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Administrative data

Description of key information

The skin and eye irritation potential of Phenyl ethyl alcohol have been evaluated in the rabbit. There was no evidence of skin irritation, however it was irritating to eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
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
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
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.
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
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
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
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
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
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.
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
Irritation parameter:
edema score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
4
Remarks on result:
other: No edema present
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.

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation, other
Remarks:
In Vivo study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Early non-GLP/non-guideline study, adequate for assessment
Principles of method if other than guideline:
The degree of injury was assessed following instillation of phenyl ethyl alcohol into the eye.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on study design:
Eye irritation was recorded using a 10 -point scale, based upon the degree of corneal necrosis that
resulted from instillation of various volumes/concentrations of the test substance into the rabbit eye i.e.
Grade 1 = very small area of necrosis after instillation of 0.5 ml undiluted substance;
Grade 5 = severe chemical burn after instillation of 0.005 ml undiluted substance;
Grade 10 = severe chemical burn after instillation of 0.5 ml of 1% dilution of substance;
Irritation parameter:
cornea opacity score
Score:
8
Max. score:
10
Reversibility:
not specified
Remarks on result:
other: Results from this non-standard test indicate severe corneal corrosion
Interpretation of results:
other: Irritant to eye
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Irritant to eye
Executive summary:

An acute eye irritation study was conducted by Carpenter et al. (1973) during a range- finding toxicity study. The test was carried on using New Zealand White rabbits. Eye irritation was recorded using a 10 -point scale, based upon the degree of corneal necrosis that resulted from instillation of various volumes/concentrations of the test substance into the rabbit eye. The score recordered was 8 of 10. Based on the condition of the study, phenylethyl alcohol was considered to be an eye irritant.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Information is available from four studies that have assessed the skin irritation potential of Phenyl ethyl alcohol, and one study that evaluated its eye irritation potential.

In the first skin irritation study (Toxicol Laboratories Limited, 1984), Phenyl ethyl alcohol was applied to the clipped skin of 3 New Zealand White female rabbits under semiocclusive patches for 4 hours. Well defined erythema (grade 2) was present in all animals at 24 hr, reducing in incidence and severity at 48 hr and 72 hr with very slight erythema (grade 1) persisting in one animal at 168 hr (mean erythema score = 1.6). Very slight edema (grade 1) was present in two animals up to 72 hr, but had fully resolved by 168 hr (mean edema score = 0.7). Under the test condition, the test material was not a skin irritant.

In the second study (Toxicol Laboratories Limited, 1985), semiocclusive patches were placed on the clipped skin of 4 New White Zealand rabbits. The patches were left in place for 4 hr and observations were recorded 24, 48, 72 and 168 hr after patch removal. Very slight erythema (grade 1) was present in all animals 24 hr after patch removal, with the number of animals affected decreasing at 48 hr and 72 hr although the severity of the response was sustained; erythema had fully resolved in all animals by 168 hr (mean erythema score = 0.8). Very slight edema (grade 1) was observed in 1 rabbit at the 24 hr and 48 hr timepoints but had fully resolved by 72 hr (mean edema score = 0.2). Phenyl ethyl alcohol was not irritating to skin under the conditions of the study.

In a study with limited reporting of methods and results, Carpenter et al. (1974) investigated the skin irritation potential of Phenyl ethyl alcohol following application of 0.01 ml undiluted test substance to New Zealand rabbit skin. The results gave an overall score of 3 out of a maximum score of 6 suggesting that small volumes of Phenyl ethyl Alcohol were not irritating to skin.

In a study of unconventional design (Huntingdon Research Centre Ltd, 1988), 0.3 ml Phenyl ethyl alcohol was applied under occlusive conditions to one of four test sites on the skin of three rabbits for contact times of 1, 2, 4 or 6 hr and reactions assessed for up to 6 days. The intensity of the response was dependent on the time the test substance was in contact with the skin, however reactions were generally quite mild (e.g. maximum mean erythema score = 2 (well defined erythema), maximum mean edema score = 1(very slight edema)) with peak responses (generally observed 2-3 days post-exposure) resolving by day 6.

The eye irritation potential of Phenyl ethyl alcohol was evaluated by Carpenter et al. (1973) using New Zealand White rabbits. Responses were recorded using a 10 -point scale, and were based upon the degree of corneal necrosis that resulted from instillation of various volumes/concentrations of the test substance into the rabbit eye. The score recorded was 8 of maximum of 10. Although the study is of unconventional design with only limited reporting of the methods used and results obtained, the results suggest that Phenyl ethyl alcohol was an eye irritant under the conditions of the test.


Effects on eye irritation: irritating

Justification for classification or non-classification

Based on the available in vivo skin irritation data, no classification for skin irritation is required according to the EU CLP Regulation (EC No. 1272/2008).

Regarding eye irritation, Phenyl ethyl alcohol should be classified Eye Irritant category 4 (H319: Causes serious eye irritation) according to Regulation (EC) No. 1272/2008.