1-phenylethanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

data is from experimental reports

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

The objective of the study was to assess the irritant and/or corrosive effects of 1-phenylethanol (CAS No. - 98-85-1) after dermal application on the intact skin in rabbits.

GLP compliance:

yes

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:

- Name of test material (as cited in study report): 1-phenylethanol
- Molecular Formula: C8H10O
- Molecular weight: 122.16439 g/mol
- Substance type: Organic
- Physical state: Liquid

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
- Analytical purity: 99.62%
- Lot/batch No.: 2014022801R-434
- Storage condition of test material: Room temperature (20 - 30°C)
- Other:
Handling and Disposal
Safety precautions: Aprons, masks, caps, gloves and goggles were used to ensure the health and safety of the personnel.
Disposal: The remaining unused test item was disposed as per internal SOPs and the same was documented in the raw data

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Procured from LIVEON BIOLABS PVT. LTD.
- Sex: Male
- Health Status: Healthy young adults rabbits were used for the study.
- Age at study initiation: 4.5 to 5.0 Months (Approximately)
- Weight at study initiation: Minimum: 1.766 kg and Maximum: 2.332
- Housing: The animals were housed individually in stainless steel cages
- Diet (e.g. ad libitum): All animals were provided conventional laboratory rabbit diet (Nutrivet Life Sciences) ad libitum. Batch No. 200004
- Water (e.g. ad libitum): Aqua guard filtered tap water was provided ad libitum
- Acclimation period: Rabbits were acclimatised to the test conditions for a period of 6 days (Animal No.-1) and 8 days (Animal No.-2 and 3) prior to the application of the test item
- Identification: During acclimatization marking was done with non toxic marker pen in the inside of left ear of rabbits and after acclimatization, animals were marked with permanent number in the inner side of right ear of rabbits. Permanent marker and cage card was used for identification. The individual cage cards were labelled with at least study no., study type, test system, sex, dose, experiment start date and experiment completion date.
- Room Sanitation: The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
- Cages and water bottle: All the cages and water bottles were changed minimum twice a week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 20.30°C and Maximum: 22.70 °C
- Humidity (%): Minimum: 48.30 % and Maximum: 68.30 %
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent vehicle

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
VEHICLE: Not applicable

Duration of treatment / exposure:

4-hour exposure period

Observation period:

1, 24, 48 and 72 hrs

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approximately 6 X 6 cm at contralateral sites
- Type of wrap if used: porous gauze dressing and non-irritating tape (Micropore 3”)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed by using cotton soaked in distilled water
- Time after start of exposure: 4hr

Control site: 0.5 ml distilled water was applied at control site.

SCORING SYSTEM: Draize Method

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The patch was removed after 4 hours and rabbits were observed for erythema and edema at 1, 24, 48 and 72 hours after patch removal, evaluated and graded as per draize method.
Animal No. 1, showed very very slight erythema (barely perceptible) and very slight oedema (barely perceptible) observed at 1 hour of observation. At 24, 48 and 72 hours observation no erythema and no oedema was observed in animal no 1.
Animal No. 2 and 3 showed very slight erythema (barely perceptible) and very slight oedema (barely perceptible) observed at 1 hour of observation. At 24, 48 and 72 hours observation no erythema and no oedema was observed in animal no. 2 and 3
The individual mean score at 24, 48 and 72 hours for Animal Nos. 1, 2 and 3 were 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively.

Other effects:

Clinical Observation
No systemic toxicity was observed at treated rabbits during the experimental period.
Mortality
No mortality was observed during the observation period.
Body weight
All rabbits showed increased in body weight at termination when compared to day 0.

Any other information on results incl. tables

Table 1: Skin Reaction

In Treated area Dose:0.5 ml of test item                                                                          Sex: Male

Animal No.	Test	Treated  area*	Erythema score				Oedema score
			1h	24h	48h	72h	1h	24h	48h	72h
1	Initial	Left	1	0	0	0	1	0	0	0
2	Confirmatory	Right	1	0	0	0	1	0	0	0
3		Left	1	0	0	0	1	0	0	0

In Control area  Dose: 0.5 ml of distilled water                Sex: Male

Animal No.	Test	Treated area*	Erythema score				Oedema score
			1h	24h	48h	72h	1h	24h	48h	72h
1	Initial	Right	0	0	0	0	0	0	0	0
2	Confirmatory	Left	0	0	0	0	0	0	0	0
3		Right	0	0	0	0	0	0	0	0

Key: h = Hour.

Erythema                                                                               Oedema

0 =No erythema                                                                   0 =No oedema

1 =Very slight erythema (barely perceptible)                 1 =Very slight oedema (barely perceptible)

2 =Well defined erythema                                                  2 = Slight oedema (edges of area well defined by definite raising)

Mean Individual Animal Score at 24, 48 and 72 hours

Animal Number                   Observations	1	2	3
Erythema	0.00	0.00	0.00
Oedema	0.00	0.00	0.00

Table 2: Individual Animal Body Weight

Animal No.	Body Weight (kg)
	Prior to Dosing	At termination
1	1.766	1.820
2	1.998	2.110
3	2.332	2.378

Table 3: Individual Animal Clinical Signs

Animal No.	Days (Post dosing Observation)
	0	1	2	3
1	1	1	1	1
2	1	1	1	1
3	1	1	1	1

Key:1 = Normal

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

The individual mean score at 24, 48 and 72 hours for Animal Nos. 1, 2 and 3 were 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively.
Hence, it was concluded that 1-phenylethanol (CAS No. - 98-85-1) was Non-Irritating to the skin of male New Zealand White rabbits under the experimental conditions tested and being classified as “Not Classified” as per CLP Classification.

Executive summary:

Acute Dermal Irritation/corrosion Study of 1-phenylethanol[CAS: 98-85-1] in Rabbits, was performed as per OECD guideline No. 404.  Three healthy young adult male New Zealand White rabbits were used for conducting acute dermal irritation/corrosion study. Body weights were recorded on day 0 (prior to application) and at termination. Rabbits with good intact skin were selected for the study. The hairs of all the rabbits were clipped at contralateral sites, approximately 24 hours prior to treatment. A dose of 0.5 ml of test item (as such) was applied to the skin, over an area of approximately 6 x 6 cm clipped of hair on one side of rabbits. The other untreated side was kept as control area and 0.5 ml of distilled water was applied at this site. At the end of 4 hours, the gauze patch was removed and test item application site was wiped with water without altering the integrity of the epidermis.

Initially, the test item was applied to the clipped area of skin of one rabbit. The test site was covered with gauze patch. Very slight erythema (barely perceptible) and very slight oedema (barely perceptible) was observed in animal No. 1 at 1 hour of observation. At 24, 48 and 72 hours observation no erythema and no oedema was observed in animal no 1. Hence the confirmatory test was conducted on additional two rabbit (no. 2 and 3) to confirm the non irritant nature of the test item. The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours after patch removal, evaluated and graded as per Draize method.

At 1 hour very slight erythema (barely perceptible) and very slight oedema (barely perceptible) was observed in all 3 animals. At 24, 48 and 72 hours observation no erythema and no oedema was observed in all 3 animals.

The individual mean score at 24, 48 and 72 hours for Animal Nos. 1, 2 and 3 were 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively.

Hence, it was concluded that 1-phenylethanol (CAS No. - 98-85-1) was Non-Irritating to the skin of male New Zealand White rabbits under the experimental conditions tested and being classified as “Not Classified” as per CLP Classification.