Neryl acetate

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

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

Principles of method if other than guideline:

Standard acute method: Test substance at three dose levels was applied to the clipped intact and abraded skin on the back of 12 albino rabbits (4/dose) for 24 hours. Animals were then observed for dermal reactions, food consumption, body weights and general behaviour for 14 days.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Neryl acetate

EC Number:

205-459-2

EC Name:

Neryl acetate

Cas Number:

141-12-8

Molecular formula:

C12H20O2

IUPAC Name:

3,7-dimethylocta-2,6-dien-1-yl acetate

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Label on test material: RIFM 71-10-56 1-13-72

Test animals

Species:

rabbit

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Housing: Individually housed in metabolism cages
- Diet (e.g. ad libitum): Rabbit pellets, ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 2 weeks

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Prior to placing the animals on test their backs were clipped free of all hair with small animal clippers. The backs were further prepared by making epidermal abrasions every two to three centimeters, longitudinally, over the clipped area of exposure. The abrasions were sufficiently deep so that they penetrated the stratum corneum bot not the dermis, so that no bleeding occurred.
- Type of wrap if used: Application areas were covered with a rubber sleeve or dam which fit snuggly around each animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Application sites were thoroughly wiped down.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0, 3.9 and 6.0 mL/kg bw

Duration of exposure:

24 hours

Doses:

2.0, 3.9 and 6.0 mL/kg bw

No. of animals per sex per dose:

4 rabbits/dose

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Examinations performed: During the observation period each animal's food consumption, body weights and general behavior were recorded. Before beginning of the test and at the end of the observation period, haematology and urinalysis were performed on all surviving animals.
- Necropsy of survivors performed: No

Statistics:

None

Results and discussion

Preliminary study:

Not applicable

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 6 mL/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

No mortality occurred during the study.

Clinical signs:

other: All animals remained normal throughout the study.

Gross pathology:

Not applicable

Other findings:

- Dermal reactions: Application sites on the back did not show any erythema or oedema and remained normal throughout the study.
- Food consumption: All animals consumed their daily ration and behaved normal throughout the study.
- Haematology: A comparison of the initial and final haematogram values of each animal did not reveal any significant changes.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 of the test substance is > 5000 mg/kg bw in rabbits therefore it is not classified according to Regulation (EC) No 1272/2008 and according to the GHS.

Executive summary:

In an acute dermal toxicity study, 2.0, 3.9 or 6.0 mL/kg bw of the test substance was applied to the clipped intact and abraded skin on the back of 12 albino rabbits (4/dose) for 24 hours. Animals were then observed for dermal reactions, food consumption, body weights and general behaviour for 14 days.

All animals consumed their daily ration, gained weight and behaved as normal laboratory acclimatized animals. Application sites on the back did not show any erythema or oedema and remained normal throughout the study. A comparison of the initial and final haematogram values of each animal did not reveal any significant changes.

Rabbit dermal LD50 > 6 mL/kg bw (equivalent to 5466 mg/kg bw, considering 0.911 g/mL as the density of the test substance).

 

Therefore, the dermal LD50 of the test substance is > 5000 mg/kg bw in rabbits and it is not classified according to Regulation (EC) No 1272/2008 and according to the GHS.