Registration Dossier

Administrative data

Endpoint:
toxicity to reproduction: other studies
Type of information:
experimental study planned
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS for Extended one generation reproductive toxicity study (EOGRTS).

Substance name: 2,2-bis[[(1-oxopentyl)oxy]methyl]propane-1,3-diyl
divalerate
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- No existing GLP studies study available for this endpoint.
- No existing non-GLP studies study available for this endpoint.
- No historical human data available for this endpoint.
- No existing (Q)SAR information can properly assess this endpoint.
- No existing in vitro method could address this endpoint.
- No sufficient information available that could fulfill the standard information requirement through the weight of evidence approach.
- No information from structurally similar substance can be used to fulfill the standard information requirement through grouping and read-across.


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:
- Extended one generation reproductive toxicity studies (EOGRTS) basic test design is the standard information requirement for substance registered for 1000 tonnes or more per year (Annex X, Section 8.7.3., column 1, of the REACH Regulation).


FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:

No evidence of effect on the reproductive organs was seen in a 28-day and a 90-day repeated dose toxicity study at dose levels up to 1000 mg/kg bw/d. An extended one generation reproductive toxicity study according to OECD 443 guideline, basic test design (cohorts 1A and 1B without extension to include a F2 generation) is proposed at the present time. The detailed study design of EOGRTS will be further assessed to ensure its adequate assessment of possible effects and avoid unnecessary vertebrate animal use. Gavage is suitable to be used in the study since the test substance likely will add a taste.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 443 Extended One generation toxicity study
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Applicant's summary and conclusion