2,2-dimethylpropane-1,3-diyl dibenzoate

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:

other: Despite the low number of animals and the lack of gross pathological examination the evaluable report provided sufficient information to evaluate this endpoint.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Low number of animals in test and no necropsy is performed at the end of the observation time.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2-dimethylpropane-1,3-diyl dibenzoate

EC Number:

224-081-9

EC Name:

2,2-dimethylpropane-1,3-diyl dibenzoate

Cas Number:

4196-89-8

Molecular formula:

C19H20O4

IUPAC Name:

3-(benzoyloxy)-2,2-dimethylpropyl benzoate

Specific details on test material used for the study:

- yellowish white chunks

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: 2310-2381 g
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: 9 days

ENVIRONMENTAL CONDITIONS
- temperature and humidity controlled quarters
- The animals were maintained in accordance with the recommendations contained in H.E.W. Publication No.74-23 (N.I.H.) entitled "Guide for the care and use of laboratory animals"

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

physiological saline

Details on dermal exposure:

The test material was applied once only to the shaved backs of the rabbits at a dosage level of 20000 mg/kg bw for 24 hours. Physiological saline was used as a wetting agent.

Duration of exposure:

24 hours

Doses:

20000 mg/kg bw

No. of animals per sex per dose:

4

Control animals:

other: untreated area at the opposite site

Details on study design:

2 male and 2 female rabbits were used. The hair was removed from the back of the rabbits (20-30 % of the body surface) with an electric clipper. The skin of 2 rabbits was abraded. The test material was applied once only to the shaved backs of the rabbits at a dosage level of 20000 mg/kg bw for 24 hours. Physiological saline was used as a wetting agent. The opposite site of the treatment area served as control. The treated area were covered by semiocclusive dressing. After 24 hours of exposure the bandages were removed and animals were observed for mortality, clinical signs , body weight development and local effects at the treatment area up to 14 days post exposure.

Statistics:

no data

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 20 000 mg/kg bw

Remarks on result:

other: No rabbit died. All rabbits appeared normal and gained body weight. Some animals showed slight to very slight discoloration at the treated area, but recovered within the 14 day observation period.

Mortality:

No rabbit died.

Clinical signs:

other: All rabbits appeared normal.

Gross pathology:

Gross pathological examination was not performed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

2,2-dimethylpropane-1,3-diyl dibenzoate was applied once only to the shaved backs of the rabbits at a dosage level of 20000 mg/kg bw for 24 hours. No rabbit died. All rabbits appeared normal and gained body weight. Thus, the LD50 is > 20000 mg/kg bw.

Executive summary:

Despite the low number of animals and the lack of gross pathological examination the following examination is similar to the guideline of today and is valid for evaluation of this endpoint: To examine the acute dermal toxicity 2 male and 2 female rabbits were used. The hair was removed from the back of the rabbits (20-30 % of the body surface) with an electric clipper. The skin of 2 rabbits was abraded. The test material was applied once only to the shaved backs of the rabbits at a dosage level of 20000 mg/kg bw for 24 hours. Physiological saline was used as a wetting agent. The opposite site of the treatment area served as control. The treated area were covered by semiocclusive dressing. After 24 hours of exposure the bandages were removed and animals were observed for mortality, clinical signs, body weight development and local effects at the treatment area up to 14 days post exposure. No rabbit died. All rabbits appeared normal and gained body weight. Some animals showed slight to very slight discoloration at the treated area, but recovered within the 14 day observation period. Thus, the LD50 is > 20000 mg/kg bw.