Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
NA
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Purity batch
> 99.0 % 7.32% active oxygenBatch 247408973
99.27 % 9407226339; 247408999
99.6 % 0410105225413
> 97 % 4289070300; 0419101226056
99.1 % 11600 0010-108
99.3 % 247413988
99.4 % 7.35 % active oxygen Batch 247409800
98.9 % 0707518256
> 99.1 % 247412384
98.5 % 0707603153
99.0 % 1703465433
99.5 % 150726; 247413309
99.3 % 000055055

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
Source: H.A.R.E. Rabbits for Research, Hewitt, New Jersey or Kuiper's Rabbit Ranch, Gary, Indiana
Housing: rabbits were individually housed in hanging wire-mesh cages in temperature and humidity controlled quarters
Conditioning period: 13 days prior to study initiation
Diet: ad libitum
Water: ad libitum
Body weights prior to administration: 2300 to 2804 g

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back of each rabbit
- % coverage: 20 - 30 % of the body surface
- Type of wrap if used: the application sites were wrapped with gauze bandaging and overwrapped with Saran Wrap. The entire application area was then wrapped with Several layers of 75 mm Elastoplast tape. A collar was also applied.


REMOVAL OF TEST SUBSTANCE
- 24 hours following application, the bandages and collars were removed and the test sites were washed with tepid tap water


Duration of exposure:
24 hours
Doses:
2.5, 5, 10 and 20 g/kg bw
No. of animals per sex per dose:
2 animals per sex per dose (total: 8 animals)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: pharmaceutical signs, mortality, dermal irritation
Statistics:
95% Confidence limits

Results and discussion

Preliminary study:
No preliminary study
Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
14 142 mg/kg bw
95% CL:
> 7 071 - < 28 284
Sex:
male
Dose descriptor:
LD50
Effect level:
20 000 mg/kg bw
95% CL:
> 10 000 - < 40 000
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
16 818 mg/kg bw
95% CL:
> 11 892 - < 23 784
Mortality:
3 animals (2 females, 1 male) died during the 14 day study period at a dosage level of 20 g.
Clinical signs:
NA
Body weight:
NA
Gross pathology:
NA
Other findings:
NA

Any other information on results incl. tables

No remarks

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Eight male and 8 female New Zealand White rabbits were used for this study. The rabbits were divided into 4 groups of 2 male and 2 female rabbits each. The test material was applied once only to the backs of the rabbits at the following dosage levels: 2.5, 5, 10 and 20 g/kg.
Based upon the data obtained, the acute dermal LD50 values and 95% confidence limits (CL) were estimated to be as follows:
male rabbits: 20 g/kg bw with 95%CL of 10 - 40 g/kg bw
female rabbits: 14.14 g/kg bw with 95%CL of 7.07 - 28.28 g/kg bw
Combined male and female rabbits: 16.82 g/kg with 95%CL of 11.89 - 23.78 g/kg
Executive summary:

Tert.-Butylperoxy- 2-ethylhexanoat was tested to eight male and 8 female New Zealand White rabbits were used for this study. The rabbits were divided into 4 groups of 2 male and 2 female rabbits each. The test material was applied once only to the backs of the rabbits at the following dosage levels: 2.5, 5, 10 and 20 g/kg.

Based upon the data obtained, the acute dermal LD50 values and 95% confidence limits (CL) were estimated to be as follows:

male rabbits: 20 g/kg bw with 95%CL of 10 - 40 g/kg bw

female rabbits: 14.14 g/kg bw with 95%CL of 7.07 - 28.28 g/kg bw

Combined male and female rabbits: 16.82 g/kg with 95%CL of 11.89 - 23.78 g/kg