2-thiazolidinylidenecyanamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study according to OECD guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

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:

-

EC Number:

427-720-1

EC Name:

-

Cas Number:

26364-65-8

Molecular formula:

C4H5N3S

IUPAC Name:

[(1,3-thiazolidin-2-ylidene)amino]formonitrile

Details on test material:

name: Cyanamide, (4,5-dihydroxy-2-thiazolyl)-
molecular formula: C4 H5 N3 S
molecular weight: 127.2
physical state: solid
analytical purity: 98 %

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CHR. FRED LEUSCHNER & CO. D-24601 Lohndorf/Post Wankendorf
- Age at study initiation: approx. 5 months
- Weight at study initiation: 2.2 - 2.7 kg
- Housing: During the exposure period the animals were kept singly in special restrainers which allowed free movement of the head but prevented a complete body turn.
Before and after the 4-hour exposure period the rabbits were kept separately in cages with dimensions of 425 mm x 600 mm x 380 mm (manufacturer: Dipl. Ing. W. EHRET GmbH, D-16352 Schonwalde).The cages excluded the possibility of irritation of the skin by excrement and urine.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C (maximum range).
- Humidity (%): Relative humidity was 50% ± 20% (maximum range).
- Photoperiod (hrs dark / hrs light): The rooms were alternately lit (1 50 lux at approximately 1.50 m room height)
and darkened for periods of 12 hours each.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 per test site.


VEHICLE
- Amount(s) applied (volume or weight with unit): sufficient water to moinsten.

Duration of treatment / exposure:

4h

Observation period:

72h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: ~ 6 cm²
- Type of wrap if used: gauze patch. The patch was held in contact with the skin by means of a semi-occlusive dressing
for the duration of the exposure period

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4h


SCORING SYSTEM
Erythema and Eschar Formation
0 = no erythema
1 = very slight erythema (barely perceptible)
2 = well-defined erythema
3 = moderate to severe erythema
4 = severe erythema (beet redness) to slight
eschar formation (injuries in depth)
preventing erythema reading
Oedema Formation
0 = no oedema
1 = very slight oedema (barely perceptible)
2 = slight oedema (edges of area well defined
by definite raising)
3 = moderate oedema (raised approx. 1 mm)
4 = severe oedema (raised more than 1 mm and
extending beyond area of exposure)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-72 h

Score:

0

Max. score:

0

Other effects:

There were no systemic intolerance reactions.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study the substance is not subject to classification.

Executive summary:

Test system: acute skin irritation, Patch-Test, in rabbits, semi-occlusive, according to EC guideline B.4. and OECD guideline 404

Test substance: 2 -Cyanimino-1,3 -thiazolidin

Under the present test conditions none of the three rabbits exposed for 4 hours to 500 mg 2-Cyanimino-1,3-thiazolidin/patch and animal (semi-occlusive condition) showed any substance-related lesions at the examination time-points 60 min, 24, 48 and 72 hours after patch removal.

There were no systemic intolerance reactions.