Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 202-396-2 | CAS number: 95-16-9
Eye irritation
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:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : lack of details on test substance
- GLP compliance:
- no
Test material
- Reference substance name:
- Benzothiazole
- EC Number:
- 202-396-2
- EC Name:
- Benzothiazole
- Cas Number:
- 95-16-9
- Molecular formula:
- C7H5NS
- IUPAC Name:
- benzothiazole
- Details on test material:
- - Name of test material (as cited in study report): Benzothiazol
- Analytical purity: no data
Constituent 1
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
