Registration Dossier

Administrative data

Description of key information

2-Phenoxyethanol is not irritating to rabbit skin, but irritating to the eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
The test substance was applied under occlusive conditions.
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was performed.
Specific details on test material used for the study:
- Name of test material (as cited in study report): 2- phenoxyethanol (technical grade)
- Physical state: liquid
- Analytical purity: no data
- Lot/batch No.: substance number: 83/143
- Expiration date of the lot/batch: May 1984
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Firma Gaukler; Offenbach, Germany
- Weight at study initiation: 2.79 kg, 2.32 kg, 3.00 kg
- Housing: single in stainless-steel cages
- Diet (e.g. ad libitum): Ovator Solikanin 4mm, Muskator-Werke Düsseldorf
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.5 mL
- Concentration (if solution):
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3 (two males and one female)
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk (2.5 x 2.5 cm)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol/water (1:1) and water
- Time after start of exposure: 4 h

SCORING SYSTEM: according to OECD guideline 404
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 30-60 min
Score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 30-60 min as well as 24, 48 and 72 h
Score:
0
Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 Jul 1983 - 01 Aug 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
non-GLP study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
- occlusive conditions were used
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): Marlophen P 1
- Physical state: liquid
- Analytical purity: >99 %
- Lot/batch No.: 5
- Expiration date of the lot/batch: maximum of 12 months storage
- Other: clear
Species:
rabbit
Strain:
other: Russian white (Chbb-SPF)
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2400 - 3100 mg
- Housing: single animals in steel wire cages
- Diet (e.g. ad libitum): K4 diet for rabbits (Ssniff)
- Water (e.g. ad libitum): tap water
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15x
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
24, 48, 72 hours and 6, 9, 10, 13 days after removal of the patch
Number of animals:
6 (3 male and 3 female)
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- % coverage:
- Type of wrap if used: Exposed animal skin was secured with linen (2.5 x 2.5 cm), polyethylene foil (6 x 6 cm) and an elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test article residue was washed with aqua dest.
- Time after start of exposure: 4 hours

SCORING SYSTEM: OECD scoring system
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: female animal showing very slight erythema (barely perceptible) after 24 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: female animal showing very slight erythema (barely perceptible) after 24 hours
Irritation parameter:
erythema score
Basis:
animal: #3,4,5,6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Interpretation of results:
GHS criteria not met
Conclusions:
Marlophen P1 induced no signs of skin irritation in male and female rabbits.
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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
the test was terminated at post-application day 15, when effects were not completely reversed
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was performed
Specific details on test material used for the study:
- Name of test material (as cited in study report): 2-Phenoxyethanol (technical grade)
- Analytical purity: no data
- Lot/batch No.: substance number: 83/143
- Expiration date of the lot/batch: May 1984
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Firma Gaukler; Offenbach, Germany
- Age at study initiation:
- Weight at study initiation: 2.51 kg, 2.37 kg, 2.61 kg
- Housing: single housing in stainless-steel cages
- Diet (e.g. ad libitum): Ovator Solikanin 4 mm, Muskator-Werke Duesseldorf, Germany
- Water (e.g. ad libitum): drinking water
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
The substance remained in the eye, therefore 15 days.
Observation period (in vivo):
15 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: according to OECD and Draize

Corneal Opacity (maximum possible: 4)
0 = no finding
1 = slight opacity
2 = well-defined opacity
3 = severe opacity
4 = very severe opacity

Involved corneal area
1 = > 0 - < ¼
2 = >= 1/4 - < ½
3 = >= ½ - < ¾
4 = >= 3/4

Iris (maximum possible: 2)
0 = no finding
1 = ciliary injection
2 = iritis

Conjunctival redness (maximum possible: 3)
0 = no finding
1 = slight redness
2 = well-defined redness
3 = severe redness

Conjunctival swelling (maximum possible: 4)
0 = no finding
1 = slight swelling
2 = well-defined swelling
3 = severe swelling
4 = very severe swelling

Secretion (maximum possible: 3)
0 = no finding
1 = slight increase
2 = well-defined increase
3 = severe increase

Calculation of the irritation index:
For each animal and each reading time point, the irritation index (I) was calculated according to following formula:
I = A + B + C
A = 5 x opacity x involved corneal area
B = 5 x iris
C = 2 x (conjunctival redness + swelling + secretion)

The primary irritation index (PI) was the sum of all irritation indices for all animals and all reading time points (24, 48 and 72 h), subdivided by 3 x the number of animals.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h
Score:
0
Reversibility:
not fully reversible within: 15 days
Remarks on result:
other: occurence of effects after 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 15 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Reversibility:
fully reversible within: 15 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 h
Score:
0
Reversibility:
fully reversible within: 15 days
Remarks on result:
other: occurence of effects after 24 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Reversibility:
fully reversible within: 15 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Reversibility:
fully reversible within: 8 days
Other effects:
Additional symptoms such as narrowness of pupil, scarred retraction of eyelid, marginal corneal vascularisation and suppuration were also considered.
No clinical signs observed.
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
CLP: eye irritation Cat. 2
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

A mild primary irritation was observed in one rabbit 1 hour after application, which was reversible within 24 hours (BASF AG, 1983). Although the test conditions were not in full accordance with OECD guideline 404, the results should be considered representative for the toxicological properties of 2-phenoxyethanol. 2-Phenoxyethanol was not an irritant to rabbit skin.

According to OECD 404, the skin irritation potential of 2-phenoxyethanol was determined (Sasol, 1983).The test substance was applied to the intact skin of rabbits for 4 hours under occlusive conditions. After removal of the test substance, no oedema, but very slight erythema were noted in 2 of 6 animals. All erythema were reversible within 48 hours. Under the test conditions, 2-Phenoxyethanol was not irritating to the skin.

Eye irritation: The single application of 0.1 mL unchanged test material in the eye of each of 3 rabbits clearly induced signs of irritation in all 3 animals; the signs were of maximal severity between 48 and 72 hours following application (BASF AG, 1983). Thereafter, a tendency to reversibility was observed and after 15 days, only one animal still displayed slight corneal opacity affecting less than ¼ of the corneal area of the treated eye. The test substance 2-phenoxyethanol is therefore considered an eye irritant.

Effects on eye irritation: irritating

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Skin irritation: not irritating to skin.

Eye Irritation:

EU: Xi R36

CLP: Cat. 2