Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out : 1-ethoxy-2-(2-methoxyethoxy)ethane
- Name of the substance for which the testing proposal will be used [if different from tested substance] : N/A

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies : Data are available from a 28-day oral toxicity test according to the OECD 422 test guideline and a 28-day oral toxicity test according to the OECD 407 test guideline
- Available non-GLP studies : No data
- Historical human data: No data
- (Q)SAR: No data
- In vitro methods: No data
- Weight of evidence: No data
- Grouping and read-across : No grouping or read across is available for this registration.
- Substance-tailored exposure driven testing [if applicable] : Not applicable
- Approaches in addition to above [if applicable] : Not applicable
- Other reasons [if applicable]: Not applicable

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:
- The data available for the substance do not meet the specific adaptations from Column B of Annex IX. Column B of Annex IX requires that the OECD 414 study should be conducted initiially in a single species. It is therefore proposed that the study should be conducted initially in rats.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]: No specific modification proposed to the rat OECD 414 study.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Clear colorless liquid
Details on test material:
Name: DEGMEE
CAS No.: 1002-67-1
Lot No.: 20130625
Storage condition: Room temperature [(1 ~30)℃],
Expiration date: 2014-06-25
Appearance: Clear colorless liquid
Purity: 99.98 %
Molecular formula and M.W.: C2H5O(CH2CH2O)2CH3 / 148.20
Specific gravity: 0.918 – 0.928
Water solubility: Soluble
Treatment after end of study: Dispose

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion