Registration Dossier
Registration Dossier
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EC number: 205-232-8 | CAS number: 136-23-2
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:
- comparable to guideline study with acceptable restrictions
- Remarks:
- GLP-compliant study, available as unpublished report, adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize, J.H., Woodard, G., and Calvery, H.O., 1944
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Zinc bis(dibutyldithiocarbamate)
- EC Number:
- 205-232-8
- EC Name:
- Zinc bis(dibutyldithiocarbamate)
- Cas Number:
- 136-23-2
- Molecular formula:
- C18H36N2S4Zn
- IUPAC Name:
- zinc bis(dibutyldithiocarbamate)
- Details on test material:
- BUTASAN, off—white powder
Purity: 99.9 %
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: 1sf: (NZW), Isaac’s Farm, Litchfield, illinois
- Age at study initiation: young adult
- Weight at study initiation: 2.57 — 2.83 kilograms
- Housing: one per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: animals were quarantined for 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 39 mg, determined to occupy a volume of 0.1 ml of test material - Duration of treatment / exposure:
- A single administration of the test material.
- Observation period (in vivo):
- Observations for signs of irritation were conducted on the first, second, and third days after dosing.
- Number of animals or in vitro replicates:
- 3 males and 3 females per dose
- Details on study design:
- 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:
- 0.3
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48 hr
- Irritation parameter:
- chemosis score
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- The cornea and iris score were 0 at all time points in all animals. One rabbit had a conjunctivae score 4 and another a conjunctivae score 2 at 24 hr examination. In both cases irritation was resolved at 48 hr examination.
Applicant's summary and conclusion
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