4-tert-pentylcyclohexanone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Study was performed predating current guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

1

Reference substance name:

4-tert-pentylcyclohexanone

EC Number:

240-642-0

EC Name:

4-tert-pentylcyclohexanone

Cas Number:

16587-71-6

Molecular formula:

C11H20O

IUPAC Name:

4-tert-pentylcyclohexanone

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

not specified

Sex:

not specified

Administration / exposure

Type of coverage:

not specified

Vehicle:

not specified

Duration of exposure:

Not specified

Doses:

3.2, 4.0, 5.0 and 6.3 g/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

4 700 mg/kg bw

Based on:

test mat.

95% CL:

>= 4 200 - <= 5 260

Mortality:

1/6, 5/6 and 6/6 animals died in the 7 day observation period after exposure to 4.0, 5.0 and 6.3 g/kg respectively
Distribution of mortality:
- 3200 mg/kg bw: no mortality
- 4000 mg/kg bw dose group: 1 animal died on day 5
- 5000 mg/kg bw dose group: 3 animals died on day 2 and 2 animals died on day 4.
- 6300 mg/kg bw dose group: 6 animals died on day 1

Clinical signs:

Ataxia (uncoordinated movements) and dermal irritation was seen.

Gross pathology:

Hemorrhagic enteritis (inflammation of the gut) was seen.

Applicant's summary and conclusion

Interpretation of results:

other: Not acute harmful

Remarks:

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

Conclusions:

The acute dermal toxicity test showed an LD50 of 4700 mg/kg bw in rabbits.

Executive summary:

A pre-guideline study, equivalent to OECD guideline 402, was performed to identify the acute dermal toxicity of the test substance. In this study 6 rabbits (sex unspecified) were administered 3.2, 4.0, 5.0 and 6.3 g/kg bw test substance on the skin. 1/6, 5/6 and 6/6 animals died in the 7 day observation period after exposure to 4.0, 5.0 and 6.3 g/kg respectively. Clinical signs was ataxia and hemorrhagic enteritis during gross pathology. Under the conditions of the test, the acute dermal LD50 for the substance in rabbits was 4700 mg/ kg bw. Based on these results, the test substance is not considered to be acute harmful.