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Diss Factsheets

Administrative data

Description of key information

Test substance 3-Phenoxybenzylalcohol (CAS No :13826-35-2) was eye irritant to New Zealand white rabbits whereas the other study indicate that it is not irritating to skin when applied to New Zealand white rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
(Q)SAR
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from QSAR Toolbox version 3.3
Justification for type of information:
QSAR prediction: migrated from IUCLID 5.6
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
The prediction is done using QSAR Toolbox version 3.3
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
no data
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
no data
Duration of treatment / exposure:
24 Hrs
Observation period:
24 Hrs
Number of animals:
no data
Details on study design:
no data
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 Hr
Reversibility:
no data
Remarks on result:
other: Irritation parameter: Negative





Estimation method: Takes mode value from the 5 nearest neighbours
Domain  logical expression:Result: In Domain

(("a" and "b" )  and ("c" and "d" )  )

Domain logical expression index: "a"

Referential boundary: The target chemical should be classified as Benzyl Alcohols by Aquatic toxicity classification by ECOSAR

Domain logical expression index: "b"

Referential boundary: The target chemical should be classified as High (Class III) by Toxic hazard classification by Cramer (original) ONLY

Domain logical expression index: "c"

Parametric boundary:The target chemical should have a value of log Kow which is >= 2.59

Domain logical expression index: "d"

Parametric boundary:The target chemical should have a value of log Kow which is <= 4.68

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance 3-Phenoxybenzyl alcohol was estimated to be non-irritating to the skin of rabbits.
Executive summary:

The test substance3-Phenoxybenzyl alcoholwas estimated to be non-irritating to the skin of rabbits.

Considering the CLP criteria for classification of substances, it is concluded that3-Phenoxybenzyl alcoholis not likely to be classified as skin irritant.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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
Qualifier:
according to guideline
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
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
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.
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

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / corrosion:

The test substance3-Phenoxybenzyl alcoholwas estimated to be non-irritating to the skin of rabbits.

Considering the CLP criteria for classification of substances, it is concluded that 3-Phenoxybenzyl alcoholis not likely to be classified as skin irritant.

Eye irritation:

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.


Justification for selection of skin irritation / corrosion endpoint:
The endpoint for the 3-Phenoxybenzylalcohol (CAS No: 13826-35-2) for New Zealand white rabbits were found to be non- skin irritating.

Justification for selection of eye irritation endpoint:
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.

Justification for classification or non-classification

On the basis of available information, the substance 3-Phenoxybenzylalcohol (CAS NO. 13826-35-2) is likely to be irritating to eyes of rabbits but not irritating to skin of rabbit and is therefore classified as "Not Irritating" to skin and “Irritating “to eye as per the CLP criteria.