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: 202-607-8 | CAS number: 97-77-8
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- other: Comparable to guideline study, GLP-compliance, available as unpublished report, adequate for assessment.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:
- N,N-diethyl[(diethylcarbamothioyl)disulfanyl]carbothioamide
- 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:
- other: 24, 48 and 72 hours
- 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:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean of readings at
- Time point:
- other: 24, 48 and 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:
- other: 24, 48 and 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:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- reading at
- Time point:
- other: 24 h
- Score:
- 16
- 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 #1
- Remarks:
- mean of readings at
- Time point:
- other: 48 and 72 h
- Score:
- 2
- 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 #2
- Remarks:
- mean of readings at
- Time point:
- other: 24, 48 and 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:
- other: 24, 48 and 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:
- other: 24, 48 and 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:
- other: 24, 48 and 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:
- other: 24, 48 and 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.
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
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.
Route: .live1