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EC number: 273-992-8 | CAS number: 69416-61-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- end on 8 July 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: screening test, sufficiently described
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- screening test (only one animal used)
- GLP compliance:
- no
Test material
- Reference substance name:
- Potassium (R)-(4-hydroxyphenyl)[(3-methoxy-1-methyl-3-oxoprop-1-enyl)amino]acetate
- EC Number:
- 273-992-8
- EC Name:
- Potassium (R)-(4-hydroxyphenyl)[(3-methoxy-1-methyl-3-oxoprop-1-enyl)amino]acetate
- Cas Number:
- 69416-61-1
- Molecular formula:
- C13H15NO5.K
- IUPAC Name:
- potassium (4-hydroxyphenyl)[(3-methoxy-1-methyl-3-oxoprop-1-en-1-yl)amino]acetate
- Details on test material:
- - Name of test material (as cited in study report): FGH-KZ
- Substance type: monoconstituent substance
- Physical state: data not available
- Analytical purity: data not available
- Impurities (identity and concentrations): data not available
- Purity test date: data not available
- Lot/batch No.: 1109 A
- Expiration date of the lot/batch: data not available
- Stability under test conditions: data not available
- Storage condition of test material: data not available
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source, Age at study initiation, Weight at study initiation, Fasting period before study, Housing, Diet, Water, Acclimation period: data not available
ENVIRONMENTAL CONDITIONS
- Temperature, Humidity, Air changes, Photoperiod: data not available
IN-LIFE DATES: data not available
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- moistened
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5g of HPG-ds
- Concentration: moistened with distilled water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- one animal
- Details on study design:
- TEST SITE
- Area of exposure: data not available
- % coverage: data not available
- Type of wrap if used: The patch was fixed with a dressing, which was wrapped around the abdomen and secured with an elastic bandage. The
application should be regarded as a semi-occlusive application.
REMOVAL OF TEST SUBSTANCE
- Washing: Four hours after the application, the dressing was removed and the remaining test substance removed using a tissue moistened with tap-water and subsequently a dry tissue.
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to OECD guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours (mean value)
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours (mean value)
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No skin irritation was observed in the treated skin-area after a four hour exposure to FGH-KZ (batch 1109 A).
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- HPG-ds is not irritating to the skin
- Executive summary:
In a primary dermal irritation study, one New Zealand White rabbit was dermally exposed to 0.5g of HPG-ds (potassium (R)-(4-hydroxyphenyl)[(3-methoxy-1-methyl-3-oxoprop-1-enyl)amino]acetate) moistened with distilled water for 4 hours (under semi-occlusive conditions). Animals then were observed for 72 hours. Irritation was scored by the method of OECD.
No skin irritation was observed in the treated skin-area after a four hour exposure.The mean scores at 24, 48 and 72 hours are:
- erythema: 0
- edema: 0
In this study, HPG-ds (potassium (R)-(4-hydroxyphenyl)[(3-methoxy-1-methyl-3-oxoprop-1-enyl)amino]acetate) is not a dermal irritant and is not classified according to EU criteria.
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