Registration Dossier

Administrative data

Description of key information

The key dermal irritation study using 3 rabbits tested according to the Draize method demonstrated that Epoxide 8 was a moderate irritant to the skin of rabits.  Other older studies confirmed these results.
In an eye irritation study according to Draize, undiluted Epoxide No. 8 ( 0.1 ml) was placed in the conjunctival sac of one eye of an albino rabbit (three animlas in each group), while the remaining eye served as control. Eyes were scored at one hour; and one day according to Draize. The study and scoring was discontinued since there was no gross evidence of any irritation to the ocular tissue. Undiluted Epoxide No. 8 produced very slight conjunctivitis which cleared readily within 24 hours.

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:
supporting study
Study period:
1977
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment
Principles of method if other than guideline:
New zealand rabbit were treated on open-intact, covered-intact and covered-abraded skin areas. The application was repeated.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
other: open-intact, covered-intact and covered-abraded
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
100% - no data on the amount
Duration of treatment / exposure:
24-hour exposure. Repeated applications. Depending on the site two or three applications.
Observation period:
Five days
Number of animals:
Two
Details on study design:
Skin irriatation study was conducted on New Zealand albino rabbits. Two animals were treated on open-intact skin, covered-intact skin and covered-abraded skin. Observations were recorded at various intervals. Application duration was 24 hours and repeated twice or three times depending on the application site.
Irritation parameter:
primary dermal irritation index (PDII)
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Prolonged contact (24 hours) with the test material on the skin of an albino rabbit expsoed to air resulted in moderate redness, moderate swelling and slight chemical burn.
Prolonged contact (24 hours) with the skin of an albino rabbit in confinment resulted in slight redness and swelling.
When contact was repeated three times, moderate redness, moderate swelling and a slight chemical burn resulted. When the skin was abraded, the contact resulted in moderate redness and a slight chemical burn after 2 applications.
Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
24-hour expsoure to the test material on open-intact, covered-intact and covered-abraded skin areas resulted in redness and swelling. The severity increased when the application was repeated. The substance is therefore considered to be irritating the skin
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:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
Principles of method if other than guideline:
The study was conducted according to the method outlined by Draize et al.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
no details given
Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
3
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
4.08
Reversibility:
no data
Remarks on result:
probability of moderate irritation
Remarks:
Cumulative scores and mean values provided
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
probability of moderate irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
probability of moderate irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
probability of moderate irritation
Irritant / corrosive response data:
Primary Irritation Index = 4.08
Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US OSHA
Conclusions:
Undiluted Epoxide No. 8 produced moderate primary irritation upon prolonged exposure to rabbits' skin by closed patch technique.
Executive summary:

Three New Zealand Albino rabbits per group, were treated with  0.5ml of Epoxide 8, applied to a 1" x I" l2-ply gauze pad. The pads were taped on both an intact and abraded site on each animal.. The narrow adhesive tape was crossed in an ‘X’ to hold the gauze pad but not to occlude the ventilation.

After 24 hours, the animals were removed from the stocks, patches were removed and the resulting-reactions evaluated on the basis of scores indicated by Draize. The cumulative scores (24 and 72 hours; abraded and intact) are averaged separately for both erythema and edema and are then added together to arrive at a Primary Irritation Index.

Undiluted Epoxide No. 8 produced moderate primary irritation (PII = 4.08) upon prolonged exposure to rabbits' skin by closed patch technique.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: According to Guideline at the time of study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
no 14 day observation period
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Strain and source of animals: New Zealand Albino Rabbits (Sweetwater Farms)
Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5ml
Duration of treatment / exposure:
24 hrs
Observation period:
72 hrs
Number of animals:
6
Details on study design:
Primary irritation to the skin is measured by a patch-test technique on the abraded and intact skin of the albino rabbit, clipped free of hair. A minimum of six subjects are used in abraded and intact skin tests. Introduce under a square patch, such as surgical gauze measuring 1 inch by 1 inch and two single layers thick, 0.5 milliliter (in the case of liquids) or 0.5 gram (in the case of solids and semisolids) of the test substance. Dissolve solids in an appropriate solvent and apply the solution as for liquids. The animals are immobilized with patches secured in place by adhesive tape. The entire trunk of the animal is then wrapped with an impervious material, such as rubberized cloth, for the 24-hour period of exposure. This material aids in maintaining the test patches in position and retards the evaporation of volatile substances. After 24 hours of exposure, the patches are removed and the resulting reactions are evaluated on the basis of the designated values in the following table:
Skin reaction
Erythema and eschar format Value*
No erythema.................................................................................................... 0
Very slight erythema (barely perceptible) .................................................. I
Well-defined erythema................................................................................... 2
Moderate to severe erythema....................................................................... 3
Severe erythema (beet redness) to slight eschar formations
(injuries in depth)............................................................................................4

Edema formation:
No edema............................................................................................................. 0
Very slight edema (barely perceptible) ........................................................... I
Slight edema (edges of area well defined by definite raising) .....................2
Moderate edema (raised approximately I millimeter) ...................................3
Severe edema (raised more than I millimeter and extending
beyond the area of exposure) ..........................................................................4
* The "value" recorded for each reading is the average value of the six or more animals subject to the test.

Readings are again made at the end of a total of 72 hours (48 hours after the first reading). An equal number of exposures are made on areas of skin that have been previously abraded. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding. Evaluate the reactions of the abraded skin at 24 hours and 72 hours, as described in this paragraph.
Add the values for erythema and eschar formation at 24 hours and at 72 hours for intact skin to the values on abraded skin at 24 hours and at 72 hours (four values). Similarly, add the values for edema formation at 24 hours and at 72 hours for intact and abraded skin (four values). The total of the eight values is divided by four to give the primary irritation score.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 4 hr
Score:
5.75
Max. score:
6
Reversibility:
no data

Epoxide No. 8 (ZHI-140,UDX-8552)

PRIMARY IRRITATION INDEX 4-HOUR EXPOSURE (INTACT SKIN)

 

Erythema-eschar formation

Edema Observation

Score *

Rabbit Number

 

4 hr

 

52 hr

 

4 hr

 

52 hr

 

1

3

4

3

2

6.00

2

3

4

3

2

5.50

3

3

3

3

2

5.50

4

3

4

3

2

6.00

5

3

4

3

2

6.00

6

3

4

2

2

5.5

*Sum of individual values for each animal divided by two

 

PRIMARY IRRITATION INDEX = 5.75

 

Erythema and edema extended beyond patch site on all animals.

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Epoxide was non-corrosive but irritating to the skin of rabbits.
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: not according to GLP and not an internationally recognized method.
Principles of method if other than guideline:
A 5 day skin irritation/corrosion study in albino rabbits was performed to determine the irritant or corrosive potency of TK 10642 on the albino rabbit skin.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Weight at study initiation: 2 - 3 kg
- Housing: individually in metal cages
- Diet: ad libitum, NAFAG No. 814 Tox
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): 15 air changes/hrs
- Photoperiod (hrs dark / hrs light): 12 hours light dark cycle
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent vehicle
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
24 hours/day and the fifth dressing was removed after 8 hours
Observation period:
10 days from the first application
Number of animals:
3 males and 3 females
Details on study design:
The entire back and flank of the rabbits were shaved with an electric clipper. Gauze patch of 4 x 5 cm soaked with 0.5 mL of the substance were applied to the skin. The occlusive dressings were removed after 24 hoursand the skin reaction assessed after removal of the dressing. A new patch was then applied to the dorsal area and the procedure reapeated for a total of 5 consecutive days. The fifth dressing was removed after 8 hours.
Skin reactions were recorded again on days 8,9 and 10.
Body weights were recorded on day -3, at the initiation and on day 3 and 5 of the btreatment period as well as at day 8 and 10 of the observation period. Toxic symptoms were recorded daily.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 day
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 2 day
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 3
Score:
3.17
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4 day
Score:
3.17
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 5 day
Score:
3.33
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 8 day
Score:
3.83
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 9 day
Score:
3.83
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 10 day
Score:
3.66
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 day
Score:
1.83
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 2 day
Score:
2.33
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 3 day
Score:
2.83
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4 day
Score:
2.83
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 5 day
Score:
2.83
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 8 day
Score:
3.5
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 9 day
Score:
3.5
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 10 day
Score:
3.5
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:

The vehcile treated patches showed no irritation effect on the skin of the rabbits.
Other effects:
At necropsy, in all animals the application sites showed necrosis, the rythema extending beyond the treated areas and a breaking-off of the treated skin area, during the test as well as the observation period.

Under the experimental conditions the animals showed:

a primary reaction score of 3.8

a mean reaction score of 5.5

a final reaction score of 6.2

After treatment there was no tendency of recovery during the observation period.

The body weights were not decreased in the rabbit during the treatment period.

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Under the experimental condition employed, TK 10642 was found to cause marked irritation when applied to rabbit skin. It must be concluded that TK 10642 possess a cumulative skin irritation potential in albino rabbits.
Executive summary:

3 male and 3 female New Zealand white rabbits were treated occlusively with 0.5 mL of the undiluted substance 24 -hour/day on five consecutive days. The fifith application was removed after 8 hours. After each application the skin reaction was assessed and a new patch applied. Skin recation was recorded again on days 8, 9 and 10.

Under the experimental conditions the animals showed:

a primary reaction score of 3.8

a mean reaction score of 5.5

a final reaction score of 6.2

After treatment there was no tendency of recovery during the observation period.

The body weights were not decreased in the rabbit during the treatment period.

Based on the above mentioned results it was concluded that under the conditions of the present experiment TK 10642 was found to cause marked irritation when applied to the rabbit skin.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

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:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
according to: Draize, J. H. (1959) Appraisal of the Safety of Chemicals in Foods, Drug~ and Cosmetics, Assoc. of Food &Drug Officials of the U.S., Editorial Committee, Baltimore, Md., 40-52.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
-No details given
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Undiluted (No Rinse) - 0.1 ml
Observation period (in vivo):
7
Number of animals or in vitro replicates:
3
Details on study design:
Test Method
All eyes are examined prior to testing and only those that are grossly normal are used in eye irritation studies. The test material is placed into the
conjunctival sac of one eye of an albino rabbit, while the remaining eye serves as control.
Three eyes are treated for each test group. No rinsing was done.
Scoring of Eye Irritation
Eyes are scored at one hour; one, two, three, four and seven days; then weekly thereafter for a maximum of five weeks. Scoring may be discontinued at any time during the observation period if there is no gross evidence of any irritation to the ocular tissue or if the damage is so severe that
there is no hope for improvement. The scale for scoring ocular lesions is performed according to the method of Draize (1).
Aids for visual observation of corneal involvement include fluorescein staining, magnification by binocular head band and/or use of the Concept
Cobalt Blue Slit-Beam Light (Model 022). For more detailed observation, a Haag~Streit Slit Lamp Biomicroscope is utilized. .
Our scoring method differs from that recommended by the FDA (2) in that slight dulling (bedewing) and/or stippling, of the cornea is recorded 'as a grade 0.5 in our method. The' end result is that our scoring system results in slightly higher Maximum Average Scores (MAS) than would be expected if one adhered to the FDA Guidelines. MAS is the highest average score observed on any given day for the three animals in a given test group, regardless of the time required to produce these scores.

(1) Draize, J. H. (1959) Appraisal of the Safety of Chemicals in Foods, Drug~ and Cosmetics, Assoc. of Food &Drug Officials of the U.S., Editorial Committee, Baltimore, Md., 40-52.
(2) Illustrated Guide for Grading Eye Irritation by Hazardous Substances, U.S. Dept. ·of Health, Education, and Welfare, Food & Drug Administration
Test Method
All eyes are examined prior to testing and only those that are grossly normal are used in eye irritation studies. The test material is placed into the
conjunctival sac of one eye of an albino rabbit, while the remaining eye serves as control.
Three eyes are treated for each test group. No rinsing was done.

Scoring of Eye Irritation
Eyes are scored at one hour; one, two, three, four and seven days; then weekly thereafter for a maximum of five weeks. Scoring may be discontinued at any time during the observation period if there is no gross evidence of any irritation to the ocular tissue or if the damage is so severe that there is no hope for improvement. The scale for scoring ocular lesions is performed according to the method of Draize (1).
Aids for visual observation of corneal involvement include fluorescein staining, magnification by binocular head band and/or use of the Concept Cobalt Blue Slit-Beam Light (Model 022). For more detailed observation, a Haag-Streit Slit Lamp Biomicroscope is utilized. .

The scoring method differed from that recommended by the FDA (2) in that slight dulling (bedewing) and/or stippling, of the cornea is recorded 'as a grade 0.5 in this method. The end result is that this scoring system results in slightly higher Maximum Average Scores (MAS) than would be expected if one adhered to the FDA Guidelines. MAS is the highest average score observed on any given day for the three animals in a given test group, regardless of the time required to produce these scores.

(1) Draize, J. H. (1959) Appraisal of the Safety of Chemicals in Foods, Drug~ and Cosmetics, Assoc. of Food &Drug Officials of the U.S., Editorial Committee, Baltimore, Md., 40-52.
(2) Illustrated Guide for Grading Eye Irritation by Hazardous Substances, U.S. Dept. •of Health, Education, and Welfare, Food & Drug Administration
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation

Material

Treatment

Mean Average Score

Corneas involved

Eyes Normal

(In Indicated

Number of

Days)

Epoxide No. 8

Undiluted (NR)

2.0

0/3

3 (1 day)

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US OSHA
Conclusions:
Epoxide No. 8 would be classified as minimally irritating to the rabbit eye according to the classification described by John H. Kay and
Joseph C. Calandra, "Interpretation of Eye Irritation Tests" , J. Soc. Cosmet. Chem. 13, 281-289, 1962. Since the rabbit eye is'considerably more sensitive to foreign materials' than the human eye, Epoxide No.8 is expected to be non-irritating in case of accidental spilling or splashing into the
human eye.
Executive summary:

Undiluted Epoxide No. 8 ( 0.1 ml) was placed in the conjunctival sac of one eye of an albino rabbit (three animlas in each group), while the remaining eye served as control. Eyes were scored at one hour; and one day according to Draize. The study and scoring was discontinued since there was no gross evidence of any irritation to the ocular tissue

Undiluted Epoxide No. 8 produced very slight conjunctivitis which cleared readily within 24 hours.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment
Qualifier:
equivalent or similar to
Guideline:
other: Draize, J. H. (1959)
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no data
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1ml
Duration of treatment / exposure:
one group rinsed at 4 seconds
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
Test Method
All eyes are examined prior to testing and only those that are grossly normal are used in eye irritation studies. The test material is placed into the
conjunctival sac of one eye of an albino rabbit, while the remaining eye serves as control.
Three eyes are treated for each test group. Rinsing when indicated, is performed about 4 seconds after instillation with 20 ml of lukewarm tap
water. One person immobilizes the rabbit by cradling it with his forearms, and opens the eyelids with his hands. Rinse water from a 20 ml syringe
containing a "snubbed" 18 gauge hypodermic needle is then directed, under moderate pressure, to all parts of the eye so that all test material is
effectively removed. After the eye is rinsed, the water about the eye is removed by blotting with a soft cloth towel.

Scoring of Eye Irritation
Eyes are scored at one hour; one, two, three, four and seven days; then weekly thereafter for a maximum of five weeks. Scoring may be discontinued at any time during the observation period if there is no gross evidence of any irritation to the ocular tissue or if the damage is so severe that there is no hope for improvement. The scale for scoring ocular lesions is performed according to the method of Draize (1).
Aids for visual observation of corneal involvement include fluorescein staining, magnification by binocular head band and/or use of the Concept Cobalt Blue Slit-Beam Light (Model 022). For more detailed observation, a Haag-Streit Slit Lamp Biomicroscope is utilized. .

The scoring method differed from that recommended by the FDA (2) in that slight dulling (bedewing) and/or stippling, of the cornea is recorded 'as a grade 0.5 in this method. The end result is that this scoring system results in slightly higher Maximum Average Scores (MAS) than would be expected if one adhered to the FDA Guidelines. MAS is the highest average score observed on any given day for the three animals in a given test group, regardless of the time required to produce these scores.

(1) Draize, J. H. (1959) Appraisal of the Safety of Chemicals in Foods, Drug~ and Cosmetics, Assoc. of Food &Drug Officials of the U.S., Editorial Committee, Baltimore, Md., 40-52.
(2) Illustrated Guide for Grading Eye Irritation by Hazardous Substances, U.S. Dept. •of Health, Education, and Welfare, Food & Drug Administration
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US FDA
Conclusions:
Epoxide No.8 produced only mild, transient conjunctivitis with both treatments.
Executive summary:

Undiluted Epoxide No. 8 ( 0.1 ml) was placed in the conjunctival sac of one eye of an albino rabbit (three animlas in each group). In one group, the eye was rinsed, while the other group, the eye was not rinsed. Eyes were scored at one hour; and daily according to Draize. The study and scoring was discontinued since there was no gross evidence of any irritation to the ocular tissue

Undiluted Epoxide No. 8 produced very slight conjunctivitis which cleared readily within 6 days.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Effects on skin irritation/corrosion: moderately irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Based on the above stated assessment of the skin irritation potential of the substance does have to be classified as R38: Irritating to skin according to Council Directive 2001/59/EC and Category 2 (H315 Causes skin irritation) according to CLP (Regulation (EC) No 1272/2008 Of the European parliament and of the Council.

Base on the above assessment of the eye irritation potential, the substance does not have to be classified according to Council Directive 2001/59/EC and according to CLP (Regulation (EC) No 1272/2008 Of the European parliament and of the Council.