[1R-(1α,2β,5α)]-1-(isopropyl)-2-methoxy-4-methylcyclohexane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 Feb - 12 Mar 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted in Feb 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

(92/69/EEC)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

The Department of Health of the Government of the United Kingdom

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[1R-(1α,2β,5α)]-1-(isopropyl)-2-methoxy-4-methylcyclohexane

EC Number:

216-365-6

EC Name:

[1R-(1α,2β,5α)]-1-(isopropyl)-2-methoxy-4-methylcyclohexane

Cas Number:

1565-76-0

Molecular formula:

C11H22O

IUPAC Name:

[1R-(1α,2β,5α)]-1-(isopropyl)-2-methoxy-4-methylcyclohexane

Test animals

Species:

rat

Strain:

other: Sprague-Dawley CD (Crl:CD (SD) IGS BR)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 265-275 g (males), 206-216 g (females)
- Housing: 5 animals of the same sex per cage in suspended polypropylene cages, bedding woodflakes, individually during the 24-hour exposure period
- Diet: Rat and Mouse SQC Expanded Diet No. 1 (Special Diets Services Limited, Witham, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: clipped skin of back and flanks
- % coverage: 10%
- Type of wrap: The treated skin was covered with a piece of surgical gauze, which was held in place with a piece of self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed with a suitable solvent.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: 2.29 mL/kg bw
- Constant volume or concentration used: yes

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for deaths or overt signs of toxicity 30 min and 1, 2 and 4 hours after administration and subsequently once daily for up to 14 days. Individual body weights were determined prior to application of the test substance on day 0 and on days 7 and 14 or at death.
- Necropsy of survivors performed: yes
- Other examinations performed: After removal of the dressings and subsequently once daily for 14 days, the test sites were examined for evidence of primary irritation and scored according Draize.

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:

One male died at day 13 post-dose.

Clinical signs:

other: No clinical signs of systemic toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

Abnormalities noted in the male that died during the study were haemorrhagic lungs, dark liver and dark kidneys. No abnormalities were noted at necropsy of animals that were killed at the end of the study.

Other findings:

There were no signs of dermal irritation. All scores for erythema and oedema were 0 at all reading time points.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

In this acute dermal toxicity study in rats a LD50 value > 2000 mg/kg bw was found in both sexes.

Executive summary:

The acute dermal median lethal dose (LD50) of the test material, in the Sprague-Dawley CD (Cr1:CD® ( SD) IGS BR) strain rat was found to be greater than 2000 mg/kg bodyweight.