2-Butanone, peroxide

Acute Toxicity: dermal

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

Test material information

Constituent 1

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.