Thiophanate-methyl

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 July 1986 - 21 November 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Thiophanate-methyl

EC Number:

245-740-7

EC Name:

Thiophanate-methyl

Cas Number:

23564-05-8

Molecular formula:

C12H14N4O4S2

IUPAC Name:

methyl N-{[2-({[(methoxycarbonyl)amino]methanethioyl}amino)phenyl]carbamothioyl}carbamate

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Sizuoka Laboratory Animal Center (Sizuoka)
- Age at study initiation: about 3 months
- Weight at study initiation: 3.02 ± 0.20 kg (at dosing)
- Housing: individually housed in a steel mesh cages (33 x 45 x 35 cm)
- Diet: Standardized pellets of dry diet, RC-4 (Oriental Yeast Co., Ltd., Tokyo), ad libitum
- Water: tap water, ad libitum
- Acclimation period: quarantined for a week prior to use

ENVIRONMENTAL CONDITIONS
- Temperature (°C):19 - 25 (mean temperature: 21.1)
- Humidity (%): 40 - 80 (mean humidity at 9 am: 59.6)
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

Skin changes such as erythema and edema were scored at 0, 0.5, 1, 24, 48 and 72 hours after the removal of the test item.

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 3 cm²

REMOVAL OF TEST SUBSTANCE
- At the end of the exposure period, the patch was removed and the skin was wiped (but not washed) to remove any test substance still remaining.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
- 0, 0.5, 1, 24, 48 and 72 hours after the removal of the test item

SCORING SYSTEM:
- Method of calculation: Draize scoring

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1 -#6

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

edema score

Basis:

animal: #1 - #6

Time point:

24/48/72 h

Score:

0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was determined not to be irritating to the skin.

Executive summary:

In this assessment of the primary dermal irritation, 0.5 g of the test item moistened with water was spread over lint patches which were kept in contact the skin of 6 rabbits. Four hours after the application the patch was removed and the skin was wiped to remove any test substance still remaining. The dermal irritation scores were recorded after removal of the patches. No skin reaction was observed in any rabbits treated with the test item. The test item was determined not to be irritating to the skin.