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EC number: 223-211-1 | CAS number: 3770-97-6
- 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
OECD 471: negative
OECD 476: positive (-S9), negative (+S9)
OECD 473: positive (-S9)
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 Aug - 18 Aug 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- 1993
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his operon, trp operon
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9 induced by ß-Naphthoflavone/phenobarbital
- Test concentrations with justification for top dose:
- 1st series: 5, 15.8, 50, 158, 500, 1580, 5000 µg/plate (with and without S9 mix)
2nd series: 50, 158, 500, 1580, 5000 µg/plate (with and without S9 mix) - Vehicle / solvent:
- - Solvent used: DMSO, final concentration 10 µL per plate
- Justification for choice of solvent: solubitlity properties of the test item, non toxicity to bacteria - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- sodium azide
- other: 2-aminoanthracene 2-10 µg/plate, daunomycin 1 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 2-3 days
NUMBER OF REPLICATIONS: 3 replicates for test item concentrations and positive controls, 6 replicates for solvent controls
DETERMINATION OF CYTOTOXICITY
- Method: counting numbers of revertants
OTHER:
-S9 concentration: 1st series 10%, 2nd series 20% - Evaluation criteria:
- A test material was to be defined as positive or mutagenic in this assay if
- the assay is considered valid AND
- a biologically relevant increase in the mean number of revertants above a threshold of 2-fold (TA98, TA100, WP2 uvrA) or 3-fold (TA1535, TA1537) as compared to the concurrent negative controls is observed.
- an increase exceeding the threshold at only one concentration is considered as biologically meaningful if reproduced in a 2nd independent experiment.
- a concentration-dependent increase is considered biologically meaningful if the threshold is exceeded at more than one concentration
A test material is considered negative or non-mutagenic in this assay if
- the assay is considered valid AND
- non of the above criteria are met - Statistics:
- Not performed as not mandatory for this test system.
- Key result
- Species / strain:
- S. typhimurium TA 1535
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1537
- 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
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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
- Key result
- Species / strain:
- S. typhimurium 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
- Key result
- 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
- Additional information on results:
- Following treatment with the test item, no precipitation on the agar plates occurred. No toxicity to the bacteria was observed.
Under the experimental conditions described, there were no relevant increases in revertant numbers observed after exposure to the test item un the absence and presence of S9-mix.
According to the criteria for negative and positive results as predetermined in the study plan, the test item was not mutagenic under the described experimental conditions. - Conclusions:
- The test item is considered not mutagenic in bacteria according to OECD Guideline 471.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 Apr - 15 Oct 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosomal Aberration Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- other:
- Details on mammalian cell type (if applicable):
- human lymphocyte cultures prepared from the pooled blood of three Female
donors - Metabolic activation:
- with and without
- Metabolic activation system:
- The mammalian liver post-mitochondrial fraction (S-9) used for metabolic activation
was obtained from Molecular Toxicology Incorporated, USA where it was prepared
from male Sprague Dawley rats induced with Aroclor 1254. The S-9 was supplied as
lyophilized S-9 mix (MutazymeTM), stored frozen at <-20°C, and thawed and
reconstituted with purified water to provide a 10% S-9 mix just prior to use. Each
batch was checked by the manufacturer for sterility, protein content, ability to convert
ethidium bromide and cyclophosphamide to bacterial mutagens, and cytochrome
P-450-catalysed enzyme activities (alkoxyresorufin-O-dealkylase activities). - Test concentrations with justification for top dose:
- 0, 40, 70, 100 µg/mL
- Vehicle / solvent:
- DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Evaluation criteria:
- For valid data, the test article was considered to induce clastogenic events if:
1. A statistically significant increase in the proportion of cells with structural
aberrations (excluding gaps) at one or more concentrations was observed (p≤0.05)
2. The incidence of cells with structural aberrations (excluding gaps) at such a
concentration that exceeded the normal range in both replicate cultures
3. A concentration-related increase in the proportion of cells with structural
aberrations (excluding gaps) was observed (positive trend test).
The test article was considered positive in this assay if all of the above criteria were
met.
The test article was considered negative in this assay if none of the above criteria
were met.
Results which only partially satisfied the above criteria were to be dealt with on a
case-by-case basis. Evidence of a concentration-related effect was considered useful
but not essential in the evaluation of a positive result (Scott et al., 1990). Biological
relevance was taken into account, for example consistency of response within and
between concentrations, or effects occurring only at high or very toxic concentrations,
and the types and distribution of aberrations.
Scott D, Dean B J, Danford N D and Kirkland D J (1990). Metaphase chromosome
aberration assays in vitro. Basic Mutagenicity Tests; UKEMS recommended
procedures. Kirkland D J (Ed), pp 62-86 - Statistics:
- Standard statistical methods have been applied for data processing.
- Key result
- Species / strain:
- mammalian cell line, other: human lymphocytes
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- mammalian cell line, other: human lymphocytes
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Conclusions:
- The test material induced structural chromosome aberrations in cultured human peripheral blood lymphocytes when tested for 20+0 hours in the absence of a rat liver metabolic activation system (S-9) under the experimental conditions described.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 Apr - 31 Oct, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test using the Hprt and xprt genes)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell gene mutation test using the Hprt and xprt genes
- Target gene:
- HPRT
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- tk +/-
- Metabolic activation:
- with and without
- Metabolic activation system:
- The mammalian liver post-mitochondrial fraction (S-9) used for metabolic activation
was obtained from Molecular Toxicology Incorporated, USA where it was prepared
from male Sprague Dawley rats induced with Aroclor 1254. The S-9 was supplied as
lyophilized S-9 mix (MutazymeTM), stored frozen at <-20°C, and thawed and
reconstituted with purified water to provide a 10% S-9 mix just prior to use. Each
batch was checked by the manufacturer for sterility, protein content, ability to convert
ethidium bromide and cyclophosphamide to bacterial mutagens, and cytochrome
P-450-catalysed enzyme activities (alkoxyresorufin-O-dealkylase activities). - Test concentrations with justification for top dose:
- 1st series -S9: 0, 80, 90, 100, 110, 120, 150 µg/mL
1st series +S9: 0, 100, 110, 120, 130, 150, 180 µg/mL
2nd series -S9: 0, 80, 100, 120, 150, 180, 210, 240, 270, 300, 350 µg/mL
2nd series +S9: 0, 80, 100, 120, 150, 180, 240, 270, 300, 350, 400 µg/mL
The maximum concentrations selected for testing in Mutation Experiment 1 were
based on the toxicity information obtained in the Range-Finder Experiment. In the
Range-Finder, excessive toxicity (<10% RS) was observed in the absence of S-9 and
an appropriate limit concentration (10-20% RS) was achieved in the presence of S-9.
Concentrations chosen for testing in Experiment 1 were selected to allow for any
marginal shifts in toxicity but no toxicity at all was observed at any concentration
tested for either treatment condition. No significant increases in MF were observed in
Mutation Experiment 1. There was a significant linear trend in the presence of S-9
(p<0.05) but in the absence of any significant increases in MF this was considered not
biologically relevant. As an appropriate limit concentration was not achieved, the
experiment could not be considered sufficiently robust and an additional experiment
was conducted (Mutation Experiment 2). - Vehicle / solvent:
- DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- benzo(a)pyrene
- Details on test system and experimental conditions:
- see below
- Evaluation criteria:
- For valid data, the test article was considered to be mutagenic in this assay if:
1. The MF at one or more concentrations was significantly greater than that of the
negative control (p≤0.05)
2. There was a significant concentration-relationship as indicated by the linear trend
analysis (p≤0.05)
3. If both of the above criteria were fulfilled, the results should exceed the upper
limit of the last 20 studies in the historical negative control database (mean MF +/-
2 standard deviations.
The test article was considered positive in this assay if all of the above criteria are
met.
The test article was considered negative in this assay if none of the above criteria are
met.
Results that only partially satisfied the assessment criteria described above were
considered on a case-by-case basis. Positive responses seen only at high levels of
cytotoxicity required careful interpretation when assessing their biological relevance.
Extreme caution was exercised with positive results obtained at levels of RS lower
than 10%. - Statistics:
- Standard statistical methods have been applied for data processing.
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Conclusions:
- It was concluded that the test material did induce mutation at the hprt locus in mouse lymphoma L5178Y cells when tested for 3 hours in the absence of a rat liver metabolic activation system (S-9), under the experimental conditions described. In the same test system, the test material did not induce biologically relevant increases in mutation when tested up to the limit of toxicity for 3 hours in the presence of S-9.
Referenceopen allclose all
Table 1: Summary of Experiment 1
Metabolic Activation |
Test material |
Concentr. (µg/plate) |
Revertant Colony Counts (Mean ± SD) |
||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvrA |
|||
Without Activation |
DMSO |
|
40 +/- 7 |
112 +/- 15 |
29 +/- 6 |
7 +/- 3 |
27 +/- 7 |
Test item |
5 |
34 +/- 6 |
115 +/- 17 |
27 +/- 4 |
4 +/- 1 |
29 +/- 4 |
|
15.8 |
34 +/- 4 |
127 +/- 17 |
25 +/- 4 |
6 +/- 2 |
27 +/- 3 |
||
50 |
32 +/- 8 |
111 +/- 13 |
22 +/- 4 |
8 +/- 2 |
29 +/- 2 |
||
158 |
33 +/- 2 |
115 +/- 17 |
34 +/- 5 |
8 +/- 1 |
28 +/- 7 |
||
500 |
35 +/- 3 |
135 +/- 3 |
22 +/- 1 |
7 +/- 4 |
33 +/- 6 |
||
1580 |
33 +/- 2 |
113 +/- 19 |
23 +/- 2 |
6 +/- 4 |
28 +/- 4 |
||
5000 |
34 +/- 10 |
122 +/- 8 |
23 +/- 5 |
7 +/- 2 |
33 +/- 5 |
||
DAUN |
1 |
257 +/- 37 |
|
|
|
|
|
NaN3 |
2 |
|
1724 +/- 63 |
911 +/- 4 |
|
|
|
9-AA |
50 |
|
|
|
1282 +/- 397 |
|
|
NQO |
2 |
|
|
|
|
1618 +/- 171 |
|
With Activation |
DMSO |
|
40 +/- 9 |
126 +/- 11 |
21 +/- 4 |
11 +/- 2 |
37 +/- 5 |
Test item |
5 |
45 +/- 4 |
121 +/- 3 |
25 +/- 11 |
11 +/- 2 |
29 +/- 6 |
|
15.8 |
43 +/- 11 |
110 +/- 10 |
15 +/- 6 |
6 +/- 5 |
37 +/- 4 |
||
50 |
36 +/- 2 |
99 +/- 26 |
16 +/- 6 |
7 +/- 1 |
39 +/- 13 |
||
158 |
32 +/- 7 |
102 +/- 15 |
19 +/- 4 |
10 +/- 3 |
38 +/- 11 |
||
500 |
40 +/- 3 |
115 +/- 4 |
23 +/- 10 |
9 +/- 6 |
38 +/- 9 |
||
1580 |
37 +/- 6 |
107 +/- 9 |
22 +/- 8 |
9 +/- 1 |
27 +/- 3 |
||
5000 |
43 +/- 3 |
114 +/- 5 |
25 +/- 5 |
9 +/- 2 |
33 +/- 4 |
||
2-AA |
2 |
817 +/- 123 |
1486 +/- 107 |
|
|
||
2-AA |
5 |
|
|
187 +/- 12 |
466 +/- 14 |
|
|
2-AA |
10 |
|
|
|
|
301 +/- 5 |
Table 1: Summary of Experiment 2
Metabolic Activation |
Test material |
Concentr. (µg/plate) |
Revertant Colony Counts (Mean ± SD) |
||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvrA |
|||
Without Activation |
DMSO |
|
37 +/- 7 |
109 +/- 18 |
19 +/- 4 |
8 +/- 4 |
27 +/- 6 |
Test item |
5 |
-- |
-- |
-- |
-- |
-- |
|
15.8 |
-- |
-- |
-- |
-- |
-- |
||
50 |
35 +/- 5 |
118 +/- 29 |
21 +/- 6 |
8 +/- 1 |
30 +/- 5 |
||
158 |
35 +/- 2 |
113 +/- 10 |
16 +/- 5 |
7 +/- 4 |
33 +/- 3 |
||
500 |
40 +/- 8 |
118 +/- 3 |
25 +/- 7 |
8 +/- 4 |
26 +/- 12 |
||
1580 |
39 +/- 6 |
115 +/- 15 |
19 +/- 3 |
7 +/- 2 |
34 +/- 3 |
||
5000 |
40 +/- 4 |
129 +/- 21 |
19 +/- 6 |
6 +/- 4 |
30 +/- 7 |
||
DAUN |
1 |
205 +/- 22 |
|
|
|
|
|
NaN3 |
2 |
|
1586 +/- 50 |
877 +/- 9 |
|
|
|
9-AA |
50 |
|
|
|
1176 +/- 244 |
|
|
NQO |
2 |
|
|
|
|
1530 +/- 159 |
|
With Activation |
DMSO |
|
50 +/- 10 |
106 +/- 7 |
20 +/- 3 |
11 +/- 3 |
36 +/- 5 |
Test item |
5 |
-- |
-- |
-- |
-- |
-- |
|
15.8 |
-- |
-- |
-- |
-- |
-- |
||
50 |
42 +/- 1 |
113 +/- 10 |
19 +/- 6 |
12 +/- 6 |
37 +/- 8 |
||
158 |
45 +/- 4 |
112 +/- 14 |
13 +/- 1 |
14 +/- 2 |
36 +/- 2 |
||
500 |
45 +/- 7 |
108 +/- 16 |
16 +/- 4 |
9 +/- 5 |
37 +/- 11 |
||
1580 |
39 +/- 8 |
109 +/- 12 |
20 +/- 1 |
13 +/- 2 |
30 +/- 2 |
||
5000 |
47 +/- 17 |
105 +/- 6 |
16 +/- 4 |
7 +/- 4 |
33 +/- 5 |
||
2-AA |
2 |
275 +/- 23 |
439 +/- 11 |
|
|
||
2-AA |
5 |
|
|
132 +/- 25 |
89 +/- 8 |
|
|
2-AA |
10 |
|
|
|
|
205 +/- 23 |
Key to Positive Controls
NaN3 Sodium azide
2-AA 2-Aminoanthracene
9-AA 9-Aminoacridine
DAUN Daunomycin
NQO 4-Nitroquinoline-N-oxide
Range-Finder Experiment - 3 Hour
Treatment in the Absence and Presence of S-9
Concentration / [µg/mL] |
- S9 |
+ S9 |
%RS |
%RS |
|
0 |
100 |
100 |
62.5 |
43 |
59 |
125 |
3 |
18 |
250 |
0 |
0 |
500 |
0 |
0 |
1000 |
0 |
0 |
2000 |
0 |
0 |
Mutation Experiment 1 Summary
of Data - 3 Hour treatment in the Absence and Presence of S-9
Concentration / [µg/mL] | %RS | MF (day 7) | Concentration / [µg/mL] | %RS | MF (day 7) |
0 |
100 |
5.96 |
0 |
100 |
3.56 |
80 |
140 |
4.19 NS | 100 |
96 |
3.84 NS |
90 |
120 |
5.88 NS | 110 |
95 |
5.26 NS |
100 |
134 |
3.95 NS | 120 |
96 |
3.34 NS |
110 |
140 |
4.30 NS | 130 |
101 |
5.13 NS |
120 |
125 |
5.57 NS | 150 |
102 |
6.34 NS |
150 |
125 |
5.89 NS |
180 |
93 |
4.46 NS |
NQO 0.15 |
84 |
25.22 |
B[a]P 2 |
39 |
45.72 |
NQO 0.2 |
77 |
30.54 |
B[a]P 3 |
33 |
29.07 |
Mutation Experiment 2 Summary
of Data - 3 Hour treatment in the Absence and Presence of S-9
Concentration / [µg/mL] | %RS | MF (day 7) | Concentration / [µg/mL] | %RS | MF (day 7) |
0 |
100 |
2.05 |
0 |
100 |
3.47 |
80 |
88 |
2.88 NS | 80 |
66 |
6.17 NS |
100 |
92 |
4.09 NS | 100 |
89 |
3.29 NS |
120 |
71 |
4.47 NS | 120 |
83 |
2.62 NS |
150 |
75 |
6.61 * |
150 |
63 |
1.85 NS |
180 |
64 |
2.65 NS | 180 |
54 |
3.86 NS |
210 |
46 |
2.62 NS | 210 |
49 |
5.69 NS |
240 |
42 |
3.94 NS | 240 |
43 |
5.70 NS |
270 |
27 |
5.90 * |
270 |
31 |
4.70 NS |
300 |
19 |
9.20 *# |
300 |
26 |
2.73 NS |
350 |
14 |
5.54 * |
350 |
11 |
7.32 # |
NQO 0.15 |
19 |
31.77 |
B[a]P 2 | 39 |
14.64 |
NQO 0.2 |
23 |
28.15 |
B[a]P 3 | 25 |
19.97 |
%RS Percent relative survival adjusted by post treatment cell
counts
NS Not significant
*, **, *** Test for linear trend: χ2 (one-sided), significant at 5%, 1%
and 0.1% level respectively
* Comparison of each treatment with control: Dunnett's test (one-sided),
significant at 5% level
# MF value exceeds the upper limit of the last 20 studies in the
historical negative control database
(mean MF±2 standard deviations)
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Genetic toxicity in vivo
Link to relevant study records
- Endpoint:
- genetic toxicity in vivo, other
- Remarks:
- In vivo mammalian somatic cell study: gene mutation and chromosome aberrations
- Data waiving:
- exposure considerations
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the provided information there is no need for classification according to the EU Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures, as amended for the 10th 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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