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

Endpoint summary

Description of key information

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 (reference 7.2.1 -1).

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

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

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

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

not specified

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

Data are considered reliable to cover this endpoint

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

Acute oral toxicity

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.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

The available data for acute toxicity are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The test item is not considered to be classified for acute oral toxicity  according to EU Regulation (EC) No 1272/2008 (CLP), as amended for fifteenth time in Regulation (EU) No 2020/217.