2-isopropyl-5-methyl-cyclohexanone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Limited level of detail documented

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1976

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

4 animals were used, one dose level, abraded skin

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

DL Isomenthone

IUPAC Name:

DL Isomenthone

Constituent 2

Reference substance name:

Isomenthone

EC Number:

207-727-4

EC Name:

Isomenthone

Cas Number:

491-07-6

Molecular formula:

C10H18O

IUPAC Name:

rel-(2R,5R)-2-isopropyl-5-methylcyclohexanone

Details on test material:

- Name of test material (as cited in study report): Iso-menthone Pure
- Analytical purity: pure
- Impurities (identity and concentrations): no data

Test animals

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: yes
- Fasting period before study: no data
- Housing: in a multiple animal holder for 24 h of exposure and following 14 day period in metabolism cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least two weeks

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 2-3 cm longitudinally
- Type of wrap if used: covered with a rubber sleeve or dam

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped down
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 mL/kg
- Concentration (if solution): pure

Duration of exposure:

24 h

Doses:

5 mL/kg

No. of animals per sex per dose:

4

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Other examinations performed: clinical signs, body weight

Statistics:

no data

Results and discussion

Effect levels

Effect levels 1

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths

Effect levels 2

Sex:

not specified

Dose descriptor:

LD0

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths

Mortality:

No deaths

Clinical signs:

other: All animals showed a mild erythema on both the intact and abraded areas.

Gross pathology:

No data

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance was acutely not toxic to rabbits in an acute dermal toxicity test with LD50 value >5 mL/kg bw. The substance is not classified according to CLP.

Executive summary:

The acute dermal toxicity of DL Isomenthone (CAS 491-07-6) was studied in a non-GLP test. A group of four animals were exposed to single dermal dose of 5 mL/kg bw. Animals were observed during a period of 14 days. No deaths occured at a level of 5 mL/kg bw. All the animals showed a mild erythema on both the intact and abraded areas.