3,5,5-trimethylcyclohex-2-enone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

purity not reported

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Studies on the design of animal tests for the corrosiveness of industrial chemicals

Author:

Potokar M, Grundler OJ, Heusener A, Jung R, Mürmann P, Schöbel C, Suberg H and Zechel HJ

Year:

1985

Bibliographic source:

Food Chem Toxicol 23: 615-617

Reference 2

Reference Type:

other: OECD SIDS

Title:

3,5,5-Trimethylcyclohex-2-enone (Isophorone), CAS No. 78-59-1

Author:

OECD SIDS

Year:

2003

Bibliographic source:

SIDS Initial Assessment Report for SIAM 16

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

3,5,5-trimethylcyclohex-2-enone

EC Number:

201-126-0

EC Name:

3,5,5-trimethylcyclohex-2-enone

Cas Number:

78-59-1

Molecular formula:

C9H14O

IUPAC Name:

3,5,5-trimethylcyclohex-2-enone

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: various breeders
- Weight at study initiation: 2-4 kg
- Housing: individually
- Diet: standard diet, ad libitum
- Water: ad libitum

Test system

Type of coverage:

other: occlusive and semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

up to 4 hours

Observation period:

The results were assessed 1, 24, 48 and 72 hours and 7 days after removal of the patches

Number of animals:

6 (male and female)

Details on study design:

The dorsal and lateral parts of the trunk were shorn 15-24 hours before treatment. 0.5 mL test substance/patch were applied to 3 cm x 3 cm gauze pads. Four samples were attached to the prepared skin areas of each animal: The patches were fixed and covered by wrapping an air-permeable circular bandage (semi-occlusive method) or air-tight plastic foil (occlusive method) around the animals. The local reactions were determined after 1 and 4 hours exposure both under occlusive and semi-occlusive conditions. After removal of the bandages and patches the treated skin areas were rinsed with water and dried.
Skin changes, i.e. erythema and eschar formation, and edema formation were recorded as indicated by the OECD (1981). In addition, special effects were also recorded. The criteria used to define irritation and corrosion were those given in the EEC directive (EEC, 1983).

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: mean

Score:

0

Max. score:

4

Remarks on result:

other: 1 and 4 hour exposure, occlusive and semiocclusive conditions

Other effects:

No mortality occurred

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met