Registration Dossier
Registration Dossier
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EC number: 205-232-8 | CAS number: 136-23-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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- GLP-compliant study, available as unpublished report, minor restrictions in design in comparison to modern guidelines, but adequate for assessment.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
- Principles of method if other than guideline:
- Differs from current testing guidelines by using a 24-hr contact period rather than a 4-hr contact period, use of both intact and abraded skin, and PII calculated using 24- and 72-hr observations instead of 24-, 48- and 72-hr time points.
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: 1sf: (NZW), Isaac’s Farm, Litchfield, Illinois
- Age at study initiation: young adult
- Weight at study initiation: 2.91—3.20 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
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved; then 2 out of 4 test sites abraded
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ± .004 grams - Duration of treatment / exposure:
- 24 hours
- Observation period:
- Observations for skin irritation was made after 1 hour, 24 hours and 72 hours after removal of the wrappings.
- Number of animals:
- 3 males and 3 females per dose
- Details on study design:
- TEST SITE
- Area of exposure: one inch square
- Type of wrap if used: an occlusive wrap of latex rubber secured by bandaging and elastic tape.
REMOVAL OF TEST SUBSTANCE
- The occlusive wrap and gauze patches were removed after approximately 24 hours, and the excess material was wiped from the treated sites of
the animals.
SCORING SYSTEM:
Dermal irritation was scored by the method of Draize (1944), and results were recorded on the first and third days after topical application.
The Primary Irritation Index was calculated by averaging the mean scores at 24 and 72 hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24,72 hours
- Score:
- 0.1
- Max. score:
- 8
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- other: overall score for both intact and abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hr
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: 48 h is not measured
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: 48 h is not measured
Applicant's summary and conclusion
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