Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Remarks:
Including Cohort 1C
Type of information:
experimental study planned
Justification for type of information:
Testing Proposal for OECD 443 study - EOGRT:
A testing proposal is suggested on this endpoint as no available studies (neither GLP or non-GLP) nor historical human data are available to cover the information requirements for this tonnage level. Any potential grouping and read across has been evaluated. The use of (Q)SAR as well as in vitro methods are limited for this type of endpoint. There therefore is no possibility to fill the data gap by any other means than performing the proposed test.

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:
5-ethyl-1,3-dioxane-5-methanol
EC Number:
225-967-8
EC Name:
5-ethyl-1,3-dioxane-5-methanol
Cas Number:
5187-23-5
Molecular formula:
C7H14O3
IUPAC Name:
(5-ethyl-1,3-dioxan-5-yl)methanol
Test material form:
liquid
Details on test material:
5-ethyl-1,3-dioxan-5-yl)methanol / 5187-23-5 / 225-967-8

Results and discussion

Applicant's summary and conclusion