(1α,2α,5α)-2,2,6-trimethylbicyclo[3.1.1]heptan-2-ol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979-03-12 to 1979-05-31

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:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

See "Principles of method other than guideline"

Principles of method if other than guideline:

- Principle of test: Acute dermal toxicity test in rabbits
- Short description of test conditions: A single dermal treatment was given to 3 male and 3 female albino rabbits. The skin of three rabbits was abraded, the remaining animal's skin remained intact. The test side was occluded for 24 hours. Animals were observed for sign of toxicity for 14 days and then subjected to gross pathology. No detailed description of environmental conditions, dose preparation, vehicle identity and clinical signs are available. Body weights were not recorded during the study. Times of death were not described.
- Parameters analysed / observed: Mortality, gross pathology

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(1α,2α,5α)-2,2,6-trimethylbicyclo[3.1.1]heptan-2-ol

EC Number:

225-591-4

EC Name:

(1α,2α,5α)-2,2,6-trimethylbicyclo[3.1.1]heptan-2-ol

Cas Number:

4948-28-1

Molecular formula:

C10H18O

IUPAC Name:

(1R,2S,5S)-2,6,6-trimethylbicyclo[3.1.1]heptan-2-ol

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

Albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Rationale for use of males: Both males and females were used
- Age at study initiation: 3-4 months
- Weight at study initiation: 1.76 - 2.32 kg
- Housing: In galvanized cages with indirect bedding
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Temperature-controlled room
- Humidity (%): Not specified
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From day 0 to day 15

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

REMOVAL OF TEST SUBSTANCE
- Washing: The remaining test item was wiped off the skin after 24 hours
- Time after start of exposure: 24 hours

Duration of exposure:

24 hours

Doses:

One single dose of 5000 mg/kg bw

No. of animals per sex per dose:

3 animals per sex were treated with a single dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for pharmacologic activity and drug toxicity 1, 3, 6 and 24 hours after treatment and daily thereafter. Body weights were recorded at the beginning of the study and after the 14-day observation period.
- Necropsy of survivors performed: Yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

None of the animals died within the treatment and post-treatment period.

Clinical signs:

other: No clinical signs observed

Gross pathology:

The internal organs and superficial examination appeared normal.

Other findings:

In two male animals with abraded skin, small scab has formed and detached.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute dermal toxicity study in male and female rabbits, all animals survived after a single dose of 5000 mg/kg bw. The LD50 is thus >5000 mg/kg bw.

Executive summary:

In a GLP compliant acute dermal toxicity study in 3 male and 3 female New Zealand white rabbits, the test item was applied at a single dose of 5000 mg/kg bw by occlusive administration to abraded (2 males and 1 female) and non-abraded (1 male, 2 females) skin. The test side was occluded for 24 hours. After the treatment period, the occlusive wrap and all remaining test item was removed. Animals were observed for pharmacologic activity and drug toxicity 1, 3, 6 and 24 hours after treatment and daily thereafter for a total of 14 days. Non-survivors and and animals surviving the 14-day observation period were subjected to gross necropsy. No deaths, clinical signs or changes in body weight gain were observed. Thus, the LD50 was found to be >5000 mg/kg bw.