3-Thiopheneacetic acid, 5-amino-4-cyano-2-(methoxycarbonyl)-, methyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

methyl 5-amino-4-cyano-3-(2-methoxy-2-oxoethyl)thiophene-2-carboxylate

Cas Number:

674773-12-7

Molecular formula:

C10H10N2O4S

IUPAC Name:

methyl 5-amino-4-cyano-3-(2-methoxy-2-oxoethyl)thiophene-2-carboxylate

Constituent 2

Reference substance name:

dimethyl 5-amino-4-cyanothiophene-2,3-dicarboxylate

IUPAC Name:

dimethyl 5-amino-4-cyanothiophene-2,3-dicarboxylate

Details on test material:

- Name of test material (as cited in study report): Thiofaminomet (dimethyl 5-amino-4-cyanothiophene-2,3-dicarboxylate)
- Physical state: greenish yellow
- Purity test date: 30 10 2003
- Lot/batch No.: 45
- Expiration date of the lot/batch: 09 2004 (based on the bottle label)
- Storage condition of test material: at room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeder: Ferenc Sándor
Address: Vörös Hadsereg 131, H-2173 Kartal, Hungary
- Age at study initiation: 11 weeks
- Weight at study initiation: 3020 -3166 g
- Housing: individually, in metal cages
- Diet (e.g. ad libitum): PURISTAR standard diet for rabbits by AGRIBANDSEurope, ad libitum
- Water (e.g. ad libitum): tap water (for human consumption) ad libitum from automatic self supplying water system
- Acclimation period: 16 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12 / 12 hours

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

72 hours (examinations for responses were scored at 1, 24, 48, 72 hours after the patch removal)

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: gauze patch fixed loosely with adhesive but not irritating tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with body temperature water
- Time after start of exposure: 4 hours (after thetreatment period)


SCORING SYSTEM: Draize (1959)

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1, 24, 48, 72 h

Score:

0

Max. score:

0

Reversibility:

other: no signs

Irritant / corrosive response data:

The test item was applied to the intact skin of rabbits in a single dose of 0.5 g. The irritation symptoms were examinde at 1, 24, 48 and 72 hours after the patch removal.
No primary irritation symptoms, like erythema and oedema, or other signs occured during the obsevation period.
Th combined irritation index was 0.

Other effects:

72 hours after the treatment the study was terminated, since no primary irritation symptoms occured.
During the study the general state and behaviour of animals were normal.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

On the basis of the results of present study the test item Thiofaminomet is non-irritant to skin.