1-phenylethanol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed journals

Data source

Reference

Reference Type:

publication

Title:

The Sensitization Potential of Some Perfume Ingredients Tested Using a Modified Draize Procedure

Author:

D.W. Sharp

Year:

1978

Bibliographic source:

Toxicology, 9 (1978) 261-271

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Modified Draize Technique was employed to determine the concentrations suitable for sensitization testing [injection challenge concentration(ICC) and application challenge concentration ( ACC) ] of 1-Phenylethanol

GLP compliance:

not specified

Type of study:

Draize test

Justification for non-LLNA method:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

1-phenylethanol

EC Number:

202-707-1

EC Name:

1-phenylethanol

Cas Number:

98-85-1

Molecular formula:

C8H10O

IUPAC Name:

1-phenylethan-1-ol

Test material form:

liquid

Details on test material:

IUPAC name: 1-phenylethan-1-ol
Mol. formula: C8H10O
Molecular Weight: 122.166 g/mol
Substance form: Colourless liquid
Substance type: organic
InChI: 1S/C8H10O/c1-7(9)8-5-3-2-4-6-8/h2-7,9H,1H3
Smiles :c1(ccccc1)C(C)O

Specific details on test material used for the study:

- IUPAC name: 1-phenylethan-1-ol
- Common Name: 1-Phenylethanol
- Mol. formula: C8H10O
- Molecular Weight: 122.166 g/mole
- InChI: 1S/C8H10O/c1-7(9)8-5-3-2-4-6-8/h2-7,9H,1H3
- Smiles: c1(ccccc1)C(C)O
- Substance type: Organic
- Physical state: Clear colourless liquid

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS

- Weight at study initiation: 350 g
- Housing: Housed in wire mesh cages in pairs of the same sex
- Diet (e.g. ad libitum): Pelleted guinea pig diet, cabbage and hay ad libitum
- Water (e.g. ad libitum): water ad libitum

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Vehicle:

not specified

Concentration / amount:

0.1 mL at 2.5 X 0.25%(ICC) : 10 guinea pigs

Day(s)/duration:

no data available

Adequacy of induction:

other: The concentration giving slight but perceptible irritation with no oedema was selected as the injection challenge concentration (ICC).

Challenge

No.:

#1

Route:

intradermal and epicutaneous

Vehicle:

not specified

Concentration / amount:

Challenge concentration: 0.1 mL at 0. 25% (ICC) and 30% (ACC): 10 guinea pigs
Re- challenge concentration: 0.1 mL at 0.25%(ICC) and 30% (ACC): 10 guinea pigs

Day(s)/duration:

24 hours

Adequacy of challenge:

other: The concentration giving slight but perceptible irritation with no oedema was selected as the injection challenge concentration (ICC). The highest concentration which caused no irritation was selected as the application challenge concentration (ACC).

No. of animals per dose:

10: 4 males and 6 females

Details on study design:

MAIN STUDY
RANGE FINDING TESTS: For each test material preliminary irritation tests were done in guinea pigs to determine concentrations suitable for sensitization testing.


A. INDUCTION EXPOSURE: Intradermal
- No. of exposures:4
- Exposure period: No Data Available
- Test groups:10 guinea pigs
- Control group: No Data Available
- Site: 4 sites, 2 auxillary and 2 inguinal lymph nodes
- Frequency of applications:1
- Duration: No Data Available
- Concentrations: 0.1 mL at 2.5 X 0.25% (ICC)

B. CHALLENGE EXPOSURE: Intradermal and Epicutaneous
- No. of exposures:1
- Day(s) of challenge: Fourteen days later, challenge test was performed
- Exposure period:24 hours
- Test groups:10 guinea pigs
- Control group: No Data Available
- Site: onto the shaved flank in a small circular area
- Concentrations: 0.1 mL at 0.25% (ICC) and 30%(ACC).
- Evaluation (hr after challenge):24 hours

C. RECHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: 7 Days Later , rechalleange test was performed.
- Exposure period: No Data Available
- Test groups:10 animal
- Control group: 4 animal (same sex)
- Site: Intradermally and topically on opposite flanks
- Concentrations: 0.1 mL at 0.25% (ICC) and 30% (ACC).
- Evaluation (hr after challenge): No Data Available

-Other:

Observations and scoring –
Each injection reaction was given a total score based on size (2 largest diameters), erythema and oedema. Individual reactions were considered positive when their total score was significantly greater than the average total score for control reactions. Application reactions were scored on a 0 to +++ scale. Reactions were examined under a Philips colour-matching unit with 3 Philips 40 W Actinic Blue 05 fluorescent tubes and 3 Philips 40 W White 35 fluorescent tubes.

Challenge controls:

At each challenge with controls, 4 previously untreated animals of the same sex and similar weight to the test animals were treated intradermally and topically on opposite flanks with 0.1 ml aliquots of test substance at the ICC and ACC respectively.

Positive control substance(s):

not specified

Results and discussion

Positive control results:

No data available

In vivo (non-LLNA)

Results

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.1 mL at 0.25% (ICC) and 30% (ACC).

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

No skin sensitization was observed at tested concentrations

Remarks on result:

no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

other: not sensitizing

Conclusions:

No signs of contact sensitization were observed at 0.25% ICC and 30% ACC concentrations. Hence, 1-phenylethanolThe skin sensitization study of 1 -Phenylethanol was carried out in 10 Inbred Hartley strain albino the guinea pigs of to determine its sensitization potential according modified Draize sensitization test.

Executive summary:

The skin sensitization study of 1 -Phenylethanol was carried out in 10 Inbred Hartley strain albino the guinea pigs of to determine its sensitization potential according modified Draize sensitization test.

The preliminary irritation tests were done in guinea pigs to determine concentrations suitable for sensitization testing [injection challenge concentration(ICC) and application challenge concentration(ACC)].

In the induction phase, the total dose was administered on one occasion as 4 intradermal injections, each 2.5 times the ICC (2.5X 0.25). Fourteen days later each animal was challenged intradermally in one flank and topically in the other with 0.1 ml aliquots of test substance at the respective ICC and ACC (0.25 and 30 respectively). Twenty-four hours later the reactions were observed. In the absence of sensitization reactions at first challenge the induction and challenge procedures were repeated, and apparent sensitization reactions confirmed 7 days later by a second challenge with controls included.

Based upon the second challenge, it can be concluded that 1 -phenylethanol was considered to be non-sensitizing to the skin of albino Hartley guinea pigs at 0.25% ICC and 30% ACC concentrations.