4-(isopropyl)cyclohexyl propionate

Endpoint summary

Description of key information

Acute oral toxicity: OECD TG 401: 6600 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

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.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

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.

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.

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.       

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

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.

Also acute dermal and inhalation studies are available and only the results are presented because they do not change the classification and labelling.

Acute dermal toxicity was assessed in the same study and resulted in mortality in 1 animal/sex at 7940 mg/kg bw. The LD50 was > 5010 mg/kg bw.

Acute inhalation toxicity was assessed in the same study and resulted in absence of mortality at 0.1 mg/l (100 mg/m3).

Justification for classification or non-classification

According to the criteria outlined in EU CLP 1272/2008/EC (and its amendments), the substance does not have to be classified as acute toxic by the oral route.