4-(isopropyl)cyclohexyl propionate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was conducted in March 1977.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Reliability 2 is assigned because although the study was conducted similar to the current OECD TG 401, the study is non-GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

1

Reference substance name:

4-(isopropyl)cyclohexyl propionate

EC Number:

264-165-2

EC Name:

4-(isopropyl)cyclohexyl propionate

Cas Number:

63449-95-6

Molecular formula:

C12H22O2

IUPAC Name:

4-(isopropyl)cyclohexyl propionate

Test material form:

other: liquid

Details on test material:

- Storage condition of test material: Store in cool dark place at room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Test substance was administered undiluted in a single oral dose to nonfasted rats.

Doses:

Five doses were used in the study: 3980, 5010, 6310, 7940 and 10000 mg/kg bw.

No. of animals per sex per dose:

5 rats per dose

Control animals:

no

Details on study design:

Duration of observation period following administration: 14 days.
Animals of two sexes were used instead of one sex.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

6 600 mg/kg bw

Based on:

test mat.

95% CL:

> 4 950 - < 8 780

Mortality:

The following numbers of animals died in the study at the doses:
- 3980 mg/kg bw: 1
- 5010 mg/kg bw: 2
- 6310 mg/kg bw: 2
- 7940 mg/kg bw: 3
- 10000 mg/kg bw: 5.

Clinical signs:

Signs of intoxication included: reduced appetite and activity (one to five days in survivors), increasing weakness, tremors, convulsions, collapse and death.

Gross pathology:

Gross autopsy demonstrated: hemorrhagic areas of the lungs, liver hyperemia and acute gastrointestinal inflammation.

Other findings:

In survisors (at 14 days) viscera appeared normal.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

According to EU CLP 1272/2008 and its amendments.

Conclusions:

The acute oral toxicity test showed an LD50 of 6600 mg/kg bw. Based on the results of this study, test substance is not acute orally toxic.

Executive summary:

Acute oral toxicity was performed similar to the guideline OECD TG 401. Five rats (males and females) per dose were administered the substance at doses: 3980, 5010, 6310, 7940 and 10000 mg/kg bw. The following numbers of rats died during the study: 1 at 3980 mg/kg bw, 2 at 5010 mg/kg bw, 2 at 6310 mg/kg bw, 3 at 7940 mg/kg bw and 5 at 10000 mg/kg bw. The clinical signs observed during the study included: reduced appetite and activity (one to five days in survivors), increasing weakness, tremors, convulsions, collapse and death. Gross autopsy demonstrated: hemorrhagic areas of the lungs, liver hyperemia and acute gastrointestinal inflammation. The acute oral LD50 for the substance in male and female rats was determined to be 6600 mg/kg bw, therefore the substance is not toxic by the oral route.