Allyl phenoxyacetate

Endpoint summary

Description of key information

skin irritation (equivalent to OECD 404): not irritating

eye irritation (equivalent to OECD 405): not irritating

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:

key study

Study period:

Nov 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Poor description of the test substance (no purity)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

yes

Remarks:

Poor description of the test substance (no purity).

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 10 - 12 weeks
- Weight at study initiation: approx. 2 kg
- Housing: individually in grid bottomed metal cages
- Diet: SQC standard rabbit pellets (Special Diets Services, Witham, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 5 - 24 (The system was set to maintain temperature within the range of 17 - 23 °C but the heating equipment failed during the acclimatisation period. Temperature was typically greater than 14 °C during the study period.)
- Humidity (%): 37 - 68
- Air changes (per hr): 6
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin areas

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

7 days
Reading time points: 1, 24, 48 and 72 h and 7 days

Number of animals:

4

Details on study design:

TEST SITE
- Area of exposure: dorsal surface of the trunk
- Type of wrap: The test substance was placed over a 2.5 cm square of surgical lint. The lint square was placed either on the left or on the right flank. The lint patch was held in place by encircling the trunk with a length of adhesive bandage (Elastoplast) 10 cm wide.

REMOVAL OF TEST SUBSTANCE
- Washing: The skin was cleaned of residual test substance by gentle swabbing with cotton wool soaked in warm water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system; Reaction to treatment considered to fall mid-way between the points described was scored as a fraction (i.e. 0.5, 1.5, 2.5, etc).

Irritation parameter:

erythema score

Basis:

mean

Remarks:

#1 and #3

Time point:

other: mean after 24/48/72 h

Score:

0.17

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

other: mean after 24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: mean after 24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

mean

Remarks:

#2 and #3

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

mean

Remarks:

#1 and #4

Time point:

other: mean after 24/48/72 h

Score:

0.17

Max. score:

4

Reversibility:

fully reversible within: 48 h

Table 1. Results of the irritation study.

Observation time	Rabbit no.
	1		2		3		4
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	0	0	0.5	0.5	0.5	0	0	0
24 h	0.5	0.5	0.5	0	0.5	0	0.5	0.5
48 h	0	0	0.5	0	0	0	0.5	0
72 h	0	0	0.5	0	0	0	0	0
7 days	0	0	0	0	0	0	0	0
Mean value 24 + 48 + 72 h	0.17	0.17	0.5	0.0	0.17	0	0.33	0.17

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

Under the conditions of this skin irritation study in rabbits the test substance was not irritating to the skin.

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:

key study

Study period:

07 - 16 July 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

No information on purity was given.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1981

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Modified Federal Hazardous Substances Labelling Act Method (Federal Register, 1964, 29 13009)

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: at least 7 weeks
- Weight at study initiation: 1 - 2 kg
- Housing: singly before and during the test
- Diet: commercially available, pelleted diet, ad libitum
- Water: ad libitum

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye was used as an untreated control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

7 days
Reading time points: 15 min and 24, 48 and 72 h and 7 days

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: Draize scoring system; Reaction to treatment considered to fall mid-way between the points
described was scored as a fraction (i.e. 0.5, 1.5, 2.5, etc).

TOOL USED TO ASSESS SCORE: slit lamp / fluorescein in one animal

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: mean after 24/48/72 h

Score:

0.17

Max. score:

4

Reversibility:

fully reversible within: 2 days

Irritation parameter:

cornea opacity score

Basis:

animal: #2 and #3

Time point:

other: mean after 24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean after 24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 2 days

Irritation parameter:

conjunctivae score

Basis:

animal: #2 and #3

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

The test substance caused slight corneal opacities affecting up to 0.5 of the cornea in all 3 animals. One animal also had slight conjunctivitis. One animal healed by Day 2, two by Day 7.

Table 1. Results of the eye irritation study.

Animal	Time (h)	Conjunctivae		Cornea	Iris
		Redness	Chemosis
1	15 min	1	0	-	-
	1	1	0	0.5	0
	2	0	0	0	0
	3	0	0	0	0
	7 d	0	0	0	0
	Average 24+48+72	0.3	0	0.17	0
2	15 min	1	0	-	-
	1	0	0	0.5	0
	2	0	0	0.5	0
	3	0	0	0.5	0
	7 d	0	0	0	0
	Average 24+48+72	0	0	0.5	0
3	15 min	1	0	-	-
	1	0	0	0.5	0
	2	0	0	0.5	0
	3	0	0	0.5	0
	7 d	0	0	0	0
	Average 24+48+72	0	0	0.5	0

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

Under the conditions of this eye irritation study in rabbits the test substance was not irritating to the eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin

The skin irritation potential of the test substance was determined in a primary skin irritation/corrosion study equivalent or similar to OECD Guideline 404 and in compliance with GLP (1989). Four animals were treated with 0.5 mL undiluted test substance under semi-occlusive conditions for 4 h. Scoring of skin reactions (erythema and edema) was performed 1, 24, 48 and 72 h and 7 days after removal of the patch. Additionally to regular Draize scoring system slight effects were assessed with a value of 0.5. One hour after the four hour dosing period erythema (score 0.5) was apparent in two animals and edema (score 0.5) was apparent in one of these animals. Erythema (score 0.5) was observed at the treated skin of all animals 24 h after dosing. Edema (score 0.5) was observed in two animals. The incidence of irritant response had declined by the 48 h examination when erythema (score 0.5) remained in two animals. No irritation remained after 7 days. The mean irritation score over 24, 48 and 72 h was 0.3 for erythema and 0.1 for edema. Based on the results, the test substance was not irritating to the skin under the conditions of the test.

Eye

The eye irritation potential of the test substance was investigated in three albino rabbits equivalent or similar to OECD Guideline 405 (1980). 0.1 mL of the test substance was applied in one eye of each animal after pretreatment of the eyes with corneal anaesthetic. The other eye remained untreated and served as control. The eyes were examined and scored according to the Draize scoring system 15 min, 1, 2, 3 and 7 days after application. Additionally to regular Draize scoring system slight effects were assessed with a value of 0.5. A slight redness of the conjunctivae (score 1) of the treated eye was observed in one animal fully reversible within 2 days. The test substance caused slight corneal opacities (score 0.5) in all 3 animals fully reversible within 2 days in one animal and within 7 days in two animals. The mean scores for cornea at 24/48/72 for each animal were 0.17, 0.5 and 0.5, respectively. No effects on chemosis of conjunctivae or effects on iris were observed in any animal. Based on the results of this study, the test substance was not irritating to the eyes under the conditions of the test.

Justification for classification or non-classification

The available data on skin and eye irritation do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.