Registration Dossier
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EC number: 219-371-7 | CAS number: 2425-79-8
Toxicity to reproduction
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
- 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.
Constituent 1
Results and discussion
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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