2,6-dimethyloctan-2-ol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982

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:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

limit test with 9 females, 1 male

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

2,6-dimethyloctan-2-ol

EC Number:

242-361-9

EC Name:

2,6-dimethyloctan-2-ol

Cas Number:

18479-57-7

Molecular formula:

C10H22O

IUPAC Name:

2,6-dimethyloctan-2-ol

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

not specified

Remarks:

Albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals (received on July 27 and August 24, 1982)
- Weight at study initiation: 1.9-2.5 kg
- Housing: 2 animals per cage in suspended wire mesh cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: abdomen
- % coverage: 10% of the body surface
- Type of wrap if used: gauze patch, wrapped wtih plastic, secured with tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the site was wiped
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): between 11.6-14.0 ml
- Concentration (if solution): 0.82 g/ml
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

9 females, 1 male

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 24 hours post dose and on days 7 and 14 for mortality, toxicity and pharmacological effect.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died.

Clinical signs:

other: Dermal reactions (erythema and edema) were slight to moderate observed on day 1, severe on day 7, and minimal on dag 14. Physical signs observed were: Alopecia, diarrhea, few feces, yellow nasal discharge, ptosis.

Gross pathology:

No abnormalities were found on the internal organs on superficial examination for 7/10 rabbits. Of the remaining 3 animals, alopecia adjacent to the treated site and intestinal abnormalities were noted.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

according to EU CLP criteria (EC 1272/2008 and its updates)

Conclusions:

Under the conditions of this test, an acute dermal LD50 of >5000 mg/kg bw was determined for Tetrahydromyrcenol.

Executive summary:

An acute dermal toxicity study was performed according to a method similar to OECD TG 402. In this study, 10 healthy albino rabbits were dosed dermally with Tetrahydromyrcenol at 5000 mg/kg bw of body weight. The test article was kept in contact with the skin for 24 hours. All rabbits survived the 5000 mg/kg bw dermal dose. Physical signs noted in 3 or more rabbits included yellow nasal discharge, diarrhea, alopecia and few feces. Dermal responses, slight to moderate on Day 1, were severe on Day 7 and minimal on Day 14. Body weight changes were normal for 7/10 rabbits. Three rabbits, exhibited diarrhea and/or few feces, lost weight. The internal organs on superficial examination appeared normal for 7/10 rabbits. Of the remaining 3 animals, alopecia adjacent to the treated site and intestinal abnormalities were noted. Under the conditions of this test, an acute dermal LD50 of >5000 mg/kg bw was determined for Tetrahydromyrcenol.