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Toxicological information

Acute Toxicity: oral

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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:
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
Clinical signs observed were: decreased motor activity, coarse body tremors, blanching, salivation, pilo erection, and diarrhea.
Body weight:
Normal body weight gain was observed.
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.