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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:
1993
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

Constituent 1
Chemical structure
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 (R)-(4-hydroxyphenyl)[(3-methoxy-1-methyl-3-oxoprop-1-enyl)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

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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