2-{2-chloro-4-(methylsulfonyl)-3-[(tetrahydrofuran-2-ylmethoxy)methyl]benzoyl}cyclohexane-1,3-dione

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8 - 18 June 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

24 April 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), Testing Guidelines for Toxicology Studies, 12 NohSan No. 8147

Version / remarks:

amended 10 Dec 2002

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-{2-chloro-4-(methylsulfonyl)-3-[(tetrahydrofuran-2-ylmethoxy)methyl]benzoyl}cyclohexane-1,3-dione

Cas Number:

473278-76-1

Molecular formula:

C20 H23 Cl O7 S

IUPAC Name:

2-{2-chloro-4-(methylsulfonyl)-3-[(tetrahydrofuran-2-ylmethoxy)methyl]benzoyl}cyclohexane-1,3-dione

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

other: New Zealand Albino

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CEGAV breeding establishment, Saint Mars d'Egrenne, France
- Weight at study initiation: 2.7 - 3.2 kg
- Housing: individually in cages of standard size
- Diet: SDS/DIETEX STANRAB (P) SQC, distributed daily at fixed times
- Water: drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 21
- Humidity (%): 45 - 65
- Air changes (per hr): approximately 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: substance was moistened with sterile water

Controls:

other: adjacent areas of the untreated skin of each animal served as controls

Amount / concentration applied:

TEST MATERIAL - Amount applied: 0.5 g (moistened with 0.5 mL sterile water)

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: 6 cm² of the right flank region
- Type of wrap if used: The test substance was moistened with vehicle and placed on a gauze square. The gauze square was protected by a pad consisting of a sem-occlusive micro-porous and non-allergenic dressing and held in place with a supple and aerated fastening system consisting of elastic, adhesive, hyperallergenic tape.

REMOVAL OF TEST SUBSTANCE
- Washing: any residual test substance was removed using steril water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
1, 24, 48 and 72 h

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Other effects:

The application of the test substance did not induce colouring of the application site and did not interfere with grading of any skin lesion.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this skin irritation study in rabbits the test substance was not irritating to the skin.