Methyl 2,6,6-trimethylcyclohex-2-ene-1-carboxylate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP study following a method equivalent to a recognised guideline at a limit dose. Minor deviations (abraded skin plus occlusive dressing) to recognised OECD guideline that do not impact the reliability of the study. Since by expert assessment would increase the potential for positive response (evidence of toxicity) by increasing dermal permeability relative to intact skin within the OECD guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Limit test of 2000 mg/kg bw on clipped-abraded skin.

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.40

Deviations:

no

Principles of method if other than guideline:

The principles of the method were in accordance with the US 16 CFR 1500.40 method and utilised US 16 CFR 1500.3 definitions.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl 2,6,6-trimethylcyclohex-2-ene-1-carboxylate

EC Number:

248-792-9

EC Name:

Methyl 2,6,6-trimethylcyclohex-2-ene-1-carboxylate

Cas Number:

28043-10-9

Molecular formula:

C11H18O2

IUPAC Name:

methyl 2,6,6-trimethylcyclohex-2-ene-1-carboxylate

Test material form:

other: liquid

Details on test material:

- Physical state: liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: Not reported.
- Weight at study initiation: Between 2.0 and 3.0 kg
- Housing: The animals were housed in compliance with US 9 CFR Part 3.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Not reported.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported.
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: All rabbits were weighed and the correct amount of experimental material was applied to the back of each animal
- Type of wrap if used: covered with large gauze patches and an impervious material was wrapped snugly around the trunk of each animal. The dressings were removed after twenty-four hours and any excess material was removed and the approximate amount remaining was noted.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the exposure site was wiped, but not washed, to remove excess material as per US 16 CFR 1500.40.
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg

Duration of exposure:

24h

Doses:

2000 mg/kg

No. of animals per sex per dose:

3 males and 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed for signs of toxicity and for mortalities. Gross autopsies were performed on all animals which died during the 14 day observation period and also on all survivors of the 14 day observation period.
- Necropsy of survivors performed: Yes.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities.

Clinical signs:

other: There were no unusual behavioral signs noted.

Gross pathology:

Gross pathologic examination revealed nothing remarkable.

Other findings:

No other observations (such as local responses) were noted within the report.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study the LD50 was determined to be > 2000 mg/kg via the dermal route in male/female rabbits.

Executive summary:

The GLP study was performed following a method similar to OECD 402 to assess the dermal toxicity of the test material to the albino rabbit. The test substance was evaluated in six rabbits. A dose of 2000 mg/kg test substance (undiluted), was applied to the back clipped-abraded skin site of the rabbit under a occlusive dressing for 24 hours. After twenty-four hours and any excess material was removed and the approximate amount remaining was noted. The animals were observed for a 14 day period for signs of toxicity and for mortalities. Gross autopsies were performed on all animals. There were no unusual behavioural signs noted and gross pathologic examination revealed nothing remarkable. Under the conditions of this study the LD50 was determined to be greater than 2000 mg/kg via the dermal route in male/female albino rabbits.