Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
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:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
, number of animals per sex and dose, dose levels examined, no necropsy of the survivers
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

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
- Weight at study initiation: 2374 to 2776 gr.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The hair was clipped from the back of each rabbit. The skin was abraded for 1/2 of the rabbits in each group. The test material was applied, as received, to the backs in appropriate doses. the site of application was covered with gause bandaging and occluded with saran wrap.
Duration of exposure:
24 hours
Doses:
1000, 2000, 4000, 8000 mg/ kg bw
No. of animals per sex per dose:
2 animals of one sex were used for each dose level
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight, organ weights

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
8 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 8 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortality was observed
Clinical signs:
Not indicated
Body weight:
All rabbits exhibited body weight gains or maintained their body weight during the14 day observation period
Gross pathology:
Not performed as all animals survived

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A LD50 value of > 8000 mg/kg bw was determined in the study for the test substance 75 % t-butyl peroxyneodecacnoate in solvent. A LD50 value of > 6000 mg/kg bw was calculated for 100 % t-butyl peroxyneodecanoate.
Executive summary:

The test substance 75 % t-butyl peroxyneodecanoate in mineral spirits was examined for its acute dermal toxicity, similar to an OECD no. 402 study guideline. Eight New Zealand white rabbits were equally divided to sex and to 4 dosage groups of 1000, 2000, 4000, and 8000 mg/kg bw. The hair was clipped from the back of each rabbit, the test substance was applied for 24 hours, as received to the backs in appropriate doses and the application site was covered with gauze bandaging and occluded with saran wrap.

After observation time of 14 days no mortality was observed and all rabbits exhibited body weight gains or maintained their body weight during the 14 day observation period. Thus, the deduced LD0 and LD50 values and are 8000 mg/kg bw and > 8000 mg/kg bw respectively. A LD50 value of > 6000 mg/ kg bw is calculated for 100 % t-butyl peroxyneodecanoate.