Potassium (R)-[(3-ethoxy-1-methyl-3-oxoprop-1-enyl)amino]phenylacetate

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:

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

Test material information

Constituent 1

Reference substance name:

Potassium (R)-[(3-ethoxy-1-methyl-3-oxoprop-1-enyl)amino]phenylacetate

EC Number:

213-510-5

EC Name:

Potassium (R)-[(3-ethoxy-1-methyl-3-oxoprop-1-enyl)amino]phenylacetate

Cas Number:

961-69-3

Molecular formula:

C14H17NO4.K

IUPAC Name:

potassium [(3-ethoxy-1-methyl-3-oxoprop-1-en-1-yl)amino](phenyl)acetate

Details on test material:

- Name of test material (as cited in study report): FG-KZE
- 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.: 989 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 PG-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

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24, 48, 72h (mean value)

Score:

1

Max. score:

4

Reversibility:

fully reversible within:

Remarks on result:

other: 72 hours

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24, 48, 72h (mean value)

Score:

ca. 0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

Well defined erythema and slight oedema were observed in the treated skin-area after a four hour exposure to FG-KZE (batch 989 A). The skin irritation had resolved within 72 hours after exposure.

Any other information on results incl. tables

Table 1: results (rabbit 1305)

Time after exposure	erythema	oedema	comments
30 minutes	1	2	-
24 hours	2	1	-
48 hours	1	0	-
72 hours	0	0	-

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

PG-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 PG-ds (potassium (R)-[(3-ethoxy-1-methyl-3-oxoprop-1-enyl)amino]phenylacetate) 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.

 

Well defined erythema and slight oedema were observed in the treated skin-area after a four hour exposure to FG-KZE (batch 989 A). The skin irritation had resolved within 72 hours after exposure. The mean scores at 24, 48 and 72 hours are:

- erythema: 1

- edema: 0.3

 

In this study, PG-ds (potassium (R)-[(3-ethoxy-1-methyl-3-oxoprop-1-enyl)amino]phenylacetate) is

not a dermal irritant and is not classified according to EU criteria.