Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Method similar to OECD402, differences: only 2 males tested, no details reported
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Dermal toxicity of (...) triethylene glycol dimethyl ether
Author:
Clark, B. , Furlong, J., Ladner, A., Slovnak, A.
Year:
1984
Bibliographic source:
IRCD Med. Sci. 12, 296-297, 1984.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
only one sex tested, only 2 animals per dose tested, limitations in study reporting
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in publication): Triglyme
- Analytical purity: not stated

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
-Strain: COBS/Wistar rats
- Age at study initiation: no data
- Weight at study initiation: 225-306 g (male animals)
- Animalsa caged singly

Administration / exposure

Type of coverage:
other: non-occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: shaved, ca. 20 - 25% of the body surface on the backs and the flanks of the animals

Duration of exposure:
no data
Doses:
1.7 g/kg body weight
3.5 g/kg body weight
6.9 g/kg body weight
No. of animals per sex per dose:
2 males
Control animals:
no
Details on study design:
The tests used a non-occluded technique.
Volumes of the compound (0.1 ml to 2.0 ml maximum) were applied to shaved areas (approximately 20-25% of the body surface) on the backs and the flanks of the animals. "Toby" collars prevented grooming and the contaminated areas were not covered.
Animals were caged singely under normal conditions.
Statistics:
not required

Results and discussion

Preliminary study:
no preliminary study performed
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 6 900 mg/kg bw
Mortality:
No mortality
Clinical signs:
no effects observed
Body weight:
no data
Gross pathology:
no data
Other findings:
No further findings

Any other information on results incl. tables

-

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose (LD50) of triethylene glycol dimethylether for the dermal route of application is greater 6900 mg/kg body weight in male rats.
Executive summary:

The median lethal dose (LD50) of triethylene glycol dimethylether for the dermal route of application is greater 6900 mg/kg body weight in male rats. Therefore Triethylene glycol dimethyl ether is classified as practically nontoxic.