Registration Dossier
Registration Dossier
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EC number: 204-876-7 | CAS number: 128-04-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Individual bodyweights were not reported.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium dimethyldithiocarbamate
- EC Number:
- 204-876-7
- EC Name:
- Sodium dimethyldithiocarbamate
- Cas Number:
- 128-04-1
- Molecular formula:
- C3H7NS2.Na
- IUPAC Name:
- sodium dimethyldithiocarbamate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Cheshire, UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2000-3500 g
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): With distilled water
- Time after start of exposure: 4 h
SCORING SYSTEM:
According to Draize scoring system.
Erythema 0-4:
0: No erythema, 1: very slight erythema (barely perceptible), 2: well-defined erythema, 3 moderate to severe erythema, 4: severe erythema (beet redness) to slight eschar formation (injuries in depth)
Oedema 0-4:
0: No oedema, 1: very slight oedema (barely perceptible), 2: well-defined oedema (edges of area well-defined by definite raising), 3: moderate to severe oedema (raised approximately 1mm), 4: severe oedema (raised more than 1 mm extending beyond the area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
Any other information on results incl. tables
Observation time |
Rabbit number and sex |
|||||
#29 male |
#31 male |
#45 male |
||||
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
|
1 h |
2 |
2 |
2 |
3 |
2 |
3 |
24 h |
2 |
1 |
2 |
2 |
2 |
1 |
48 h |
1 |
0 |
1 |
1 |
1 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
Mean value |
1.00 |
0.33 |
1.00 |
1.00 |
1.00 |
0.33 |
Reversibility |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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