Registration Dossier

Administrative data

Endpoint:
eye 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:
other:
Principles of method if other than guideline:
Primary eye irritation study was performed on New Zealand White rabbits for 7 days.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: The Ethyl Corporation, Ferndale, Michiga
- Age at study initiation: No data available
- Weight at study initiation: 2045 to 2330 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:

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

ENVIRONMENTAL CONDITIONS
- Temperature (°C): in temperature controlled quarters
- Humidity (%):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

Vehicle:
not specified
Controls:
other: The left eye served as the untreated control for each rabbit.
Amount / concentration applied:
0.1 milliliter of the undiluted test material
Duration of treatment / exposure:
The 3 rabbits in Group I did not receive a washout. The 3 rabbits in Group II received a 300 ml distilled water washout 5 minutes following instillation. This washout was accomplished over a one minute period.
Observation period (in vivo):
24 hours following instillation,48 hours,72 hours,7 days
Number of animals or in vitro replicates:
6 animals(3 male and 3 female)
Details on study design:
TEST SITE
- Area of exposure: not applicable
- % coverage: not applicable
- Type of wrap if used: not applicable

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The 3 rabbits in Group II received a 300 ml distilled water washout 5 minutes following instillation. This washout was accomplished over a one minute period.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 7 days
Score:
1
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: Corneal luster was observed in unwashed eye.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 7 days
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: Iris irritation was observed in unwashed eye.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 7 days
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: Chemosis was observed in unwashed eye.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 7 days
Score:
2
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: corneal luster was observed in washed eyes
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 7 days
Score:
3
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: Iridal irritation was observed in washed eyes

Any other information on results incl. tables

For Group 1:Unwashed eye

Eye Irritation in the Albino rabbit

 

Average score (range)

 

                          Period

Area

24 hours

48 hours

72 hours

Days 7

Cornea

0.5

0.5

0.5

0

Iris

0

0

0

0

Conjunctivae

0.6

0

0.6

0

Total score

1.1

0.5

1.1

0

 

 

For Group 2: Washed eye

Eye Irritation in the Albino rabbit

 

Average score (range)

 

                          Period

Area

24 hours

48 hours

72 hours

Days 7

Cornea

2.5

3.5

2.5

0

Iris

0

0

0

0

Conjunctivae

1.4

0.6

0.6

0

Total score

3.9

4.1

3.1

0

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The end point for 3-Phenoxybenzylalcohol (CAS No :13826-35-2) on New Zealand white rabbits was found to be for
Group I (Unwashed Eyes): A possible primary eye irritant.
Group II (washed Eyes): A probable primary eye irritant.
Executive summary:

Eye irritation experiment was performed onNew Zealand white rabbits. 3 males and 3 female of weight 2045 and 2330 grams were used in this study. The rabbits were individually housed in hanging wire-mesh cages in temperature and humidity controlled quarters maintained in accordance with the recommendations contained in H.E.W. Publication No. 74-23 (N.I.H.) entitled "Guide for the Care and Use of Laboratory Animals".

 

The eyes of each rabbit were examined with ultraviolet light after instillation of one drop of  2.0 percent sodium fluorescein solution. The 6 rabbits were divided into 2 groups of 3 rabbits each and received 0.1 ml of undiluted test material.

 

The test material was placed on right eye and left eye was used as a control.Group I group did not receive washout and group II 3 rabbits received a 300 ml distilled water washout 5 minutes following instillation and observed on 24, 48, 72 hours and 7 days.

 

So, according to the grading system result found that concluded thatend point for 3-Phenoxybenzylalcohol (CAS No: 13826-35-2) on New Zealand white rabbits was found to be for Group I (Unwashed Eyes): A possible primary eye irritant.

Group II (washed Eyes): A probable primary eye irritant.