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Description of key information

Supporting evidence of absence of skin and eye irritation properties.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
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
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
Species:
rat
Strain:
Wistar
Details on test animals or test system and environmental conditions:
Initial weight: 300-350 g
Housed in groups of 3
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
Irritation parameter:
overall irritation score
Basis:
mean
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye 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
Qualifier:
no guideline followed
Principles of method if other than guideline:
One drop of a 20% solution diluted at 1/100 was instilled in the eye of 3 male Wistar rats
GLP compliance:
no
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
Species:
rat
Strain:
Wistar
Details on test animals or tissues and environmental conditions:
Initial weight: 300-350 g
Vehicle:
other: DMSO
Controls:
yes, concurrent no treatment
Amount / concentration applied:
One drop of a 20% (w/v) solution diluted at 1/100
Duration of treatment / exposure:
Not applicable
Observation period (in vivo):
No data
Number of animals or in vitro replicates:
3
Details on study design:
No data
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: no data
Score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, the test item did not show any signs of eye irritation.
Executive summary:

One drop of a 20% (w/v) solution of test item in DMSO, diluted at 1/100, was instilled in the eye of 3 male Wistar rats. No signs of irritation were recorded.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

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.

One drop of a 20% (w/v) solution of test item in DMSO, diluted at 1/100, was instilled in the eye of 3 male Wistar rats. No signs of irritation were recorded.

Justification for classification or non-classification

Although the substance was not tested undiluted, available data show supporting evidence that the registered substance may not have skin or eye irritation properties.

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