Registration Dossier
Registration Dossier
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EC number: 201-072-8 | CAS number: 77-95-2
Acute Toxicity: oral
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:
- 1 980
- Bibliographic source:
- Drug Chem Toxicol. 3(3):249-58
- Reference Type:
- secondary source
- Title:
- ChemIDplus Advanced
- Author:
- U.S. National Library of Medicine
- Year:
- 2 013
- 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 substance name:
- Cyclohexanecarboxylic acid
- EC Number:
- 202-711-3
- EC Name:
- Cyclohexanecarboxylic acid
- Cas Number:
- 98-89-5
- IUPAC Name:
- cyclohexanecarboxylic acid
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Cyclohexanecarboxylic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: FDRL Strain
- Sex:
- male/female
- Details on test animals or test system 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
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