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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26.05.2004 - 27.10.2004

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 405 (Acute Eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Male New Zealand white rabbits were obtained from Ferenc Sandor Breeder
- The rabbits were in the body weight range of 3340-3458g at the beginning of the study.
- The young adult rabbits were less than 15 weeks old.

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 to 6:00pm

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.1 g of test item

Duration of treatment / exposure:

eyelids closed gently for several seconds to prevent the loss of the test item

Observation period (in vivo):

1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

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. Care was taken to select only those animals that have a normal eye condition, any with ocular lesions were rejected.
The test item was instilled into the conjunctival sac of the left eye of each animal.0.1g of the test item was used for the study in pure state, in a single dose. The eyes of the test animals were not washed out after the test item application.
The duration of the observation period was sufficient for the statement of the reversibility or irreversibility of changes.
At the end of the observation period all animals were sacrificed under carbon dioxide anaesthesia. The eye irritation scores will be evaluated according to the scoring system by Draize (1959) and OECD 405 (24 April 2002).

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 h

Score:

0

Max. score:

0

Applicant's summary and conclusion

Interpretation of results:

other: not classified acc. CLP

Conclusions:

The test item SND 919 Precursor 3a, applied to the rabbits` eye micosa, caused irritant effects, which can be evaluated as fully reversible within 24h. According to the EC criteria for classification and labbeling requirements for dangerous substances and preparations the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.