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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:
weight of evidence
Study period:
1977-05-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline 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)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Strain:
other: Charles river (CD)
Sex:
male/female
Details on test animals and environmental conditions:
0 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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
- Concentration in vehicle: 40%
Doses:
1900 mg/kg bw, 2700 mg/kg bw, 3800 mg/kg bw, 5300 mg/kg bw
No. of animals per sex per dose:
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
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 870 mg/kg bw
Based on:
test mat.
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
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.