2-phenylethanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

In Vivo study

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Near guideline, GLP animal experimental study, available as published report, fully adequate for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Principles of method if other than guideline:

The procedure used were based on the test for skin irritation described in the methods for the determination of toxiciy in Annex V of the ECC Directive 79/B31

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Phenylethyl alcohol

IUPAC Name:

Phenylethyl alcohol

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Not reported
- Age at study initiation: not indicated
- Weight at study initiation: not indicated
- Sex: female
- Delivered on: 19 April, 10 May, 01 June 1984
- Housing: Animals were places in anodised aluminium cages with grid floors.
- Diet (e.g. ad libitum): ad libitum commercially available pelletted rabbit diet (S.Q.C. Standard Rabbit Diet, Special Diet Services Limited, Witham, Essex).
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days prior testing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-23 °C
- Humidity (%): 40-80%
- Air changes (per hr): air conditioned
- Photoperiod (hrs dark / hrs light): 12 hrs light/ 12 hrs dark

Test system

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 hrs

Observation period:

24, 48, 75 and 168 hrs after exposure

Number of animals:

3

Details on study design:

The day before running the test, the dorsal surfaces of the truck clipped free of hair using an Oster Model A2 clipper with Angra blade. Only animals with undamaged skin were selected for the test.
0.5 ml of liquid test material was placed over 2.5 cm square of surgical lint. The lint square was places onto the animals's skin on the left flank and immidiately caudal to the last rib. A second material was applied in the same manner to the skin of the right flank. Two other materials were applied caudal to the sites dosed with the first two materials. The lint patches were held in place by an elastic adhesive bandage 10cm wide. After a period of 4 hrs the adhesive tapes were removed and the treated sites cleaned bt gentle swabbing with cotton wool soaked in warm water.
Observation were recorded after 24, 48, 72, 168 hrs after patch removal. Erythema, Eschar Formation and Oedema Formation were assessed using a numerical value from 0 to 4. Corrosive effects and other signs of reaction were also recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 168 hr for two animals out of 3

Remarks on result:

other: Erytema score 2 for 3 animals

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 168 hr for 2 animals

Remarks on result:

other: Erythema score 1 for 2 animals

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 168 hr for 2 animals of 3

Remarks on result:

other: Erythema score 1 for 2 animals; score 2 for 1 animal

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

7 d

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 168 hr for 2 animals of 3

Remarks on result:

other: Erythema score 1 hoe 1 animal

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 1 68 hr

Remarks on result:

other: Edema score 1 for 2 animals. Edema score 1 for 2 animals

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 168 hr

Remarks on result:

other: Edema score 1 for 2 animals.

Results 7

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 168 hr

Remarks on result:

other: Edema score 1 for 2 animals

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

7 d

Score:

0

Max. score:

4

Remarks on result:

other: No edema present

Applicant's summary and conclusion

Interpretation of results:

other: Not irritant

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The overall average of erythema observations was 1.6, while the overall average of edema observation was 0.7.

Executive summary:

The test material Phenyl ethyl alcohol was tested on 3 New Zealand White female rabbits to evaluate the degree of irritation. Semi-occlusive patches were places on the shaved skin of the animals for 4 hours. Erythema and edema observations were recorded after 24, 48, 72 and 168 hours after patch removal. One hour after the 4 hr treatment, erythema and edema were observed in 2 rabbits. Twenty-four and 72 hours after dosing, a very well defined erythema was observed in all 3 animals, while edema appeared only in 1 animals. The erythema remained at the treated site of one rabbit after 168 hours, while the edema was fully reversible.

In conclusion, the overall average of erythema and edema observations ware 1.6 and 0.7, respectively. Under the test condition, the test material Phenyl ethyl alcohol is not considered to be a skin irritant.