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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(2-Methyl-4,5,6,7-tetrahydro-benzothiazol-6-yl)-acetamide hydrobromide
EC Number:
600-588-4
Cas Number:
104617-50-7
Molecular formula:
C9 H13 O N3 S x HBr
IUPAC Name:
N-(2-Methyl-4,5,6,7-tetrahydro-benzothiazol-6-yl)-acetamide hydrobromide

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH
- Age at study initiation: 48 - 59 weeks
- Weight at study initiation: 4.4 - 6 kg

- Housing: Individual accommodation in stainless steel wire cages, with a floor area of
3878 cm2.


- Feed: Standardized pelleted feed 9980 (Altromin, Lage). Certificates of analysis relating to nutritional content and presence of contaminants of the batches used are kept in the archives of the Laboratory Animal Services Unit of Boehringer lngelheim.

- drinking water: Filtered, demineralized water of drinking quality was adjusted to pH 2.6 ± 0.2 with hydrochloric acid and was freely available to the animals.

- Acclimation period: > 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 3 -1 °C
- Relative Humidity (%): 55 (50 - 65) %
- Photoperiod (hrs dark / hrs light): A cycle of 12:12 hrs. light: darkness was maintained

IN-LIFE DATES: From: To: 27.03.1995 - 31.03.1995

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg SND 919 CL2 Y Precursor 1 (2-Amino-6-acetylamino-4,5,6,7- tetrahydrobenzothiazole x HBr) were instilled into the conjunctiva! sac of the right eyes of the rabbits, while the left eyes served as controls.
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
4
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM:

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Other effects:
no other effects

Applicant's summary and conclusion

Interpretation of results:
other: not classified acc. to CLP
Conclusions:
SND 919 CL2 Y Precursor 1 = SND 919 Thiazol was evaluated to be not eye irritating.
Executive summary:

Under the conditions described in this report, 100 mg SND 919 CL2 Y Precursor 1 (2-Amino-6-acetylamino-4,5,6,7-tetrahydrobenzothiazole x HBr) = SND 919 Thiazol were instilled into the conjunctival sac of the right eyes of New Zealand White rabbits. 1 h to 24 h post administration, only slight redness of the conjunctiva was seen in two of the four rabbits.

It was no longer evident 48 h post administration. No other findings were recorded. Mean maximal score for conjunctival redness was 0.25 - 0.5.

No special labelling is necessary in accordance with German regulations "Gefahrstoffverordnung" (Dangerous Compounds Regulations ),

since the mean score for conjunctival redness was below 2.5.