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Diss Factsheets

Administrative data

Description of key information

The LD50 of the read across substance cyclohexanecarboxylic acid for rats is 3265 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 265 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The acute toxicity of the read across substance cyclohexanecarboxylic acid was tested on rats via oral route and was published by Moran, 1980. From this study it is shown, that the LD50 of cyclohexanecarboxylic acid is 3265 mg/kg bw. Thus we conclude that the LD50 of quinic acid is approx. 3265 mg/kg bw, too.

Justification for selection of acute toxicity – oral endpoint

The study is not done according to OECD guideline but it is a well documented publication.

Justification for classification or non-classification

The LD50 of the read across substance cyclohexanecarboxylic acid for rats after oral application is 3265 mg/kg bw. We consider that quinic acid has a similar LD50 value. According to CLP 1272/2008 criteria for oral toxicity quinic acid is not considered as harmful and does not need to be classified (LD50 >2000 mg/kg bw).