cis-2-tert-butylcyclohexyl acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

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

Constituent 1

Reference substance name:

cis-2-tert-butylcyclohexyl acetate

EC Number:

243-718-1

EC Name:

cis-2-tert-butylcyclohexyl acetate

Cas Number:

20298-69-5

Molecular formula:

C12H22O2

IUPAC Name:

2-tert-butylcyclohexyl acetate

Test material form:

liquid

Details on test material:

Test material used is consistent with the substance identity as described in section 1.2 of IUCLID - company composition for the quality described under the common name Verdox.

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

not specified

Doses:

1.31, 3.2, 5.0 and 6.5 g/kg bw

No. of animals per sex per dose:

10 / dose, sex unknown

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observation: at 1-4 hours, afterwards daily
- Necropsy of survivors performed: not clear from report

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

4 600 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 700 - <= 7 800

Mortality:

1 animal died on day 7 in the group dosed with 1.31 g/kg bw; 5 animals died on the first day in the group dosed with 3.2 g/kg bw; 4 animals died on day 1 and 2 on day 2 in the group dosed with 5.0 g/kg bw and 3 animals died on day 1 and 1 on day 2 in the group dosed with 6.5 g/kg bw.

Clinical signs:

other: No symptoms were observed in rats dosed with 1.31 g/kg bw. In the group dosed with 3.2 g/kg bw, ataxia was observed in half of the animals, piloerection in 2-3 animals. In the group dosed with 5.0 g/kg bw, lethargy and tetanic convulsion were observed at

Gross pathology:

Very dark lungs were observed in 5 rats of 3.2 g/kg bw group; in 6 rats of 5.0 g/kg bw group and in 4 rats of 6.5 g/kg bw group. Very red stomach was observed in 1 rat from 3.2 g/kg bw group, 3 rats from 5.0 g/kg bw group and 1 rat from 6.5 g/kg bw group. Very red small intesting was found in 4 rats from 3.2 g/kg bw group, 5 rats from 5.0 g/kg bw group, and 1 rat from 6.5 g/kg bw group. Blood around nose and mouth was observed in 5 rats from 3.2 g/kg bw group, 2 rats from 5.0 g/kg bw group, and 4 rats from 6.5 g/kg bw group.

Applicant's summary and conclusion

Interpretation of results:

other: Not acute harmful

Remarks:

in accordance with EU CLP (1272/2008 and its updates)

Conclusions:

A LD50 of 4600 mg/kg bw (95% CI = 2700-7800) was obtained in the acute oral toxicity study with rats.

Executive summary:

In an acute oral toxicity study with rats, similar to OECD TG 401 but without GLP, the LD50 was 4600 mg/kg bw (95% CI - 2700 -7800). Groups of 10 animals (sex, strain and age unspecified) were dosed with 1.3, 3.2, 5.0 and 6.5 g/kg bw and observed for 14 days. The numbers of animals that died were 1 at 1.31 g/kg bw, 5 at 3.2 g/kg bw, 6 at 5.0 g/kg bw, and 4 at 6.5 g/kg bw. Clinical findings included ataxia, piloerection, lethargy, convulsions and ptosis. Necropsy findings included very dark lungs, very red stomach and small intestines, and blood around the nose and mouth.