Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to OECD402; no individual data reported

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
only one sex tested, limitations in study reporting
Principles of method if other than guideline:
acute dermal toxicity after single application
GLP compliance:
no
Remarks:
performed before GLP guidelines
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Monoethylenglykoldimethylether
- Analytical purity: not stated
- physical state: clear colourless liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breed
-Strain: Hoe WISKf(SPF71)
- Age at study initiation: no data
- Weight at study initiation: 170 - 176 g (female animals); (mean = 172,7 g; s = ± 2,42; n = 6)
- Diet (e.g. ad libitum): Altromin 1324 ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Housing: single, in plastic cages, softwood pellets

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 30 cm2
- % coverage: 100
- Type of wrap if used: aluminium foil (6 x 8 cm) fixed with elastic bandage (Elastoplast, 8 cm)


REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:


TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Constant volume or concentration used: yes/no
- For solids, paste formed: yes/no


VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of exposure:
24 hours
Doses:
5000 mg/kg body weight
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observation after application; weighing once weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality

Results and discussion

Preliminary study:
no preliminary study performed
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality
Clinical signs:
No clinical symptoms detectable.
Body weight:
Uneffected.
Gross pathology:
No macroscopic visible changes.
Other findings:
No further findings.

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 diethylenglykol dimethylether was derived from the structural analogue supporting substance monoethylene glycol dimethyl ether to be greater 5000 mg/kg body weight in female rats.
Executive summary:

The median lethal dose (LD50) of diethylenglykol dimethylether was derived from the structural analogue supporting substance monoethylene glycol dimethyl ether to be greater 5000 mg/kg body weight in female rats. Therefore diethyleneglycol dimethyl ether is classified as practically nontoxic.