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Description of key information

The test substance and structural analogues (diszazocondensation red pigments) were found to be non irritating to rabbit skin and eyes. Studies were performed according to or similar to OECD testing guidelines 404 and 405 and regarded as valid with restrictions. Effects were either absent or clearly below the threshold for classification and labelling.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was conducted according to the Draize-Test (1959). In contrast to OECD guideline 404 the Draize-test is done under occlusive conditions, exposure time is 24 hrs, substance is applied to intact and abrated skin, and washing of substance after application is omitted.
Qualifier:
according to guideline
Guideline:
other: Draize-Test
Principles of method if other than guideline:
The test was conducted according to the patch test technique as described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).

GLP compliance:
no
Remarks:
GLP was not mandatory when the study was done
Species:
rabbit
Strain:
other: Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 1.5 - 2.1 kg
- Housing: housing singly in metal cages
- Diet (e.g. ad libitum): Nafag (ad libitum)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/- 1
- Humidity (%): 55+/- 5%
- Photoperiod (hrs dark / hrs light): 10/14

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: untreated skin from same rabbit was used as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
24 hrs
Observation period:
7 days
Number of animals:
3 females, 3 males
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap: gauze patch was maintained in place by using an impermeable foil 5 x 5 cm which was fixed by an adhesive tape

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hrs

SCORING SYSTEM:
- Draize Scoring System
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no animal had erythema over the complete observation period
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no animal had edema over the complete observation period
Irritant / corrosive response data:
no animal showed signs of irritation
Other effects:
Testing was done on intact and scarified skin. Only intact skin was considered for assessment of irritation.
Nevertheless the abraded skin showed no signs of irritation, too.
Interpretation of results:
not irritating
Remarks:
Migrated information
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Justification for type of information:
Please refer to attached read across justification document (Chapter 13).
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no animal had erythema over the complete observation period
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no animal had edema over the complete observation period
Irritant / corrosive response data:
no animal showed signs of irritation
Other effects:
Testing was done on intact and scarified skin. Only intact skin was considered for assessment of irritation.
Nevertheless the abraded skin showed no signs of irritation, too.
Interpretation of results:
not irritating
Remarks:
Migrated information
Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was conducted according to the Draize-test (1959). In contrast to OECD guideline 405, 6 animals instead of 3 were used. For 3 animals substance was washed out after 30 seconds, whereas for the remaining animals eyes were not washed. Observation period was stopped after 72 hrs since no effects were seen.
Qualifier:
according to guideline
Guideline:
other: Draize-Test
Principles of method if other than guideline:
The test was conducted with slight modification according to the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965)
GLP compliance:
no
Remarks:
(GLP was not mandatory when the study was done)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 9-13 weeks
- Weight at study initiation: 2.6 kg (male, average), 2.0 kg (female, average)
- Diet (e.g. ad libitum): commercial irradiated (Styles-Oxoid), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): 14/10
Vehicle:
unchanged (no vehicle)
Controls:
other: right eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 40 mg
Duration of treatment / exposure:
for 3 animals test substance was washed out after 30 s
for 3 animals no washing out was performed
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6 (4 males, 2 females)
Details on study design:
SCORING SYSTEM:
Scoring according to the Draize system ( "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.)
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no corneal opacity detected after 24, 48, 72 hrs
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: no iritis detected after 24, 48, 72 hrs
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: no conjunctival redness detected after 24, 48, 72 hrs
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no chemosis detected after 24, 48, and 72 hrs
Irritant / corrosive response data:
A transient conjunctival reaction was seen in 2/3 unwashed and 1/3 washed eyes one hour after application. In one case the effect persisted for 6 hrs.
All eyes were normal at 24 hours. For regulatory purposes only time points of 24, 48, 72 hrs are considered, therefore test substance is defined as non-irritating.
Interpretation of results:
not irritating
Remarks:
Migrated information
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was conducted according to the Draize-test (1959). In contrast to OECD guideline 405, 6 animals instead of 3 were used. For 3 animals substance was washed out after 60 seconds, whereas for the remaining animals eyes were not washed. Observation period was 8 days.
Qualifier:
according to guideline
Guideline:
other: Draize-Test
Principles of method if other than guideline:
The test was conducted as described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
GLP compliance:
no
Remarks:
(GLP was not mandatory when the study was done)
Species:
rabbit
Strain:
other: Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.6 -2.0 kg
- Housing: single housing in metal cages, overall dimensions of cage 47x32x34 cm,
- Diet (e.g. ad libitum): NAFAG, ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 1
- Humidity (%): 55 +/- 5
- Photoperiod (hrs dark / hrs light): 10/14
Vehicle:
unchanged (no vehicle)
Controls:
other: right eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
for 3 animals test substance was washed out after 60 s with physiological saline solution
for 3 animals no washing out was performed
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
6 (3 males, 3 females)
Details on study design:
SCORING system:
Draize Scoring System

REMOVAL OF TEST SUBSTANCE ONLY for 3 out of 6 animals
- Washing (if done): Washing with physiological saline solution
- Time after start of exposure: 1 minute

TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no corneal opacity detected after 24, 48, 72 hrs
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: no iritis detected after 24, 48, 72 hrs
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: no conjunctival redness detected after 24, 48, 72 hrs
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no chemosis detected after 24, 48, and 72 hrs
Irritant / corrosive response data:
A transient conjunctival reaction was seen in all treated eyes one hour after application (redness grade 1, accompanied by discharge grade 1 in 2 cases). All eyes were normal at 6 hours. For regulatory purposes only time points of 24, 48, 72 hrs are considered, therefore test substance is defined as non-irritating.
Interpretation of results:
not irritating
Remarks:
Migrated information
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to attached read across justification document (Chapter 13).
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no corneal opacity detected after 24, 48, 72 hrs
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: no iritis detected after 24, 48, 72 hrs
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: no conjunctival redness detected after 24, 48, 72 hrs
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no chemosis detected after 24, 48, and 72 hrs
Irritant / corrosive response data:
A transient conjunctival reaction was seen in 2/3 unwashed and 1/3 washed eyes one hour after application. In one case the effect persisted for 6 hrs.
All eyes were normal at 24 hours. For regulatory purposes only time points of 24, 48, 72 hrs are considered, therefore test substance is defined as non-irritating.
Interpretation of results:
not irritating
Remarks:
Migrated information
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to attached read across justification document (Chapter 13).
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
A transient conjunctival reaction was seen in all treated eyes one hour after application (redness grade 1, accompanied by discharge grade 1 in 2 cases). All eyes were normal at 6 hours. For regulatory purposes only time points of 24, 48, 72 hrs are considered, therefore test substance is defined as non-irritating.
Interpretation of results:
not irritating
Remarks:
Migrated information
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 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

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008


The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result, the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008.