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)
Remarks:
based on test guideline
Type of information:
experimental study planned (based on read-across)
Remarks:
already approved by Decision number: TPE-D-2114440646-47-01/F
Study period:
2020
Justification for type of information:
See attached justification document!
This testing proposal has been approved meanwhile by ECHA (decision number TPE-D-2114440646-47-01/F, August 31st, 2018) and the study is performed during 2020. Results are expected to become available in quarter 4, 2020 and will be communicated as dossier update to the joint submission dossier EC number: 618-939-5; subsequently, this dossier of the read-across substance will become updated, in which this study is used as source study for read across to the corresponding C4 homologues substance, as outlined in the supporting justification to the endpoint study record "DW_Toxicity to reproduction_EOGRTS".
The testing ordered by ECHA consist of the following basic test design:
Extended one-generation reproductive toxicity study (Annex X, Section 8.7.3.; test method: EU B.56./OECD TG 443) in rats, oral route with the registered substance (1,6-hexanediol reaction product chloromethyloxirane) specified as follows:
- Ten weeks premating exposure duration for the parental (P0) generation;
- Dose level setting shall aim to induce some toxicity at the highest dose level;
- Cohort 1A (Reproductive toxicity);
- Cohort 1B (Reproductive toxicity) without extension to mate the Cohort 1B animals to produce the F2 generation.

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
Principles of method if other than guideline:
See attached justification document
Justification for study design:
See attached justification document

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of hexane-1,6-diol with 2-(chloromethyl)oxirane (1:2)
EC Number:
618-939-5
Cas Number:
933999-84-9
Molecular formula:
C6H14O2 + C3H5ClO
IUPAC Name:
Reaction products of hexane-1,6-diol with 2-(chloromethyl)oxirane (1:2)
Details on test material:
As per IUCLID5 Sections 1.1 - 1.4.

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion