Bis(2,4-dichlorobenzoyl) peroxide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: No guideline followed. Not a GLP study. Evaluation of clinical symptoms was not reported. The identity of the test material was not established.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Graded doses of the test material were applied to the skin of rabbits and observed for 14 days.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2,4-dichlorobenzoyl) peroxide

EC Number:

205-094-9

EC Name:

Bis(2,4-dichlorobenzoyl) peroxide

Cas Number:

133-14-2

Molecular formula:

C14H6Cl4O4

IUPAC Name:

2,4-dichlorobenzoyl 2,4-dichlorobenzene-1-carboperoxoate

Test material form:

not specified

Details on test material:

Details were not provided clearly and completely except a handwritten note "50% in silicone oil" on page 1 of the entire report summarizing the conclusions from 3 different toxicity studies. In the dermal toxicity study report, the test material is stated as Cedox TS-50.

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Eight rabbits equally divided as to sex, weighing 2317 to 2831 gms were used. No other details were provided.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

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 divided into four groups of 2 rabbits (one male and one female) for each group (dose levels of 1000, 2000, 3000, and 4000 mg/kg). The test material was applied as received to the backs in appropriate doses. The site of application was covered with gauze bandaging and occluded with Saran wrap.

Duration of exposure:

14 days

Doses:

1000, 2000, 4000 and 8000 mg/kg

No. of animals per sex per dose:

one male and female per dose.

Control animals:

no

Details on study design:

No other details provided

Statistics:

None

Results and discussion

Preliminary study:

The rabbits were observed for death at 24 hours and daily thereafter for a total of 14 days. It was concluded that the acute dermal toxicity (LD50) value in albino rabbits would be greater than 8000 mg/kg.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 8 000 mg/kg bw

Based on:

other:

Remarks on result:

other: Not clear as to how the dose formulations were calculated and prepared from the test item.

Mortality:

None.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal toxicity (LD50) value in albino rabbits would be greater than 8000 mg/kg.

Executive summary:

There were no mortalities.

Although the study concluded that the LD50 value in rabbits was greater than 8000 mg/kg, due to the non-GLP nature of the experiment, and the lack of some details on the test item and some experimental conditions, the level of confidence in the conclusions is somewhat less reliable.