Registration Dossier

Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Type of information:
experimental study planned
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS for Extended one generation reproductive toxicity study (EOGRTS) via oral route of exposure.

Substance name: Hexan-6-olide

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 90-day repeated dose inhalation toxicity study at dose levels up to 45 ppm (203 mg/m3). 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. It is proposed that the EOGRTS study will be scheduled to run after the proposed Prenatal Developmental Toxicity Study (OECD 414) in rat has been performed. This would allow data from the OECD 414 study to be taken into account in the dose selection for the EOGRTS study.

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:
As in accordance with the data requirements in REACH annex X.

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexan-6-olide
EC Number:
207-938-1
EC Name:
Hexan-6-olide
Cas Number:
502-44-3
Molecular formula:
C6H10O2
IUPAC Name:
oxepan-2-one
Constituent 2
Reference substance name:
e-caprolactone
IUPAC Name:
e-caprolactone
Details on test material:
The test material was Capa Monomer (CAS 502-44-3), batch no. WNI 5874. One container, holding approximately 1000 mL of test item, was received under ambient
conditions at Charles River, Edinburgh on 17 September 2009. Upon arrival, the test item, a liquid, was stored at ambient temperature, protected from light and under nitrogen. A purity value of 99.93% and an expiry date of 16 March 2010 were supplied by the Sponsor.

Results and discussion

Applicant's summary and conclusion