Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study, comparable to OECD 402 guideline. Raw data available. Nevertheless there is few data on the substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: LaCrosse Industries, Inc., Schenectady, New York
- Age at study initiation: no data (young adults)
- Weight at study initiation: no data
- Housing: The rabbits were individually housed in wire mesh bottom cages in environment-controlled rooms and provided NIH 09 Rabbit Ration (Zeigler Brothers, Gardners, PA) and had water ad libitum
- Acclimation period: minimum of 5 days

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The test article was administered to intact skin under an occlusive binder at a level of 2.0 g/kg body weight. The binder consisted of a layer of plastic wrap and stockinette sleeve all securely held in place with mask­ ing tape.
Duration of exposure:
24 hours
Doses:
2 g/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
After an exposure period of 24 hours, the binders were removed. The exposure sites were gently wiped with clean gauze to remove
as much non-absorbed test article as possible.
All animals were observed frequently on the day of dosing and twice daily thereafter for the remainder of the study.
All external signs of toxicity or pharmacological effects were noted. Necropsy was performed on all animals
Body weights were recorded initially, on days 8 and 15 or at death.
Statistics:
not applicable

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
Anorexia : 1/5 male and 0/5 female
Diarrhea 1/5 male and 1/5 female
Nasal discharge: 1/5 male and 0/5 female
Soft stools: 1/5 male and 1/5 female
Body weight:
no significal changes (male: intial mean body weight: 2.37; after 8 days: 2.49; after 15 days: 2.69 Kg, female: intial mean body weight: 2.36; after 8 days: 2.41; after 15 days: 2.60 Kg)
Other findings:
No noteworthy findings at necropsy

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions, t-Butyl-2-Ethylhexyl-monoperoxycarbonate did not cause mortality in an acute dermal toxicity test at 2 g/kg.
Executive summary:

t-Butyl-2-Ethylhexyl-monoperoxycarbonate was evaluated for acute dermal toxicity in male and female white rabbits in a limit test similar to OECD 402 guideline. The test article was applied to each of ten rabbits at a level of 2.0 g/kg body weight.

There was noteworthy findings at necropsy. All animals survived the 15 day post-application observation period. Based on this result, the acute dermal LD50 of the test article is considered to be greater than 2.0 g/kg body weight.