Bicyclo[3.1.1]hept-2-ene-2-ethanol, 6,6-dimethyl-, 2-acetate, (1R,5S)-

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 similar to OECD Guideline No 402 with deviations: no data about purity and no test substance certificate of analysis ; no data on age, gender and source of animals; no data on housing and environmental conditions; observation period: 7 days instead of 14; performed on abraded skin

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:

no data about purity and no certificate of analysis of test substance; no data on age, gender and source of animals; no data on housing and environmental conditions; observation period: 7 days; performed on abraded skin

Principles of method if other than guideline:

not applicable

GLP compliance:

no

Remarks:

pre-dating GLP regulation

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

800-940-9

Cas Number:

35836-72-7

Molecular formula:

C13H20O2

IUPAC Name:

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

Test material form:

liquid

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: 1.9-2.4 kg

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

Area of exposure: clipped abraded abdominal skin
Type of wrap if used: wrapped with binders of rubber dam, gauze and adhesive tape

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

10 rabbits

Control animals:

not specified

Details on study design:

Mortality and toxic effects were observed for a period of 7 days.

Necropsy of survivors performed: Yes
Other examinations performed: dermal reactions: erythema, edema and atonia

Statistics:

no data

Results and discussion

Preliminary study:

Not applicable

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality

Clinical signs:

other: No evidence of toxicity; all animals appeared normal at the end of the study.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

Dermal reactions:
- slight erythema in 8, 4 and 1 animal on Days 1, 2 and 3, respectively; moderate erythema in 1 animal on Day 1
- slight edema in 8 and 4 animals on Days 1 and 2, respectively; moderate edema in 1 animal on Day 1
- complete recovery within 4 days
- no signs of atonia were observed during the study

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 of nopyl acetate is greater than 2000 mg/kg bw in rabbits therefore it is not classified for acute dermal toxicity according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.

Executive summary:

In an acute dermal toxicity study (limit test), a group of 10 New Zealand White rabbits were administered a single dermal dose of nopyl acetate at 2000 mg/kg bw on clipped abraded abdominal skin using an occlusive patch for 24 h. Animals were then observed for mortality, clinical signs, bodyweights and dermal reactions for 7 days and were all macroscopically necropsied after sacrifice.

 

No deaths occurred throughout the study. Normal body weight gain was observed in all animals. At necropsy, macroscopic examination of main organs showed no abnormalities. Adverse dermal reactions noted were slight to moderate erythema and edema, which completely recovered to normal within four days. The acute dermal LD₅₀ was therefore greater than 2000 mg/kg bw under test conditions.

 

The acute dermal LD₅₀ of nopyl acetate is greater than 2000 mg/kg bw in rabbits. Therefore it is not classified for acute dermal toxicity according to Directive 67/548/EEC and according to CLP Regulation (EC) No 1272/2008.