Registration Dossier

Administrative data

Description of key information

Disperse Red 086 was not considered to be an irritant to the skin and 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:
From 21 September, 1993 to 24 September, 1993
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
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Test material: FAT 36034/E
Batch No.: 9300102
Expiry date: July, 1998
Purity: 93 %
Solubility: in water <0.1 g/L
Colour: red
Storage: at room temperature
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Weight at study initiation: 2310 to 2350 g
- Housing: The animals were housed individually in metal cages.
- Diet: Standard rabbit pellet – Nafag No. 814, Gossau, Switzerland (ad libitum)
- Water: Fresh water (ad libitum)
- Acclimation period: At least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3 °C.
- Humidity: 30-70 %
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral flank
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): undiluted
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3 males
Details on study design:
PROCEDURE:
- An area of at least 36 cm² was shaved on both flanks of the animals approx. 24 h before treatment.
- A gauze patch (approx. 12-16 cm²) bearing 500 mg of the test substance was applied to the right flank of each animal. The skin area exposed directly to the test substance was approx. 6 cm². A control gauze patch was applied to the contralateral flank. Before application both patches were moistened with 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80.
- The patches were loosely covered with an aluminium foil (approx. 36 cm²) and held in place for 4 h by an adhesive tape.
- The skin reactions were evaluated 1, 24, 48, and 72 h after removing the gauze patches

SCORING SYSTEM:
Dermal irritation was graded in each animal according to the following scoring scale:
- Erythema and eschar formation:
0 no erythema
1 very slight erythema (barely perceptible)
2 well-defined erythema
3 moderate to severe erythema
4 severe erythema (beet redness) to slight eschar formation (injuries in depth).

- Edema formation:
0 no edema
1 very slight edema (barely perceptible)
2 slight edema (edges of area well-defined by definite raising)
3 moderate edema (raised approximately 1 mm)
4 severe edema (raised more than 1 mm and extending beyond area of exposure).
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
Irritant / corrosive response data:
No skin reactions were observed in any of the tested animals.

Body weights (g):

Animal no.

1

2

3

At start of test

2310

2330

2350

After 3 d (end)

2440

2440

2420

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance did not induce skin irritation.
Executive summary:

An in vivo study was conducted to evaluate the skin irritation potential of the test substance (of ca. 93 % purity) in rabbits according to OECD Guideline 404 and EU method B4 in compliance with GLP. 500 mg of test substance was applied on a gauze patch (moistened with 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80) which was then applied to the shaved skin of rabbits for 4 h under occlusive conditions. A control gauze patch was applied to the contra lateral flank. After the 4 h of application period, the gauze patches were removed and the application sites were assessed for oedema and erythema at 1, 24, 48, 72 h. No skin reaction was induced by the test substance. Under the study conditions, the test substance did not induce skin irritation in albino rabbit.

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:
From 05 October, 1993 to 22 October, 1993
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
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
Test material: FAT 36034/E
Batch No.: 9300102
Expiry date: July, 1998
Purity: 93 %
Solubility: in water <0.1 g/L
Colour: red
Storage: at room temperature
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Weight at study initiation: 2420 to 2630 g
- Housing: The animals were housed individually in metal cages.
- Diet (e.g. ad libitum): Standard rabbit pellet – Nafag No. 814, Gossau, Switzerland (ad libitum)
- Water (e.g. ad libitum): Fresh water (ad libitum)
- Acclimation period: At least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3 °C.
- Humidity: 30-70 %
- Photoperiod (hrs dark / hrs light): 12 h/12 h


Vehicle:
unchanged (no vehicle)
Controls:
other: the second eye of the treated animals served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL (i.e., 47 mg)
- Concentration (if solution): undiluted
Duration of treatment / exposure:
Duration of treatment same as observation period.
Observation period (in vivo):
72 h after the treatment
Number of animals or in vitro replicates:
3 males
Details on study design:
- 0.1 mL (i.e., 47 mg) of test substance was placed into the conjunctival sac of the left 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 substance.
-The right eye remained untreated and was used as untreated control.
-The ocular reaction were evaluated 1, 24, 48, and 72 h after instillation of test substance with the aid of slit-lamp

SCORING SYSTEM:
The ocular reactions were according to the OECD scoring system.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
The eye reactions observed were reversed by Day 2.
Interpretation of results:
GHS criteria not met
Conclusions:
FAT 36034/E is not irritating to the eyes.
Executive summary:

An in vivo study was conducted to evaluate the acute eye irritation potential of the test substance (of ca. 93 % purity) in rabbits according to OECD Guideline 405 and EU method B5 in compliance with GLP. 0.1 mL (47 mg) of the test substance was placed into the conjunctival sac of the left eye of three male rabbits without rinsing. The right eye remained untreated and was used for control purposes. Observation were made at 1, 24, 48 and 72 h following treatment. The corneal or iridial effects were reversible within 24 h. Conjunctival irritation was observed in all the treated animals which was reversible within the observation period of 72 h. Under the study conditions, the test substance does not need to be classified as irritating to the eyes.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Benzenesulfonamide, N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo- 1-anthracenyl)-4-methyl- was tested in vivo for skin and eye irritation in rabbits.


 


Skin:


An in vivo study was conducted to evaluate the skin irritation potential of the test substance (FAT 36034/E, ca. 93 % purity) in rabbits according to OECD Guideline 404 and EU method B4 in compliance with GLP. 500 mg of test substance was applied on a gauze patch (moistened with 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80) which was then applied to the shaved skin of rabbits for 4 h under occlusive conditions. A control gauze patch was applied to the contra lateral flank. After the 4 h of application period, the gauze patches were removed and the application sites were assessed for oedema and erythema at 1, 24, 48, 72 h. No skin reaction was induced by the test substance. Under the study conditions, the test substance did not induce skin irritation in albino rabbit.


This conclusion was further supported in the studies with FAT 36034/A and FAT 36034/B, as the subtsance was found to be not irritating according to Regulation (EC) No. 1272/2008.


 


Eye:


An in vivo study was conducted to evaluate the acute eye irritation potential of the test substance (FAT 36034/E, ca. 93 % purity) in rabbits according to OECD Guideline 405 and EU method B5 in compliance with GLP. 0.1 mL (47 mg) of the test substance was placed into the conjunctival sac of the left eye of three male rabbits without rinsing. The right eye remained untreated and was used for control purposes. Observations were made at 1, 24, 48 and 72 h following treatment. No corneal or iridial effects were noted. Conjunctival irritation was observed in all the treated animals which was reversible within the observation period of 72 h. Under the study conditions, the test substance produced irritation of the conjunctiva which was reversible within 72 h.


In another study, FAT 36034/A was also found to be not irritating when instilled in the eyes of rabbits.

Justification for classification or non-classification

Based on the above stated assessment of the skin irritation potential of Benzenesulfonamide, N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthracenyl)-4-methyl- the substance does not have to be classified as irritating to skin according to CLP (Regulation (EC) No 1272/2008 Of the European Parliament and of the Council.


 


Base on the above assessment of the eye irritation potential of Benzenesulfonamide, N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthracenyl)-4-methyl- slight eye irritation was noted but severity was not sufficient to warrant classification. Therefore the substance does not have to be classified as Irritating to eyes according to CLP (Regulation (EC) No 1272/2008 Of the European parliament and of the Council.