Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 287-267-9 | CAS number: 85455-32-9
- 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

Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Hydrogen hydroxy[2-hydroxy-3-[(2-hydroxy-3-nitrobenzylidene)amino]-5-nitrobenzenesulphonato(3-)]chromate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
- EC Number:
- 287-267-9
- EC Name:
- Hydrogen hydroxy[2-hydroxy-3-[(2-hydroxy-3-nitrobenzylidene)amino]-5-nitrobenzenesulphonato(3-)]chromate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
- Cas Number:
- 85455-32-9
- Molecular formula:
- C13H7CrN3O10S.C11H25NO.H
- IUPAC Name:
- Hydrogen hydroxy[2-hydroxy-3-[(2-hydroxy-3-nitrobenzy-lidene)amino]-5-nitrobenzenesulphonato(3-)]chromate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
- Test material form:
- solid: particulate/powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/ß-Naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate / pre-experiment/experiment I
3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate / experiment II
3, 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate / experiment IIa - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: best suitable solvent
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide; 4-nitro-o-phenylene-diamine; methyl methane sulfonate, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar plate incorporation; preincubation;
DURATION
- Preincubation period: 1 hour
- Exposure duration: 72 hours
NUMBER OF REPLICATIONS: 3 plates
DETERMINATION OF CYTOTOXICITY
A reduction in the number of spontaneous revertants (below the induction factor of 0.5) or a clearing of the bacterial background lawn.
- Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
Results and discussion
Test results
- Key result
- Species / strain:
- other: TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: not soluble
- Precipitation: The test item precipitated in the overlay agar in the test tubes in experiment I from 1000 to 5000 µg/plate with and without S9 mix, in experiment II from 333 to 5000 µg/plate in the presence S9 mix and from 1000 to 5000 µg/plate in the absence of S9 mix, and in experiment IIa from 333 to 5000 µg/plate in the absence of S9 mix. Precipitation of the test item in the overlay agar on the incubated agar plates was observed I from 333 to 5000 µg/plate with and without S9 mix in experiment, from 1000 to 5000 µg/plate without S9 mix and from 333 to 5000 µg/plate with S9 mix in experiment II, and from 333 to 5000 µg/plate without S9 mix in experiment IIa. The undissolved particles had no influence on the data recording.
- Other confounding effects: none
COMPARISON WITH HISTORICAL CONTROL DATA: The number of colonies did not quite reach the lower limit of our historical control data In experiment I in the negative control of strain WP2 uvrA with S9 mix and the data in the solvent control of strain TA 100 with S9 mix were slightly above our historical control range in experiment II. Since these deviations are rather small, this effect is judged to be based upon statistical fluctuations and has no detrimental impact on the outcome of the study.
ADDITIONAL INFORMATION ON CYTOTOXICITY:Toxic effects, evident as a reduction in the number of revertants (below the induction factor of 0.5), were observed at the following concentrations (µg/plate):
Strain Experiment I Experiment II Experiment IIa
without S9 mix with S9 mix without S9 mix with S9 mix without S9 mix
TA 1535 / / 5000 / n.p
TA 1537 / 5000 2500 – 5000 / n.p.
TA 98 5000 5000 5000 5000 2500 - 5000.
TA 100 5000 5000 333 – 5000 333 – 5000 n.p
WP2 uvrA 5000 2500 – 5000 5000 / n.p
/ = no toxic effects, evident as a reduction in the number of revertants (below the induction factor of 0.5)
n.p. = not performed - Remarks on result:
- other: other: reverse mutation assay
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Summary Tabellen
Table1 Summary of Experiment I
Study Name: 1743704 |
Study Code: Envigo 1743704 |
Experiment: 1743704 VV Plate |
Date Plated: 15/01/2016 |
Assay Conditions: |
Date Counted: 18/01/2016 |
Metabolic Activation |
Test Group |
Dose Level (per plate) |
|
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|
|
|
|
|
|
|
|
|
Without Activation |
DMSO |
|
|
13 ± 5 |
9 ± 4 |
24 ± 2 |
193 ± 8 |
47 ± 4 |
Untreated |
|
|
10 ± 5 |
13 ± 1 |
36 ± 5 |
204 ± 4 |
50 ± 2 |
|
Savinyl-Gelb |
3 µg |
|
13 ± 6 |
9 ± 3 |
30 ± 8 |
222 ± 13 |
44 ± 14 |
|
2GLS 01 |
10 µg |
|
13 ± 4 |
12 ± 4 |
22 ± 2 |
217 ± 9 |
41 ± 7 |
|
trocken |
33 µg |
|
15 ± 2 |
12 ± 3 |
28 ± 9 |
223 ± 2 |
44 ± 1 |
|
|
100 µg |
|
12 ± 0 |
11 ± 3 |
30 ± 6 |
226 ± 4 |
41 ± 4 |
|
|
333 µg |
|
14 ± 3P |
13 ± 4P |
30 ± 7P |
195 ± 13P |
42 ± 3P |
|
|
1000 µg |
|
12 ± 3P |
16 ± 3P |
34 ± 6P |
183 ± 27P |
33 ± 3P |
|
|
2500 µg |
|
13 ± 5P |
12 ± 3P M |
31 ± 3P |
188 ± 21P |
27 ± 4P |
|
|
5000 µg |
|
12 ± 3P M |
4 ± 2P M |
5 ± 2P M |
28 ± 8P |
8 ± 2P M |
|
NaN3 |
10 µg |
|
1145 ± 83 |
|
|
2013 ± 9 |
|
|
4-NOPD |
10 µg |
|
|
|
316 ± 20 |
|
|
|
4-NOPD |
50 µg |
|
|
79 ± 7 |
|
|
|
|
MMS |
2.0 µL |
|
|
|
|
|
1021 ± 114 |
|
|
|
|
|
|
|
|
|
|
With Activation |
DMSO |
|
|
12 ± 0 |
11 ± 1 |
25 ± 6 |
206 ± 10 |
52 ± 7 |
Untreated |
|
|
20 ± 6 |
9 ± 2 |
30 ± 4 |
207 ± 14 |
64 ± 7 |
|
Savinyl-Gelb |
3 µg |
|
14 ± 5 |
11 ± 4 |
24 ± 3 |
218 ± 21 |
47 ± 12 |
|
2GLS 01 |
10 µg |
|
12 ± 6 |
9 ± 4 |
36 ± 2 |
223 ± 18 |
51 ± 15 |
|
trocken |
33 µg |
|
14 ± 0 |
9 ± 5 |
32 ± 5 |
226 ± 18 |
64 ± 8 |
|
|
100 µg |
|
13 ± 4 |
11 ± 2 |
28 ± 7 |
221 ± 7 |
50 ± 4 |
|
|
333 µg |
|
11 ± 2P |
13 ± 4P |
25 ± 4P |
207 ± 13P |
44 ± 8P |
|
|
1000 µg |
|
7 ± 2P |
14 ± 1P |
31 ± 4P |
220 ± 17P |
44 ± 4P |
|
|
2500 µg |
|
7 ± 2P |
8 ± 1P M |
12 ± 3P M |
174 ± 28P |
18 ± 4P |
|
|
5000 µg |
|
6 ± 2P M |
4 ± 1P M |
2 ± 2P M |
87 ± 13P |
9 ± 2P M |
|
2-AA |
2.5 µg |
|
516 ± 21 |
133 ± 35 |
3246 ± 818 |
5206 ± 183 |
|
|
2-AA |
10.0 µg |
|
|
|
|
|
332 ± 8 |
|
|
|
|
|
|
|
|
|
|
Key to Positive Controls |
Key to Plate Postfix Codes |
||
|
|
||
NaN3 2-AA 4-NOPD MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine methyl methane sulfonate |
P M |
Precipitate Manual count |
Table2 Summary of Experiment II
Study Name: 1743704 |
Study Code: Envigo 1743704 |
Experiment: 1743704 HV2 Pre |
Date Plated: 28/01/2016 |
Assay Conditions: |
Date Counted: 03/02/2016 |
Metabolic Activation |
Test Group |
Dose Level (per plate) |
|
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|
|
|
|
|
|
|
|
|
Without Activation |
DMSO |
|
|
9 ± 3 |
11 ± 2 |
19 ± 8 |
158 ± 5 |
33 ± 5 |
Untreated |
|
|
7 ± 3 |
7 ± 1 |
23 ± 6 |
200 ± 3 |
37 ± 6 |
|
Savinyl-Gelb |
3 µg |
|
8 ± 2 |
8 ± 1 |
20 ± 6 |
138 ± 8 |
33 ± 3 |
|
2GLS 01 |
10 µg |
|
11 ± 2 |
8 ± 2 |
25 ± 3 |
141 ± 10 |
30 ± 6 |
|
trocken |
33 µg |
|
8 ± 3 |
8 ± 5 |
20 ± 1 |
145 ± 4 |
30 ± 3 |
|
|
100 µg |
|
11 ± 2 |
12 ± 3 |
25 ± 5 |
132 ± 8 |
36 ± 12 |
|
|
333 µg |
|
12 ± 3 |
8 ± 1 |
33 ± 7 |
70 ± 8 |
26 ± 3 |
|
|
1000 µg |
|
9 ± 3P |
11 ± 2P |
41 ± 7P |
63 ± 12P |
27 ± 6P |
|
|
2500 µg |
|
9 ± 3P |
5 ± 1P M |
18 ± 4P M |
10 ± 3P |
16 ± 4P |
|
|
5000 µg |
|
1 ± 1P M |
2 ± 1P |
1 ± 1P M |
2 ± 1P |
13 ± 1P |
|
NaN3 |
10 µg |
|
1046 ± 92 |
|
|
1697 ± 99 |
|
|
4-NOPD |
10 µg |
|
|
|
362 ± 15 |
|
|
|
4-NOPD |
50 µg |
|
|
102 ± 14 |
|
|
|
|
MMS |
2.0 µL |
|
|
|
|
|
640 ± 14 |
|
|
|
|
|
|
|
|
|
|
With Activation |
DMSO |
|
|
12 ± 4 |
11 ± 1 |
28 ± 8 |
133 ± 7 |
40 ± 4 |
Untreated |
|
|
10 ± 6 |
11 ± 1 |
31 ± 4 |
174 ± 8 |
37 ± 2 |
|
Savinyl-Gelb |
3 µg |
|
10 ± 2 |
14 ± 2 |
24 ± 4 |
119 ± 8 |
45 ± 2 |
|
2GLS 01 |
10 µg |
|
12 ± 3 |
15 ± 1 |
30 ± 10 |
126 ± 6 |
40 ± 6 |
|
trocken |
33 µg |
|
7 ± 2 |
10 ± 4 |
32 ± 6 |
128 ± 5 |
47 ± 10 |
|
|
100 µg |
|
9 ± 2 |
11 ± 4 |
33 ± 7 |
120 ± 7 |
40 ± 8 |
|
|
333 µg |
|
8 ± 2P |
11 ± 4P |
34 ± 7P |
41 ± 6P |
35 ± 11P |
|
|
1000 µg |
|
10 ± 3P |
12 ± 1P |
38 ± 10P |
24 ± 5P |
34 ± 5P |
|
|
2500 µg |
|
6 ± 1P |
11 ± 2P |
38 ± 3P |
9 ± 3P |
35 ± 12P |
|
|
5000 µg |
|
12 ± 4P |
12 ± 3P |
4 ± 2P M |
1 ± 1P M |
27 ± 6P |
|
2-AA |
2.5 µg |
|
383 ± 46 |
169 ± 12 |
4199 ± 453 |
3167 ± 228 |
|
|
2-AA |
10.0 µg |
|
|
|
|
|
351 ± 11 |
|
|
|
|
|
|
|
|
|
|
Key to Positive Controls |
Key to Plate Postfix Codes |
||
|
|
||
NaN3 2-AA 4-NOPD MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine methyl methane sulfonate |
P M |
Precipitate Manual count |
Table3 Summary of Experiment IIa
Study Name: 1743704 |
Study Code: Envigo 1743704 |
Experiment: 1743704 HV2a Pre |
Date Plated: 10/02/2016 |
Assay Conditions: |
Date Counted: 16/02/2016 |
Metabolic Activation |
Test Group |
Dose Level (per plate) |
|
Revertant Colony Counts (Mean ±SD) |
|
|
|
|
|
|
|
|
|
TA 98 |
|
|
|
|
|
Without Activation |
DMSO |
|
|
22 ± 2 |
Untreated |
|
|
31 ± 4 |
|
Savinyl-Gelb |
3 µg |
|
25 ± 3 |
|
2GLS 01 |
10 µg |
|
31 ± 10 |
|
trocken |
33 µg |
|
31 ± 5 |
|
|
100 µg |
|
26 ± 8 |
|
|
333 µg |
|
29 ± 2P |
|
|
1000 µg |
|
35 ± 5P |
|
|
2500 µg |
|
5 ± 2P M |
|
|
5000 µg |
|
0 ± 1P |
|
4-NOPD |
10 µg |
|
447 ± 4 |
|
|
|
|
|
|
|
|
|
|
|
Key to Positive Controls |
Key to Plate Postfix Codes |
||
|
|
||
4-NOPD |
4-nitro-o-phenylene-diamine |
P M |
Precipitate Manual count |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. - Executive summary:
The test item was assessed for its potential to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II and IIa) using theSalmonella typhimuriumstrains TA 1535, TA 1537, TA 98, TA 100, and theEscherichia colistrain WP2 uvrA. Since a minor increase in revertant colony numbers was observed in experiment II in strain TA 98 without S9 mix, this part was repeated (reported as experiment IIa).
The assay was performed in three independent experiments with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations:
Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment IIa with TA98 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
The test item precipitated in the overlay agar in the test tubes in experiment I from 1000 to 5000 µg/plate with and without S9 mix, in experiment II from 333 to 5000 µg/plate in the presence S9 mix and from 1000 to 5000 µg/plate in the absence of S9 mix, and in experiment IIa from 333 to 5000 µg/plate in the absence of S9 mix. Precipitation of the test item in the overlay agar on the incubated agar plates was observed I from 333 to 5000 µg/plate with and without S9 mix in experiment, from 1000 to 5000 µg/plate without S9 mix and from 333 to 5000 µg/plate with S9 mix in experiment II, and from 333 to 5000 µg/plate without S9 mix in experiment IIa. The undissolved particles had no influence on the data recording.
The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without S9 mix in all strains used.
Toxic effects, evident as a reduction in the number of revertants (below the induction factor of 0.5), were observed at the following concentrations (µg/plate):
Strain
Experiment I
Experiment II
Experiment IIa
without S9 mix
with S9 mix
without S9 mix
with S9 mix
without S9 mix
TA 1535
/
/
5000
/
n.p
TA 1537
/
5000
2500 – 5000
/
n.p.
TA 98
5000
5000
5000
5000
2500 - 5000.
TA 100
5000
5000
333 – 5000
333 – 5000
n.p
WP2uvrA
5000
2500 – 5000
5000
/
n.p
/ = no toxic effects, evident as a reduction in the number of revertants (below the induction factor of 0.5)
n.p. = not performed
No relevant increase of the number of revertant colonies occurred in any of the strains up to the maximal concentration tested, neither in the presence nor in the absence of metabolic activation. In experiment II, an isolated increase (2.1) in revertant colony numbers slightly exceeding the threshold of twice the number of the corresponding solvent control, was observed in strain TA 98 in the absence of metabolic activation. This borderline effect was considered as biologically irrelevant since it was not reproduced in Experiment IIa.
Appropriate reference mutagens were used as positive controls. They showed a distinct increase in induced revertant colonies.
The number of colonies did not quite reach the lower limit of our historical control data In experiment I in the negative control of strain WP2uvrAwith S9 mix and the data in the solvent control of strain TA 100 with S9 mix were slightly above our historical control range in experiment II. Since these deviations are rather small, this effect is judged to be based upon statistical fluctuations and has no detrimental impact on the outcome of the study.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.