Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report Date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
: no analytics; 2 animals/sex/dose
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Lupersol 223 (Di-(2-ethylhexyl)peroxydicarbonate)
- Substance type: organic peroxide
- Physical state: clear liquid
- Lot/batch No.: OMQG 281

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1810 to 2450 g
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Type of wrap if used: gauze bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): tepid tap water
- Time after start of exposure: 24 h
Duration of exposure:
24 h
Doses:
200 mg/kg and 2000 mg/kg
No. of animals per sex per dose:
2
Control animals:
not specified
Details on study design:
The hair was removed from the back of each rabbit with an electric clipper. The skin of one male and one female rabbit in each group was abraded with a scalpel blade.
The test material was applied only once, following which the site of application was occluded and wrapped with a gauze bandage. 24 hours later the bandages were removed and the backs washed with tepid tap water.

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at the beginning of the study, 7 days and 14 days after compound application
- Necropsy of survivors performed: no

Statistics:
none

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None
Body weight:
Each of the rabbits showed gains in body weight during the 14 day period of observation
Gross pathology:
None
Other findings:
At 24 hours following application, erythema (moderate to marked) and edema (slight to moderate) was observed in all rabbits. Additionally blanching was observed. Desquamation was noted during the 14 day observation period. Each of the rabbits showed gains in body weight during the observation period.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 is > 2000 mg/kg. Thus, the test item is not considered a toxic substance by the dermal route of administration.
Executive summary:

In an acute dermal toxicity study groups of male and female New Zealand white rabbits (2 male and 2 females) were dermal exposed in a limit test to Lupersol 223(Bis-(2 -ethylhexyl)) peroxycarbonate for 24 hours at doses of  200 and 2000  mg/kg bw.  Animals then were observed for 14 days. At 24 hours following application, erythema (moderate to marked) and edema (slight to moderate) was observed in all rabbits. Additionally blanching was observed. Desquamation was noted during the 14 day observation period. Each of the rabbits showed gains in body weight during the observation period.

The dermal LD0 is 2000 mg/kg bw. Lupersol 223 (Bis-(2 -ethylhexyl)peroxycarbonate) is not toxic by the dermal route.