(1R)-6,6-dimethylbicyclo[3.1.1]hept-2-en-2-ethanol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Study conducted similarly to OECD Guideline 402 with deviations: purity of test item not reported; source and sex of animals and environmental conditions not reported; acclimation period not reported; observation period was 3 days instead of 14 days

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

purity of test item not reported; duration of exposure, source and sex of animals and environmental conditions not reported; acclimation period not reported; observation period was 3 days instead of 14 days

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

(1R)-6,6-dimethylbicyclo[3.1.1]hept-2-en-2-ethanol

EC Number:

252-744-2

EC Name:

(1R)-6,6-dimethylbicyclo[3.1.1]hept-2-en-2-ethanol

Cas Number:

35836-73-8

Molecular formula:

C11H18O

IUPAC Name:

(1R,5S)-2-(6,6-dimethylbicyclo[3.1.1]hept-2-en-2-yl) ethanol

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

not specified

Sex:

not specified

Administration / exposure

Type of coverage:

not specified

Vehicle:

not specified

Doses:

2500 and 5000 mg/kg bw

No. of animals per sex per dose:

2 animals at 2500 mg/kg and 8 at 5000 mg/kg

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 3 days
- Necropsy of survivors performed: Yes; gross necropsy was performed on all animals at the termination of the study.

Statistics:

None

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: One rabbit died on Day 2 and one on day 3, out of 8 animals

Mortality:

One rabbit died on Day 2 and one on Day 3

Clinical signs:

other: Slight redness at 5000 mg/kg in one rat and moderate redness and edema in others, ataxia, ptosis and piloerection were observed.

Gross pathology:

Liver mottled, lungs dark and area of exposure very red and edematous in one animal.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal LD50 of Nopol is higher than 5000 mg/kg bw in rabbits therefore it is not classified according to CLP Regulation (EC) N° 1272/2008 and GHS.

Executive summary:

In an acute dermal toxicity study performed similarly to Guideline OECD 402, groups of rabbits (2 to 8 animals/dose) were given a single dermal application of Nopol at 2500 (2 animals) and 5000 (8 animals) mg/kg bw. Animals were observed for mortality and clinical signs for 3 days.

Slight to moderate erythema and edema were noticed throughout the observation period. Ataxia, ptosis and piloerection were observed at 5000 mg/kg bw. The dermal LD50 of the test item was considered to be higher than 5000 mg/kg bw in rabbits.

The acute dermal LD50 of Nopol is higher than 2000 mg/kg bw in rabbits therefore it is not classified according to CLP Regulation (EC) N° 1272/2008 and GHS.