Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Data is from online Chemical Repository Database

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other:
Principles of method if other than guideline:
Primary skin irritation study was performed on New Zealand White rabbits for 72 hrs.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
3-phenoxybenzylic alcohol
EC Number:
237-525-1
EC Name:
3-phenoxybenzylic alcohol
Cas Number:
13826-35-2
Molecular formula:
C13H12O2
IUPAC Name:
(3-phenoxyphenyl)methanol
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): 3-Phenoxybenzyl alcohol
- Molecular formula (if other than submission substance): C13H12O2
- Molecular weight (if other than submission substance): 200.23318 g/mol
- Smiles notation (if other than submission substance): C1=CC=C(C=C1) OC2=CC=CC (=C2) CO
- InChl (if other than submission substance): InChI=1S/C13H12O2/c14-10-11-5-4-8-13(9-11)15-12-6-2-1-3-7-12/h1-9, 14H, 10H2
- Substance type: Organic
- Physical state: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: The Ethyl Corporation, Ferndale, Michiga
- Age at study initiation: No data available
- Weight at study initiation: 2031 to 2251 grams
- Fasting period before study: No data available
- Housing: In hanging wire-mesh cages
- Diet (e.g. ad libitum): Purina Rabbit Chow(ad libitum)
- Water (e.g. ad libitum): Water(ad libitum)
- Acclimation period: No data available

Or Test Tissue
- Source: not applicable
- Type: not applicable
- Acclimation : not applicable
- Housing conditions: not applicable

ENVIRONMENTAL CONDITIONS
- Temperature (°C): kept in temperature controlled quarters
- Humidity (%):kept in humidity controlled quarters
- Air changes (per hr):No data available
- Photoperiod (hrs dark / hrs light): No data available

IN-LIFE DATES: From: To: No data available

Test system

Type of coverage:
other: Gauze bandaging and occluded with Saran Wrap
Preparation of test site:
other: shaved and clipped
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
0.5 milliliter of the test material
Duration of treatment / exposure:
72 hrs
Observation period:
4,24, 48 and 72 hrs
Number of animals:
6 rabbits (3 male and 3 female)
Details on study design:
TEST SITE
- Area of exposure: back of each rabbit
- % coverage: 20-30% of the body surface
- Type of wrap if used: Sites were then covered with gauze bandaging and occluded with Saran Wrap.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Four hours later the bandages were removed and the sites were washed with tepid tap water and examined for skin irritation
- Time after start of exposure:4, 24, 48 and 72 hours

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hrs.
Score:
0.2
Max. score:
8
Reversibility:
no data

Any other information on results incl. tables

Individual Rabbit Scores and Score Calculation

Intact skin

 

Erythema

Edema

Observation (Hours)

Observation (Hours)

Animals

No./Sex

4

24

48

72

4

24

48

72

Male

0

0

0

0

0

0

0

0

Female

0

1.0

0

0

0

0

0

0

Female

0

1.0

0

0

0

0

0

0

 

 

 

 

 

 

 

 

 

Total

0

2.0

0

0

0

0

0

0

 

 

Abraded Skin

 

Erythema

Edema

Observation (Hours)

Observation (Hours)

Animals

No./Sex

4

24

48

72

4

24

48

72

Male

0

0

0

0

0

0

0

0

Male

0

0

0

0

0

0

0

0

Female

0

1.0

0

0

0

1.0

0

0

 

 

 

 

 

 

 

 

 

Total

0

1.0

0

0

0

1.0

0

0

Calculation for Primary Skin Irritation Score (Score = the average of all the erythema scores plus the average of all the edema scores): (3.0 /24) + (1.0/ 24) = 0.2.

 

 

Number of Animals Exhibiting Signs with Scoring "Value"

 

 

Intact Skin

Abraded Skin

 

Observation (Hours)

Observation (Hours)

Observations

Value

4

24

48

72

4

24

48

72

Erythema,

Eschar

Formation

0

3/3

1/3

3/3

3/3

3/3

2/3

3/3

3/3

1

 

2/3

 

 

 

1/3

 

 

2

 

 

 

 

 

 

 

 

3

 

 

 

 

 

 

 

 

4

 

 

 

 

 

 

 

 

Edema

Formation

0

3/3

3/3

3/3

3/3

3/3

2/3

3/3

3/3

1

 

 

 

 

 

1/3

 

 

2

 

 

 

 

 

 

 

 

3

 

 

 

 

 

 

 

 

4

 

 

 

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The endpoint for the 3-Phenoxybenzylalcohol (CAS No: 13826-35-2) for New Zealand white rabbits were found to be non- skin irritating.
Executive summary:

Primary skin irritation study in the albino rabbit was performed with 3-Phenoxybenzylalcohol. 6 animals (3 male/ 3 female) used for the study with 2031 to 2251 grams at beginning of the study. They were housed in hanging wire-mesh cages in temperature and humidity controlled quarters.The hair was removed from the back of each rabbit with an electric clipper. The skin of 3 of the rabbits was abraded with a scalpel blade.0.5 milliliter of the test material was applied to the back of each rabbit and covered with gauze bandaging and occluded with saran wrap.Four hours later the bandages were removed and the sites were washed with tepid tap water and examined for skin irritation with 24, 48 and 72 hours.

 

From the individual rabbit scores and the computed primary irritation score it was found to be 0.2 which exit between the ranges 0.1-0.5.

Therefore, the endpoint for the 3-Phenoxybenzylalcohol (CAS No: 13826-35-2) for the New Zealand white rabbits were found to be non- skin irritating.