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EC number: 202-607-8 | CAS number: 97-77-8
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
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- Terrestrial toxicity
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

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- other: Comparable to guideline study, GLP-compliance, available as unpublished report, adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Disulfiram
- EC Number:
- 202-607-8
- EC Name:
- Disulfiram
- Cas Number:
- 97-77-8
- Molecular formula:
- C10H20N2S4
- IUPAC Name:
- disulfiram
- Details on test material:
- - Name of test material (as cited in study report): ETHYL THIURAD
- Physical state: off-white powder
- Purity: 98.6%
- Lot/batch No.: 5394
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Isaac’s Farm, Litchfield, Illinois
- Age at study initiation: young adult
- Weight at study initiation: 2.16-2.37 kilograms
- Housing: one per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A mass of 32 ± 1 mg, determined to occupy a volume of 0.1 mL of test material - Duration of treatment / exposure:
- single eye instillation
- Observation period (in vivo):
- 24, 48, 72 hours and 7 day
- Number of animals or in vitro replicates:
- 6 animals (3 males and 3 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No washing
SCORING SYSTEM: The method of Draize (1944)
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4.2
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 tested animals and mean of readings at
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean of readings at
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Iris values according to current EU classification criteria
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean of readings at
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Iris values according to current EU classification criteria
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of the remaining 4 tested animals and mean of readings at
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean of readings at
- Time point:
- 24/48/72 h
- Score:
- 6.67
- Max. score:
- 20
- Reversibility:
- fully reversible within: 7 days
- Remarks:
- the scores were 16 after 24 h, and 2 after 48 and 72 h
- Remarks on result:
- other: max. score as a sum of redness, chemosis and discharge
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean of readings at
- Time point:
- 24/48/72 h
- Score:
- 2.66
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: max. score as a sum of redness, chemosis and discharge
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean of readings at
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 20
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: max. score as a sum of redness, chemosis and discharge
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Remarks:
- mean of readings at
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: max. score as a sum of redness, chemosis and discharge
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Remarks:
- mean of readings at
- Time point:
- 24/48/72 h
- Score:
- 2.66
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: max. score as a sum of redness, chemosis and discharge
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Remarks:
- mean of readings at
- Time point:
- 24/48/72 h
- Score:
- 2.66
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: max. score as a sum of redness, chemosis and discharge
- Irritant / corrosive response data:
- Only one out of 6 tested animals showed stronger irritation of conjunctivae. No data on chemosis was available.
Any other information on results incl. tables
Table 1: Ethyl Thiurad: Primary Eye Irritation to Rabbits - Individual Irritation Scores*
Animal # |
Obs. Day |
Cornea |
Iris |
Conjunctivae |
Total |
Average of 24, 48 and 72 h |
1 |
1 |
0 |
5 |
16 |
21 |
8.33 |
2 |
0 |
0 |
2 |
2 |
||
3 |
0 |
0 |
2 |
2 |
||
7 |
0 |
0 |
0 |
0 |
||
2 |
1 |
0 |
0 |
8 |
8 |
2.66 |
2 |
0 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
0 |
||
3 |
1 |
0 |
5 |
8 |
13 |
5.66 |
2 |
0 |
0 |
2 |
2 |
||
3 |
0 |
0 |
2 |
2 |
||
7 |
0 |
0 |
0 |
0 |
||
4 |
1 |
0 |
0 |
8 |
8 |
3.33 |
2 |
0 |
0 |
2 |
2 |
||
3 |
0 |
0 |
0 |
0 |
||
5 |
1 |
0 |
0 |
6 |
6 |
2.66 |
2 |
0 |
0 |
2 |
2 |
||
3 |
0 |
0 |
0 |
0 |
||
6 |
1 |
0 |
0 |
6 |
6 |
2.66 |
2 |
0 |
0 |
2 |
2 |
||
3 |
0 |
0 |
0 |
0 |
* Scores according to Draize, J.H. et al., 1944, J. Pharmacol. Exp. Therap. 82: 377-390.
Iris Values were given as total scores x 5
Conjunctivae values were given as total results from (A+B+C) x 2 with a total maximum of 20 (A = Redness, B = Chemosis and C = Discharge)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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