Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1974-1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP, non-guideline
Justification for type of information:
Read across is based on the category approach. Please refer to attached category document.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Principles of method if other than guideline:
LD50 calculation
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material: diethylene glycol
- Physical state: liquid
- Lot/batch No.: 37-519

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3-5 months
- Diet (e.g. ad libitum): ad libitum, except during period of manipulation or confinement
- Water (e.g. ad libitum): ad libitum, except during period of manipulation or confinement

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Rabbits are immobilized furing the 24 hour contact period with the compound retained under impervious sheeting on the clipped intact skin of the trunk. Thereafter, excess fluid is removed to prevent ingestion. Maximum dose that can be retained is 16 ml/kg.
Duration of exposure:
24 hours
Doses:
5, 10, 20 ml/kg
No. of animals per sex per dose:
4 males/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
LD50s are calculated by the moving average method based on a 14 day observation period

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
11.2 mL/kg bw
Based on:
test mat.
95% CL:
ca. 5.28 - ca. 23.9
Mortality:
At 20 ml/kg, 3 of 4 rabbits died, all on day 5. At 10 ml/kg, 2 of 4 rabbits died on days 5 and 7. No deaths occurred at 5 ml/kg.
Clinical signs:
No clinical signs were observed. No skin irritation was observed.
Body weight:
No additional information.
Gross pathology:
In victims, lungs and livers were kard and kidneys were pale. In survivors, kidneys were pale and mottled.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
LD50 (11.2 ml/kg) does not meet criteria for classification
Conclusions:
Slightly toxic following acute covered dermal application.
Executive summary:

The LD50 was 11.2 ml/kg (about 12500 mg/kg based on a density of 1.118 at 20 degrees C) for rabbits exposed to diethylene glycol for 24 hours under occlusive conditions.