Registration Dossier
Registration Dossier
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EC number: 233-593-1 | CAS number: 10254-57-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 17 to 24 June 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with relevant guidelines. Not conducted under GLP conditions..
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4,4'-methylene bis(dibutyldithiocarbamate)
- EC Number:
- 233-593-1
- EC Name:
- 4,4'-methylene bis(dibutyldithiocarbamate)
- Cas Number:
- 10254-57-6
- Molecular formula:
- C19H38N2S4
- IUPAC Name:
- N,N-dibutyl({[(dibutylcarbamothioyl)sulfanyl]methyl}sulfanyl)carbothioamide
- Details on test material:
- Batch No.: not specified
Purity: not specified
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young adult
- Housing: The animals were housed and maintained in compliance with the Animal Welfare Act 9 CFR Part 3.
No additional data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
No additional data - Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test material was not washed from the eyes.
SCORING SYSTEM: Draize Scale of Scoring Ocular Lesions.
No additional data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effects were observed during 7 day observation period.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effects were observed during 7 day observation period.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effects were observed during 7 day observation period.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No effects were observed during 7 day observation period.
- Irritant / corrosive response data:
- No information provided
- Other effects:
- No information provided
Any other information on results incl. tables
Individual Daily Scores
Rabbit number |
Tissue |
Item |
Readings |
||||
1 day |
2 day |
3 day |
5 day |
7 day |
|||
1 |
Cornea |
Opacity Area |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Iris |
Value |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
Redness Chemosis Discharge |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
2 |
Cornea |
Opacity Area |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Iris |
Value |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
Redness Chemosis Discharge |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
3 |
Cornea |
Opacity Area |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Iris |
Value |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
Redness Chemosis Discharge |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
4 |
Cornea |
Opacity Area |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Iris |
Value |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
Redness Chemosis Discharge |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
5 |
Cornea |
Opacity Area |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Iris |
Value |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
Redness Chemosis Discharge |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
6 |
Cornea |
Opacity Area |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Iris |
Value |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
Redness Chemosis Discharge |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Methylenebis (dibutyldithiocarbamate) is not irritating to the rabbit eyes in this test.
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