Reaction mass of 1-(3,3-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one and 1-(5,5-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 August, 1979 - 10 September, 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Reliability has been presented as 2 because similar to OECD Guideline protocol has been followed but not GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

(1981)

Deviations:

yes

Remarks:

No details on test material, no purity, no details on environmental conditions, no details on test animals, abraded skin.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 1-(3,3-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one and 1-(5,5-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one

EC Number:

944-482-9

Molecular formula:

C13H20O

IUPAC Name:

Reaction mass of 1-(3,3-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one and 1-(5,5-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: between 2.0 and 3.0 kg

ENVIRONMENTAL CONDITIONS
no data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
All animals had their backs clipped free of hair free of hair 24 hours prior to dosing. All of the animals had their backs abraded prior to dosing.
The test substance was applied to the back of each animal. The treated areas were covered with large gauze patches and an impervious material was wrapped snugly around the trunk of each animal.

REMOVAL OF TEST SUBSTANCE
The dressing were removed 24 hours after dosing and any excess material was removed and the approximate amount remaining was noted.

No details on the calculation of the individual doses (test material density approximately 1 g/mL).

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: no data
- Bodyweights: at the start and at the end of the study
- Necropsy of survivors performed: yes
- Other examinations performed: none

Statistics:

Not performed.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

No unusual behavioral signs were noted.

Body weight:

All animals showed gains in bodyweight over the study period.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified.

Remarks:

According to Regulation (EC) No. 1272/2008.

Conclusions:

The acute dermal toxicity of the substance was >2000 mg/kg bw.

Executive summary:

In this study performed equivalent to OECD TG 402 guideline, 6 rabbits (3 males and 3 females) were administered to the substance at a dose level of 2000 mg/kg bw. No deaths occurred and no unusual behavioral signs were noted. There were no signs of dermal irritation and no abnormalities were noted at necropsy. Based on the results in this study, the acute dermal LD50 for the substance in male and female rats was determined to be >2000 mg/kg bw and the substance does not have to be classified for acute toxicity by the dermal route according to Regulation (EC) No. 1272/2008.