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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
not specified
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Significant experimental and reporting deficiencies: purity/stability of test item missing; number of animals per dose too low; observation period was stated to be at least 24 hour, but no further information was given on the length of the observation period; body weight and gross pathology measurements missing; acclimatisation period missing; housing conditions missing; fasting period not stated

Data source

Reference Type:
Inactive malic acid as a food acidulent
Weiss, J. M. et al.
Bibliographic source:
Ind. Eng. Chem. 15: 628 - 630.

Materials and methods

Test guideline
no guideline followed
Principles of method if other than guideline:
Female rabbits were administered citric acid anhydrous at dose levels of 3800, 4600, 5100, 6500 and 7000 mg/kg bw via gavage. One rabbit was dosed at each dose level and the animals were observed at least once an hour for 24 hours. Clinical signs and mortality were recorded.
GLP compliance:
not specified
not specified in the publication, but GLP was not compulsory at time of study conduct
Limit test:

Test material

Constituent 1
Reference substance name:
Citric acid
EC Number:
EC Name:
Citric acid
Cas Number:
Molecular formula:
Test material form:
solid: crystalline
Details on test material:
- Name of test material: citric acid
- State of aggregation: U.S.P. crystals
Specific details on test material used for the study:
not specified

Test animals

other: Belgian hare and Flemish Giant
Details on test animals or test system and environmental conditions:
TEST ANIMALS - growing animals
- Weight at study initiation: 1.675 kg to 2.166 kg
- Diet: hay and oats, supplemented by green vegetables
- Water

Administration / exposure

Route of administration:
oral: gavage
unchanged (no vehicle)
Details on oral exposure:
The doses were administered in a solution, or in a suspension when the solubility of the substance did not permit complete solution, using a total volume of 30 to 35 cc.
3800, 4600, 5100, 6500 and 7000 mg/kg bw
No. of animals per sex per dose:
1 female rabbit
Control animals:
Details on study design:
- Duration of observation period following administration: the animals were observed at least once an hour for 24 hours.
not specified

Results and discussion

Preliminary study:
not specified
Effect levels
Remarks on result:
other: Estimated initial minimum fatal dose: 7000 mg/kg bw of citric acid
7000 mg/kg bw: animal died 2 hours after feeding
3800, 4600, 5100, and 6500 mg/kg bw: all animals survived after test item adminsitration.
Clinical signs:
other: 7000 g/kg bw: the animal showed unfavorable symptoms 15 minutes after feeding; nervous tremors, violent twitching, and convulsions. 3800, 4600, 5100, and 6500 g/kg bw: no effects were observed. All animals showed no abnormal symptoms
Gross pathology:
not specified

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
According to the authors, the estimated initial minimum fatal dose for citric acid anhydrous was 7000 mg/kg bw.