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Acute Toxicity: dermal

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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

Referenceopen allclose all

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 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 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

Constituent 1
Chemical structure
Reference substance name:
Maleic anhydride
EC Number:
203-571-6
EC Name:
Maleic anhydride
Cas Number:
108-31-6
Molecular formula:
C4H2O3
IUPAC Name:
furan-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:
not available
Body weight:
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.

 

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