Registration Dossier
Registration Dossier
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EC number: 608-271-2 | CAS number: 28861-00-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Tyrosine, N-(aminocarbonyl)-3-methoxy-O,α-dimethyl-
- EC Number:
- 608-271-2
- Cas Number:
- 28861-00-9
- Molecular formula:
- C13H18N2O5
- IUPAC Name:
- Tyrosine, N-(aminocarbonyl)-3-methoxy-O,α-dimethyl-
- Details on test material:
- Name of test material (as cited in study report): Ureido-karbonsav
- Substance type: organic
- Physical state: white crystalline powder
- Stability under test conditions: stable
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3101.66 g average weight
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 h/12h
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g (onto 6 cm2 surface)
- Concentration (if solution): - - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30-60 min, 24h, 48 h, 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm^2
- % coverage: full
- Type of wrap if used: gauze and aluminium foil, nylon foil and linen bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize method
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 4 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 4 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Neither edema, nor erythema was observed in the treated skin area of the animals.
- Other effects:
- In the first 48 h, the exposure procedure might have disturbed the animals. The body weight decreased in this time period relative to the control animals. Later the body weight gain became similar to the control animals.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance does not classified as skin irritant.
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