Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin irritation/Corrosion:

Pigment Orange 34 (nano form): not irritating (OECD 404)

Structure analogue: Pigment Red 38 (nano form): not irritating (OECD 404)

Structure analogue: Pigment Orange 13 (nano form): not irritating (OECD 404)

Eye irritation:

Pigment Orange 34 (nano form): not irritating

Structure analogue: Pigment Red 38 (nano form): not irritating (OECD 405)

Structure analogue: Pigment Orange 13 (nano form): not irritating (OECD 405)

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
Study period:
From 14 Mar 1977 to 18 Mar 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study according to FDA guideline
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: FDA, Fed. Reg. 38, No. 187, 27.9.1973, p.27019
Deviations:
no
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was conducted
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5-2.0 kg
- Housing: individually
- Diet (ad libitum): ERKA 8300 (Futtermittelwerke Robert Koch, Hamm, Germany), ad libitum
- Water (ad libitum): tap water, ad libitum

ENVIRONMENTAL CONDITIONS
no data
Type of coverage:
occlusive
Preparation of test site:
other: one site shaved, one site shaved and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
Duration of treatment / exposure:
24 h (no rinsing after removal of coverage)
Observation period:
24, 48 and 72 h after application
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: flank, each site 3 x 3 cm
- Type of wrap if used: PVC film

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according to FDA guideline
Erythema:
0: no erythema
1: very light erythema, barely perceptible
2: well defined erythema
3: moderate to severe edema
4: severe erythema (beet redness) to slight eschar formation (injuries in depth)

Edema:
0: no edema
1: very slight, barely perceptible edema
2: slight edema (edges of area well defined by definite raising
3: moderate edema, raised approx. 1 mm
4: severe edema (raised more than 1 mm and extending beyond area of exposure

Values for erythema and eschar formation at 24 and 72 h post application on intact and abraded skin each (4 values) have to be added.
Values for edema formation at 24 and 72 h post application on intact and abraded skin each (4 values) have to be added.
The total of eight values is divided by four, yielding the primary irritation index.

0-0.5: non irritant
0.6-3.0: slightly irritant
3.1-5.0: moderately irritant
5.1-8.0: severely irritant
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
other: 24 h exposure duration, observation time points: 48 and 72 h after start of exposure (24 h post application no examination of erythema was possible due to intensive staining of the application site)
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
other: 24 h exposure duration, observation time points: 48 and 72 h after start of exposure (24 h post application no examination of erythema was possible due to intensive staining of the application site)
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
other: 24 h exposure duration, observation time points: 48 and 72 h after start of exposure (24 h post application no examination of erythema was possible due to intensive staining of the application site)
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
other: 24 h exposure duration, observation time points: 48 and 72 h after start of exposure (24 h post application no examination of erythema was possible due to intensive staining of the application site)
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
other: 24 h exposure duration, observation time points: 48 and 72 h after start of exposure (24 h post application no examination of erythema was possible due to intensive staining of the application site)
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 48, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: 24 h exposure duration, observation time points: 48 and 72 h after start of exposure (24 h post application no examination of erythema was possible due to intensive staining of the application site)
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
- 24 h post application no examination of erythema was possible due to intensive staining of the application site; no erythema were detectable at any later time point
- no edema were observed at any time point
- identical results were obtained with intact and scarified skin
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test item was not irritating to the skin of rabbits.

This conclusion is legitimated even though the applied testing regime differs from today's standard methods. Since the test conditions were more stringent than required by OECD 404 (i.e. 24 treatment, occlusive coverage, and scarified skin instead of 4 h treatment, semi-occlusive coverage, and intact skin) the test results are considered adequate to fulfill the endpoint requirements.
Executive summary:

6 New Zealand White rabbits were dermally exposed to 500 mg of the test item for 24 h on shaved intact and abraded skin under occlusive conditions. Obervations were performed 24, 48 and 72 h after start of exposure. Twenty four hours after application no examination of erythema was possible due to intensive staining of the application site. No signs of irritation (edema and erythema score 0) were observed on the intact or abraded skin. Under the conditions of this study the test item was not irritating to the skin of rabbits.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 19 May 1992 to 22 May 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 404), GLP compliant
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Chemisch Pharmazeutische Fabrik Dr. K. Thomae, Biberach, Germany
- Weight at study initiation: 2.3-2.6 kg
- Housing: individually
- Diet (ad libitum): Altromin 2123 maintenance diet - rabbits (Altromin GmbH, Lage, Germany)
- Water (ad libitum): deionised, chlorinated water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3
- Humidity (%): 55 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: Polyethylenglycol 400
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g pasted in 0.75 mL Polyethylenglycol 400
- Concentration (if solution):

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.75 mL
Duration of treatment / exposure:
4 h
Observation period:
30-60 min, 24, 48, 72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: cellulose patch on surgical plaster, covered with semi-occlusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm tap water
- Time after start of exposure: 4 h

SCORING SYSTEM:
according to Draize and guidelines
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Other effects:
The treated areas were discoloured by the test substance
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test substance was not irritating to the skin of rabbits.
Executive summary:

Three rabbits were dermally exposed to 0.5 g of the test substance, pasted in polyethylene glycol 400 for 4 h. After removal of the test substance the exposed area was evaluated at 24, 48 and 72 h. There were no signs of skin irritation in all animals.Under the conditions of this study the test substance was not irritating to the skin of rabbits.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 28 Jun 2006 to 17 Jul 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 404), GLP compliant
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Netherlands, Horst, Netherlands
- Age at study initiation: 10-11 weeks (males), 9-10 weeks (females)
- Weight at study initiation: 1854 to 1972 g
- Housing: individually in stainless steel cages
- Diet (ad libitum): Provimi Kliba 3418 rabbit diet (Provimi Kliba, Kaiseraugst, Switzerland)
- Water (ad libitum): community tap water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: purified water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of test substance moistened with 0.5 ml of purified water
Duration of treatment / exposure:
4 h
Observation period:
14 days after exposure
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 4 x 4 cm
- Type of wrap if used: surgical gauze patch, covered by semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lukewarm water
- Time after start of exposure: 4 h

SCORING SYSTEM:
according to guidelines; observation time points: 1 h, 24 h, 48 h, 72 h, 7 d, 10d, 14d after removal of the dressing
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
- No edema or erythema were observed at any time point after removal of the dressing; observation continued for 14 days due to red staining of the skin caused by the red colored test item.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test item was not irritating.
Executive summary:

An OECD guideline 404 (Acute dermal irritation / corrosion) study was performed in three rabbits. The animals were dermally exposed to 0.5 g of the test item for 4 h under semiocclusive coverage. After removal of the test substance the exposed area was oberved for 14 days. There were no signs of skin irritation in any animals at any time point. The test substance was not irritating to skin under the conditions of the test.

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to attached read across justification document (Chapter 13).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached read across document (Chapter 13).

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached read across justification document (Chapter 13).

4. DATA MATRIX
Please refer to attached read across justification document (Chapter 13).
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Other effects:
The treated areas were discoloured by the test substance
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test substance was not irritating to the skin of rabbits.
Executive summary:

Three rabbits were dermally exposed to 0.5 g of the test substance, pasted in polyethylene glycol 400 for 4 h. After removal of the test substance the exposed area was evaluated at 24, 48 and 72 h. There were no signs of skin irritation in all animals.Under the conditions of this study the test substance was not irritating to the skin of rabbits.

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to attached read across justification document (Chapter 13).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached read across document (Chapter 13).

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached read across justification document (Chapter 13).

4. DATA MATRIX
Please refer to attached read across justification document (Chapter 13).
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
- No edema or erythema were observed at any time point after removal of the dressing; observation continued for 14 days due to red staining of the skin caused by the red colored test item.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test item was not irritating.
Executive summary:

An OECD guideline 404 (Acute dermal irritation / corrosion) study was performed in three rabbits. The animals were dermally exposed to 0.5 g of the test item for 4 h under semiocclusive coverage. After removal of the test substance the exposed area was oberved for 14 days. There were no signs of skin irritation in any animals at any time point. The test substance was not irritating to skin under the conditions of the test.

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

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
From 14 Mar 1977 to 18 Mar 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study according to FDA guideline, although not tested till full reversibility of effects in all animals a final conclusion was feasible
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: FDA, Fed. Reg. 38, No. 187, 27.9.1973, p.27019
Deviations:
no
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was conducted
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no data

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as internal control
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
- Time after start of exposure: 24 h


SCORING SYSTEM: according to Appraisal of the Safety of Chemicals in Food, Drugs and cosmetics, S.51, 1975 (Draize scoring system)
Cornea
A. Opacity, Degree of density (area which is most dense is taken for reading
1: Scattered or diffuse area, details of iris clearly visible
2: Easily discernible translucent areas, details of iris slightly obscured
3: Opalescent areas, no details of iris visible, size of pupil barely discernible
4: Opaque, iris invisible
B. Area of cornea involved
1: One quarter (or less) but not zero
2: Greater than one quarter but less than one-half
3: Greater than one-half but less than three quarters
4: Greater than three quarters up to whole area


Iris
A. Values
1: Folds above normal, congestion, swelling, circumcorneal injection (any one or all of
these or combination of any thereof), iris still reacting to light (sluggish reaction is
positive)
2: No reaction to light, hemorrhage; gross destruction (any one or all of these) 2


Conjunctiva
A. Redness (refers to palpebral conjunctiva only)
1: Vessels definitely injected above normal
2: More diffuse, deeper crimson red, individual vessels not easily discernible
3: Diffuse beefy red
B. Chemosis
1: Any swelling above normal (includes nictitating membrane)
2: Obvious swelling with partial eversion of the lids
3: Swelling with lids about half closed
4: Swelling with lids about half closed to completely closed

C. Discharge
1: Any amount different from normal (does not include small amount observed in inner
canthus of normal rabbits
2: Discharge with moistening of the lids and hairs just adjacent to the lids
3: Discharge with moistening of the lids and considerable area around the eye


TOOL USED TO ASSESS SCORE: 0.01% fluorescein
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
not reversible
Remarks:
within 72 h after start of exposure
Remarks on result:
other: no later observation points, but considered to be fully reversible in the course of a prolonged observation period
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3 each
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: no later observation points, but considered to be fully reversible in the course of a prolonged observation period
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: no later observation points, but considered to be fully reversible in the course of a prolonged observation period
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: no later observation points, but considered to be fully reversible in the course of a prolonged observation period
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
- no effects on cornea or iris were observed at any time point (score 0)
- slight conjunctivae redness (score 1) was detectable in all animas after 1, 7 and 24 h; this effect persisted in 5 animals (score 1) and was fully reversible in one animal 48 h after start of exposure; 72 h after start of exposure the effect was fully reversible in all animals except one which still showed a slight effect (score 1)

- chemosis scores 1, 7, 24, 48, 72 h after start of exposure:

Animal #1: 1, 1, 1, 1, 1
Animal #2: 0, 1, 1, 1, 1
Animal #3: 1, 1, 1, 1, 1
Animal #4: 1, 1, 1, 1, 0
Animal #5: 1, 1, 1, 0, 0
Animal #6: 2, 1, 1, 0, 0

- no observations at later time points were performed
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test item was slightly irritating to the eyes of rabbits: No effects on cornea and iris, slight effects on conjunctiva. The mean scores were clearly below the critical values for classification according to Regulation (EU) No 1272/2008, but full reversibilityof the effects was only seen in 3/6 animals 72 hours after start of exposure. Conjunctivae redness (score 1) and chemosis (score 1) persisted in 1/6 and 3/6 animals 72 hours after start of exposure, respectively. Based on the results of three animals which showed full reversibility of the sligth effects on eyes within 72 h it can plausibly be assumed that the slight effects observed in the three remaining animals would also have been fully reversible, if the observation time would have been extended up to 14 days, indicating that the test item has not to be classified as irritating to eyes.
Executive summary:

100 mg of the test item were placed into the left eye of 6 New Zealand White rabbits. Irritation was examined at 1, 7, 24, 48 and 72 h after application and scored according to Draize. No effects on cornea and iris and slight effects on conjunctiva were observed. Full reversibility of the effects was seen in 3/6 animals 72 hours after start of exposure. Conjunctivae redness (score 1) and chemosis (score 1) persisted in 1/6 and 3/6 animals 72 hours after start of exposure, respectively. No observations were performed at later time points.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 26 Mai 1992 to 5 Jun 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 405), GLP compliant
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Chemisch pharmazeutische Fabrik Dr. K. Thomae, Biberach, Germany
- Age at study initiation: 3-5 months
- Weight at study initiation: 3.4-3.7 kg
- Housing: individually
- Diet: Altromin 2123 maintenance diet - rabbits (Altromin GmbH, Lage/Lippe, Germany) (ad libitum) and hay (about 15 g/d)
- Water (ad libitum): deinonised, chlorinated water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3
- Humidity (%): 55 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as internal control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline at about 37 °C, if eyes showed discharge or after corneal examination with fluorescein
- Time after start of exposure: 24 h and 72 h after application

SCORING SYSTEM: according to guideline

TOOL USED TO ASSESS SCORE: one drop of 0.01% fluorescein at 24 and 72 h after application
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects observed at any time points
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed at any time points
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed at any time points
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed at any time points
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed at any time points
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed at any time points
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed at any time points
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed at any time points
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed at any time points
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed at any time points
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
1 h after application the conjunctivae showed evident hyperemia to diffuse crimson coloured reddenings and slight swellings. Up to 48 h evident hyperemia was noted at the conjunctivae of 2 animals, but not at later time points. No effects on iris or cornea were observed.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test item was not irritating to the eyes of rabbits
Executive summary:

In an eye irritation study according to guidelines OECD 405 and EU B.5, 100 mg of the test item was applied to the conjunctival sac of the left eyes of 3 New Zealand Albino rabbits. 1 h after application the conjunctivae showed evident hyperemia to diffuse crimson coloured reddenings and slight swellings. Up to 48 h evident hyperemia was noted at the conjunctivae of 2 animals. The mean conjunctivae redness score of the three animals was 0.0, 0.33, and 0.67 respectively. All other scores were 0.

Under the conditions of this study the test item was not irritating to the eyes of rabbits.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 17 Jul 2006 to 28 Jul 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 405), GLP compliant
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Netherlands, Horst, Netherlands
- Age at study initiation: 13-14 weeks (males), 10-12 weeks (females)
- Weight at study initiation: 2488-2557 g
- Housing: individually in stainless steel cages
- Diet (ad libitum): Provimi Kliba 3418 rabbit diet (Provimi Kliba, Kaiseraugst, Switzerland)
- Water (ad libitum): community tap water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as internal control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
7 days
Observation period (in vivo):
7 days (single instillation without washing)
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure:

SCORING SYSTEM:
according to guidelines

TOOL USED TO ASSESS SCORE: diagnostic lamp
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
- no corneal opacity, iritis or chemosis at any time point (score 0)
- conjunctivae redness scores after 1 h, 24, h, 48 h, 72 h, 7d:
animal #1: 1, 1, 1, 0, 0
animal #2: 1, 0, 0, 0, 0
animal #3: 1, 1, 0, 0, 0

- Slight discharge was evident in all animals 1 h after application and remnants of the test item were obervable in the eyes or conjunctival sac up to 72 h
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test itme was not irritating to the eyes of rabbits
Executive summary:

 In an eye irritation study according to guidelines OECD 405 and EU B.5, 100 mg of the test item were applied to the conjunctival sac of the left eyes of 3 New Zealand Albino rabbits. 1 h after application the conjunctivae showed slight reddening, which was reversible within 72 h. The mean conjunctivae redness scores (mean of 34, 48, 72h) of the animals #1, #2, #3 were 0.67, 0.00, 0.33, respectively.There were no effects on iris, cornea or conjunctivae chemosis (all scores 0). Under the conditions of this study the test item was not irritating to the eyes of rabbits.

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to attached read across justification document (Chapter 13).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached read across document (Chapter 13).

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached read across justification document (Chapter 13).

4. DATA MATRIX
Please refer to attached read across justification document (Chapter 13).
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects observed at any time points
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed at any time points
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed at any time points
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed at any time points
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed at any time points
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed at any time points
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed at any time points
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed at any time points
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed at any time points
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed at any time points
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
1 h after application the conjunctivae showed evident hyperemia to diffuse crimson coloured reddenings and slight swellings. Up to 48 h evident hyperemia was noted at the conjunctivae of 2 animals, but not at later time points. No effects on iris or cornea were observed.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test item was not irritating to the eyes of rabbits
Executive summary:

In an eye irritation study according to guidelines OECD 405 and EU B.5, 100 mg of the test item was applied to the conjunctival sac of the left eyes of 3 New Zealand Albino rabbits. 1 h after application the conjunctivae showed evident hyperemia to diffuse crimson coloured reddenings and slight swellings. Up to 48 h evident hyperemia was noted at the conjunctivae of 2 animals. The mean conjunctivae redness score of the three animals was 0.0, 0.33, and 0.67 respectively. All other scores were 0.

Under the conditions of this study the test item was not irritating to the eyes of rabbits.

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to attached read across justification document (Chapter 13).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached read across document (Chapter 13).

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached read across justification document (Chapter 13).

4. DATA MATRIX
Please refer to attached read across justification document (Chapter 13).
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
- no corneal opacity, iritis or chemosis at any time point (score 0)
- conjunctivae redness scores after 1 h, 24, h, 48 h, 72 h, 7d:
animal #1: 1, 1, 1, 0, 0
animal #2: 1, 0, 0, 0, 0
animal #3: 1, 1, 0, 0, 0

- Slight discharge was evident in all animals 1 h after application and remnants of the test item were obervable in the eyes or conjunctival sac up to 72 h
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test itme was not irritating to the eyes of rabbits
Executive summary:

 In an eye irritation study according to guidelines OECD 405 and EU B.5, 100 mg of the test item were applied to the conjunctival sac of the left eyes of 3 New Zealand Albino rabbits. 1 h after application the conjunctivae showed slight reddening, which was reversible within 72 h. The mean conjunctivae redness scores (mean of 34, 48, 72h) of the animals #1, #2, #3 were 0.67, 0.00, 0.33, respectively.There were no effects on iris, cornea or conjunctivae chemosis (all scores 0). Under the conditions of this study the test item was not irritating to the eyes of rabbits.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

No classification

The test material was not irritant to skin and eyes in in vivo assays in rabbits.