Ccolumn 2 or Annex XI adaptions.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- A study is proposed to be conducted with CAPA 3050 according to OECD test guideline 443 (basic design) in the rat via the oral route. The study will include cohorts 1A and 1B, without extension.

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 443 (Extended One-Generation Reproductive Toxicity Study)
Justification for study design:
SPECIFICATION OF STUDY DESIGN FOR EXTENDED ONE-GENERATION REPRODUCTION TOXICITY STUDY WITH JUSTIFICATIONS

- Premating exposure duration for parental (P0) animals: 10 weeks, to cover a complete cycle of spermatogenesis

- Basis for dose level selection: to be confirmed, based on the results of the proposed 90-day study

- Inclusion/exclusion of extension of Cohort 1B: exclusion. The standard requirement is not to include the extension of Cohort 1B; however this will be confirmed based on the presence of any findings of concern (triggers) in the proposed 90-day study

- Termination time for F2: not relevant

- Inclusion/exclusion of developmental neurotoxicity Cohorts 2A and 2B: exclusion. The standard requirement is not to include the extension of Cohorts 2A and 2B; however this will be confirmed based on the presence of any findings of concern (triggers) in the proposed 90-day study

- Inclusion/exclusion of developmental immunotoxicity Cohort 3: exclusion. The standard requirement is not to include the extension of Cohort 3; however this will be confirmed based on the presence of any findings of concern (triggers) in the proposed 90-day study

- Route of administration: oral (dietary)

- Other considerations, e.g. on choice of species, strain, vehicle and number of animals: not applicable.

Test material

Constituent 1
Reference substance name:
CAPA 3050
IUPAC Name:
CAPA 3050
Constituent 2
Chemical structure
Reference substance name:
ε-Caprolactone, oligomeric reaction products with propylidynetrimethanol
EC Number:
500-099-5
EC Name:
ε-Caprolactone, oligomeric reaction products with propylidynetrimethanol
Cas Number:
37625-56-2
Molecular formula:
(C6H14O3)x.C6H10O2 (x=0-6)
IUPAC Name:
ε-Caprolactone, oligomeric reaction products with propylidynetrimethanol
Constituent 3
Reference substance name:
2-Oxepanone, polymer with 2-ethyl-2-(hydroxymethyl)-1, 3-propanediol
IUPAC Name:
2-Oxepanone, polymer with 2-ethyl-2-(hydroxymethyl)-1, 3-propanediol
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

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion