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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
2 rabbits per sex and dose / poorly documented
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
Purity of each material was checked in the Organic Chemicals Synthesis Laboratory, AEQI, in Beltsville by gas chromatography: > 98%

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.9-3.1 kg

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Back
- % coverage: 30
- Type of wrap if used: The site of application was covered by wrapping the trunk of the animal with plastic sheeting that was taped securely in place, and oral contact with the test material was prevented by fitting each animal with a light-weight flexible plastic collar that was worn throughout the observation period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not specified.
- Time after start of exposure: 24 h.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2025 mg/kg bw
Duration of exposure:
24 hours
Doses:
2025 mg/kg bw
No. of animals per sex per dose:
2 rabbits per sex.
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days- Duration of observation period following administration: 14 days (or other?)
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 025 mg/kg bw
Based on:
test mat.
Mortality:
No deads were observed in the highest dose tested.
Clinical signs:
No untoward behavioral reactions were seen. All the test chemicals caused local skin reactions characterized at the end of the 24-hr contact period by erythema and edema.
Gross pathology:
Necropsies revealed no abnormal findings other than these dermal alterations.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 was determined to be greater than 2025 mg/kg bw after 24h dermal exposure to rabbits.
Executive summary:

An acute dermal toxicity test was performed in Albino rabbits of the New Zealand strain. The backs of the rabbits were shaved with electric clippers; the shaved area on each animal was about 30% of the total body surface. After a 24 h waiting period to allow the stratum corneum to recover from any disturbance accompanying the close-clipping procedure and to permit healing of any microscopic abrasions, the undiluted liquid test material was applied, using two male and two female rabbits at each dose level. All materials were tested at 2025 mg/kg. The site of application was covered by wrapping the trunk of the animal with plastic sheeting that was taped securely in place, and oral contact with the test material was prevented by fitting each animal with a light-weight flexible plastic collar that was worn throughout the observation period. When the test material had been in contact with the skin for 24 h, the plastic sheeting was removed and all residues of test material were washed off, the test sites were examined for local skin reactions, and the animals were returned to their separate cages. Observations were continued for 14 days following the skin applications. Necropsies were conducted on all animals that died during the study and on all animals that survived the observation period. No deads were observed in the highest dose tested. No untoward behavioral reactions were seen. All the test chemicals caused local skin reactions characterized at the end of the 24 h contact period by erythema and edema. Necropsies revealed no abnormal findings other than these dermal alterations. The LD50 was determined to be greater than 2025 mg/kg bw after 24h dermal exposure to rabbits.