(2RS,3RS)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-[(1H-1,2,4-triazol-1-yl)methyl]oxirane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

May 1981

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(2RS,3RS)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-[(1H-1,2,4-triazol-1-yl)methyl]oxirane

EC Number:

406-850-2

EC Name:

(2RS,3RS)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-[(1H-1,2,4-triazol-1-yl)methyl]oxirane

Cas Number:

133855-98-8

Molecular formula:

C17 H13 Cl F N3 O

IUPAC Name:

1-{[(2R,3R)-3-(2-chlorophenyl)-2-(4-fluorophenyl)oxiran-2-yl]methyl}-1H-1,2,4-triazole

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach (Main)
- Age at study initiation: not specified
- Weight at study initiation: female: 2.37kg
- Housing: Cage made of stainless steel with wire mesh walk floors, floor area 40x51 cm; single
- Diet (e.g. ad libitum): Kliba 341, 4MM, Klingentalmuehle AG, 130g per animal per day
- Water (e.g. ad libitum): about 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study, same housing conditions as during the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g of the suspension
- Concentration (if solution):50% aqueous formulation

Duration of treatment / exposure:

4h

Observation period:

72h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure:upper third of the back or flanks
- % coverage: semi-occlussive
- Type of wrap if used: porous dressing (four layers of absorbent gauze and porous bandage)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of the exposure period with Lutrol and Lutrol/water (1:1)
- Time after start of exposure:4h

SCORING SYSTEM:
Erythema and edema:
0=none
1=very slight
2=well-defined
3=moderate to severe
4= severe to very severe

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

None of the animals showed erythema or edema.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions the substance does not show a skin irritating potential.

Executive summary:

The substance was tested for its skin irritating potential. The test method was based on EPA (FIFRA) and OECD 404 guidelines. GLP requirements were fulfilled. Approx. 0.5g of a 50% aqueous suspension of the test substance was applied to the intact dorsal skin of 6 female white Vienna rabbits each under a semi-occlusive dressing for 4 hours. After the patches were removed the treated area was rinsed with Lutrol and Lutro/water (1:1).

No signs of irritation were observed after application.