Registration Dossier
Registration Dossier
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EC number: 202-409-1 | CAS number: 95-31-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: limited but acceptable documented study report which meets basic scientific principles
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Reference Type:
- publication
- Title:
- Acute toxicologic evaluation of Santocure NS vulcanization accelerator
- Author:
- Randall, D.J. and Bannister, R.M.,
- Year:
- 1 990
- Bibliographic source:
- Acute Toxic. Data 1 (2), 104-105
Materials and methods
- Principles of method if other than guideline:
- Method: Draize Test
- GLP compliance:
- no
Test material
- Reference substance name:
- N-tert-butylbenzothiazole-2-sulphenamide
- EC Number:
- 202-409-1
- EC Name:
- N-tert-butylbenzothiazole-2-sulphenamide
- Cas Number:
- 95-31-8
- Molecular formula:
- C11H14N2S2
- IUPAC Name:
- N-(1,3-benzothiazol-2-ylsulfanyl)-2-methylpropan-2-amine
- Details on test material:
- test substance purity: 97 %
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 6 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Draize score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.5
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 7.6
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: (conjunctiva + chemosis + discharge) x 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 7.6
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: (conjunctiva + chemosis + discharge) x 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
Any other information on results incl. tables
The test substance was slightly irritating to the rabbit eye (mean irritation score 24, 48, and 72 hours: 2.5/110.0). Effects on the conjunctivae were noted in all animals at 24 hours (mean score 24 h: 7.6/110) but were reversible within 48 hours. The test substance was classified as not eye irritating according to F.H.S.A.
EU mean chemosis score: 0
EU mean corneal score: 0
EU mean iritis score: 0
Draize score: 2.5/110
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
100 mg of finely ground Santocure NS vulcanization accelerator was placed into the conjunctivial sac of 6 New Zealand albino male and female rabbits. A 7-d observation period followed application. Eye responses were scored in accordance with the Federal Hazardous Substances Act, 21 CFR, § 191.12 (1964).
The test substance was slightly irritating to the rabbit eye (mean irritation score 24, 48, and 72 hours: 2.5/110.0). Effects on the conjunctivae were noted in all animals at 24 hours (mean score 24 h: 7.6/110) but were reversible within 48 hours. The test substance was classified as not eye irritating according to F.H.S.A.
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