Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is not GLP compliant but equivalent to guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.9 to 2.4 kg

Administration / exposure

Type of coverage:
occlusive
Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Erythema and edema signs: Daily; Weights: pre-and post treatment
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No
Clinical signs:
Yes, signs of dermal irritation were observed.
Body weight:
No significant changes
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the acute dermal toxicity study the discriminating dose was determined to be > 5000 mg/kg bw.
Executive summary:

In the non- GLP compliant but guideline similar acute dermal toxicity study New Zealand White rabbits were used. A dose of 5000 mg/kg bw was administrated 24 hours to the clipped abraded abdominal skin of ten rabbits.

Following exposure the binders were removed and observations made for mortality and toxic effects for a period of seven days.

No animals died during the course of the study. There was no evidence of toxicity from percutaneous absorption of the test substance. Signs of dermal irritation (erythema and edema) were observed until day 7.

No abnormalities were noted at necropsy.

All animals were essentially normal by the termination of the study. Therefore, the LD50 was determined to be > 5000 mg/kg bw.