5-Isothiazolecarboxamide, 3,4-dichloro-N-(2-cyanophenyl)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 Aug 2005 - 28 Dec 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries, 12-Nousan-No.8147, Skin Irritation Study

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,4-dichloro-N-(2-cyanophenyl)-1,2-thiazole-5-carboxamide

EC Number:

619-682-1

Cas Number:

224049-04-1

Molecular formula:

C11H5Cl2N3OS

IUPAC Name:

3,4-dichloro-N-(2-cyanophenyl)-1,2-thiazole-5-carboxamide

Constituent 2

Reference substance name:

3,4-dichloro-2'-cyano-1,2-thiazole-5-carboxanilide

IUPAC Name:

3,4-dichloro-2'-cyano-1,2-thiazole-5-carboxanilide

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: KITAYAMA LABES Co., Ltd. (Ina, Japan)
- Age at study initiation: 15 weeks
- Weight at study initiation: 2.73 - 2.88 kg
- Housing: The animals were caged individually in suspended aluminium cages with stainless steel wire-meshed front and floor (W45 x D55 x H35 cm, Yamato Scientific Co., Ltd., Japan). The cages were placed on racks. Cages were changed once per two weeks with washed and sterilized ones.
- Diet: Approximately 120 g/day of LRC4 (Lot No. 050518, Oriental Yeast Co., Ltd., Japan).
- Water: Filtered tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±2 (actual temperature measured: 21.7 - 22.2 °C)
- Humidity (%): 30 - 70 (actual humidity level measured: 51.7 - 71.9%)
- Air changes (per hr): More than 10 per hour
- Photoperiod (hrs dark / hrs light): 12/12 hrs

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Remarks:

The powder was moistened with 0.5 mL of water for injection.

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 hrs

Observation period:

72 hrs

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: The gauze patch (translated as 'lint patch' from the Japanese) with the test substance was held in place with surgical tape and a pressure bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exposed area of skin was wiped with adsorbent cotton dipped in tap water.
- Time after start of exposure: 4 hrs

SCORING SYSTEM:
Performed according to the Draize method

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 hrs

Score:

0

Max. score:

4

Remarks on result:

other: No effects

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 hrs

Score:

0

Max. score:

4

Remarks on result:

other: No effects

Any other information on results incl. tables

No clinical effects were observed.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information