Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1976
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

Reference
Name:
Unnamed
Type:
Constituent
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 levelsopen allclose all
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
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
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
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:
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.