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EC number: 271-176-6 | CAS number: 68516-73-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
in vitro: Ames: negative; OECD 471, study
with target substance and read-across with CAS 5280-80-8, CAS 5580-57-4,
CAS 79953-85-8 and CAS 5580-58-5
Chromosome aberration: negative; OECD 473; read-across with CAS 5280-80-8
HPRT: negative; OECD 476; read-across with CAS 5280-80-8
Mouse lymphoma assay: negative; OECD 476
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
In vivo genotoxicity study does not need to be conducted since all in vitro gene and cytogenetic mutation studies were all negative.
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Reliable data from several studies on genetic toxicity are summarized in the table below:
|
PY 93 |
PY 94 |
PY 95 |
PY 128 |
155 |
5580-57-4 |
5580-58-5 |
5280-80-8 |
79953-85-8 |
68516-73-4 |
|
Bacterial mutagenicity |
Non mutagenic K1 Non Prival |
Non mutagenic K1 Prival |
Non mutagenic K2 Non Prival |
Non mutagenic K1 Non Prival |
Non mutagenic, four strains K2 Non Prival |
Clastogenicity in vitro |
Non clastogenic (read across) |
Non clastogenic (read across) |
Non clastogenic K1
|
Non clastogenic (read across) |
No indications of clastogenicity seen in the MLA |
Mutagenicity in mammalian cells in vitro |
Non mutagenic (read across) |
Non mutagenic (read across) |
Non mutagenic K1
|
Non mutagenic (read across) |
Non mutagenic K1
|
Bacterial gene mutation:
Mutagenicity in bacterial reverse mutation assays (Ames test) have
been investigated with all members of the 'yellow disazo condensation
pigments' (CAS 5580-57-4, 5280-80-8, 68516-73-4, 79953-85-8, and
5580-58-5). Pigment Yellow 94 was tested using the Prival modification
for azo substances. The pigments do contain an azo function which is
embedded in a larger conjugated system and probably not accessible to
enzymes.
Negative results were obtained in all tests with and without metabolic
activation. All relevant tester stains were tested and test item
concentrations were adequate.
Mammalian gene mutation:
Mutagenicity in mammalian cells has been investigated in two
reliable studies according to OECD guideline 476 with CAS 5280-80-8
(BASF, 2012) and with CAS 68516-73-4. Whereas the latter is the smallest
molecule of the group, the other is the one containing as building
blocks the most critical aromatic amines.
The GLP guideline study with CAS 5280-80-8
was performed to investigate the potential of the test substance to
induce gene mutations at the HPRT locus in V79 cells of the Chinese
hamster. The assay was performed in two independent experiments, using
two parallel cultures each. The first main experiment was performed with
and without liver microsomal activation and a treatment period of 4
hours. The second experiment was performed with a treatment time of 4
hours with and 24 hours without metabolic activation.The highest
concentration applied in the pre-experiment (840 µg/mL) was limited by
the suspendibility of the test item in aqueous medium. The concentration
range of the main experiments was limited by the occurrence of
precipitation of the test item. No substantial and reproducible dose
dependent increase of the mutation frequency was observed up to the
maximum concentration with and without metabolic activation. Appropriate
reference mutagens (and DMBA), used as positive controls, induced a
distinct increase in mutant colonies and thus, showed the sensitivity of
the test system and the activity of the metabolic activation system. In
conclusion it can be stated that under the experimental conditions
reported the test item did not induce gene mutations at the HPRT locus
in V79 cells. Therefore, the test substance is considered to be
non-mutagenic in this HPRT assay.
CAS 68516-73-4 was tested for its ability to induce gene mutations at
the thymidine kinase (TK) locus in L5178Y TK+/- mouse lymphoma cells in
vitro with the microwell method (BASF 2012). The study was performed
under GLP following OECD testing guideline 476 using well characterized
test material and it is therefore valid without restrictions. Two
independent experiments were carried out with and without the addition
of induced rat liver S9 mix (exogenous metabolic activation). According
to an initial range-finding cytotoxicity test for the determination of
the experimental doses and taking into account the cytotoxicity actually
found in the main experiments, the following doses were tested and
evaluated in this study: 1st Experiment without S9 mix (4-hour exposure
period) 0; 0.31; 0.63; 1.25; 2.5; 5.0; 10.0; 20.0 μg/mL with S9 mix
(4-hour exposure period) 0; 0.31; 0.63; 1.25; 2.5; 5.0; 10.0; 20.0 μg/mL
2nd Experiment without S9 mix (24-hour exposure period) 0; 0.31; 0.63;
1.25; 2.5; 5.0; 10.0 μg/mL with S9 mix (4-hour exposure period) 0; 0.25;
0.5; 1.0; 2.0; 4.0; 8.0 μg/mL.After a treatment period of 4 hours both
with and without metabolic activation and of 24 hours without metabolic
activation, an expression phase of about 48 hours and a selection period
of about 10 days, the colonies of each test group were counted and the
number of large and small colonies was determined. The negative controls
gave mutant frequencies within the range expected for the L5178Y TK+/-
mouse lymphoma cell line. Both positive controls, MMS and CPP, led to
the expected increase in the frequencies of forward mutations. No
cytotoxicity indicated by either reduced relative cloning efficiency 1
or reduced relative total growth of below 20% of control was observed in
both main experiments. The test substance was poorly soluble. Thus, dose
selection was performed with regard to the solubility properties of the
test substance in culture medium. At least the highest applied
concentrations tested for gene mutations were clearly above the border
of test substance solubility in culture medium. On the basis from the
results of the present study, the test substance did not cause any
biologically relevant increase in the mutant frequencies both either
without S9 mix or after adding a metabolizing system in two experiments
performed independently of each other. Thus, under the experimental
conditions described, the test substance did not induce forward
mutations in vitro in the mouse lymphoma assay with L5178Y TK+/- cells
in the absence and the presence of metabolic activation.
Cytogenicity study in mammalian cells:
Clastogenicity in mammalian cells has been
investigated in a reliable study with CAS 5280-80-8 (chromosome
aberration test according to OECD 473, BSL, 2012) and indications on the
absence of clastogenic properties can also gained from the mouse
lymphoma assay with CAS 68516-73-4. As all available information
indicates that the pigments are not taken up by cells, having one test
was considered sufficient for in-vitro testing of clastogenicity.
CAS 5280-80-8 contains the most problematic amines as buidling blocks.
In the GLP-compliant in-vitro study for clastogenicity, the chromosomes
were prepared 20 h after start of treatmentwith the test item. The
treatment interval was 4h with and without metabolic activation in
experiment I. In experiment II, the treatment intervalwas 4 h with and
20h without rnetabolic activation. Duplicate cultures were treated at
each concentration. 100 metaphasesper culture were scored for structural
chromosomal aberrations. The following concentrations were evaluated for
microscopicanalysis:
Experiment I:
without metabolic activation: 0.975, 7.8, 62.5, 125 and 250 µg/mL
with metabolic activation: 7.8, 250, 500 and 1000 µg/mL
Experiment II:
without metabolic activation: 62.5, 125, 250 and 500 µg/mL
with metabolic activation:10, 400, 750 and 900 µg/mL
The test item was prepared in cell culture medium (MEM). Precipitation
of the test item were observed at the end of the treatment by the
unaided eye with and without metabolic activation in experiment I and
II.Toxic effects of the test item were noted with and without metabolic
activation in experiment I and II. In both experiments, no biologically
relevant increase of the aberration rates was noted after treatment with
the test item with and without metabolic activation. The aberration
rates of all dose groups treated with the test item were within the
historical control data of the negative control. In the experiments I
and II with and without metabolic activation no biologically relevant
increase in the frequencies of polyploid cells was found after treatment
with the test item as compared to the controls. The positive controls
induced distinct and biologically relevant increases in cells with
structural chromosomal aberrations.
Taking together all results, it is concluded that the 'yellow disazo condensation pigments' do not induce gene mutations and are non-clastogenic.
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 (EC) No 1272/2008. Based on
available data on genetic toxicity, the test item is not classified
according to Regulation (EC) No 1272/2008 (CLP), as amended for the
tenth time in Regulation (EU) No 2017/776.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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