But-3-en-3-olide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1973

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Dermal toxicity data are tabulated in a continuing program to predict potential acute hazards to health of accidental human contact. Table only, no further information.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1974

Report date:

1973

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: H.F. Smyth et al., 1962, Range finding toxicity data: List VI, Am. Ind. Hyg. J., 23, 95-107

Deviations:

not specified

Principles of method if other than guideline:

Groups of four male albino New Zealand rabbits were used. The fur is removed from the entire trunk by clipping, and the dose is retained beneath an impervious plastic film. The animals are immobilized during the 24-hour contact period, after which the film is removed and the rabbits are caged for the subsequent 14-day observation period. The LD50 is calculated.

GLP compliance:

no

Remarks:

performed before GLP guidelines

Test type:

other: single skin penetration

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

But-3-en-3-olide

EC Number:

211-617-1

EC Name:

But-3-en-3-olide

Cas Number:

674-82-8

Molecular formula:

C4H4O2

IUPAC Name:

4-methylideneoxetan-2-one

Constituent 2

Reference substance name:

Keten dimer

IUPAC Name:

Keten dimer

Details on test material:

no data

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

no data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Method: Penetration of rabbit skin is estimated by a technique closely to the on-day cuff method of Draize and associates, using groups of four male albino New Zealand rabbits weighing 2.5 to 3.5 kg. The fur is removed from the entire trunk by clipping, and the dose is retained beneath an impervious plastic film. Dosages greater than 20 ml/kg cannot be retained in contact with the skin. The animals are immobilized during the 24-hour contact period, after which the film is removed and the rabbits are caged for the subsequent 14-day observation period. The LD50 is calculated by the method of Thompson using the Tables of Weil.

Duration of exposure:

24 h

Doses:

up to 20 mL/kg bw

No. of animals per sex per dose:

4

Control animals:

not specified

Details on study design:

Please refer to "Details on dermal exposure"

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

3 100 mg/kg bw

Based on:

test mat.

95% CL:

> 1 914 - < 5 000

Remarks on result:

other: rabbit

Mortality:

no data

Clinical signs:

other: no data

Gross pathology:

no data

Other findings:

no data

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

With respect to the LD50 value of 2.83 mL/kg bw corresponding to 3100 mg/kg bw the test substance needs not be classified

Executive summary:

Please refer to "Conclusions"