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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Pigment Brown 41 (nano form): Negative (Ames)

Analogue substance: Pigment Red 242 (nano form): Negative (Ames, CA)

Analogue substance: Pigment Red 166 (not specified form): Negative (Ames, OECD 476, OECD 474)

Analogue substance: Pigment Red 144 (nano and not specified form): Negative (Ames)

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro gene mutation study in bacteria
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint:
in vitro gene mutation study in mammalian cells
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP compliant study, similar to OECD 471, Very limited information on test item
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
no independent repeat assay
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Species / strain / cell type:
S. typhimurium, other: TA 1538
Metabolic activation:
with and without
Metabolic activation system:
induced rat liver S9
Test concentrations with justification for top dose:
10, 50, 100, 500, 1000 and 5000 µg/plate
Vehicle / solvent:
DMSO
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-AA with S9; AF2 and sodium azide without S9
Evaluation criteria:
"Significant increases"
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium, other: TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Conclusions:
Interpretation of results (migrated information):
negative
Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

Analogue substance Pigment Red 166 (not specified form): Negative (MN)

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (purity not reported)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Version / remarks:
(1997)
GLP compliance:
no
Type of assay:
micronucleus assay
Species:
hamster, Chinese
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 23-30 g, female: 21-29 g
- Housing: single cage (individually)
- Diet (e.g. ad libitum): NAFAG No. 924
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-24°C
- Humidity (%): 46 - 70%
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
- Vehicle(s)/solvent(s) used: PEG 400
- Concentration of test material in vehicle: 62.5 , 125, 250 mg/mL
- Amount of vehicle (if gavage or dermal): 20 mL/kg
Details on exposure:
after 48 hrs of first application animals were sacrificed
Duration of treatment / exposure:
48 hrs
Frequency of treatment:
2 doses per animal; once daily
Post exposure period:
24 hrs
Remarks:
Doses / Concentrations:
1250 mg/kg bw
Basis:

Remarks:
Doses / Concentrations:
2500 mg/kg bw
Basis:

Remarks:
Doses / Concentrations:
5000 mg/kg bw
Basis:

No. of animals per sex per dose:
6
Control animals:
yes, concurrent vehicle
Positive control(s):
cyclophosphamide:
- Route of administration: oral
- Doses / concentrations: 128 mg/kg in 20 mL/kg PEG 400
Tissues and cell types examined:
Blood cells of bone marrow
Details of tissue and slide preparation:
Bone marrow was harvested from the shafts of both femurs. In a siliconized pipette filled with approx. 0.5 μL rat serum the bone marrow was drawn up. Small drops of the mixture were transferred on the end of a slide, and the preparations were air-dried. After 3 hrs, the slides were stained in undiluted May-Gruenwald solution for 2 min then in May-Gruenwald solution/water 1/1 for 2 min and then in Giemsa's, 40% for 20 min. After being rinsed in methanol 55% for 5-8 s and washed off twice in water, they were left immersed in water for approx. 2 min. After rinsing with distilled water and air-drying, the slides were cleared in Xylol and mounted in Eukitt.
Evaluation criteria:
1000 bone marrow cells each were scored per animal and the following anomalies were registered: a) Single Jolly bodies, b) fragments of nuclei in erythrocytes, c) micronuclei in erythroblasts, d) micronuclei in leucopoietic cells, e) polyploid cells.
Statistics:
Significance of differences between doses were assessed by chi-square test
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
One female animal of the low-dose group died after the 1st application. Due to lack of dose-dependency and affection of a single animal, a treatment-related but not a substance-related effect is assumed.

In all treatments with the substance and in the negative control, the mean percentage of anormal cells was 0.1 while the positive control substance caused 10% abnormal cells, indicating the absence of a genotoxic effect in this test system and a suitable sensitivity of the test system (see table).

  dose
 [mg/kg bw]
average number
of cell anomalies
per animal
negative control
(PEG 400)
  0,1
positive control
(Cyclophosphamide)
128 10
test substance 1250 0,1
test substance 2500 0,1
test substance 5000 0,1
Conclusions:
Interpretation of results (migrated information): negative
Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to attached read across justification document (Chapter 13).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached read across document (Chapter 13).

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached read across justification document (Chapter 13).

4. DATA MATRIX
Please refer to attached read across justification document (Chapter 13).
Reason / purpose for cross-reference:
read-across source
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
One female animal of the low-dose group died after the 1st application. Due to lack of dose-dependency and affection of a single animal, a treatment-related but not a substance-related effect is assumed.

In all treatments with the substance and in the negative control, the mean percentage of anormal cells was 0.1 while the positive control substance caused 10% abnormal cells, indicating the absence of a genotoxic effect in this test system and a suitable sensitivity of the test system (see table).

  dose
 [mg/kg bw]
average number
of cell anomalies
per animal
negative control
(PEG 400)
  0,1
positive control
(Cyclophosphamide)
128 10
test substance 1250 0,1
test substance 2500 0,1
test substance 5000 0,1
Conclusions:
Interpretation of results (migrated information): negative
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

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 mutagenicity under Regulation (EC) No. 1272/2008, as amended for the third time in Directive EC 618/2012.