3,7-dimethylocta-2,6-dienyl acetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

not GLP

Justification for type of information:

This information is used for read-across to Neryl acetate multi.

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:

no details on test material (purity not indicated), no details on environmental conditions.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

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:

(2Z)-3,7-dimethylocta-2,6-dien-1-yl acetate

Test animals

Species:

rabbit

Strain:

other: Albino

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Not mentioned
- Age at study initiation: Not specified
- Weight at study initiation: 2 - 3 kg
- Housing: housed individually in metabolism cages
- Diet: Free acces to rabbit pellets
- Water: Free access to tap water.
- Acclimation period: At least 14 days.
During acclimation period: hematology consisting of a red and white cell count, differential, grams hemoglobin, per cent hematocrit and a urinalysis was performed on each animal.

ENVIRONMENTAL CONDITIONS
Not specified

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Clipped and abraded back skin
- Coverage: Rubber sleeve or dam

REMOVAL OF TEST SUBSTANCE
- Via wiping
- Time after start of exposure: 24 hours

Duration of exposure:

24 hours

Doses:

2.0 mL/kg bw
3.9 mL/kg bw
6.0 mL/kg bw

No. of animals per sex per dose:

4

Control animals:

not required

Details on study design:

Study Design:
On the day before application the rabbits were clipped free of fur on the back using small animal clippers. Backs were further prepared by making epidermal abrasions every two/three centimers that did not penetrate the stratunum corneum. Test item was applied to clipped intact and abraded skin and thereafter covered with a rubbersleeve or dam. Animals were placed in a multiple animal holder for 24 hours. During this period animals were allowed its daily ration of rabbit pellets and water. After 24 hours, the rubbersleeve or dam was removed and treated skin was wiped thoroughly.

Observations:
Animals were observed for 14 days after the removal of the dressings and test substance.
Effects to the skin were recorded immediatly after removal of the rubbersleeve.
During observation period food consumption and general behaviour were observed

- Other examinations performed: After the 14 day observation period hematology and urinalysis was performed on all animals as was done during the acclimation period.

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 466 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred

Clinical signs:

other: No skin irritation or other clinical signs were observed

Gross pathology:

No data

Other findings:

Animals behaved normal during observation period.
No significant changes were seen in the intitial and final hematogram.

Applicant's summary and conclusion

Interpretation of results:

other: Not acutely harmful.

Remarks:

according to EU CLP (EC No. 1272/2008 and its amendments).

Conclusions:

The acute dermal LD50 is >5466 mg/kg bw in rabbits.

Executive summary:

The dermal acute toxicity of Neryl Acetate (‘mono’) was investigated in a study comparable to OECD TG 402 (non-GLP). In this study, three groups of 4 rabbits were administered dermal doses of 2, 3.9, or 6.0 mL (1822, 3553, and 5466 mg/kg bw based on a relative density of 0.911) for 24 hours on intact and abraded skin, followed by a 14-day observation period. Treated skin was covered with a rubber sleeve or dam (occlusive exposure). Examination of treated skin after 24 hours, showed no signs of erythema or oedema, and remained normal during the 14-day observation period. No test item-related effects on feeding, body weight or behaviour were recorded. Haematology and urinalysis revealed no significant changes. No mortalities occurred. Based on these findings, the acute dermal LD50 of Neryl Acetate (‘mono’) was determined to >5466 mg/kg bw.