Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
Reason / purpose:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Evaluation of the Developmental Toxicity of Ethylene Glycol Aerosol in the CD Rat and CD-1 Mouse by Whole-Body Exposure.
Author:
Tyl RW, Ballantyne B, Fisher LC, Fait DL, Savine TA, Dodd DE, Klonne DR, Pritts IM
Year:
1995
Bibliographic source:
Fundamental and Applied Toxicology 24: 57-75
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Principles of method if other than guideline:
LC50 value derived from teratogenicity study.
GLP compliance:
yes
Test type:
other: LC50 value derived from teratogenicity study
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
see 7.8.2 Developmental toxicity / teratogenicity

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Details on inhalation exposure:
see 7.8.2 Developmental toxicity / teratogenicity
Duration of exposure:
6 h
Concentrations:
60, 400 or 1000 ppm
150, 1000 or 2500 mg/m3 (0.15, 1.00 or 2.5 mg/L)
No. of animals per sex per dose:
see 7.8.2 Developmental toxicity / teratogenicity
Control animals:
yes
Details on study design:
see 7.8.2 Developmental toxicity / teratogenicity
Statistics:
see 7.8.2 Developmental toxicity / teratogenicity

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2.5 mg/L air
Based on:
test mat.
Exp. duration:
6 h

Applicant's summary and conclusion