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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, reasonably well documented publication
Justification for type of information:
he extrapolation from sorbic acid to potassium sorbate or vice versa is considered not to be restricted in any way, since the determinant of potential toxicity is on the "sorbate" anion.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Sorbic acid as a fungistatic agent for foods: I. Harmlessness of sorbic acid as a dietary component
Author:
Deuel, H.J. et al.
Year:
1954
Bibliographic source:
Food Research, Vol. 19: 1 -12.

Materials and methods

Principles of method if other than guideline:
Method followed: acute oral toxicity test, no guideline specified at the time of conduct
The acute oral toxicity of sorbic acid was tested in Sherman rats. The substance was administered orally by incorporation into the diet.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Sorbic acid
- Specification: commercial grade
- Batch No.: Drum No. 460-R
- Purity: > 99 %
- Expiration date of the batch: the test substance was considered to be stable for the duration of the study


Test animals

Species:
rat
Strain:
Sherman
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Mellon Institute of Ind. Research, Pittsburgh, U.S.A.
- Weight at study initiation: 90 to 120 g

Administration / exposure

Route of administration:
oral: feed
Vehicle:
other: 1 % "Tergitol" Penetrant 7 and 0.25 % agar solution
Details on oral exposure:
DOSAGE PREPARATION: suspension of 0.2 g/ml sorbic acid in vehicle

Doses:
no data (individual doses tested are not stated)
No. of animals per sex per dose:
 5 males / 5 females per group
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Examinations: mortality
Statistics:
Estimation not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
10 500 mg/kg bw
95% CL:
9 170 - 12 030

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 = 10.50 g/kg bw (95% CI = 9.17-12.03 g/kg bw)
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