Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Study conducted pre-GLP and pre-GLP but performed similarly to OECD Guideline 402 with deviations: purity of test item not reported; source and sex of animals and environmental conditions not reported; acclimation period not reported; observation period was 7 days instead of 14 days.

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:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
purity of test item not reported; source and sex of animals and environmental conditions not reported; acclimation period not reported; observation period was 7 days instead of 14 days
Principles of method if other than guideline:
standard acute method
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Appearance: Clear liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.9-2.2 kg

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Clipped abraded abdominal skin
- Type of wrap if used: Animals were wrapped with binders of rubber dam, gauze and adhesive tape.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw
Duration of exposure:
24 h
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: Yes; gross necropsy was performed on all animals at the termination of the study.
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
No clinical signs were observed.
Body weight:
Body weight evolution of the animals remained normal throughout the study.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
Slight to moderate erythema and edema were noticed throughout the observation period.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the dermal LD50 of test item is higher than 5000 mg/kg bw in rabbits therefore it is not classified according to the Regulation (EC) No. 1272/2008 and to the GHS.
Executive summary:

In an acute dermal toxicity study performed pre-GLP and pre-OECD but conducted similarly to OECD Guideline 402, a group of New Zealand white rabbits (10 animals/dose) were given a single dermal application of Compound No. 72-22 at 5000 mg/kg bw. The test item was applied to the abraded abdominal skin. The test site was then covered by a semi-occlusive dressing for 24 h. Animals were then observed for mortality, clinical signs and bodyweights for 7 days and were all sacrificed for macroscopic examination.

No mortality or clinical signs was observed. Slight to moderate erythema and edema were noticed throughout the observation period. Body weight evolution of the animals remained normal throughout the study. No abnormalities were noted at necropsy. The dermal LD50 of test item was considered to be higher than 5000 mg/kg bw in rabbits.

Under the test conditions, the dermal LD50 of test item is higher than 5000 mg/kg bw in rabbits therefore it is not classified according to the Regulation (EC) No. 1272/2008 and to the GHS.

This study is acceptable and satisfies the requirements for acute dermal toxicity endpoint.