Maleic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

no data

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Documentation insufficient for assessment

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1976

Reference 2

Reference Type:

secondary source

Title:

Acute Toxicologic Evaluation of Maleic Anhydride

Author:

Randall DJ

Year:

1990

Bibliographic source:

J. Am. Coll. Toxicol. Pt. B: Acute Toxicity Data 1(1): 75

Materials and methods

Test guideline

Qualifier:

no guideline followed

Guideline:

other: no data

Deviations:

not applicable

Principles of method if other than guideline:

Test substance was applied as a 40% suspension in corn oil or a 40% aqueous solution with an exposure time of 24 hours and a 14 day exposure observation period. One animal per dose.

GLP compliance:

no

Test type:

other: no data

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:

furan-2,5-dione

Details on test material:

Maleic anhydride hydrolyses under test conditions. As a result it is believed that maleic acid and its sodium salt were the test materials investigated in this study. See also SIDS Initial Assessment.

Test animals

Species:

rabbit

Strain:

not specified

Sex:

not specified

Administration / exposure

Type of coverage:

not specified

Vehicle:

other: corn oil or water

Details on dermal exposure:

Test substance was applied as a 40% suspension in corn oil or a 40% aqueous solution.

Duration of exposure:

24 hours

Doses:

suspension in corn oil: 631, 1000, 1580, and 2510 mg/kg
aqueous solution: 251, 398, 631 and 1000 mg/kg

No. of animals per sex per dose:

1 (sex unknown)

Control animals:

not specified

Details on study design:

observation period: 14 days

Statistics:

no data

Results and discussion

Effect levels

Effect levels 1

Sex:

not specified

Dose descriptor:

LD100

Effect level:

1 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: test substance administered as 40 % suspension in corn oil

Effect levels 2

Sex:

not specified

Dose descriptor:

LD0

Effect level:

631 mg/kg bw

Based on:

test mat.

Remarks on result:

other: test substance administered as 40 % suspension in corn oil

Effect levels 3

Sex:

not specified

Dose descriptor:

LD100

Effect level:

631 mg/kg bw

Based on:

test mat.

Remarks on result:

other: test substance administered as 40 % aqueous solution

Effect levels 4

Sex:

not specified

Dose descriptor:

LD0

Effect level:

398 mg/kg bw

Based on:

test mat.

Remarks on result:

other: test substance administered as 40 % aqueous solution

Mortality:

In the corn oil group, the rabbits survived at 631 mg/kg, but died within 1 day at 1000, 1580, and 2510 mg/kg.
In the aqueous group, the animals survived at 251 and 398 mg/kg, but died within 16 hours at 631 and 1000 mg/kg.

Clinical signs:

other: Effects of both treatments produced reduced appetite and activity, increasing weakness, collapse and death.

Gross pathology:

Gross pathological findings included lung and liver hyperemia, enlarged gallbladder, discoloration of the spleen and kidney, and gastrointestinal inflammation. In survivors, the viscera appeared normal.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to the mortalities observed, the LD50 is higher than 398 mg/kg body weight and lower than or equal to 631 mg/kg body weight.

Executive summary:

Maleic anhydride was administered at various dosed to groups of one rabit each at doses between 251 and 2510 mg/kg body weight. The test substance was either suspended in corn oil (40 %) or dissolved in water (40 %). Maleic anhydride hydrolyses under test conditions. As a result it is believed that maleic acid and its sodium salt were the test materials investigated in this study.

In the corn oil group, the rabbit survived at 631 mg/kg, but died within 1 day at 1000, 1580, and 2510 mg/kg. In the aqueous group, the animals survived at 251 and 398 mg/kg, but died within 16 hours at 631 and 1000 mg/kg. Effects of both treatments produced reduced appetite and activity, increasing weakness, collapse and death. Gross pathological findings included lung and liver hyperemia, enlarged gallbladder, discoloration of the spleen and kidney, and gastrointestinal inflammation. In survivors, the viscera appeared normal.

The LD50,acute,dermal,rabbit is therefore estimated to be between 398 (practically: 400) and 1000 mg/kg body weight.