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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 Aug 2005 - 25 Jan 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

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:

rat

Strain:

other: Crl:CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Japan Inc., Hino Breeding Centre, Shiga, Japan
- Age at study initiation: 8 weeks
- Weight at study initiation: 309 - 314 g (males), 205 - 221 g (females)
- Housing: The animals were caged individually in suspended aluminium cages with stainless steel wire-meshed front and floor. The cages were placed on racks, with an aluminium cage tray under each cage. The cages were changed once a week and the cage trays twice per week. Feed racks were changed every week. All cage material was autoclaved.
- Diet: Pelleted diet CRF-1 (Oriental Yeast Co.Ltd, Tokyo, Japan), ad libitum
- Water: Filtered tap water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ±2
- Humidity (%): 55 ±15
- Air changes (per hr): More than 10 times per hour
- Photoperiod (hrs dark / hrs light): 12/12 hrs

IN-LIFE DATES: From: 5 Sep 2005 (females) and 12 Sep 2005 (males) To: 20 Sep 2005 (females) and 27 Sep 2005 (males)

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorsal area, app. 4 x 5 cm2
- % coverage: Not reported


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Exposed area was cleaned with cotton moistened with water.
- Time after start of Exposure: 24 hrs

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: No
- For solids, paste formed: Yes, substance was ground in a mortar and moistened with 0.5-1.0 mL water before application.

Duration of exposure:

24 hrs

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations of clinical signs and mortality were performed after 10 and 30 minutes, 1, 2, and 4 hrs after treatment (day 0), and once daily for 14 days (day 1-14) thereafter. All animals were weighed on the day of administration (day 0), and on day 7 and 14.
- Necropsy of survivors performed: Yes. Performed after the observation period on all animals.
- Other examinations performed: Clinical signs, body weight, gross pathology (all organs/tissues were examined macroscopically).

Statistics:

Averages and standard deviations were calculated for body weights and body weight gain (the differences from previous values).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality

Mortality:

There was no mortality.

Clinical signs:

other: There were no clinical signs during the exposure period or during the observation period.

Gross pathology:

The retention of a white substance was observed in 3 male rats. However, this is not considered to be test substance-related, as this is a common finding in this strain of rat.

Any other information on results incl. tables

Observed effects of test substance administration:

Number/sex	dose mg/kg bw.			Clinical signs	Time of death	mortality (%)
5/male	2000			-	-	0
5/female	2000			-	-	0