Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Deviations: no details on test material, limited details on test animals and environmental conditions.
GLP compliance:
no
Remarks:
not present at the time of performance.
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: New Zealand
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: Young adult rabbits
- Weight at study initiation: 2.5 - 3.1 kg
- Housing: Individually housed in hanging rabbit cages
- Diet: Free access to standard laboratory rabbit ration
- Water: Free access to water
- Acclimation period: At least 7 days

ENVIRONMENTAL CONDITIONS
No data.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
Twenty-four hours prior to the dermal applications, the backs of the rabbits were shaved free of hair with electric clippers. The shaved area on each animal constituted about 30% of the total body surface area. The animals were then returned to their cages to await testing on the following day. The 24-hour waiting period allowed recovery of the stratum corneum from the disturbance which accompanied the close-clipping procedure and also permitted healing of any microscopic abrasions possibly produced during the process.
On the testing day, four rabbits received skin applications of the respective test material. The exposure site was covered by wrapping the trunk of the animal with an impervious plastic sheeting which was securely taped in place. This plastic wrap insured intimate contact of epidermis and test substance. To further prevent oral ingestion of the test substance, each animal was fitted with a light-weight, flexible plastic collar which was worn throughout the observation period.

REMOVAL OF TEST SUBSTANCE
- Washing: No
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for mortality, local skin reactions, behavioral abnormalities and initial and final body weights were recorded.
- Necropsy of survivors performed: A necropsy was conducted on all animals at the end of the observation period.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
No untoward behavioral reactions were exhibited by any of the animals.
Body weight:
Body weights were not significantly increased, neither decreased.
Gross pathology:
No gross pathologic alterations were noted.
Other findings:
Pale red erythema and slight edema were noted after 24 hours. By seven days, dryness was evident. Dryness persisted to the end of the 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute dermal toxicity study with rats, performed equivalent to OECD 402 guidelines, an LD50 of >2000 mg/kg bw was determined.
Executive summary:

The test item was tested in an acute dermal toxicity study with rats, performed equivalent to OECD 402 guideline.

No deaths occurred. No untoward behavioral reactions were exhibited by any of the animals. Body weights were not significantly increased, neither decreased. No gross pathologic alterations were noted. Pale red erythema and slight edema were noted after 24 hours. By seven days, dryness was evident. Dryness persisted to the end of the 14-day observation period. Based on the results, an LD50 of >2000 mg/kg bw was determined.