2-phenylethanol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2600 (Skin Sensitisation)

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Phenylethyl alcohol

IUPAC Name:

Phenylethyl alcohol

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Interfauna UK Limited, Blackthorne, Bicester, Oxon, UK
- Age at study initiation: Young adults
- Weight at study initiation: 16.4-20.2g
- Sex: Female
- Number used: 4 per group
- Housing:cage suitables for animals of this strain and weight range
- Diet and water (e.g. ad libitum): Diet (RM1) was supplied by Special Diets Service Limited, Witham, Essex, UK, and mains water, supplied by an automatic system, were available ad libitum
- Acclimation period: 5 days prior to the start of dosing.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3°C
- Humidity (%): 30-70%
- Air changes (per hr): a minimum of 15 changes per hr
- Photoperiod (hrs dark / hrs light): Artificial, giving 12 hr light, 12 hr dark

Study design: in vivo (LLNA)

Vehicle:

other: 25% ethanol; 75% diethylphthalate

Concentration:

2.5, 5, 10, 25 or 50% w/v

No. of animals per dose:

4

Positive control substance(s):

other: Hexylcinnamaldehyde

Statistics:

The EC3 value was derived by interpolating two points on the Sensitisation Index (SI) axis, one immediately above and the other immediately below the SI value of 3 (vehicle-treated control values [SI=1] not being used for the latter). Where the data point lying immediately above and below the SI value of three have the co-ordinates a ( the concetration giving the SI immediately below 3) and d(the SI of c), the EC3 value was calculated using the following equation:

EC3=[(3-d)/b-d)] x (a-c)+c

Results and discussion

Positive control results:

The positive control Hexylcinnamaldehyde was tested at concentration of 2.5, 5 and 5% w/v. The results showed a test control ratio average of 6.15.

In vivo (LLNA)

Results

Results 1

Key result

Parameter:

SI

Remarks:

Ratio of test to control lymphocyte proliferation

Value:

ca. 1.06

Test group / Remarks:

2.5% tested concetration

Remarks on result:

other: negative result

Results 2

Key result

Parameter:

SI

Remarks:

Ratio of test to control lymphocyte proliferation

Value:

ca. 1.01

Test group / Remarks:

5% tested concetration

Remarks on result:

other: negative result

Results 3

Key result

Parameter:

SI

Remarks:

Ratio of test to control lymphocyte proliferation

Value:

ca. 0.87

Test group / Remarks:

10% tested concentration

Remarks on result:

other: negative result

Results 4

Key result

Parameter:

SI

Remarks:

Ratio of test to control lymphocyte proliferation

Value:

ca. 0.95

Test group / Remarks:

25% tested concentration

Remarks on result:

other: negative result

Results 5

Key result

Parameter:

SI

Remarks:

Ratio of test to control lymphocyte proliferation

Value:

ca. 0.84

Test group / Remarks:

50% tested concetration

Remarks on result:

other: negative result

Any other information on results incl. tables

Skin sensitisation potential of Phenylethyl Alcohol
Concentration of the test substance	No of lymph nodes assayed	Disintegration per min. (dpm)	dpm per limph node	Test control ratio
0	8	5432	679	N/A
2.5	8	5776	722	1.06
5	8	5504	688	1.01
10	8	4709	589	0.87
25	8	5167	646	0.95
50	8	4536	567	0.84
50	Greater than 50% w/v (greater than 12500 µg/cm2
Skin sensitisation potential of the positive control substance ( Hexylcinnamaldehyde)
Concentration of the test substance	No of lymph nodes assayed	Disintegration per min. (dpm)	dpm per limph node	Test control ratio
0	8	2570	321	N/A
2.5	8	16088	2011	6.26
5	8	15659	1957	6.1
10	8	15611	1951	6.08

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

The test material Phenylethyl Alcohol was not a sensitiser under the condition of the test.

Executive summary:

In this study, Phenylethyl alcohol was assessed for its skin sensitisation potential using the mouse Local Lymph Node Assay. Concentration of 2.5, 5, 10, 25 or 50% w/v preparation in 25% ethanol/ 75% diethylphthlate were tested on groups of four female mice. Hexylcinnamaldehyde at concentration of 2.5, 5 and 5% w/v was used as positive control. The test material was applied to the dorsal surface of each ear and the test was repeated for three consecutive days, following the same procedure.

The results showed that the application of the test substance at concentrations of 2.5, 5, 10, 25 or 50% w/v preparation in 25% ethanol/ 75% diethylphthlate resulted in an isotope incorporation which was less than 3 -fold at all concentrations. Consequently, the test substance is unlikely to be a skin sensitizer. The estimated concertation giving rise to a 3 -fold increase in lymphocyte proliferation (EC3) was greater than 50%w/v (greater than 12500 µg/cm2 ), therefore 2 -phenylethyl alcohol is not considered to be a sensitizer under the test conditions.