Registration Dossier

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Diss Factsheets

Administrative data

Description of key information

Key studies were available for 
- skin irritation: in vivo rabbit study showing mean scores over 24, 48 and 72 hours for each animal of 0, 0.3 and 0 for erythema and 0, 0 and 0 for oedema. and mean scores for the three animals of 0.1 for erythema and 0 for oedema. Under the experimental conditions, the test substance is non-irritant when applied topically to rabbits.
- eye irritation: in vivo rabbit study showing mean scores over 24, 48 and 72 hours of 1, 2 and 2 for corneal opacity, 0.3, 1 and 1 for iris lesions, 2.7, 3 and 3 for chemosis and 3, 3 and 3 for redness of the conjunctiva, and mean scores for the three animals of 1.7 for corneal opacity, 0.8 for iris lesions, 2.9 for chemosis and 3 for redness of the conjunctiva. A slight corneal opacity was recorded in all animals at the 24-hour examination and persisted through 48 or 72 hours. Chemosis and redness were still present in two animals on day 21 ; discharge cleared no later than day 10. A slight iritis was noted in two animals from 1 hour through 7 days after treatment; in the third animal iritis was seen only at 24 hours. A black area on the conjunctiva was seen in two animals from the 24-hour examination through day 14 or 17. All reactions were clear in all animals by day 36. Under the experimental conditions, the test substance is irritant when administered by ocular route in rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to internationally accepted test guidance and good laboratory practices guidance.
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
Principles of method if other than guideline:
The study was performed in accordance with Study Protocol No. 20698 TAL and subsequent amendments, with the following deviations from the agreed Study Protocol:
- the relative humidity recorded in the animal room was sometimes outside of the target ranges specified in the protocol,
- during the study, the animals had free access to 110 pelleted diet instead of 112 C pelleted diet,
- since the signed Study Specific Supplement was received at CIT after the end of the study, it was not audited by the CIT Quality Assurance Unit. Nevertheless, the standard Novartis protocol had been previously audited.
These minor deviations were not considered to have compromised the validity or integrity of the study.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France.
- Age at study initiation: No data provided.
- Weight at study initiation: On the day of treatment, the animals weighed 2.7, 2.8 and 2.7 kg, respectively.
- Housing: The animals were housed individually in polystyrene cages ( 48.2 cm x 58 cm x 36.5 cm). Each cage was equipped with a food container and a water bottle.
- Diet (e.g. ad libitum): During the study, the animals had free access to 110 pelleted diet (UAR, 91360 Villemoisson-sur-Orge, France). Food is analysed regularly by the supplier for composition and contaminant levels.
- Water (e.g. ad libitum): Drinking water filtered by a FG Millipare membrane (0.22 micron) was provided ad libitum.
Bacteriological and chemical analyses of water are performed regularly by external laboratories.
These analyses include the detection of possible contaminants (pesticides, heavy metals and nitrosamines). No contaminants were known to have been present in the diet or drinking water at levels which may be expected to have interfered with or prejudiced the outcome of the study. The results of the appropriate diet and water analyses are maintained in the test facility archive.
- Acclimation period: At least 5 days before the beginning of the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): Approximately 12 cycles/hour of filtered, non-recycled air.
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: From: 19 September 2000 (experimental starting date first animal) To: 24 September 2000 (end of the observation period)

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: Purified water (prepared at CIT by reverse osmosis) was used in order to moisten the pad and ensure a good contact with the skin.
Controls:
other: The untreated skin served as control.
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 500 mg
Duration of treatment / exposure:
As possible irritant effects were anticipated, the test substance was first evaluated on a single animal (No. 874). The duration of exposure was 3 minutes on one flank (left flank) and 4 hours on the other flank (right flank). Since the test substance was not irritant on this first animal, it was then applied for 4 hours to two other animals (Nos. 884 and 885).
Observation period:
The skin was examined approximately 1 hour, 24, 48 and 72 hours after removal of the dressing.
Following the OECD and EC guidelines, because there was no evidence of dermal irritation after 72 hours, the study was ended.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: flank
- % coverage: No data provided.
- Type of wrap if used: Doses of 500 mg of the test substance were placed on a moistened gauze pad, which was then applied to the right flank (application for 4 hours) or the left flank (application for 3 minutes) of the animals. The test substance and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage. The untreated skin served as control.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: After removal of the dressing (after 3 minutes or after 4 hours), any residual test substance was wiped off by means of a moistened gauze pad (water).


SCORING SYSTEM:
The skin was examined approximately 1 hour, 24, 48 and 72 hours after removal of the dressing.
Following the OECD and EC guidelines, because there was no evidence of dermal irritation after 72 hours, the study was ended.

Erythema and eschar formation:
. no erythema : 0
. very slight erythema (barely perceptible): 1
. well-defined erythema : 2
. moderate to severe erythema : 3
. severe erythema (beet redness) to slight eschar formation (injuries in depth) : 4

Oedema formation
. no oedema: 0
. very slight oedema (barely perceptible): 1
. slight oedema (edges of area well-defined by definite raising): 2
. moderate oedema (raised approximately 1 millimetre): 3
. severe oedema (raised more than 1 millimetre and extending beyond area
of exposure): 4

Any other lesions were noted.

Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under our experimental conditions, the test substance is non-irritant when applied topically to rabbits.
According to the classification criteria laid down in Commission Directive 93/21/EEC, CA 3105 A (Intermediate of CGA 362622) is not required to be classified as irritating to the skin.
Executive summary:

The potential of the test substance CA 3105 A (Intermediate of CGA 362622) to induce skin irritation was evaluated in rabbits according to OECD (No. 404, 17th July 1992) and EC (92/69/EEC, B.4, 31 st July 1992) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.

 

The test substance was first applied for periods of 3 minutes and 4 hours to a single male New Zealand White rabbit. Since the test substance was not irritant on the first animal, it was then applied for 4 hours to two other animals. A single dose of 500 mg of the test substance in its original form was applied to the closely-clipped skin of one flank. The test substance was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing.

After a 3-minute exposure (one animal), no cutaneous reactions were observed. After a 4-hour exposure (three animals), a very slight erythema was noted in 2/3 animals on day 1; it persisted up to day 2 in one of them.

Mean scores over 24, 48 and 72 hours for each animal were 0, 0.3 and 0 for erythema and 0, 0 and 0 for oedema. Mean scores for the three animals were 0.1 for erythema and 0 for oedema.

Under our experimental conditions, the test substance is non-irritant when applied topically to rabbits.

According to the classification criteria laid down in Commission Directive 93/21/EEC, CA 3105 A (Intermediate of CGA 362622) is not required to be classified as irritating to the skin.

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000-2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to internationally accepted test guidance and good laboratory practices guidance.
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
Principles of method if other than guideline:
The study was performed in accordance with Study Protocol No. 20699 TAL and subsequent amendments, with the following deviations from the agreed Study Protocol:
. the relative humidity recorded in the animal room was sometimes outside of the target ranges specified in the protocol,
. during the study, the animals had free access to 110 pelleted diet instead of 112 C pelleted diet.

These minor deviations were not considered to have compromised the validity or integrity of the study.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France.
- Age at study initiation: No data provided.
- Weight at study initiation: On the day of treatment, the animals weighed 2.9, 3.1 and 3.3 kg, respectively.
- Housing: The animals were housed individually in polystyrene cages ( 48.2 cm x 58 cm x 36.5 cm). Each cage was equipped with a food container and a water bottle.
- Diet (e.g. ad libitum): During the study, the animals had free access to 110 pelleted diet (UAR, 91360 Villemoisson-sur-Orge, France). Food is analysed regularly by the supplier for composition and contaminant levels.
- Water (e.g. ad libitum): Drinking water filtered by a FG Millipare membrane (0.22 micron) was provided ad libitum. Bacteriological and chemical analyses of water are performed regularly by external laboratories. These analyses include the detection of possible contaminants (pesticides, heavy metals and nitrosamines). No contaminants were known to have been present in the diet or drinking water at levels which may be expected to have interfered with or prejudiced the outcome of the study. The results of the appropriate diet and water analyses are maintained in the test facility archive.
- Acclimation period: At least 5 days before the beginning of the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): Approximately 12 cycles/hour of filtered, non-recycled air.
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: From: 26 September 2000 (experimental starting date) To: 7 November 2000 (end of the observation period)

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye, which remained untreated, served as control.
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): A single dose of 100 mg of the test substance in its original form was introduced into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball. The lower and upper eyelids were held together for about one second to avoid any loss of test substance.
Duration of treatment / exposure:
Single dose: the lower and upper eyelids were held together for about one second to avoid any loss of test substance.
Observation period (in vivo):
The eyes were examined approximately 1 hour, 24, 48 and 72 hours after administration of the test substance. Following the OECD and EC guidelines, because there was persistent ocular irritation after 72 hours, the observation period was extended to 21 or 36 days in order to determine the progress of the lesions and their reversibility.
Number of animals or in vitro replicates:
As possible irritant effects were anticipated, the test substance was first administered to a single animal (No. 874). Since the test substance was not severely irritant on this first animal, it was then evaluated on two other animals (Nos. 900 and 885).
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No. The eyes were not rinsed after administration of the test substance.

SCORING SYSTEM:
Ocular reactions were evaluated for each animal according to the following numerical scale:

CONJUNCTIVAL LESIONS AND DISCHARGE
Chemosis (Iids and/or nictitating membranes)
. no swelling : 0
. any swelling above normal (includes nictitating membranes): 1
. obvious swelling with partial eversion of lids: 2
. swelling with lids about half-closed: 3
. swelling with lids more than half-closed: 4

Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)
. blood vessels normal: 0
. a number of blood vessels definitely hyperemic (injected): 1
. diffuse, crimson colour, individual vessels not easily discernible: 2
. diffuse, beefy red: 3

Discharge
. absence of discharge: 0
. slight discharge (does not include small amounts normally found in inner canthus): 1
. discharge with moistening of lids and hairs adjacent to lids: 2
. discharge with moistening of lids and hairs on wide area around the eye: 3

IRIS LESIONS
. normal: 0
. markedly deepened rugae, congestion, swelling, moderate circum-corneal hyperemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive): 1
. no reaction to light, haemorrhage, gross destruction (any or all of these): 2

CORNEAL LESIONS
Cornea (direct examination or, if necessary, with an Ultra-Violet lamp)
Opacity (degree of intensity: area most dense taken for reading)
. no ulceration or opacity: 0
. scattered or diffuse areas of opacity (other than slight dulling or normal lustre), details of iris clearly visible: 1
. easily discernible translucent area, details of iris slightly obscured: 2
. nacrous areas, no details of iris visible, size of pupil barely discernible: 3
. opaque cornea, iris not discernible through the opacity: 4
Area of opacity
. one quarter ( or less) but not zero: 1
. greater than one quarter but less than a half: 2
. greater than one half but less than three quarters: 3
. greater than three quarters up to whole area: 4

Any other lesions observed were noted.
Conjunctival discharge and area of corneal opacity were scored but were not used in the calculation of indices.

TOOL USED TO ASSESS SCORE: To determine the presence or absence of corneal opacification and to evaluate the affected area, the eyes were examined on day 2 and whenever necessary under an UV lamp after instillation of one or two drops of 0.5% sodium fluorescein solution.
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.8
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2.9
Max. score:
4
Remarks on result:
other: Chemosis still present in two animals on day 21
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
3
Max. score:
3
Remarks on result:
other: Redness still present in two animals on day 21

Very slight to moderate conjunctival reactions including very slight to moderate chemosis (grades 1 to 3), very slight to moderate redness of the conjunctiva (grades 1 to 3) and clear to whitish purulent discharge were observed in all animals from day 1: the chemosis and redness were still present in two animals on day 21; the discharge cleared no later than day 10.

A slight iritis (grade 1) was noted in all animals, from day 1 up to day 7 (two animals) or on day 2 only ( one animal).

A very slight or slight corneal opacity (grade 1 or 2) was also recorded in all animals from day 2; it persisted up to day 4 at the latest.

A black area on the conjunctiva was seen in two animals from the 24-hour examination through day 14 or 17.

Mean scores calculated for each animal over 24, 48 and 72 hours were 1, 2 and 2 for corneal opacity, 0.3, 1 and 1 for iris lesions, 2.7, 3 and 3 for chemosis and 3, 3 and 3 for redness of the conjunctiva.

Mean scores calculated for the three animals were 1.7 for corneal opacity, 0.8 for iris lesions, 2.9 for chemosis and 3 for redness of the conjunctiva.

Table 1. Individual ocular examinations and summary indices

Rabbit number

Region of eye

Description of ocular reactions

Scores

Mean score

1h

24h

48h

72h

Day 7

Day 10

Day 14

Day 17

Day 21

Day 36

24-72 h

874

Cornea

Opacity

0

2

1

0

0

0

0

0

0

-

1

 

Iris

 

0

1

0

0

0

0

0

0

0

-

0.3

 

Conjunctivae

Chemosis

2

3

3

2

1

1

1

0

0

-

2.7

 

 

Redness

2

3

3

3

2

1

1

1

0

-

3

 

 

 

 

 

 

 

 

 

 

 

 

 

 

900

Cornea

Opacity

0

2

2

2

0

0

0

0

0

0

2

 

Iris

 

1

1

1

1

1

0

0

0

0

0

1

 

Conjunctivae

Chemosis

2

3

3

3

2

1

1

1

1

0

3

 

 

Redness

2

3

3

3

3

3

3

2

1

0

3

 

 

 

 

 

 

 

 

 

 

 

 

 

 

885

Cornea

Opacity

0

2

2

2

0

0

0

0

0

0

2

 

Iris

 

1

1

1

1

1

0

0

0

0

0

1

 

Conjunctivae

Chemosis

2

3

3

3

2

2

2

2

1

0

3

 

 

Redness

2

3

3

3

3

2

2

2

1

0

3

 

 

 

 

 

 

 

 

 

 

 

 

 

 

All

 

 

 

 

 

 

 

 

 

 

 

 

Grand mean 24-72 h

 

Cornea

Opacity

 

 

 

 

 

 

 

 

 

 

1.7

 

Iris

 

 

 

 

 

 

 

 

 

 

 

0.8

 

Conjunctivae

Chemosis

 

 

 

 

 

 

 

 

 

 

2.9

 

 

Redness

 

 

 

 

 

 

 

 

 

 

3

- = Not performed

 

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under our experimental conditions, the test substance is irritant when administered by ocular route in rabbits.
According to the classification criteria laid down in Commission Directive 93/21/EEC, CA 3105 A (Intermediate of CGA 362622) should be classified as R 36: “Irritating to eyes”.
Executive summary:

The potential of the test substance CA 3105 A (Intermediate of CGA 362622) to induce ocular irritation was evaluated in rabbits according to OECD (No. 405, 24th February 1987) and EC (92/69/EEC, B.5, 31st July 1992) guidelines. The study was conducted in comp1iance with the principles of Good Laboratory Practice Regulations.

The test substance was first administered to a single male New Zealand White Rabbit. Since the test substance was not severely irritant on this first animal, it was then evaluated in two other animals. A single dose of 100 mg of the test substance in its original form was introduced into the left conjunctival sac. The right eye served as control. The eyes were not rinsed after administration of the test substance.

Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration/ and then on days 7, 10, 14, 17, 21 and 36.

Very slight to moderate chemosis, very slight to moderate redness of the conjunctiva and clear to whitish purulent discharge were observed in all animals from the 1-hour observation. The chemosis and redness were still present in two animals on day 21 ; the discharge cleared no later than day 10. A slight iritis was noted in two animals from 1 hour through 7 days after treatment; in the third animal iritis was seen only at 24 hours. A slight corneal opacity was recorded in all animals at the 24-hour examination and persisted through 48 or 72 hours. A black area on the conjunctiva was seen in two animals from the 24-hour examination through day 14 or 17. All reactions were clear in all animals by day 36.

Mean scores calculated for each animal over 24, 48 and 72 hours were 1, 2 and 2 for corneal opacity, 0.3, 1 and 1 for iris lesions, 2.7, 3 and 3 for chemosis and 3, 3 and 3 for redness of the conjunctiva. Mean scores calculated for the three animals were 1. 7 for corneal opacity, 0.8 for iris lesions, 2.9 for chemosis and 3 for redness of the conjunctiva.

Under our experimental conditions, the test substance is irritant when administered by ocular route in rabbits.According to the classification criteria laid down in Commission Directive 93/21/EEC, CA 3105 A (Intermediate of CGA 362622) should be classified as R 36: “Irritating to eyes”.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A key study for dermal irritation/corrosion was performed in rabbits according to OECD (No. 404) and EC (92/69/EEC, B.4) guidelines (Griffon, 2000). The test substance was first applied for periods of 3 minutes and 4 hours to a single male New Zealand White rabbit. Since the test substance was not irritant on the first animal, it was then applied for 4 hours to two other animals. A single dose of 500 mg of the test substance in its original form was applied to the closely-clipped skin of one flank. The test substance was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing. After a 3-minute exposure (one animal), no cutaneous reactions were observed. After a 4-hour exposure (three animals), a very slight erythema was noted in 2/3 animals on day 1; it persisted up to day 2 in one of them. Mean scores over 24, 48 and 72 hours for each animal were 0, 0.3 and 0 for erythema and 0, 0 and 0 for oedema. Mean scores for the three animals were 0.1 for erythema and 0 for oedema. Under the experimental conditions, the test substance is non-irritant when applied topically to rabbits.

 

A key study for eye irritation was performed in rabbits according to OECD (No. 405) and EC (92/69/EEC, B.5) guidelines (Griffon, 2001). The test substance was first administered to a single male New Zealand White Rabbit. Since the test substance was not severely irritant on this first animal, it was then evaluated in two other animals. A single dose of 100 mg of the test substance in its original form was introduced into the left conjunctival sac. The right eye served as control. The eyes were not rinsed after administration of the test substance.

Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration/ and then on days 7, 10, 14, 17, 21 and 36.

Very slight to moderate chemosis, very slight to moderate redness of the conjunctiva and clear to whitish purulent discharge were observed in all animals from the 1-hour observation. The chemosis and redness were still present in two animals on day 21 ; the discharge cleared no later than day 10. A slight iritis was noted in two animals from 1 hour through 7 days after treatment; in the third animal iritis was seen only at 24 hours. A slight corneal opacity was recorded in all animals at the 24-hour examination and persisted through 48 or 72 hours. A black area on the conjunctiva was seen in two animals from the 24-hour examination through day 14 or 17. All reactions were cleared in all animals by day 36.

Mean scores calculated for each animal over 24, 48 and 72 hours were 1, 2 and 2 for corneal opacity, 0.3, 1 and 1 for iris lesions, 2.7, 3 and 3 for chemosis and 3, 3 and 3 for redness of the conjunctiva. Mean scores calculated for the three animals were 1.7 for corneal opacity, 0.8 for iris lesions, 2.9 for chemosis and 3 for redness of the conjunctiva. Under the experimental conditions, the test substance is irritant when administered by ocular route in rabbits.


Justification for selection of skin irritation / corrosion endpoint:
Key study

Justification for selection of eye irritation endpoint:
Key study

Effects on eye irritation: irritating

Justification for classification or non-classification

Based on the results of the dermal irritation/corrosion study in rabbits, Sodium {[3-(2,2,2-trifluoroethoxy)-2-pyridinyl]sulfonyl}azanide (TFEPSN) does not have to be classified and has no obligatory labelling requirement for skin irritation according to the EU labelling regulations Commision directive 93/21/EEC and the CLP regulation (No. 1272/2008 of 16 December 2008).

According to the classification criteria laid down in Commission Directive 93/21/EEC, Sodium {[3-(2,2,2-trifluoroethoxy)-2-pyridinyl]sulfonyl}azanide (TFEPSN) should be classified as R 36: “Irritating to eyes”. According the CLP regulation (No. 1272/2008 of 16 December 2008), it should be classified as Category 1 (H318; causes serious eye damage), taking into account that there were still effects seen on day 21. Nevertheless, on day 36 all effects were cleared.