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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Study was conducted on the test material and followed OECD guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
All animals will be housed individually hourse in stainless steel cages and will be offered food and water ad libitum

Administration / exposure

Type of coverage:
occlusive
Details on dermal exposure:
Twenty-four hours prior to application of the test material, the trunk of the rabbit is shaved. The 24-hour period between shaving and application of the test material allows recovery of the stratum corneum from hte disturbance caused by shaving. All animals are weighed on day of dosing. Based upon the animal's body weight, the test material is applied and a sleeve of plastic sheeting is fitted oven the shaven trunk of the animals and secured in place with adhesive tape. The test material remains in contact with the skin for a 24 hour period after which time the wrap is removed and any remaining test article wiped off
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 animals/sex/dose
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
No mortalities were recorded during the duration of the study
Clinical signs:
No clinical signs of toxicity were reported
Gross pathology:
No gross chnages observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 is greater than 2000 mg/kg
Executive summary:

No mortalities or clinical signs of toxicity were observed during the duration of the study. The LD50 is > 2000 mg/kg and does not meet the criteria for classification under GHS