2,6-Benzothiazolediamine, 4,5,6,7-tetrahydro-, (6S)-, (2R,3R)-2,3-dihydroxybutanedioate, hydrate (1:1:3)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26.05.2004 - 28.06.2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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:

not specified

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(6S)-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine 2,3-dihydroxybutanedioic acid trihydrate

EC Number:

928-472-1

Cas Number:

1184301-52-7

Molecular formula:

C11-H17-N3-O6-S x 3H2O

IUPAC Name:

(6S)-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine 2,3-dihydroxybutanedioic acid trihydrate

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

In the study report is mentioned that a dihydrate was used for testing, this statement is not correct. After further evaluation of the substances it was found out that it is a trihydrate. The batch for testing was a typical production batch.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Male New Zealand whit rabbits were obtained from Ferenc Sandor Breeder
- The rabbits were in a body weight range of 2813g - 3487g at the beginning of the study
- The young adult rabbits were less than 11 weeks old at arrival

CONDITIONS
- The animals were housed individually in metal cages designed to permit 8-12 air exchange/hour by central air-condition system. The target temperature and relative humidity ranges were 20 +/- 3 degree Celsius and 30-70 %, respectively.
- Light cycle is 12 hours daily, from 6:00am - 6:00pm

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

water

Controls:

yes

Amount / concentration applied:

0.5g of test item

Duration of treatment / exposure:

4h

Observation period:

1, 24, 48 and 72h

Number of animals:

3 male

Details on study design:

Three male animals in acceptable health condition were used for the test as certified by the veterinarian. Each animal was examined 24 hours before starting the test. Animals showing any dermal defects or pre-existing dermal injury were not used.
Patch testing was used to detect primary irritating effects of the test item. 0.5g of the test item was applied in substantia to the skin of the experimental animals. The test item was moistened sufficiently with water to ensure good contact with skin. The test item was applied as a single dose. Sterile gauze pads were placed on the skin of the rabbits. These gauzes were kept in contact with the skin by a patch with surrounding adhesive hypoallergenic plaster. The entire trunk of the animals was wrapped with plastic wrap for 4 hours.
At the end of the observation period all animals were sacrificed under carbon dioxide anaesthesia.
The animals were observed for 72 hours, the duration of the study was sufficient to evaluate fully the reversibility or irreversibility of the effects observed. The dermal irritation scores were evaluated according to the scoring system Draize (1959).

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1, 24, 48, 72h

Score:

0

Max. score:

4

Applicant's summary and conclusion

Interpretation of results:

other: not classified acc. to CLP

Conclusions:

On the basis of the results of the present study the test item is Non irritant.