4-trans-(4-trans-Propylcyclohexyl)-cyclohexancarbonic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Only a brief summary of the results is available

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

02-1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(1r,1's,4r,4'r)-4'-propyl-[1,1'-bi(cyclohexane)]-4-carboxylic acid

EC Number:

613-782-9

Cas Number:

65355-32-0

Molecular formula:

C16 H28 O2

IUPAC Name:

(1r,1's,4r,4'r)-4'-propyl-[1,1'-bi(cyclohexane)]-4-carboxylic acid

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

not specified

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Remarks:

Methocel(R) K4M Premium solution

Details on oral exposure:

not specified

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

not specified

Control animals:

no

Details on study design:

In this GLP study performed according to the OECD GL 401, the test item was tested for acute toxicity in rats after single oral administration of 2000 mg/kg body weight. Directly before administration the test material was prepared with aqueous Methocel K4M Premium solution as the vehicle. The duration of observation period following administration was 14 days.

Statistics:

not specified

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

All rats survived the observation period.

Clinical signs:

other: No signs of toxicity were seen in dosed rats.

Gross pathology:

The gross pathological examination revealed no organ alterations.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the result of this study, it is concluded that the test material has no acute toxic potential up to the limit dose of 2000 mg/kg bw. Therefore, the LD50 value is higher than 2000 mg/kg bw after single oral administration in rats.

Executive summary:

The test material was tested for acute toxicity in rats after oral administration of 2000 mg/kg bw. Directly before the administration, the test material was prepared with aqueous Methocel K4M Premium solution. No signs of intoxication were detected after treatment. Thus, the study was performed as limit test. The gross pathological examination revealed no organ alterations. For regulatory purposes, the median lethal dose (LD50) for males and females, can be declared as >2000 mg/kg bw after an observation period of 15 days.