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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1987
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A group of 3 adult Wistar rats was applied 0.4 mL of the test item at 20% (w/v) in DMSO on a 4 cm² of shaved skin once on one area and twice at one day's interval on another area without covering.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Propanamide, N-[2-(4-phenoxyphenoxy)ethyl]-
EC Number:
600-606-0
Cas Number:
104825-66-3
Molecular formula:
C17H19NO3
IUPAC Name:
Propanamide, N-[2-(4-phenoxyphenoxy)ethyl]-
Test material form:
solid
Details on test material:
Appearance: brown-beige solid
Molecular weight: 286
Melting point: 110 °C
Not soluble in water, PEG400 and oilve oil
Specific details on test material used for the study:
Appearance: brown-beige solid
Test item name (as cited in the report): para phenoxy phenoxy ethyl propionamid
Molecular weight: 286
Melting point: 110 °C
Not soluble in water, PEG400 and oilve oil

Test animals

Species:
rat
Strain:
Wistar
Details on test animals or test system and environmental conditions:
Initial weight: 300-350 g
Housed in groups of 3

Test system

Type of coverage:
open
Preparation of test site:
shaved
Vehicle:
other: DMSO
Controls:
no
Amount / concentration applied:
0.4 mL of solution of test item in DMSO (20% (w/v))
Duration of treatment / exposure:
Area 1: one application on Day 1
Area 2: one application on Day 1 and another application on Day 2
Number of animals:
3/group
Details on study design:
TEST SITE
- Area of exposure: 4 cm²

SCORING SYSTEM:
- Method of calculation: 4 grades of lesions
0: no reaction
1: Transcient simple redness
2: Redness + edema without/without crusts with reversibility
3: necrosis with eschar leading to premature sacrifice of the animal

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, the test item at 20% (w/v) in DMSO is not irritating to the skin.
Executive summary:

A group of 3 adult Wistar rats was applied 0.4 mL of the test item at 20% (w/v) in DMSO on a 4 cm² of shaved skin once on one area and twice at one day's interval on another area. The sites of application were not covered and the animals were restrained during a few minutes, until the solution was visually absorbed by the skin. At the time of reading, the substance did not show any signs of irritation.

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