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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
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
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
see below
Principles of method if other than guideline:
The hair was clipped from the back of each rabbit. The skin was abraded for 1/2 of the rabbits in each group. The rabbits were equally in 4 dosage levels (1000, 2000, 4000 and 8000 mg/kg). The test material was applied, to the backs in appropriate doses. The site of application was covered with gauze bandaging and occluded with Saran Wrap.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[(2-hydroperoxybutan-2-yl)peroxy]butane-2-peroxol; butane-2,2-diperoxol
EC Number:
700-954-4
Cas Number:
1338-23-4
Molecular formula:
Mixture of C4H10O4 and C8H18O6
IUPAC Name:
2-[(2-hydroperoxybutan-2-yl)peroxy]butane-2-peroxol; butane-2,2-diperoxol

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2317 to 2548 grams

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The skin was abraded for 1/2 of the rabbits in each group. The test material was applied, to the backs in appropriate doses. The site of application was covered with gauze bandaging and occluded with Saran Wrap.
Doses:
1000, 2000, 4000 and 8000 mg/kg
No. of animals per sex per dose:
1 animal per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: The rabbits were observed for death at 24 hours and daily thereafter for a total of 14 days.
- Necropsy of survivors performed: no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 000 mg/kg bw
Based on:
test mat.
95% CL:
2 000 - 8 000
Mortality:
Three animals died on day 1. (Details see "any other information on results incl. tables".)

Any other information on results incl. tables

Table: Dose - Mortality Table

Dose levels (mg/kg)

Number of deaths

Mortality incidence

days

1

2

Male

Female

Total

1000

 

 

0/1

0/1

0/2

2000

 

 

0/1

0/1

0/2

4000

1

 

0/1

1/1

1/2

8000

2

 

1/1

1/1

2/2

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The calculated actue dermal toxicity (LD50) value in male and female albino rabbits was found to be 4000 (2000 - 8000) mg/kg.
Executive summary:

Methyl-ethylketone peroxide in DMP was tested in a acute dermal study to eight New Zealand White rabbits, equally divided as to sex in 4 groups. The hair was clipped from the back of each rabbit. The skin was abraded for 1/2 of the rabbits in each group. The dosage levels were 1000, 2000, 4000 and 8000 mg/kg. The test material was applied to the backs in appropriate doses. The site of application was covered with gauze bandaging and occluded with Saran Wrap.

The rabbits were observed for death at 24 hours and daily thereafter for a total of 14 days.

The calculated actue dermal toxicity (LD50) value in male and female albino rabbits was found to be 4000 (2000 - 8000) mg/kg.