Registration Dossier
Registration Dossier
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EC number: 280-622-9 | CAS number: 83732-72-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01.02. - 16.02.1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 83732-72-3
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Age: 14 weeks
Body weight: 2519-2646 grams
Acclimatisation: At least five days under test conditions
Conditions: Standard Laboratory Conditions. Air-conditioned with 7.5-15 air changes per hour and hourly monitored environment with temperature 20 ± 3°C and relative humidity 30-70%, 12 hours artificial fluorescent light /12 hours dark.
Accommodation: Individually in cages with perforated floors equiped with an automatic drinking system (ITL, Bergen I The Netherlands).
Diet: Standard laboratory rabbit diet approx. 100 gram per day.
Water:Free access to tap-water diluted with decalcified water.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: reverse osmosis water
- Amount / concentration applied:
- 0.5 g (moistened)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- other: mildly irritating
- Executive summary:
Under the conditions of this study, 3-AMMP resulted in a primary irritation index of 0.3 (mildly irritating) when applied to the intact rabbit skin.The observed skin irritation consisted of very slight erythema. In one animal, also 3 brown spots with crust formation were observed. The irritation was reversible within 7 days after exposure. In the area of application, brown staining of the treated skin by test article was observed. No corrosive effect occurred on the skin and no signs of systemic intoxication were observed in any of the rabbits.
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