Registration Dossier

Administrative data

Description of key information

Based on the study results, the test substance was determined to non-irritating to the skin, whereas moderately to severely irritating to the eye.

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 18 Jan, 1994 to and 21 Jan, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: Approx 17 to 19 weeks
- Weight at study initiation: 3.7 to 4.0 kg
- Housing: Individually in plastic cages with perforated floors in Building R 14 Room 1.
- Diet: SDS Stanrab (P) Rabbit Diet ( ad libitum)
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 19°C
- Humidity: 30-70%
- Air changes: 19 air changes/h
- Photoperiod: 12 h of artificial Iight (0700 - 1900 h) in each 24 h period
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
4 d
Number of animals:
3
Details on study design:
Approx 24 h prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approx 100 mm x 100 mm. A 0.5 mL amount of the test substance was applied under a 25 mm x 25 mm gauze pad to one intact
skin site on each animal. Each treatment site was covered with "Elastoplast" elastic adhesive dressing for 4 h. The animals were not restrained during the exposure period and were returned to their cages immediately after treatment. At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (30° to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 3 d
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: No adverse effects were observed.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 3 d
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: No adverse effects were observed.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 3 d
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: No adverse effects were observed.
Irritant / corrosive response data:
Very slight erythema was seen in all three animals on Days 1 and 2. The skin were normal on Day 3.

Dermal reactions observed after application of the test substance:

Rabbit number and sex

E=Erythema

O=Oedema

Day

1

2

3

4

 

2945 (male)

E

O

1

0

1

0

0

0

0

0

2946 (male)

E

O

1

0

1

0

0

0

0

0

2947 (male)

E

O

1

0

1

0

0

0

0

0

Interpretation of results:
other: EU CLP criteria not met
Conclusions:
Under the study conditions, the test substance was determined to be not irritating to the skin.
Executive summary:

A study was conducted to determine the skin irritation potential of test substance, DPHA to rabbit according to EU Method B.4, in compliance with GLP. Three rabbits were administered a single dermal dose of 0.5 mL under semi-occlusive dressing for 4 h. At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water to remove residual test substance. The treated area was blotted dry with absorbent paper. All animals were observed daily for signs of toxicity and ill health. Examinations of treated skin were made on Day 1 (60 mins after removal of dressing), and on Days 2, 3 and 4 (i.e., 24, 48 and 72 h after exposure). Dermal irritation was assessed using the numerical grading system. Very slight erythema was seen in all three animals on Days 1 and 2. Skin was normal on Day 3. Under the study conditions, the test substance was determined not to be irritating to the skin (Parcell, 1994).

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 16 Nov, 1998 to 25 Nov, 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, Oxon, England
- Age at study initiation: 14 weeks
- Weight at study initiation: 2.5 to 3.8 kg
- Housing: Individually in stainless steel cages with perforated floors in Building R14 Room 5.
- Diet: Special Diet Services STANRAB (P) SQC pellet (ad libitum)
- Water: Ad libitum
- Acclimation period: 11 d

ENVIRONMENTAL CONDITIONS
- Temperature: 17.5 to 19.5 °C
- Humidity: 39- 56%.
- Photoperiod: 12 h of artificial light (0700- 1900 h) in each 24 h period
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
10 d
Number of animals:
3
Details on study design:
Approx 24 h prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approx 100 mm x100 mm. Approx 0.5 mL of the test substance was applied under a 25 mm x 25 mm gauze pad to one intact site on each animal. Each treatment site was covered with "Elastoplast" elastic adhesive dressing for 4 h. The animals were not restrained during the exposure period and were returned to their cages immediately after treatment. At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (38°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0.67
Max. score:
4
Reversibility:
fully reversible within: 6 d
Remarks on result:
other: Well defined to slight erythema was observed on Days 4 and 5. However, resolved by Day 6.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: No adverse effects were observed.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.67
Max. score:
4
Reversibility:
fully reversible within: 10 d
Remarks on result:
other: Desquamation of the Stratum corneum (characterised by dryness and sloughing of the skin) was observed with erythema on Days 5 and 6. However, resolved by Day 7.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: No adverse effects were observed.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1.33
Max. score:
4
Reversibility:
fully reversible within: 10 d
Remarks on result:
other: Desquamation of the Stratum corneum (characterised by dryness and sloughing of the skin) was observed with slight erythema on Days 8 and 9. However, resolved by Day 10.
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0.67
Max. score:
4
Reversibility:
fully reversible within: 10 d
Irritant / corrosive response data:
Transient, very slight to well-defined erythema with or without very slight oedema was seen in all animals. In addition, desquamation of the Stratum corneum (characterised by dryness and sloughing) developed in two animals. Reactions had resolved completely by Day 6, 7 or 10.
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.
Interpretation of results:
other: EU CLP criteria not met
Conclusions:
Under the study conditions, the test substance was determined to be not irritating to the skin.
Executive summary:

A study was conducted to determine the skin irritation potential of test substance, DPHA according to EU Method B.4, OECD Guideline 404 and EPA Guideline OPPTS 870.2500, in compliance with GLP. Three rabbits were topically applied with a single dermal dose of 0.5 mL under semi-occlusive dressing for 4 h. At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (38°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper. All animals were observed daily for signs of toxicity and ill health. Examinations of treated skin were made on Day 1 (60 mins after removal of dressing), and on Days 2, 3 and 4 (i.e., 24, 48 and 72 h after exposure). Additional observations daily were made for all three animals on Days 5 and 6, for two animals on Day 7 and for one animal Days 8 and 10. Dermal irritation was assessed using the numerical grading system. There were no signs of toxicity or ill health in any rabbit during the observation period. Transient, very slight to well-defined erythema with or without very slight oedema was seen in all animals. In addition, desquamation of the Stratum corneum (characterized by dryness and sloughing) developed in two animals. Reactions had resolved completely by Day 6, 7 or 10. Under the study conditions, the test substance was determined not to be irritating to the skin (Parcell, 1999).

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
Study period:
From 24 Jan, 1994 to 14 Feb, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England.
- Age at study initiation: 12 to 14 weeks
- Weight at study initiation: 2.8 to 3.2 kg
- Housing: Individually in plastic cages with perforated floors in Building R 14 Room 1.
- Diet: SDS Stanrab (P) Rabbit Diet (ad libitum)
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 19°C
- Humidity: 30-70%
- Air changes: 19 air changes/h
- Photoperiod: 12 h of artificial light (0700 - 1900 h) in each 24 h period
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
14 d
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

TOOL USED TO ASSESS SCORE: Handheld light.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: No adverse effects were observed.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1.33
Max. score:
3
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0.67
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: No adverse effects were observed.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 1.67
Max. score:
3
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 1.67
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: No adverse effects were observed.
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1.67
Max. score:
3
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritant / corrosive response data:
Corneal opacities developed in all three animals. No iridial inflammation was observed. A diffuse crimson red colouration of the conjunctivae accompanied by swelling with partial eversion of the eyelids or with the eyelids about half closed was seen in all three animals. The eyes were normal 7 or 14 d after instillation.

There were no signs of toxicity or ill health in any rabbit during the observation period.

Interpretation of results:
other: Category 2 (irritating to eyes) based on EU CLP criteria
Conclusions:
Under the study conditions, the test substance was determined to irritating to the eye.
Executive summary:

A study was conducted to determine the eye irritation potential of test substance, DPHA to the rabbit according to EU Method B.5 in compliance with GLP.  Three rabbits were each administered a single ocular dose of 0. 1 mL of the test substance in one eye, whereas contralateral eye remained untreated and observed for a maximum of 14 d after instillation. All animals were observed daily for signs of ill health and toxicity. Examination of the eye was made after 1 h and 1, 2 and 3 days after instillation (24, 48 and 72 h). Additional observations were made 4, 7 and 14 days after instillation. Observations of the eyes was aided by the use of a handheld light. Ocular irritation was assessed using the numerical grading system. There were no signs of toxicity or ill health in any rabbit during the observation period. Corneal opacities developed in all animals. No iridial inflammation was observed. A diffuse crimson red colouration of the conjunctivae accompanied by swelling with partial eversion of the eyelids or with the eyelids about half closed was seen in all three animals. The eyes were normal 7 or 14 d after instillation. Under the study conditions, the test substance was determined to be irritating to the eye (Parcell, 1994).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 23 Nov, 1998 and 7 Dec, 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Ltd, Bicester. Oxon, England
- Age at study initiation: Approx 14 weeks of age
- Weight at study initiation: 2.7 kg
- Housing: Individually in a metal cage with perforated floor in Building R14 Room 4.
- Diet: Special Diet Services STANRAB (P) SQC pellet (ad libitum)
- Water: Ad libitum
- Acclimation period: 25 d

ENVIRONMENTAL CONDITIONS
- Temperature: 15-16 °C
- Humidity 32-57%
- Photoperiod (hrs dark / hrs light): 12 h of artificial light (0700 - 1900 h) in each 24 h period
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
14 d
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
2
Reversibility:
fully reversible within: 14 d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
3
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 3.66
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritant / corrosive response data:
Corneal opacification (Grade 2) and iridial inflammation (Grade 1) were observed. A diffuse, beefy red colouration of the conjunctivae and considerable swelling with the eyelids more than half closed was seen. These reactions had resolved completely by 14 d after instillation. Due to the severity of the reactions seen in the screen animal, and in the interests of animal welfare, no further animals were used.

Ocular reactions:

Rabbit number and sex

Region of eye

1 h

Days after instillation

1

2

3

4

7

14

1576 Male*

Cornea

Density

0

1

1

1

2

2

0

Area

0

2

2

2

2

1

0

Iris

 

0

1

1

1

1

1

0

Conjunctiva

Redness

2

3

3

3

3

2

0

Chemosis

3

4

4

3

2

2

0

*Screen animal

Interpretation of results:
other: Category 2 (irritating to eyes) based on EU CLP criteria
Conclusions:
Under the study conditions, the test substance was determined to irritating to the eye.
Executive summary:

A study was conducted to determine the eye irritation potential of test substance, DPHA according to OECD Guideline 405, EU Method B.5 and EPA Guideline OPPTS 870.2400, in compliance with GLP. One male rabbit was administered a single ocular dose of 0.1 mL of the test substance in eye, whereas contralateral eye remained untreated and observed for 14 d after instillation. As a result of the severe ocular reactions observed and in the interests of animal welfare, no further animals were dosed. All animals were observed daily for signs of ill health and toxicity. Examination of the eye was made after 1 h and 1, 2 and 3 days after instillation (24, 48 and 72 h). Additional observations were made 5 through 14 days after instillation. Observations of the eyes was aided by the use of a handheld light. Ocular irritation was assessed using the numerical grading system. There were no signs of toxicity or ill health in any rabbit during the observation period. Corneal opacification (Grade 2) and iridial inflammation (Grade 1) were noted. A diffuse, beefy red colouration of the conjunctivae and considerable swelling with the eyelids more than half closed was seen. These reactions had resolved completely by 14 d after instillation. Due to the severity of the reactions seen in the screen animal and in the interests of animal welfare, no further animals were tested. Under the study conditions, the test substance was determined to be irritating to the eye (Parcell, 2002).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin


A study was conducted to determine the skin irritation potential of test substance, DPHA according to EU Method B.4, OECD Guideline 404 and EPA Guideline OPPTS 870.2500, in compliance with GLP. Three rabbits were topically applied with a single dermal dose of 0.5 mL under semi-occlusive dressing for 4 h. At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (38°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper. All animals were observed daily for signs of toxicity and ill health. Examinations of treated skin were made on Day 1 (60 mins after removal of dressing), and on Days 2, 3 and 4 (i.e., 24, 48 and 72 h after exposure). Additional observations daily were made for all three animals on Days 5 and 6, for two animals on Day 7 and for one animal Days 8 and 10. Dermal irritation was assessed using the numerical grading system. There were no signs of toxicity or ill health in any rabbit during the observation period. Transient, very slight to well-defined erythema with or without very slight oedema was seen in all animals. In addition, desquamation of the Stratum corneum (characterized by dryness and sloughing) developed in two animals. Reactions had resolved completely by Day 6, 7 or 10. Under the study conditions, the test substance was determined not to be irritating to the skin (Parcell, 1999).


 


A study was conducted to determine the skin irritation potential of test substance, DPHA to rabbit according to EU Method B.4, in compliance with GLP. Three rabbits were administered a single dermal dose of 0.5 mL under semi-occlusive dressing for 4 h. At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water to remove residual test substance. The treated area was blotted dry with absorbent paper. All animals were observed daily for signs of toxicity and ill health. Examinations of treated skin were made on Day 1 (60 mins after removal of dressing), and on Days 2, 3 and 4 (i.e., 24, 48 and 72 h after exposure). Dermal irritation was assessed using the numerical grading system. Very slight erythema was seen in all three animals on Days 1 and 2. Skin was normal on Day 3. Under the study conditions, the test substance was determined not to be irritating to the skin (Parcell, 1994).


Eye


A study was conducted to determine the eye irritation potential of test substance, DPHA according to OECD Guideline 405, EU Method B.5 and EPA Guideline OPPTS 870.2400, in compliance with GLP. One male rabbit was administered a single ocular dose of 0.1 mL of the test substance in eye, whereas contralateral eye remained untreated and observed for 14 d after instillation. As a result of the severe ocular reactions observed and in the interests of animal welfare, no further animals were dosed. All animals were observed daily for signs of ill health and toxicity. Examination of the eye was made after 1 h and 1, 2 and 3 days after instillation (24, 48 and 72 h). Additional observations were made 5 through 14 days after instillation. Observations of the eyes was aided by the use of a handheld light. Ocular irritation was assessed using the numerical grading system. There were no signs of toxicity or ill health in any rabbit during the observation period. Corneal opacification (Grade 2) and iridial inflammation (Grade 1) were noted. A diffuse, beefy red colouration of the conjunctivae and considerable swelling with the eyelids more than half closed was seen. These reactions had resolved completely by 14 d after instillation. Due to the severity of the reactions seen in the screen animal and in the interests of animal welfare, no further animals were tested. Under the study conditions, the test substance was determined to be irritating to the eye (Parcell, 2002).


 


A study was conducted to determine the eye irritation potential of test substance, DPHA to the rabbit according to EU Method B.5 in compliance with GLP.  Three rabbits were each administered a single ocular dose of 0. 1 mL of the test substance in one eye, whereas contralateral eye remained untreated and observed for a maximum of 14 d after instillation. All animals were observed daily for signs of ill health and toxicity. Examination of the eye was made after 1 h and 1, 2 and 3 days after instillation (24, 48 and 72 h). Additional observations were made 4, 7 and 14 days after instillation. Observations of the eyes was aided by the use of a handheld light. Ocular irritation was assessed using the numerical grading system. There were no signs of toxicity or ill health in any rabbit during the observation period. Corneal opacities developed in all animals. No iridial inflammation was observed. A diffuse crimson red colouration of the conjunctivae accompanied by swelling with partial eversion of the eyelids or with the eyelids about half closed was seen in all three animals. The eyes were normal 7 or 14 d after instillation. Under the study conditions, the test substance was determined to be irritating to the eye (Parcell, 1994).


 

Justification for classification or non-classification

Based on the results of in vivo studies, the test substance does not warrant skin irritation classification according to CLP (EC 1272/2008) criteria. However, the test substance was irritating to eyes in an in vivo study and warrants classification as Eye Irrit. Cat. 2 - H319 (Causes serious eye irritation) according to CLP (EC 1272/2008) criteria.