Maleic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977-05-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to OECD Guideline 401 (Acute Oral Toxicity)

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

None

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Maleic acid

EC Number:

203-742-5

EC Name:

Maleic acid

Cas Number:

110-16-7

Molecular formula:

C4H4O4

IUPAC Name:

but-2-enedioic acid

Details on test material:

- Name of test material (as cited in study report): Maleic acid (A7020)
- Molecular formula (if other than submission substance): Not available
- Molecular weight (if other than submission substance): Not available
- Substance type: Pure active substance
- Physical state: Solid
- Analytical purity: See below
- Impurities (identity and concentrations): See below
- Composition of test material, percentage of components: See below
- Isomers composition: See below
- Purity test date: Not available, ~1977
- Lot/batch No.: Sample identification ALA 272
- Expiration date of the lot/batch: n/a
- Stability under test conditions: Not available
- Storage condition of test material: Room temperature
- Other: TSIN A7020

Test animals

Species:

rat

Strain:

other: Charles River (CD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc.
- Age at study initiation: Not available
- Weight at study initiation: 224 grams - 270 grams (Mean weight 251.3 grams) for Male and
190 grams - 222 grams (Mean weight 202.7 grams) for Female animal
- Fasting period before study: 18-20 hours
- Housing: Individually in suspended stainless steel cages
- Diet (e.g. ad libitum): Purina Rat Chow
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 7 days minimum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 24 DegreeC
- Humidity (%): 40 - 60%
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark


IN-LIFE DATES: 1977-05-11

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 40%
- Amount of vehicle (if gavage): None
- Justification for choice of vehicle: None
- Lot/batch no. (if required): None
- Purity: None


MAXIMUM DOSE VOLUME APPLIED: 3.1 ml


DOSAGE PREPARATION (if unusual): None


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: None

Doses:

1900 mg/kg bw, 2700 mg/kg bw, 3800 mg/kg bw, 5300 mg/kg bw

No. of animals per sex per dose:

5 Male and 5 Female animals per dose group.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At 1/4 hr, 1/2 hr, 1 hr, 2 hr and 4 hour timepoints following administration of compound, then daily thereafter for 14 days, Prefasting weights, fasting weights, and daily weights for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical observations, body weight, mortality

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 870 mg/kg bw

95% CL:

2 470 - 3 250

Mortality:

1900 mg/kg bw (0/5 Male and 2/5 Female),
2700 mg/kg bw (0/5 Male and 3/5 Female),
3800 mg/kg bw (4/5 Male and 5/5 Female),
5300 mg/kg bw (5/5 Male and 5/5 Female)

Clinical signs:

other: Clinical signs observed were: decreased motor activity, coarse body tremors, blanching, salivation, pilo erection, and diarrhea.

Gross pathology:

Soft stool (In 1 Male animal), Diarrhea (In 1 Male and 1 Female animal), Pale kidneys (In 3 Male animals)/ liver (In 3 Male
animals)/ spleen (In 2 Male animals)/, Congested liver (In 2 Male animals)/, Bright/ moderate/ deep red lungs (In 5 Male and 12 Female animals), Tan
discoloration of lungs (In 1 Female animal), Petechiae on the lungs (In 2 Male and 2 Female animals), Compound/ fluid/ gas filled stomach/ intestine
(In 9 Male and 15 Female animals), Nasal/ ocular hemorrhage (In 1 Male and 2 Female animals), Opaque left eye in 1 Male animal.

Other findings:

- Organ weights: None
- Histopathology: None
- Potential target organs: None
- Other observations: None

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The Oral LD50 = 2870 (2470-3250) mg/kg bw or Oral LD50=2382.1 (2050.1-2697.5) mg/kg bw based on active level.

Executive summary:

The Oral LD50 of Maleic acid was determined to be 2870 (2470-3250) mg/kg bw or Oral LD50=2382.1 (2050.1-2697.5) mg/kg bw based on active level. This substance is classified as OECD GHS Toxicity Category V for oral toxicity.