Nerol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1972

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 7 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:

1972

Report date:

1972

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; source and sex of animals and environmental conditions not reported; acclimation period not reported; observation period was 7 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:

Nerol

EC Number:

203-378-7

EC Name:

Nerol

Cas Number:

106-25-2

Molecular formula:

C10H18O

IUPAC Name:

3,7-dimethylocta-2,6-dien-1-ol

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Compound No. 71-53
- Physical state: Clear liquid
- Date of receipt: 11 April 1972

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.9-2.2 kg

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Clipped abraded abdominal skin
- Type of wrap if used: Animals were wrapped with binders of rubber dam, gauze and adhesive tape.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw

Duration of exposure:

24 h

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 animals

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 7 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.

Mortality:

One rabbit died on Day 2.

Clinical signs:

other: - Slight to moderate erythema and edema were noticed throughout the observation period. Moderate atonia was observed in one animal on Day 1, which was died on Day 2.

Gross pathology:

No abnormalities were noted at necropsy.

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 nerol is higher than 2000 mg/kg bw in rabbits therefore it is not classified according to Directive 67/548/EEC and CLP Regulation (EC) N° 1272/2008.

Executive summary:

In an acute dermal toxicity study performed similarly to OECD Guideline 402, a group of New Zealand white rabbits (10 animals/dose) were given a single dermal application of nerol at 5000 mg/kg bw. The test item was applied to the abraded abdominal skin. The test site was then covered by a semi-occlusive dressing for 24 h. Animals were then observed for mortality, clinical signs and bodyweights for 7 days and were all sacrificed for macroscopic examination.

Slight to moderate erythema and edema were noticed throughout the observation period. Moderate atonia was observed in one animal on Day 1, which was died on Day 2. Body weight evolution of the animals remained normal throughout the study. No abnormalities were noted at necropsy. The dermal LD₅₀ of test item was considered to be higher than 5000 mg/kg bw in rabbits.

The acute dermal LD₅₀ of nerol is higher than 2000 mg/kg bw in rabbits therefore it is not classified according to Directive 67/548/EEC and CLP Regulation (EC) N° 1272/2008.