Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
: lack of details on test substance
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Benzothiazol
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill ltd., Huntingdon, UK
- Age at study initiation: no data
- Weight at study initiation: 3 - 4 kg
- Housing: single per cage
- Diet: ad libitum(Saniff K 4, Versuchtierdiaeten GmbH, Soest/Westfalen, Germany)
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 40 - 60 %
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 hours after administration with NaCl
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3/3
Time point:
other: 24 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
2/3
Time point:
other: 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
1/3
Time point:
other: 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
3/3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
2/3
Time point:
other: 24 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
1/3
Time point:
other: 24 hours
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
2/3
Time point:
other: 48 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
1/3
Time point:
other: 48 hours
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
1/3
Time point:
other: 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
2/3
Time point:
other: 72 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
1/3
Time point:
other: 24 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
2/3
Time point:
other: 24 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3/3
Time point:
other: 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days

Any other information on results incl. tables

Eye irritation test

Time

24h

48h

72h

Mean scores

Animal No.

28

32

40

28

32

40

28

32

40

28

32

40

Cornea Sc.

A)opacity

B)area

 

1

3

 

1

4

 

1

2

 

1

3

 

1

3

 

0

0

 

1

2

 

1

2

 

0

0

 

1.0

 

1.0

 

0.3

Iris

0

0

0

0

0

0

0

0

0

0.0

0.0

0.0

Conjunctiva

A)redness

B)chemosis

 

2

2

 

3

2

 

2

1

 

1

1

 

3

1

 

1

1

 

2

1

 

2

1

 

1

1

 

1.7

1.3

 

2.7

1.3

 

1.3

1.0

Applicant's summary and conclusion

Interpretation of results:
Category II
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification:
DSD: no classification required
UN-GHS: Category 2B, Mildly irritating to eyes
EU-GHS: Category 2, Irritating to eyes
Executive summary:

Suberg (Bayer AG), 1983

The eye irritation potential of benzothiazole was investigated in 3 male New Zealand White rabbits comparable to OECD guideline 405 with acceptable restrictions. 0.1 mL undissolved test substance was applied into the conjunctival sac of one eye of each animal. The other untreated eye served as control. The eyes were rinsed 24 hours after application of the test substance. The eye irritation reactions were examined and scored using the Draize method 1, 24, 48 and 72 hours after application.

Benzothiazole induced conjunctival redness. The mean scores for the three animals were 1.7, 2.7 and 1.3. For the conjunctiva chemosis the mean scores of 1.3, 1.3 and 1.0 were calculated. Two of three animals showed a cornea opacity mean score of 1.0, for the third animal a mean value of 0.3 was calculated. The mean scores over all three time points for iritis were 0.0 in all animals. All irritation symptoms were reversible 8 days after exposure.

The mean scores for cornea opacity of 1.0 in 2 of 3 animals leads to the UN-GHS classification: Category 2B, Mildly irritating to eyes and to the EU-GHS classification: Category 2, Irritating to eyes. The criteria for DSD classification are not fulfilled.