Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is not done according to OECD guideline.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Acute oral toxicity of selected flavor chemicals.
Author:
Moran, E. J. and Easterday, O. D.
Year:
1980
Bibliographic source:
Drug Chem Toxicol. 3(3):249-58
Reference Type:
secondary source
Title:
ChemIDplus Advanced
Author:
U.S. National Library of Medicine
Year:
2013
Bibliographic source:
http://chem.sis.nlm.nih.gov/chemidplus/
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The acute oral lethal doses was for determined for cyclohexanecarboxylic acid in rats. Tests were performed at Food and Drug Research Laboratories, Inc., Waverly, New York or Gulf South Research Institute, New Iberia, Louisiana. Groups of ten animals, five males and five females, weighing 40 to 60 g (FDRL Strain, Waverly, New York) were fasted overnight prior to treatment. The test substance was administered by oral gavage as a solution or suspension in corn oil. The concentration of the test substance in corn oil was adjusted so that each group of animals in a particular study received the same volume of solution with respect to body weight. Animals had free access to water at all times and to feed (Purina Laboratory Chow) following dosing. Animals were closely observed for mortality and pharmacologic effects on the day of dosing and daily thereafter for a total of 14 observation days. Rats were weighed prior to dosing.
GLP compliance:
not specified
Test type:
other: no details available
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Cyclohexanecarboxylic acid

Test animals

Species:
rat
Strain:
other: FDRL Strain
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Waverly, New York
- Weight at study initiation: 40 to 60 g
- Fasting period before study: fasted overnight prior to treatment
- Diet (e.g. ad libitum): free access to feed (Purina Laboratory Chow)
- Water (e.g. ad libitum): free access to water at all times

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
The concentration of the test substance in corn oil was adjusted so that each group of animals in a particular study received the same volume of solution with respect to body weight.
No. of animals per sex per dose:
Groups of ten animals: five males and five females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 observation days
- Frequency of observations and weighing: Animals were closely observed for mortality and pharmacologic effects on the day of dosing and daily thereafter for a total of 14 observation days. Rats were weighed prior to dosing.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 3 265 mg/kg bw
Based on:
test mat.
95% CL:
>= 2 791 - <= 3 820

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the read across substance cyclohexanecarboxylic acid for rats is 3265 mg/kg bw. It is considered as harmful according to EU criteria and does not need to be classified.
Executive summary:

The acute toxicity of the read across substance cyclohexanecarboxylic acid was tested on rats after oral application and was published by Moran, 1980. From this study it is shown, that the LD50 of cyclohexanecarboxylic acid is 3265 mg/kg bw. This indicates that cyclohexanecarboxylic acid is not harmful according to EU criteria. We consider that quinic acid has a similar LD50 value, so that quinic acid does not need to be considered as harmful according to EU criteria, too