Registration Dossier

Administrative data

Description of key information

Disperse Blue 077 can be considered to be non-irritant to the skin and irritating to the eyes.

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:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
None
Qualifier:
according to guideline
Guideline:
other: the patch test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO)
Deviations:
not specified
GLP compliance:
no
Specific details on test material used for the study:
None
Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult ones
- Weight at study initiation: 1.5 to 2 kgs
- Housing: individually in metal cages
- Diet: standard rabbit food - NAFAG, No. 814, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: minimum 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C,
- Humidity (%): 55 ± 5 %
- Photoperiod: 10 hours light cycle day
Type of coverage:
occlusive
Preparation of test site:
other: shaved, with one side abraded and one site kept intact
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6 (3 males and 3 females)
Details on study design:
TEST SITE
- Type of wrap if used: Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin.

REMOVAL OF TEST SUBSTANCE
- Washing: not specified
- Time after start of exposure: 24 hours
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 h
Score:
0
Max. score:
8
Reversibility:
not specified
Irritant / corrosive response data:
The primary irritation index for FAT 36080/B was calculated to be 0, indicating no potential to cause irritation when applied to intact and abraded rabbit skin.
Other effects:
No other effects reported, no signs of systemic toxicity observed.

Results:

Erythema

Animal

Intact skin

Scarified skin

24 hours

72 hours

24 hours

72 hours

1

0

0

0

0

2

0

0

0

0

3

0

0

0

0

4

0

0

0

0

5

0

0

0

0

6

0

0

0

0

Oedema

Animal

Intact skin

Scarified skin

24 hours

72 hours

24 hours

72 hours

1

0

0

0

0

2

0

0

0

0

3

0

0

0

0

4

0

0

0

0

5

0

0

0

0

6

0

0

0

0

 

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 36080/B was found to be non-irritant to the skin.
Executive summary:

The irritation potential of FAT 36080/B was evaluated in a study conducted according to the patch test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). Six rabbits (3 males; 3 females) were used in this study. Gauze patches of 2.5 x 2.5 cm laden with 0.5 ml of the test material were applied to the prepared abraded and intact skin for the exposure duration of 24 hours. The reactions of the skin were appraised upon removal during an observation period of 72 hours. The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4 to get the primary irritation index. The primary irritation index was calculated to be 0.0, indicating no potential to cause irritation when applied to intact and abraded rabbit skin. Hence, FAT 36080/B was considered to be non-irritant to the skin.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
None
Qualifier:
according to guideline
Guideline:
other: the patch test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO)
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult ones
- Weight at study initiation: 1.5 to 2 kgs
- Housing: individually in metal cages
- Diet: standard rabbit food - NAFAG, No. 814, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: minimum 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C,
- Humidity (%): 55 ± 5 %
- Photoperiod: 10 hours light cycle day
Type of coverage:
occlusive
Preparation of test site:
other: shaved, with one side abraded and one site kept intact
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6 (3 males and 3 females)
Details on study design:
TEST SITE
- Type of wrap if used: Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin.

REMOVAL OF TEST SUBSTANCE
- Washing: not specified
- Time after start of exposure: 24 hours
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.06
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: Animal #6 had slight edema at 24 h, which was found to have reversed by 72 h.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 h
Score:
0.9
Max. score:
8
Reversibility:
not specified
Irritant / corrosive response data:
The primary irritation index for FAT 36080/A was calculated to be 0.9, indicating potential to cause a minimal irritation when applied to intact and abraded rabbit skin.
Other effects:
No other effects reported, no signs of systemic toxicity noted.

Results:

Erythema

Animal

Intact skin

Scarified skin

24 hours

72 hours

24 hours

72 hours

1

0

0

0

0

2

0

0

0

0

3

0

0

0

0

4

0

0

0

0

5

0

0

0

0

6

0

0

0

0

Oedema

Animal

Intact skin

Scarified skin

24 hours

72 hours

24 hours

72 hours

1

0

0

3

0

2

0

0

3

0

3

0

0

3

1

4

0

0

3

1

5

0

0

0

0

6

1

0

3

0

 

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 36080/A was considered to be non-irritant to the skin.
Executive summary:

The irritation potential of FAT 36080/A was evaluated in a study conducted according to the patch test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). 6 rabbits (3 males; 3 females) were used in this study. Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin for the exposure duration of 24 hours. The reactions of the skin was appraised upon removal during an observation period of 72. The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4 to get the primary irritation index. The primary irritation index was calculated to be 0.9, indicating potential to cause a minimal irritation when applied to intact and abraded rabbit skin. However based on the EU CLP criteria, FAT 36080/A was considered to be non-irritant to the skin.

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:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
None
Qualifier:
according to guideline
Guideline:
other: As per the procedure described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
Deviations:
no
Principles of method if other than guideline:
None
GLP compliance:
no
Specific details on test material used for the study:
None
Species:
rabbit
Strain:
other: Himalayan breed
Details on test animals or tissues and environmental conditions:
The test was performed on 3 male and 3 female rabbits of the Himalayan breed weighing 1.5 to 2 kg. The animals were housed individually in metal cages, were kept at a constant room temperature of 22 ± 1 °C, at a relative humidity of 55 ± 5 % and on a 10 hour light cycle day. The animals had ad libitum access to standard rabbit food - NAFAG, Gossau SG - and water. Prior to treatment they were adapted to our laboratories for a minimum of 4 days. Only rabbits with normal ophthalmic findings were used for these tests.
Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye was not treated and served as an untreated control.
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of lukewarm water. The remaining 3 rabbits did not receive any flushing during the entire study period.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 (3 males and 3 females)
Details on study design:
The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the 6 rabbits and the lids were gently closed for one second. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of lukewarm water. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. The primary eye irritation, index represents the sum of the mean values for cornea, iris and conjunctivae. This procedure was carried out separately for unrinsed and rinsed eyes respectively.
Irritation parameter:
cornea opacity score
Remarks:
eyes not rinsed
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
eyes rinsed
Basis:
mean
Time point:
24/48/72 h
Score:
1.22
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
iris score
Remarks:
eyes rinsed and not rinsed
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
eyes rinsed
Basis:
mean
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 7d
Irritation parameter:
chemosis score
Remarks:
eyes rinsed
Basis:
mean
Time point:
24/48/72 h
Score:
1.89
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
conjunctivae score
Remarks:
eyes not rinsed
Basis:
mean
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 7d
Irritation parameter:
chemosis score
Remarks:
eyes not rinsed
Basis:
mean
Time point:
24/48/72 h
Score:
1.6
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritant / corrosive response data:
In the present experiments the irritation index was established as 3.9 for the cornea, 0 for the iris and 6 for the conjunctivae. The test material caused therefore a minimal overall eye irritation to rabbits.
Rinsing the eyes following instillation was of practically no effect.

Table 1: Eye irritation in individual rabbits with eyes rinsed 30 sec. after treatment

Days

after

Appl.

Rabbit 1 (MALE)

Rabbit 2 (MALE)

Rabbit 3 (MALE)

Cornea

Iris

Conjunctiva

Cornea

Iris

Conjunctiva

Cornea

Iris

Conjunctiva

1

10

0

10

5

0

10

5

0

10

2

10

0

10

5

0

8

5

0

6

3

10

0

8

0

0

6

5

0

0

4

5

0

6

0

0

0

0

0

0

7

0

0

0

0

0

0

0

0

0

Cornea: 4; Iris: 0; Conjunctivae: 5.6

Table 2: Eye irritation in individual rabbits with eyes not rinsed after treatment

Days

after

Appl.

Rabbit 4 (FEMALE)

Rabbit 5 (FEMALE)

Rabbit 6 (FEMALE)

Cornea

Iris

Conjunctiva

Cornea

Iris

Conjunctiva

Cornea

Iris

Conjunctiva

1

5

0

10

5

0

12

5

0

10

2

5

0

10

5

0

10

5

0

10

3

5

0

8

5

0

8

5

0

6

4

5

0

8

0

0

6

0

0

0

7

5

0

0

0

0

0

0

0

0

Cornea: 3.7; Iris: 0; Conjunctivae: 6.5

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
FAT 36080/A can be considered as a mild eye irritant.
Executive summary:

The eye irritation potential of FAT 36080/A was evaluated in a study conducted as per the procedure described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). The test was performed on 3 male and 3 female rabbits of Himalayan breed weighing 1.5 to 2 kgs. The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the 6 rabbits and the lids were gently closed for one second. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of lukewarm water. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. The primary eye irritation, index represents the sum of the mean values for cornea, iris and conjunctivae. This procedure was carried out separately for unrinsed (A) and rinsed (B) eyes respectively. The irritation index was established as 3.9 for the cornea, 0 for the iris and 6 for the conjunctivae. The test material caused therefore a minimal overall eye irritation to rabbits. Rinsing the eyes following instillation was of practically no effect. The scores obtained in the study meet the threshold scores proposed by CLP Regulation for classification as eye irritant category 2. The mean scores for corneal opacity and conjunctival redness were scored as ≥1 and ≥2 respectively, for at least 2 out of 3 animals which received rinsing. Hence, FAT 36080/A can be classified as eye irritant category 2 according to the CLP (Regulation EC No. 1272/2008) criteria for classification.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
None
Qualifier:
according to guideline
Guideline:
other: As per the procedure described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
Deviations:
yes
Remarks:
some animals are rinsed, some not to evaluate effect of rinsing. Not rinsing the eye after test substance application represents an elevated testing condition.
Principles of method if other than guideline:
None
GLP compliance:
no
Specific details on test material used for the study:
None
Species:
rabbit
Strain:
other: Himalayan breed
Details on test animals or tissues and environmental conditions:
The test was performed on 3 male and 3 female rabbits of the Himalayan breed weighing 1.5 to 2 kg. The animals were housed individually in metal cages, were kept at a constant room temperature of 22 ± 1° C, at a relative humidity of 55 ± 5 % and on a 10 hour light cycle day. The animals had ad libitum access to standard rabbit food - NAFAG, Gossau SG - and water. Prior to treatment they were adapted to our laboratories for a minimum of 4 days. Only rabbits with normal ophthalmic findings were used for these tests.
Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye was not treated and served as an untreated control.
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of lukewarm water. The remaining 3 rabbits did not receive any flushing during the entire study period.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 (3 males and 3 females)
Details on study design:
The test material in an amount of 0.1 ml was inserted into the conjunctival sac of the left eye of the 6 rabbits and the lids were gently closed for one second. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of lukewarm water. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. The primary eye irritation, index represents the sum of the mean values for cornea, iris and conjunctivae. This procedure was carried out separately for unrinsed and rinsed eyes respectively.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
In the present experiments the irritation index was established as 0 for the cornea, 0 for the iris and 0 for the conjunctivae. The test material caused therefore no eye irritation to rabbits.

Table 1: Eye irritation in individual rabbits with eyes rinsed 30 sec. after treatment

Days

after

Appl.

Rabbit 1 (male)

Rabbit 2 (male)

Rabbit 3 (male)

Cornea

Iris

Conjunctiva

Cornea

Iris

Conjunctiva

Cornea

Iris

Conjunctiva

1

0

0

0

0

0

0

0

0

0

2

0

0

0

0

0

0

0

0

0

3

0

0

0

0

0

0

0

0

0

4

0

0

0

0

0

0

0

0

0

7

0

0

0

0

0

0

0

0

0

Table 2: Eye irritation in individual rabbits with eyes not rinsed after treatment

Days

after

Appl.

Rabbit 4 (female)

Rabbit 5 (female)

Rabbit 6 (female)

Cornea

Iris

Conjunctiva

Cornea

Iris

Conjunctiva

Cornea

Iris

Conjunctiva

1

0

0

0

0

0

0

0

0

0

2

0

0

0

0

0

0

0

0

0

3

0

0

0

0

0

0

0

0

0

4

0

0

0

0

0

0

0

0

0

7

0

0

0

0

0

0

0

0

0

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 36080/B can be considered as not an eye irritant.
Executive summary:

The eye irritation potential of FAT 36080/B was evaluated in a study conducted as per the procedure described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). The test was performed on 3 male and 3 female rabbits of Himalayan breed weighing 1.5 to 2 kgs. The test material in an amount of 0.1 ml was inserted into the conjunctival sac of the left eye of the 6 rabbits and the lids were gently closed for one second. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of lukewarm water. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. The primary eye irritation, index represents the sum of the mean values for cornea, iris and conjunctivae. This procedure was carried out separately for unrinsed (A) and rinsed (B) eyes respectively. The irritation index was established as 0 for the cornea, 0 for the iris and 0 for the conjunctivae. The test material caused no eye irritation to the eyes of rabbits. Hence the test substance can be considered as not an eye irritant.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

The skin irritation potential of Disperse Blue 077 was assessed in several studies conducted over the years.

In the key study (1977), FAT 36080/B was evaluated according to the patch test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). Six rabbits (3 males; 3 females) were used in this study. Gauze patches of 2.5 x 2.5 cm laden with 0.5 ml of the test material were applied to the prepared abraded and intact skinfor the exposure duration of 24 hours. The reactions of the skin were appraised upon removal during an observation period of 72. The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4 to get the primary irritation index. The primary irritation index was calculated to be 0.0, indicating no potential to cause irritation when applied to intact and abraded rabbit skin. Hence, FAT 36080/A was considered to be a non-irritant to the skin.

In another study conducted with similar method as discussed above, gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material (FAT 36080/A) were applied to the prepared abraded and intact skin of 6 rabbits (3 males and 3 females) for the exposure duration of 24 hours. The reactions of the skin were appraised upon removal during an observation period of 72. The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4 to get the primary irritation index.The primary irritation index was calculated to be 0.9, indicating potential to cause a minimal irritation when applied to intact and abraded rabbit skin. However, based on the EU CLP criteria, FAT 36080/A was considered to be a non-irritant to the skin.

FAT 40278/A (Disperse Blue 077 content 45 %) was also evaluated for skin irritant potential in a study conducted according to OECD Guideline 406. 3 male rabbits were used in this study. An area of at least 6 cm2 was shaved on both flanks of the animals approximately 24 h before treatment. A gauze patch (20 cm2) bearing 0.5 g of the test substance was applied to the flank. A control gauze patch was applied to the contralateral flank. Both gauze patches were moistened before application with distilled water. The patches were loosely covered with an aluminum foil (36 cm2) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg). The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system. The irritant/corrosive potency of FAT 40278/A was classified according to the EEC commission directive No. 83/467/1983. No erythema was observed for 2 out of 3 animals. Only one animal had very slight erythema at the 24 h observation, which was found to be resolved by 48 h observation. No edema was observed with the tested animals at 24/48/72 h observation. As mean values of the recordings 24 to 72 h after application are below the threshold of significance (2 score for erythema or edema), FAT 40278/A was considered to be a non-irritant to the skin.

As discussed above, it is clear that Disperse Blue 077 did not exhibit skin irritation potential in three different studies, hence it was considered to be a non irritant to the skin.

Eye irritation

The eye irritation potential of Disperse Blue 077 was assessed in several studies conducted over the years. In the key study, FAT 36080/A was evaluated as per the procedure described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). The test was performed on 3 male and 3 female rabbits of Himalayan breed weighing 1.5 to 2 kgs. The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the 6 rabbits and the lids were gently closed for one second. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of lukewarm water. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. The primary eye irritation, index represents the sum of the mean values for cornea, iris and conjunctivae. This procedure was carried out separately for unrinsed (A) and rinsed (B) eyes respectively. The irritation index was established as 3.9 for the cornea, 0 for the iris and 6 for the conjunctivae. The test material caused therefore a minimal overall eye irritation to rabbits. Rinsing the eyes following instillation was of practically no effect. The scores obtained in the study meet the threshold scores proposed by CLP Regulation for classification as eye irritant category 2. The mean scores for corneal opacity and conjunctival redness were scored as ≥1 and ≥2 respectively, for at least 2 out of 3 animals which received rinsing. Hence, FAT 36080/A can be classified as eye irritant category 2 according to the CLP (Regulation EC No. 1272/2008) criteria for classification.

In another study conducted using the same method as discussed above, the test material (FAT 36080/B) in an amount of 0.1 ml was inserted into the conjunctival sac of the left eye of the 6 rabbits (3 males and 3 females) and the lids were gently closed for one second. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of lukewarm water. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. The primary eye irritation, index represents the sum of the mean values for cornea, iris and conjunctivae. This procedure was carried out separately for unrinsed (A) and rinsed (B) eyes respectively. The irritation index was established as 0 for the cornea, 0 for the iris and 0 for the conjunctivae. The test material caused no eye irritation to the eyes of rabbits. Hence the test substance can be considered as not an eye irritant.

FAT 40278/A (Disperse Blue 077 content: 45 %) was evaluated for eye irritation potential in a study conducted as per OECD Guideline 405. The test was performed on 3 female rabbits. 0.1 ml (49 mg) test substance was placed into the conjunctival sac of the right eye of the rabbits and the lids were held together closed for one second. The left eye was not treated and served as an untreated control. The eye irritation was appraised on Days 1, 2, 3 and 7 and was scored for each individual rabbit. FAT 40278/A had no effcet on cornea and iris of the animals. However, the mean values for conjunctival redness and chemosis were calculated to be 1 and 0.22 respectively, which are significantly below the threshold values of classification. Hence, FAT 40278/A was considered as not an eye irritant.

Disperse Blue 077 was found to cause eye irritation when tested in the solid form (FAT 36080/A), while it did not lead to such effects when tested with liquid form (FAT 36080/B). Further FAT 40278/A (Disperse Blue 077 content 45 %) was also found to have no irritation potential. However, taking into account the irritating effects with FAT 36080/A and using conservative approach for assessment, it was classified as eye irritant category 2 according to CLP (Regulation EC No. 1272/2008) criteria.

Justification for classification or non-classification

Based on the available data as discussed above, Disperse Blue 077 does not warrant classification for skin irritation, however, it needs to be classified as eye irritant category 2 as per the CLP (Regulation EC No. 1272/2008) criteria.