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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
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:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: King's wheel Rabbitry at Mt.Vernon, Ohio

- Weight at study initiation: 2.2 -2.5kg

- Acclimation period: 27 days

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE

- Area of exposure: The skin of one male and two females was abraded with a clipper head so as to penetrate the stratum corneum without causing bleeding. The skin of the remaining three rabbits was left intact. The test material was weighed separately for each rabbit and spread evenly over the clipped area with a glass stirring rod.


- Type of wrap if used: The entire test site was then covered with two layers of 4 -ply gauze, occluded with rubber dental dam and fastened with Johnson and Johnson porpur tape.

REMOVAL OF TEST SUBSTANCE

- Washing (if done): After the exposure period, each rabbit was removed from the harness, the occlusive wrap was removed and any unabsorbed test material was wiped off with a wet disposable paper towel.

- Time after start of exposure: 24 hours


Duration of exposure:
24 hours
Doses:
The animals were dosed with a single application of undiluted test material at the dose level of 2g per kg body weight.
No. of animals per sex per dose:
3M, 3F
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during either the 24 hour exposure period or the 14 day observation period that followed.
Clinical signs:
No changes in behaviour or signs of systemic toxicity were observed at any time during the study. Incidental observation of gren mucoid faeces were noted. One rabbit did not eat for a day, but neither was dose related. On day 4, one of the rabbits had slight erythema.
Gross pathology:
None of the rabbits had any signs of skin irritation at the test site throughout the study. There were no visible lesions in any of the rabbits at gross necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
An acute dermal LD50 value of >2000mg/kg was determined for male and female rabbits in a reliable study conducted according to an appropriate test protocol. Not conducted according to GLP.