Registration Dossier

Administrative data

Description of key information

Skin Irritation:

Data on skin irritation study was not available for the target substance (Reactive Red 024:1). To fill the data gaps, read across approach is adapted using similar substance Reactive Red 024. A study was performed to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound, FAT 40034, on the skin of the rabbits according to the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965). 6 rabbits (3 males and 3 females), New Zealand White breed, were shaved on the whole back and flanks two days before treatment with an electric clipper. The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. 10 g of the test compound was mixed with 10 ml of water to make a solution of 15 ml. 0.75 ml of which was applied to each test site on a 2.5 cm square gauze pad. The gauze patches were removed 24 h after the application. The reaction of the skin was appraised upon removal and 72 h after it. The primary irritation index was calculated as 0.8. The effects were observed to be completely reversible by the end of 72 h. Therefore, based on the read across data generated from the skin irritation study of Reactive Red 024, the target substance (Reactive Red 024:1) is also considered to be as non-irritant to the skin of rabbits.

Eye Irritation:

Data on eye irritation study was not available for the target substance (Reactive Red 024:1). To fill the data gaps, read across approach is adapted using similar substance Reactive Red 024. A study performed to determine the eye irritation potential of FAT 40034/A in New Zealand White rabbits in accordance with the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification. The test substance was instilled in the eyes of 3 male and 3 female rabbits and observations for irritation were recorded at the time points of 1 h, 6 h, 1 day, 2 days, 3 days, 6 days and 10 days. One hour after application of the test compound there was slight opacity and ulceration of the cornea in 3/6 animals (unwashed eyes) and a conjunctival reaction in 6/6. The corneal changes had healed by day 3 and the conjunctivae were normal, apart from slight injection of vessels in one animal, by day 6. Staining of the cornea was visible up to 48 h. Based on the read across data generated from the eye irritation study of Reactive Red 024, the target substance (Reactive Red 024:1) is also considered as non-irritant to the rabbit eyes.

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:
July 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
Refer chapter 13 for the detailed analogue justification.
Qualifier:
according to guideline
Guideline:
other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965).
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Inhouse breeding
- Age at study initiation: 3 - 4 months
- Weight at study initiation: 2.65 Kgs. (male) and 2.53 Kgs.(female)
- Housing: caged singly
- Diet:commercial irradiated diet (Styles-Oxoid) ad libitum
- Water: Sterile filtered water ad libitum
- Acclimation period: One week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 50 - 70
- Photoperiod (hrs dark / hrs light): 10 h light
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
10 g of the test compound was mixed with 10 ml of water to make a solution of 15 ml. 0.75 ml of which was applied to each test site on a 2.5 cm square gauze pad.
Duration of treatment / exposure:
24 h
Observation period:
After 24 h the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema. A further assessment was made at 72 h.
Number of animals:
3 males and 3 females
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
males and females
Time point:
other: 24 and 72 h
Score:
0.8
Max. score:
8
Reversibility:
fully reversible within: 72 h
Remarks on result:
other:
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
mean
Remarks:
6 rabbits
Time point:
24 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
mean
Remarks:
6 rabbits
Time point:
24 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Remarks:
Intact and abraded skin
Basis:
mean
Remarks:
6 rabbits
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Remarks:
Intact and abraded skin
Basis:
mean
Remarks:
6 rabbits
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
mean
Remarks:
6 rabbits
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Remarks:
Abraded skin
Basis:
mean
Remarks:
6 rabbits
Time point:
24 h
Score:
1.17
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Remarks:
Intact and abraded skin
Basis:
mean
Remarks:
6 rabbits
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Remarks:
Intact and abraded skin
Basis:
mean
Remarks:
6 rabbits
Time point:
72 h
Score:
0
Max. score:
4

Individual Animal Score:

 

Erythema Score

Animal Number

Intact skin

Abraded skin

 

24 h

72 h

24 h

72 h

11

1

0

1

0

13

0

0

0

0

15

1

0

1

0

12

1

0

1

0

14

0

0

0

0

16

0

0

1

0

Mean

0.50

00

0.67

00

 

Edema Score

Animal Number

Intact skin

Abraded skin

 

24 h

72 h

24 h

72 h

11

0

0

1

0

13

0

0

1

0

15

2

0

2

0

12

2

0

1

0

14

0

0

1

0

16

2

0

1

0

Mean

1.00

00

1.17

00

 

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40034/A is to be considered as non-irritant to the skin of rabbits.
Executive summary:

A study was performed to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound, FAT 40034, on the skin of the rabbits according to the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965). 6 rabbits (3 males and 3 females), New Zealand White breed, were shaved on the whole back and flanks two days before treatment with an electric clipper. The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. 10 g of the test compound was mixed with 10 ml of water to make a solution of 15 ml. 0.75 ml of which was applied to each test site on a 2.5 cm square gauze pad. The gauze patches were removed 24 h after the application. The reaction of the skin was appraised upon removal and 72 h after it. The primary irritation index was calculated as 0.8. The effects were observed to be completely reversible by the end of 72 h. Therefore, FAT 40034/A is to be considered as a non-irritant to the skin of rabbits.

 

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:
July 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
Refer chapter 13 for the detailed analogue justification.
Qualifier:
according to guideline
Guideline:
other: "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965)
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Animals:
Healthy New Zealand White rabbits (Porton strain) aged 10-15 weeks with average body weights of 2.65 kg (Males) and 2.53 kg (Females), bred on the premises and maintained under a semi-barrier system. Six rabbits (3 males and 3 females) were acclimatised in the test area for one week prior to the start of the trial.

Husbandry:
The rabbits were caged singly in an experimental room maintained at a temperature of 20 °C. (±1°) and a relative humidity of 50-70 %. Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 h. A commercial irradiated diet (Styles-Oxoid) was fed ad lib. Sterile filtered water was available at all times.
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
100 mg of the test compound (equivalent to 0.1 ml in volume) was applied.
Duration of treatment / exposure:
30 seconds
Observation period (in vivo):
The rabbits were examined 1, 6, 24, 48 and 72 h after application of the test compound and for any further period that was considered necessary.
Number of animals or in vitro replicates:
3 males and 3 females
Details on study design:
The eyes of the experimental animals were examined and found normal prior to the test. 100 mg of the test compound (equivalent to 0.1 ml in volume) were instilled into the conjunctival sac of the left eye. The eyelids were then held closed for 1 second. The right eye served as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with 30 ml of warm water. The rabbits were examined 1, 6, 24, 48 and 72 h after application of the test compound and for any further period that was considered necessary. The ocular reactions were scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics", published by the Association of Food and Drug Officials of the UCS.A.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 rabbit
Time point:
24 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 rabbits
Time point:
48 h
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 rabbit
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 rabbits
Time point:
24/48/72 h
Score:
0.83
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 rabbits
Time point:
24 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 rabbit
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 rabbit
Time point:
72 h
Score:
0
Max. score:
4

Evaluation of the Eye Reactions: Individual animal score

Cornea

Animal No

Observation time (Hr)

Degree of intensity

Area of cornea involved

Rabbit 11

24

1

1

48

1

1

72

0

0

Rabbit 13

24

0

0

48

0

0

72

0

0

Rabbit 15

24

0

0

48

0

0

72

0

0

Rabbit 12

24

1

1

48

0

0

72

0

0

Rabbit 14

24

0

0

48

0

0

72

0

0

Rabbit 16

24

0

0

48

0

0

72

0

0

 

Iris

Animal No

Observation time (Hr)

Score

Rabbit 11

24

0

48

0

72

0

Rabbit 13

24

0

48

0

72

0

Rabbit 15

24

0

48

0

72

0

Rabbit 12

24

0

48

0

72

0

Rabbit 14

24

0

48

0

72

0

Rabbit 16

24

0

48

0

72

0

 

 

Conjunctiva

Animal No

Observation time (Hr)

Redness

Chemosis

Discharge

Rabbit 11

24

1

0

2

48

1

0

0

72

1

0

0

Rabbit 13

24

1

1

0

48

1

0

0

72

1

0

0

Rabbit 15

24

0

0

0

48

0

0

0

72

0

0

0

Rabbit 12

24

2

1

0

48

2

0

0

72

1

0

0

Rabbit 14

24

1

0

0

48

1

0

0

72

1

0

0

Rabbit 16

24

0

0

0

48

0

0

0

72

0

0

0

 

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40034/A is considered as non-irritant to the rabbit eyes.
Executive summary:

A study performed to determine the eye irritation potential of FAT 40034/A in New Zealand White rabbits in accordance with the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification. The test substance was instilled in the eyes of 3 male and 3 female rabbits and observations for irritation were recorded at the time points of 1 h, 6 h, 1 day, 2 days, 3 days, 6 days and 10 days. One hour after application of the test compound there was slight opacity and ulceration of the cornea in 3/6 animals (unwashed eyes) and a conjunctival reaction in 6/6. The corneal changes had healed by day 3 and the conjunctivae were normal, apart from slight injection of vessels in one animal, by day 6. Staining of the cornea was visible up to 48 h. Based on the study results, FAT 40034/A is considered to be a non-irritant to the eyes.

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 in the skin as well as eye irritation studies with read across substance, the Reactive Red 024:1 also does not considered to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 to be irritating to the skin and eyes.