Registration Dossier

Administrative data

Description of key information

Skin and eye irritation studies performed according to OECD test guidelines were available, showing that the substance is not irritating to skin and eyes. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
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:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK.
- Age at study initiation: 12-16 weeks.
- Weight at study initiation: 2.21-2.93 kg.
- Housing: animals were individually housed in suspended metal cages.
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: minimum period of five days.

ENVIRONMENTAL CONDITIONS
- Temperature: 19-22°C.
- Humidity: 60-65%.
- Air changes: approximately 15 air-changes per hour.
- Photoperiod: 12 hours dark / 12 hours light.
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 ml.
Duration of treatment / exposure:
Four hours.
Observation period:
72 hours.
Number of animals:
Three rabbits.
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm.
- Type of wrap if used: gauze patch.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed by gentle swabbing with cotton wool soaked in diethyl ether.
- Time after start of exposure: 4 hours.

SCORING SYSTEM: Approximately one hour following the removal of the patches, and 24, 48 and 72 hours, the test sites were examined for evidence of primary irritation and scored according to the Draize scale (0 = no reaction ; 4 = severe reaction)
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
24/48/72 h
Score:
0.4
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Individual mean scores: #1 0.3, #2 0.7, #3 0.3.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Very slight erythema was noted at two treated skin sites one hour after patch removal, at all treated skin sites at the 24-hour observation and at one
treated skin site at the 48-hour observation. All treated skin sites appeared normal 72 hours after treatment (see Table 1).

Table 1: Mean scores for dermal irritation

Skin reaction

Reading (hours)

Individual scores

Female (2.93 kg)

Male (2.65 kg)

Male (2.21 kg)

Erythema/Eschar Formation

1

0

1

1

24

1

1

1

48

0

1

0

72

0

0

0

Oedema Formation

1

0

0

0

24

0

0

0

48

0

0

0

72

0

0

0

Interpretation of results:
other: not classified according to Regulation 1272/2008/EC.
Conclusions:
Based on the results of a GLP-compliant guideline study, the substance is considered to be not irritating to rabbit skin.
Executive summary:

Skin irritating/corrosive effects of 2-amylanthraquinone were studied in 3 albino rabbits. 0.5 ml of 2-amylanthraquinone was applied on the shaved skin of test animals under semi-occlusive coverage. After 72 hours of observation no signs of skin irritation or corrosion were present. The test substance is considered to be non irritating to the skin of albino rabbit under the conditions of this study.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1986
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
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Froxfield S.P.F. Rabbits, Broadway Farm, Froxfiel, Hampshire, England.
- Age at study initiation: approximately 12 weeks.
- Weight at study initiation: 2.62-2.90 kg.
- Housing: animals were individually housed in suspended metal cages.
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: minimum period of six days.

ENVIRONMENTAL CONDITIONS
- Temperature: 18°C (range 15-23°C).
- Humidity: 55% (range 50-70%)
- Air changes: approximately 12 air-changes per hour.
- Photoperiod: 14 hours light / 10 hours dark.
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g.
Duration of treatment / exposure:
Four hours.
Observation period:
72 hours.
Number of animals:
Three rabbits.
Details on study design:
TEST SITE
- Area of exposure: 3 x 2 cm.
- Type of wrap if used: gauze patch.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed by gentle swabbing with cotton wool soaked in diethyl ether.
- Time after start of exposure: 4 hours.

SCORING SYSTEM: Assessment of skin irritation responses were made one hour, 24, 48 and 72 hours after removal of the semi-occlusive dressings according to the Draize scale (0 = no reaction ; 4 = severe reaction)
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animial #1, #2 and #3
Time point:
other: 24, 48 and 72 hours
Score:
0.2
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Individual scores: #1 0, #2 0, #3 0.7.
Irritant / corrosive response data:
Very slight erythema was evident at the test site of one rabbit, 24 and 48-hours after removal of the dressings (see Table 1). No other dermal irritation responses were observed.

Table 1: Mean scores for dermal irritation

Type of response

Reading (hours)

Individual scores

Animal 1

Animal 2

Animal 3

Erythema

1

0

0

0

24

0

0

1

48

0

0

1

72

0

0

0

Oedema

1

0

0

0

24

0

0

0

48

0

0

0

72

0

0

0

Interpretation of results:
other: not classified under Regulation 1272/2008/EC.
Conclusions:
Based on the results of a guideline study, 2-amylanthraquinone is considered to be not irritating to rabbit skin.
Executive summary:

Skin irritating/corrosive effects of 2-amylanthraquinone were studied in 3 rabbits. 0.5 ml of 2-amylanthraquinone was applied on the shaved skin of test animals under semi-occlusive coverage. After 72 hours of observation no signs of skin irritation or corrosion were observed. The test substance is considered to be non irritating to the skin of albino rabbit under the conditions of this study.

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

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
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:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK.
- Age at study initiation: 12-16 weeks.
- Weight at study initiation: 2.20-2.84 kg.
- Housing: animals were individually housed in suspended metal cages.
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: minimum period of five days.

ENVIRONMENTAL CONDITIONS
- Temperature: 19-21°C.
- Humidity: 58-65%
- Air changes: approximately 15 air-changes per hour.
- Photoperiod: 12 hours dark / 12 hours light.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml.
Duration of treatment / exposure:
One single treatment.
Observation period (in vivo):
Assessment of ocular damage/irritation was made approximately 1 hours and 24, 48 and 72 hours following treatment.
Number of animals or in vitro replicates:
One rabbit was initially treated. After consideration of the ocular responses, two additional animals were treated.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No.

SCORING SYSTEM: according to numerical evaluation according to the Draize method.

TOOL USED TO ASSESS SCORE: standard ophtalmoscope.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animals #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritant / corrosive response data:
No adverse corneal or iridial effects were noted during the study. Minimal conjunctival irritated was noted in all treated eyes at the one hour
observation. All treated eyes appeared normal 24 hours after treatment.

Table 1: Mean scores for eye irritation

Reaction

Reading (hours)

Individual scores

Male (2.84 kg)

Male (2.50 kg)

Male (2.20 kg)

Corneal opacity

1

0

0

0

24

0

0

0

48

0

0

0

72

0

0

0

Iris

1

0

0

0

24

0

0

0

48

0

0

0

72

0

0

0

Conjunctivae

1

2

6

6

24

0

0

0

48

0

0

0

72

0

0

0

Interpretation of results:
other: not classified under Regulation 1272/2008/EC.
Conclusions:
Based on the results of a GLP-compliant guideline study, 2-amylanthraquinone is considered to be not irritating to rabbit eyes.
Executive summary:

Eye irritation/corrosion caused by 2-amylanthraquinone was studied in three rabbits. 0.1 ml of 2-amylanthraquinone was placed into the conjunctival sac of each of the rabbits and the effects were examined up to 72 hours. No adverse corneal or iridial effects were noted during the study. Minimal conjunctival irritated was noted in all treated eyes at the one hour observation. All treated eyes appeared normal 24 hours after treatment. The test substance is considered to be non irritant to the eye of the rabbit.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1986
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
Principles of method if other than guideline:
In addition to specific observations required by the OECD, evaluations were made of pain responses at instillation, discharge from the eye and the area of cornea affected by lesions.
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield S.P.F. Rabbits, Broadway Farm, Froxfiel, Hampshire, England.
- Age at study initiation: > 12 weeks.
- Weight at study initiation: 3.28-3.50 kg.
- Housing: animals were individually housed in suspended metal cages.
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: minimum period of seven days.

ENVIRONMENTAL CONDITIONS
- Temperature: 18°C (range 15-23°C).
- Humidity: 55% (range 50-70%)
- Air changes: approximately 12 air-changes per hour.
- Photoperiod: 14 hours light / 10 hours dark.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g.
Duration of treatment / exposure:
One single treatment.
Observation period (in vivo):
Ocular reactions to treatment were assessed one, 24, 48 and 72 hours after treatment.
Number of animals or in vitro replicates:
Three rabbits.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No.

SCORING SYSTEM: according to numerical evaluation according to the Draize method.

TOOL USED TO ASSESS SCORE: a pencil beam torch and standard ophtalmoscope were used to facilitate inspection of the eyes.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.57
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed at any time point
Irritant / corrosive response data:
Slight injection of the conjunctival blood vessels was observed in all rabbits, and slight chemosis or ocular discharge in single animals, one hour after instillation of 0.1 g of the test material. Conjunctivis persisted among the animals at the 24 and 48-hour examinations. Resolution was complete in all animals by Day 4. Instillation of the test material caused slight or practically no initial pain responses among the animals.

Table 1: Mean scores for eye irritation

Animal number

Corneal opacity

Iridial lesions

Redness of Conjunctiva

Chemosis

1

0.0

0.0

0.7

0.0

2

0.0

0.0

0.7

0.0

3

0.0

0.0

0.3

0.0

Interpretation of results:
other: not classified under Regulation 1272/2008/EC.
Conclusions:
Based on the results of a GLP-compliant guideline study, 2-amylanthraquinone is considered to be not irritating to rabbit eyes.
Executive summary:

Eye irritation/corrosion caused by 2-amylanthraquinone was studied in three rabbits. 0.1 ml of 2-amylanthraquinone was placed into the conjunctival sac of each of the rabbits and the effects were examined up to 72 hours. Slight injection of the conjunctival blood vessels was observed in all rabbits, and slight chemosis or ocular discharge in single animals, one hour after instillation of 0.1 g of the test material. Conjunctivis persisted among the animals at the 24 and 48-hour examinations. Recovery was complete in all animals by Day 4. Instillation of the test material caused slight or practically no initial pain responses among the animals. The test substance is considered to be non irritant o the eye of the male rabbit.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Two reliable GLP-compliant skin irritation studies, performed according to OECD Guideline 404, were available. In the key study skin irritating/corrosive effects of 2-amylanthraquinone were studied in 3 albino rabbits according to OECD 404. 0.5 ml of 2-amylanthraquinone was applied on the shaved skin of test animals (semi-occlusive coverage). Very slight erythema was noted at two treated skin sites one hour after patch removal, at all treated skin sites at the 24-hour observation and at one treated skin site at the 48-hour observation. After 72 hours of observation no signs of skin irritation or corrosion were present. The test substance is considered to be non irritating to the skin of albino rabbit under the conditions of this study. In the supporting study (older study) this result was confirmed.

Two reliable GLP-compliant OECD guideline 405 eye irritation studies were available. In the key study eye irritation/corrosion caused by 2-amylanthraquinone was studied in three rabbits according to OECD 405. 0.1 ml of 2-amylanthraquinone was placed into the conjunctival sac of each of the rabbits and the effects were examined up to 72 hours. No adverse corneal or iridial effects were noted during the study. Minimal conjunctival irritated was noted in all treated eyes at the one hour observation. All treated eyes appeared normal 24 hours after treatment. The test substance is considered to be non irritant to the eye of the rabbit. In the supporting study (older study) this result was confirmed.

Justification for classification or non-classification

In reliable skin and eye irritation studies the substance was shown to be not irritating. Therefore, the substance does not need to be classified for skin and eye irritation according to CLP Regulation (EC) No 1272/2008.