Registration Dossier

Administrative data

Description of key information

Skin:

Rabbit, No irritation. OECD 404; Reliability = 1

Rabbit, No irritation. OECD 404; Reliability = 1

Rabbit, No irritation. OECD 404; Reliability = 1

Eye:

Rabbit. Irritation cleared by 48 hours. OECD 405; Reliability = 1

Rabbit. Irritation cleared by 48 hours. OECD 405; Reliability = 1

Rabbit. Irritation cleared by 24 hours. OECD 405; Reliability = 1

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
other: JMAFF 12-Nousan-8147 (2000)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: New Zealand albino
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Robinson Services, Inc. Mocksville, NC
- Age at study initiation: Young adult
- Weight at study initiation: 2131 - 3503 g
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors. A toy was placed in each cage. Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum): approximately 150 grams/day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 or 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 53-68%
- Air changes (per hr): 12-13
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
0.67 g (75% w/w mixture)
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- % coverage:
- Type of wrap if used: 1 in x 1 in 4-ply gauze applied to test site and entire trunk wrapped with semiocclusive 3-inch Micropore tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently cleansed residual test substance
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
For animal 1: immediately after removal, 30-60 mins, 24 hr, 48 hr, and 72 hr
For animals 2 & 3: 30-60 mins, 24 hr, 48 hr, and 72 hr

Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: no edema observed
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: no edema observed
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: no edema observed
Interpretation of results:
GHS criteria not met
Conclusions:
There was no dermal irritation observed at any treated dose site during the study.
Executive summary:

A primary skin irritation test was conducted with rabbits to determine the potential for the test substance to produce irritation after a single topical application in accordance with OPPTS 870.2500 and OECD 404.

The study was conducted in a stepwise manner using a single patch applied initially to one rabbit for 4 hours. Five-tenths of a gram of the test substance was moistened with distilled water and then applied to the skin of one healthy rabbit for 4 hours. The dose site was evaluated for dermal irritation immediately after patch removal and/or at 30-60 minutes and 24, 48, and 72 hours after patch removal. Since there was no irritation observed at the dose site of this animal, the test was completed on two additional animals, as described above, except the dose sites were not evaluated immediately after patch removal.

All animals appeared active and healthy and gained body weight during the study. There were no clinical signs observed. There was no dermal irritation observed at any treated dose site during the study.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
other: JMAFF 12-Nousan-8147 (2000)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: New Zealand albino
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
0.71 g
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: no edema observed
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: no edema observed
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: no edema observed
Interpretation of results:
GHS criteria not met
Conclusions:
There was no dermal irritation observed for any treated site during this study.
Executive summary:

A primary skin irritation test was conducted with rabbits to determine the potential for the test substance to produce irritation after a single topical application in accordance with OECD 404 and OPPTS 870.2500.

The study was conducted in a stepwise manner using a single patch applied initially to one rabbit for 4 hours. Five-tenths of a gram of the test substance was moistened with distilled water, applied to a patch and then to the skin of one healthy rabbit for 4 hours. The dose site was evaluated for dermal irritation immediately after patch removal and at 30-60 minutes and 24, 48, and 72 hours after patch removal. Since there was no dermal irritation noted at the dose site of this animal, the test was completed on two additional animals, as described above, except the dose sites were not evaluated immediately after patch removal.

All animals appeared active and healthy and gained body weight during the study. There were no clinical signs observed.

There was no dermal irritation observed for any treated site during this study.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
other: JMAFF 12-Nousan-8147 (2000)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: New Zealand albino
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
0.71 g (70% w/w mixture)
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: immediately after exposure, 30-60 mins, 24 h, 48 h, 72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: immediately after exposure, 30-60 mins, 24 h, 48 h, 72 h
Score:
0
Remarks on result:
other: no edema observed
Irritation parameter:
erythema score
Basis:
animal: 2 & 3
Time point:
other: 30-60 min, 24 h, 48 h, 72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: 2 & 3
Time point:
other: 30-60 min, 24 h, 48 h, 72 h
Score:
0
Remarks on result:
other: no edema observed
Interpretation of results:
GHS criteria not met
Conclusions:
There was no dermal irritation observed for any treated site during this study.
Executive summary:

A primary skin irritation test was conducted with rabbits to determine the potential for the test substance to produce irritation after a single topical application in accordance with OPPTS 870.2500, OECE 404 and EU Method B.4.

The study was conducted in a stepwise manner using a single patch applied initially to one rabbit for 4 hours. Five-tenths of a gram of the test substance was moistened with distilled water, applied to a patch and then to the skin of one healthy rabbit for 4 hours. The dose site was evaluated for dermal irritation immediately after patch removal and at 30-60 minutes and 24, 48, and 72 hours after patch removal. Since there was no dermal irritation noted at the dose site of this animal, the test was completed on two additional animals, as described above, except the dose sites were not evaluated immediately after patch removal.

All animals appeared active and healthy and gained body weight during the study. There were no clinical signs observed.

There was no dermal irritation observed for any treated site during this study.

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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
other: JMAFF 12-Nousan-8147 (2000)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: New Zealand albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Robinson Services, Inc. Mocksville, NC
- Age at study initiation: young adult
- Weight at study initiation: 2212 - 2481 g
- Housing:Individulally housed in suspended stainless steel caging with mesh floors with enrichment in each cage. Litter paper was placed beneath the cage and was changed at least 3x a week.
- Diet (e.g. ad libitum): ~150 g/day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 52-70%
- Air changes (per hr): 12-13
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.07 g of the test substance
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 females
Details on study design:
SCORING SYSTEM: numerical Draize technique

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
Mean Score
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 Hours
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
Mean Score
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
Mean score
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean score
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Interpretation of results:
GHS criteria not met
Conclusions:
Not an irritant
Executive summary:

An eye irritation study was conducted with the test substance on 3 rabbits in a stepwise fashion in accordance with the OPPTS 870.2400 and OECD 405 Guidelines. Initially, one-tenth of a milliliter (0.07 g) of the test substance was instilled in the conjunctival sac of the right eye of one healthy rabbit. The left eye was used as the control. Occular irritaiton was scored using the numerical Draize method. Since irritation cleared within 24 hours and there was no significant irritation observed in the first animal, the test was completed on two additional animals to confirm the result.

There was no iritis observed in any treated eye during the study. Corneal opacity (score of 1) was observed in the treated eye of one rabbit, conjunctival redness (score of 1) and discharge (scores of 1 and/or 2) were observed in the treated eye of three rabbits, and chemosis (scores of 1 and/or 2) was noted in the treated eye of two rabbits. Irritation cleared in the treated eye of one rabbit at 24 hours and in the treated eye of the remaining two rabbits at 48 hours.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
other: JMAFF 12-Nousan-8147 (2000)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: New Zealand albino
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
one-tenth of a milliliter (0.08 g)
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 females
Irritation parameter:
cornea opacity score
Basis:
animal: all
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: all
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
other: Conjunctival Redness
Basis:
animal: all
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
other: Conjuntival Chemosis
Basis:
animal: all
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Other effects:
Conjunctival redness (score of 1) was noted in the treated eye of all three rabbits and discharge (score of 1) was noted in the treated eye of one rabbit. Irritation cleared in the treated eye of all rabbits at 24 hours.
Interpretation of results:
GHS criteria not met
Conclusions:
not an eye irritant
Executive summary:

The study was conducted in accordance with OPPTS 870.2400, OECD 405, and EU Method B.5 with the test substance to determine the potential of eye irritaiton in one instillation.

Initially, one-tenth of a milliliter (0.08 grams) of the test substance was instilled into the conjunctival sac of the right eye of one healthy rabbit and the left eye was used as a control. Occular irritation was measured using the numerical Draize method. Since irritation cleared by 24 hours and there was no significant irritaions observed in the animal, the test was completed on two additinal animals to confirm the result.

No corneal opacity, iritis, or conjunctival chemosis was observed. Conjunctival redness (score of 1) was noted in the treated eye of all three rabbits and discharge (score of 1) was noted in the treated eye of one rabbit one hour following instillation of the test substance. Irritation cleared in the treated eye of all rabbits at 24 hours.

According to the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS) Fifth revised edition 2013, classification is not required.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
other: JMAFF 12-Nousan-8147 (2000)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: New Zealand albino
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 milliliter (0.08 g)
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 females
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
Mean score
Time point:
24/48/72 h
Score:
0.3
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
Mean score
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
Mean score
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
Mean score
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
Mean Score
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
Mean Score
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
Mean Score
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Other effects:
Conjunctival redness (score of 1) was noted in the treated eye of all three rabbits one hour after dose administration but cleared by the 24 hour reading.
Interpretation of results:
GHS criteria not met
Conclusions:
Test substance not an eye irritant
Executive summary:

This study was conducted in accordance with OPPTS 870.2400, OECD 405, and EU Method B.5 to determine the potential eye irritation from a single installation of the test substance.

Initally, one rabbit was treated with one-tenth of a milliliter of the test substance into the onjunctival sac of the right eye while the left eye served as the control. Occular irritation was evaluated by the numerical Draize method. Since irritation cleared by 48 hours and there was no significant irritation observed in this animal, the test was completed on two additional animals to confirm the initial results.

No iritis was observed during the study. Conjunctival redness (score of 1) was noted in the treated eye of all three rabbits one hour after dose administration. Opacity (score of 1) and discharge (score of 1) was noted in one treated eye within 24 hours. Irritation cleared in the treated eye of all rabbits by 48 hours. According to the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS) Fifth revised edition 2013, classification is not required.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A primary skin irritation test was conducted with rabbits according to OECD 404. The study was conducted in a stepwise manner using a single patch applied initially to one rabbit for 4 hours. Five-tenths of a gram of the test substance was moistened with distilled water and then applied to the skin of one healthy rabbit for 4 hours. The dose site was evaluated for dermal irritation immediately after patch removal and/or at 30-60 minutes and 24, 48, and 72 hours after patch removal. Since there was no irritation observed at the dose site of this animal, the test was completed on two additional animals, as described above, except the dose sites were not evaluated immediately after patch removal. All animals appeared active and healthy and gained body weight during the study. There were no clinical signs observed. There was no dermal irritation observed at any treated dose site during the study.

Two additional skin irritation tests were conducted via OECD 404 on rabbits using two other batches of the test substance. No dermal irritation was observed in either of these studies.

An eye irritation study was conducted with the test substance on 3 rabbits in a stepwise fashion in accordance with OECD 405 Guidelines. Initially, one-tenth of a milliliter (0.07 g) of the test substance was instilled in the conjunctival sac of the right eye of one healthy rabbit. Occular irritation was scored using the numerical Draize method. Since irritation cleared within 24 hours and there was no significant irritation observed in the first animal, the test was completed on two additional animals to confirm the result. There was no iritis observed in any treated eye during the study. Corneal opacity (score of 1) was observed in the treated eye of one rabbit, conjunctival redness (score of 1) and discharge (scores of 1 and/or 2) were observed in the treated eye of three rabbits, and chemosis (scores of 1 and/or 2) was noted in the treated eye of two rabbits. Irritation cleared in the treated eye of one rabbit at 24 hours and in the treated eye of the remaining two rabbits at 48 hours.

Two additional eye irritation tests were conducted via OECD 404 on rabbits using two other batches of the test substance. Ocular irritation cleared by 24 -48 hours in both of these studies.

Justification for classification or non-classification

The test substance produced no skin irritation and, therefore, does not need to be classified for skin irritation according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

The test substance produced eye irritation in the rabbit at 24 hours, which cleared by 48 hours after instillation. Since irritation cleared by 48-hours in all rabbits and the Draize scores observed did not meet criteria for classification, the substance does not need to be classified according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.