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Diss Factsheets

Administrative data

Description of key information

Skin irritation/corrosion:

In-vivo:

A key study was performed to determine the acute dermal irritation/corrosion potential of FAT 36156/A on New Zealand rabbits according to the OECD guideline 404.Three female rabbits were used in the test; 0.5 g of the test item was applied to the skin of the rabbit which was shaved not less than 24 hours before the application. The exposure duration was 4 hours. After removal of the dressing the skin reaction was assessed (for erythema and oedema) after 1, 24, 48, 72 hours and during the 7 days of observation period. The animals showed a normal body weight development. Due to intensive blue staining by the test substance a scoring of the erythema values was not possible.The dermal irritation was evaluated after the score for oedema formation only. The calculated dermal irritation index was 1.33 for oedema. Under the conditions of the present experiment FAT 36156/A was found to be slightly skin irritant and not corrosive when applied to the rabbit skin. The calculated dermal irritation index was 1.33 for oedema. The animals had recovered at the end of the observation period of 7 days as well as no systemic effects were noted in the animals during the course of the study. Based on the finding in the skin irritation studies, the test substance can be considered to be not irritant to rabbit skin.

In-vitro:

In Vitro EPIDERM™ Skin Corrosion Test (EPI-200-SCT) was carried out with FAT 36156/D according to OECD 431 and EU method B.40. The purpose of this test is to evaluate the corrosivity potential of the test item using the EpiDerm™ Human Skin Model after treatment periods of 3 and 60 minutes.The relative mean viabilities of the test item treated tissues for 60-minute exposure and 3 minute exposure was 94.3 % and 101.0 %, respectively. Based on the study results, the test item was considered to be non-corrosive to the skin.

Eye Irritation/corrosion:

In-vitro:

The purpose of Bovine Corneal Opacity and Permeability (BCOP) was to identify test items that can induce serious eye damage and to identify test items not requiring classification for eye irritation or serious eye damage. The BCOP test method is an organotypic model that provides short-term maintenance of normal physiological and biochemical function of the bovine cornea in vitro. In this test method, damage by the test item is assessed by quantitative measurements of changes in corneal opacity and permeability. The test was carried out in cattle eyes with FAT 36156/D according to OECD guideline 437 and EU method B.47. Based on the study results, thein vitroirritancy score was 7.7 for FAT 36156/D while 1.4 and 73.6 for negative and positive control respectively. So in conclusion, no prediction of eye irritation can be made.

In-Vivo:

The experiment was performed to determine the potential of FAT 36156/A to induce irritation/corrosion in New Zealand White rabbits according to the OECD Guideline 405. Three male rabbits were used in this study. 0.1 g of the test item was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were held together for about on second in order to prevent the loss of the test material.The left eye remained untreated and served as the control. The ocular reaction was examined 1, 24, 48 and 72 hours after substance instillation.The test was finished after 3 observations days. The animals showed a normal body weight gain.Two animals showed conjunctival redness of score 1 at 24 h observation period which was reversed at 48 h observation period. No other reactions to treatment were recorded during the whole observation period.

Based on the findings of the study, FAT 36'156/A is considered as non-irritant when applied to the rabbit eye. The bovine corneal opacity test could not be used for prediction owing to the IVIS of 7.7, however, using the findings of the in vivo irritation study, Disperse Blue 165:1 can be said to be not 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:
16 January 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: EN 43'693.12

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Stability under test conditions: until October 1988
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2240-2390 g
- Housing: Animals were housed individually in metal cages.
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland) ad liitum
- Water: water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 30-70
- Air changes (per hr): approximately 15 air changes/h
- Photoperiod (hrs dark / hrs light): 12 hours light/day
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Remarks:
Using electric clipper
Vehicle:
water
Remarks:
The substance was water moistened before application
Controls:
no
Amount / concentration applied:
0.5 g of the test substance was applied.
Duration of treatment / exposure:
4 h
Observation period:
7 days
Number of animals:
3 females
Details on study design:
- Application of the Substance: Not less than 24 hours before treatment on the back of the experimental animal an area was shaven of at least 6 sq. cm, by means of an electric clipper. A gauze patch bearing 0.5 g of the test substance was applied to the skin and loosely held in place by adhesive but non-irritating tape (ISOPLAST AG, CH-5200 Brugg). The substance was water moistened before application.

SCORING SYSTEM:
Evaluation of the dermal reactions.
Erythema and Eschar formation:
- No erythema: 0
- Very slight erythema: 1
- Well defined erythema: 2
- Moderate to severe erythema: 3
- Severe erythema (beet redness) to slight eschar formation: 4
- Corrosion: +

Oedema formation:
- No oedema: 0
- Very slight oedema: 1
- Slight oedema: 1
- Slight oedema (edges of area well defined by definite raising) 2
- Moderate oedema (approx. 1mm): 3
- Severe oedema (raised more than 1 mm, extended beyond. appl. site): 4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Max. score:
4
Remarks on result:
not determinable
Remarks:
Due to intensive blue staining by the test substance a scoring of the erythema values was not possible
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0.56
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
1.33
Reversibility:
fully reversible within: 7 d
Other effects:
Due to intensive blue staining by the test substance a scoring of the erythema values was not possible.
The dermal irritation was evaluated after the score for oedema formation only.
The animals showed a normal body weight development.

Scoring of erythema and eschar formation:

Animal No. / Sex 1 hr 24 hrs 48 hrs 72 hrs 7 days  
22 / F * * * * *
23 / F * * * * *
24 / F * * * * *
Total * +  * +  * +  *           = * (A)

Scoring of Oedema formation:

Animal No. / Sex 1 hr 24 hrs 48 hrs 72 hrs 7 days  
22 / F 1 1 1 1 0
23 / F 0 0 0 0 0
24 / F 2 1 1 0 0
Total 3 + 2 +  2 + 1 =   8 (B)

Index of skin irritation: A* + B = 1.33

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 36156/A is non irritant when applied to the rabbit skin.
Executive summary:

The study was performed to determine the acute dermal irritation/corrosion potential of FAT 36156/A on New Zealand rabbits according to the OECD guideline 404. Three female rabbits were used in the test; 0.5 g of the test item was applied to the skin of the rabbit which was shaved not less than 24 hours before the application. The exposure duration was 4 hours. After removal of the dressing, the skin reaction was assessed (for erythema and oedema) after 1, 24, 48, 72 hours and during the 7 days of observation period. The animals showed a normal body weight development. Due to intensive blue staining by the test substance, the scoring of the erythema values was not possible. The dermal irritation was evaluated after the score for oedema formation only. The calculated dermal irritation index was 1.33 for oedema. The animals had recovered at the end of the observation period of 7 days. Under the conditions of the present experiment, FAT 36156/A was found to be slightly irritant and not corrosive when applied to the rabbit skin. However, as per the Regulation (EC) No. 1272/2008, it does not need to be classified.

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
5 August 2015 to 3 December 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: 20140804
- Expiration date of the lot/batch: 21 August 2019
- Purity test date:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
Test system:
human skin model
Source species:
human
Source strain:
not specified
Details on test system:
EpiDerm™ Reconstructed Human Epidermis Model Kit
Supplier: MatTek
Date received: 04 August 2015
EpiDermTM Tissues (0.5cm2) lot number: 21683
Assay Medium lot number: 073015SLC

Upon receipt of the EpidermTM tissues, the sealed 24-well plate was stored in a refrigerator until use.
Duration of treatment / exposure:
3 and 60 minutes
Number of replicates:
duplicates
Irritation / corrosion parameter:
% tissue viability
Remarks:
60 minutes exposure
Value:
94.3
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation / corrosion parameter:
% tissue viability
Remarks:
3 minute exposure
Value:
101
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Direct MTT Reduction

The MTT solution containing the test item did not turn blue. This was taken to indicate the test item did not reduce MTT.

 

Assessment of Color Interference with the MTT endpoint

An assessment found that the colored test item may interfere with the MTT endpoint. Therefore, an additional procedure using viable color correction tissues was performed to measure any potential interference. However, the results obtained showed that negligible interference due to the color of the test item occurred. It was therefore considered unnecessary to use the results of the color correction tissues for quantitative correction of results or for reporting purposes.

 

Quality Criteria

The mean OD562 for the negative control treated tissues was 2.157 for the 3 Minute exposure period and 2.157 for the 60 Minute exposure period. The negative control acceptance criteria were therefore satisfied.

The relative mean tissue viability for the positive control treated tissues was 4.0% relative to the negative control following the 60 Minute exposure period. The positive control acceptance criterion was therefore satisfied. 

In the range 20-100% viability the Coefficient of Variation between the two tissue replicates of each treatment group did not exceed 30%. The acceptance criterion was therefore satisfied.

Mean OD562 Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item

 

Tissue

Exposure Period

Mean OD562of individual tissues

Mean OD562of duplicate tissues

Standard Deviation

Coefficient of Variation

(%)

Relative Mean Viability (%)

Negative Control

3 Minutes

2.145

2.157

0.016

0.74

100*

2.168

60 Minutes

2.162

2.157

0.008

0.37

2.151

Positive Control

3 Minutes

0.082

0.085

0.004

N/A

3.9

0.087

60 Minutes

0.086

0.086

0.001

N/A

4.0

0.085

Test Item

3 Minutes

2.226

2.178

0.068

3.12

101.1

2.130

60 Minutes

2.077

2.035

0.059

2.90

94.3

1.993

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 36156/D was considered to be non-corrosive to the skin.
Executive summary:

In Vitro EPIDERM™ Skin Corrosion Test (EPI-200-SCT) was carried out with FAT 36156/D according to OECD 431 and EU method B.40.The purpose of this test is to evaluate the corrosivity potential of the test item using the EpiDerm™ Human Skin Model after treatment periods of 3 and 60 minutes. Duplicate tissues were treated with the test item for exposure periods of 3 and 60 minutes. At the end of the exposure period the test item was rinsed from each tissue before each tissue was taken for MTT-loading. After MTT loading each tissue was placed in 2 mL Isopropanol for MTT extraction. At the end of the formazan extraction period each well was mixed thoroughly and triplicate 200mL samples were transferred to the appropriate wells of a pre-labeled 96 well plate. The optical density (OD) was measured at 562 nm (OD562). Data are presented in the form of percentage viability (MTT reduction in the test item treated tissues relative to negative control tissues). The relative mean viabilities of the test item treated tissues for 60-minute exposure and 3 minute exposure was 94.3 % and 101.0 %, respectively. Based on the study results, the test item was considered to be non-corrosive 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:
9 January 1984 to 23 January 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: EN 43'693.12

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Stability under storage conditions: until October 1988
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2110-2240 g
- Housing: Animals were housed individually in metal cages.
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland) ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): approximately 15 air changes/h
- Photoperiod (hrs dark / hrs light): 12 hours light/day
Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye of each animal remained untreated and served as the control.
Amount / concentration applied:
0.1 g of the test article was applied.
Duration of treatment / exposure:
One single application.
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 males
Details on study design:
0.1 g of the test article was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material.
The left eye remained untreated and served as the control.

Scoring and assessment of local reactions:
The ocular reactions were examined 1, 24, 48, and 72 hours after substance instillation and again during the following observation period.
The ocular irritation scores were evaluated according to the scoring system.
The irritating and/or corrosive potential of the test article (theoretical range: non irritant - extremely irritant) was assessed on the basis of the maximum irritant effect observed
- in one or several of the ocular tissues (conjunctiva, iris, cornea), observed over the range of observation time
- in one or more animals and taking into account the reversibility of the effect.

SCORING SYSTEM: Evaluation score for ocular lesions.

CORNEA:
Opacity: degree of density (area most dense taken for reading).
- No ulceration or opacity: 0
- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible: 1*
- Easily discernible translucent area, details of iris slightly obscured: 2*
- Nacrous area, no details of iris visible, size of pupil barely discernible: 3*
- Opaque cornea, iris not discernible through the opacity: 4*

IRIS:
- Normal: 0
- Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination of any there of, iris still reacting to light (sluggish reaction is positive): 1*
- No reaction to light , haemorrhage, gross destruction (any or a l l of these): 2*


CONJUNCTIVAE:
Redness: (refers to palpebral and bulbar conjunctivae, cornea and iris)
- Blood vessels normal: 0
- Some blood vessels definitely hyperaemic (injected): 1
- Diffuse, crimson colour, individual vessels not easily discernible: 2*
- Diffuse beefy red: 3*

CHEMOSIS:
Lids and/or nictating membranes
- No swelling: 0
- Any swelling above normal (includes nictating 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*

*Starred figures indicate positive effect.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 animal
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Remarks:
3 animal
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The animals were free of findings at the 48 hours scoring. The animals showed a normal body weight development.

CORNEA

Animal No./Sex

19/M

20/M

21/M

After 1 h

1

0

1

After 24 h

0

0

0

After 48 h

0

0

0

After 72 h

0

0

0

IRIS

After 1 h

0

0

0

After 24 h

0

0

0

After 48 h

0

0

0

After 72 h

0

0

0

CONJUNCTIVA redness in bulbar and palpebral membranes

After 1 h

2

2

2

After 24 h

1

0

1

After 48 h

0

0

0

After 72 h

0

0

0

CONJUNCTIVA chemosis in lids and nictating membranes

After 1 h

2

2

2

After 24 h

0

0

0

After 48 h

0

0

0

After 72 h

0

0

0

 

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 36'156/A is considered as non-irritant when applied to the rabbit eye.
Executive summary:

The experiment was performed to determine the potential of FAT 36156/A to induce irritation/corrosion in New Zealand White rabbits according to the OECD Guideline 405. Three male rabbits were used in this study. 0.1 g of the test item was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were held together for about on second in order to prevent the loss of the test material. The left eye remained untreated and served as the control. The ocular reaction was examined 1, 24, 48 and 72 hours after substance instillation.


The test was finished after 3 observations days. The animals showed a normal body weight gain.Two animals showed conjunctival redness of score 1 at 24 h observation period which was reversed at 48 h observation period. No other reactions to treatment were recorded during the whole observation period.


 


Based on the results, FAT 36'156/A is considered as non-irritant when applied to the rabbit eye.

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 September 2015 - 11 September 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: 20140804
- Expiration date of the lot/batch: 21 August 2019
-
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
Species:
cattle
Strain:
not specified
Remarks:
Eyes from adult cattle
Details on test animals or tissues and environmental conditions:
Eyes from adult cattle (typically 12 to 60 months old) were obtained from a local abattoir as a by-product from freshly slaughtered animals. The eyes were excised by an abattoir employee after slaughter, and were placed in Hanks’ Balanced Salt Solution (HBSS) supplemented with antibiotics (penicillin at 100 IU/mL and streptomycin at 100 μg/mL). They were transported to the test facility over ice packs on the same day of slaughter. The corneas were refrigerated on arrival and used within 24 hours of receipt.
Vehicle:
other: sodium chloride
Controls:
yes
Amount / concentration applied:
The EMEM was removed from the anterior chamber of the BCOP holder and 0.75 mL of the test item preparation or control items were applied to the appropriate corneas. The holders were gently tilted back and forth to ensure a uniform application of the item over the entire cornea. Each holder was incubated, anterior chamber uppermost, at 32 ± 1 ºC for 240 minutes.
Duration of post- treatment incubation (in vitro):
240 min
Number of animals or in vitro replicates:
3 corneas
Irritation parameter:
in vitro irritation score
Value:
7.7
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
The corneas treated with the test item or negative control item were clear post treatment. The corneas treated with the positive control item were cloudy post treatment.

Criteria for an Acceptable Test:
The positive control In Vitro Irritancy Score was within the range of 66.9 to 101.4. The positive control acceptance criterion was therefore satisfied. The negative control gave opacity of ≤4.1 and permeability ≤0.105. The negative control acceptance criteria were therefore satisfied.

Individual and Mean Corneal Opacity and Permeability Measurements

 

Treatment Cornea

Cornea

Number

Opacity

Permeability (OD)

In Vitro

Irritancy

Score

 

 

Pre-Treatment

Post-Treatment

Post-Treatment - Pre-Treatment

Corrected

Value

 

Corrected

Value

 

Negative

Control

18

5

6

1

 

0.003

 

1.4

22

5

6

1

 

0.006

 

26

5

7

2

 

-0.001

 

 

 

 

1.3*

 

0.003^

 

Positive Control

5

4

60

56

54.7

0.778

0.775

73.6

19

4

51

47

45.7

0.627

0.624

23

6

85

79

77.7

1.453

1.450

 

 

 

 

59.3#

 

0.950#

Test Item

24

4

14

10

8.7

0.047

0.044

7.7

27

5

14

9

7.7

0.018

0.015

28

5

12

7

5.7

0.021

0.018

 

 

 

 

7.3#

 

0.026#

 

OD = Optical density * = Mean of the post-treatment; - pre-treatment values; # = Mean permeability ^ = Mean corrected value

 

Corneal Epithelium Condition Post Treatment

 

Treatment

Cornea Number

Observation Post Treatment

Negative Control

18

clear

22

clear

26

clear

Positive Control

5

cloudy

19

cloudy

23

cloudy

Test Item

24

clear

27

clear

28

clear

 

Interpretation of results:
study cannot be used for classification
Conclusions:
Based on the in vitro irritation score (IVIS) of 7.7, no prediction for FAT 36156/D can be made.
Executive summary:

The purpose of Bovine Corneal Opacity and Permeability (BCOP) was to identify test items that can induce serious eye damage and to identify test items not requiring classification for eye irritation or serious eye damage. The BCOP test method is an organotypic model that provides short-term maintenance of normal physiological and biochemical function of the bovine cornea in vitro. In this test method, damage by the test item is assessed by quantitative measurements of changes in corneal opacity and permeability. The test was carried out in cattle eyes with FAT 36156/D according to OECD guideline 437 and EU method B.47.


The Eagle’s Minimum Essential Medium was removed from the anterior chamber of the BCOP holder and 0.75 mL of the test item preparation or control items were applied (20 % w/v in 0.9 % w/v sodium chloride solution) to the appropriate corneas. The holders were gently tilted back and forth to ensure a uniform application of the item over the entire cornea. Each holder was incubated, anterior chamber uppermost, at 32 ± 1 ºC for 240 minutes. At the end of the exposure period the test item and control items were removed from the anterior chamber and the cornea was rinsed three times with fresh complete EMEM containing phenol red before a final rinse with complete EMEM without phenol red. The anterior chamber was refilled with fresh complete EMEM without phenol red. A post-treatment opacity reading was taken and each cornea was visually observed. Results from the two test method endpoints, opacity and permeability, were combined in an empirically derived formula to generate an in vitro Irritancy Score. Opacity and Permeability Measurement was made. The condition of the cornea was visually assessed post treatment. Negative and positive control items were tested concurrently. The two endpoints decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an in vitro irritancy Score (IVIS).


Based on the study results, the in vitro irritancy score was 7.7 for FAT 36156/D while 1.4 and 73.6 for negative and positive control respectively. So in conclusion, no prediction of eye irritation can be made.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the findings of the skin and eye irritation studies, Disperse Blue 165 -1 does not need to be classified for skin or eye irritation according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.