2,6-Diamino-4,5,6,7-tetrahydrobenzothiazole

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

from 6 March to 21 March 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted in GLP compliance and in accordance with several internationally established guidelines (OECD, EEC guidelines, see below).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

SND 855 BS Y Precursor 2

IUPAC Name:

SND 855 BS Y Precursor 2

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): SND 919 CL2 Y precursor 2; 2,6-Diamino-4,5,6,7-tetrahydro-benzothiazol
- Physical state: solid
- Purity test date: 12 July 1994
- Lot/batch No.: KRÖ 27

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source:
- Age at study initiation: 47 (m), 52 (f) weeks
- Weight at study initiation: 4.9 kg (m), 5.3 kg (f)
- Housing: individually in plastic cates
- Diet (e.g. ad libitum): ad libitum, standardized pelleted feed 9980 (Altromin, Lage)
- Water (e.g. ad libitum): ad libitum, filtered demineralized, adjusted to pH 2.6 with hydrochloric acid

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C
- Humidity (%): 55 (50-65) %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 : 12 hours light:darkness

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

20 mg SND 919 CL2 Y Precursor 2 (2,6-Diamino-4,5,6,7-tetrahydrobenzothiazole) were instilled into the conjunctival sac of the right eyes of the rabbits, while the left eyes served as controls. Approximately 30 sec after instillation the right eye of female rabbit was thoroughly rinsed with sterile water to determine the usefulness of first aid procedures. The right eye of the male rabbit remained und rinsed.

Duration of treatment / exposure:

72 h

Observation period (in vivo):

1 h, 24 h, 48 h, 72 h, 4 d, 7d, 14 d

Number of animals or in vitro replicates:

2

Details on study design:

SCORING SYSTEM:
The eye irritation scored were evaulated according to the scoring system by Draize (1959) and OECD 405

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1 h, 24 h, 48 h, 72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible

Results 2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Time point:

other: 1 h, 24 h, 48 h, 72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1 h, 24 h, 48 h, 72 h

Score:

0

Max. score:

0

Any other information on results incl. tables

The treated unrinsed eye showed markedly deepened rugae of the iris from 1 st to 4 th day post administration, as well as slight to moderate conjunctival reddening 1 h to 7 days post administration. In the treated rinsed eye, the alterations were less severe, so that rinsing with water after an accidential ocular contamination is recommended.

Individual values: right eyes (20 mg SND 919 CL2 Y Precursor 2 (2,6 -Diamino-4,5,6,7 -tetrahydrobenzothiazol)

Animal No.	Region of Eye	Hours/post administration				Days/post administration
		1	24	48	72	4	7	14
1	Cornea:	0	0	0	0	0	0	0
	Iris:	0	1	1	1	1	0	0
	Conjunctiva Redness	1	2	2	1	1	1	0
	Chemosis	0	0	0	0	0	0	0
2	Cornea:	0	0	0	0	0	0	0
	Iris:	0	0	0	0	0	0	0
	Conjunctiva Redness	1	1	1	1	1	1	0
	Chemosis	0	1	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

Category II

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Therefore, in accordance with the USA - Interagency Regulatory Liason Group Guide-line, no further test is considered necessary. The R-phrase "Reizt die Augen" (irritant to eyes) corresponding to the German "Gefahrstoffverordnung "(Dangerous Compounds Regulations) is recommended on the basis of the results obtained in this test.