Maleic anhydride

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Acute toxicity and skin corrosion data for some organic and inorganic compounds and aqueous solutions.

Author:

Vernot E.H., MacEwen D.D., Haun C.C., Kinkead E. R.,

Year:

1977

Bibliographic source:

Toxicol. Appl. Pharmacol. 42, 417-424

Reference 2

Reference Type:

publication

Title:

Range-Finding Toxicity Data: List VI

Author:

Smyth HF, Carpenter CP, Weil CS, Pozzani UC, Striegel JA

Year:

1962

Bibliographic source:

Am. Ind. Hyg. Assoc. J., 23(4), 95-107

Reference 3

Reference Type:

review article or handbook

Title:

Maleic Anhydride and Maleic Acid, SIDS Initial Assessment Report For SIAM 18

Author:

OECD SIDS

Year:

2004

Bibliographic source:

OECD SIDS Initial Assessment Report For SIAM 18, Paris, France, 20-23 April 2004

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The method used for skin absorption toxicity was essentially that of Smyth et al. (1962). The test substance was applied epidermal to rabbits to determine the LD50.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Maleic anhydride

EC Number:

203-571-6

EC Name:

Maleic anhydride

Cas Number:

108-31-6

Molecular formula:

C4H2O3

IUPAC Name:

2,5-dihydrofuran-2,5-dione

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

female

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- Type of wrap if used: latex rubber film

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g and 0.5 ml, respectively

Duration of exposure:

24 hours

Doses:

not specified

No. of animals per sex per dose:

3 females per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

2 620 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 1930 - 3550 mg/kg bw

Mortality:

not available

Clinical signs:

other: not available

Gross pathology:

not available

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Reported LD50 value was 2620 mg/kg bw in female rabbits. Therefore, classification for acute dermal toxicity according to the CLP regulation 1272/2008 is not warranted.

Executive summary:

In an acute dermal toxicity study groups of female albino New Zealand rabbits were dermally exposed to maleic anhydride. The method used for skin absorption toxicity was essentially that of Smyth et al. (1962) except that the doses (1930 - 3550 mg/kg bw) were kept in place by gauze patches under a latex rubber film. No information on clinical signs or mortality figures were available.

 

Reported dermal LD₅₀Females = 2620 mg/kg bw

 

Therefore, classification for acute dermal toxicity according to the CLP regulation 1272/2008 is not warranted.