Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 285-083-3 | CAS number: 85029-58-9
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Based on the available information, the test item is not mutagenic in the Ames test under the selected experimental conditions.
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:
- 01 Mar 2000 to 19 Dec. 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- - Name of the test substance used in the study report: Neozapon Gelb R Stuecke ber. 100%
- Purity: Ca. 96.6%
performed under old CAS 73297-13-9
new CAS 85029-58-9, same structure - Target gene:
- S. typhimurium: his
E. coli: trp - 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:
- Aroclor-induced rat liver S-9 mix resp. uninduced hamster liver S-9 mix
- Test concentrations with justification for top dose:
- 20 µg - 5000 µg/plate (Standard Plate Test)
4 µg - 2,500 µg/plate (Prival Preincubation Test) - Vehicle / solvent:
- - Vehicle: DMSO
- Justification for choice of solvent/vehicle: Due to the limited solubility of the test substance in water, DMSO was selected as the vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- congo red
- other: 2-aminoanthracene (2-AA), benzidine, N-methyl-N'-nitro-N-nitrosoguanidine (MNNG), 4-nitro-o-phenylendiamine (NOPD)
- Details on test system and experimental conditions:
- Ames Standard Plate Test and Prival Preincubation Test
- Evaluation criteria:
- The test chemical is considered positive in this assay if the following criteria are met :
A dose-related and reproducible increase in the number of revertant colonies, i .e. about doubling of the spontaneous mutation rate in at least one tester strain either without S-9 mix or after adding a metabolizing system .
A test substance is generally considered nonmutagenic in this test if:
The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in two experiments carried out
independently of each other. - Statistics:
- no statistics, standard deviation calculated
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A bacteriotoxic effect was observed under all test conditions
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A bacteriotoxic effect was observed under all test conditions
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- An increase in the number of his+ or trp+ revertants was not observed either in the Ames standard plate test or in the Prival preincubation test without S-9 mix or after the addition of a metabolizing system.
TOXICITY
A weak bacteriotoxic effect (slight decrease in the number of revertants, slight reduction in the titer) was observed in the Ames standard plate test using the Salmonella strains depending on the strain and test conditions from about 2,500 pg/plate onward . In the Prival preincubation assay bacteriotoxicity (reduced his- or trp- background growth, decrease in the number of revertants, reduction in the titer) was observed depending on the strain and test conditions from about 100 pg - 500 pg/plate onward .
SOLUBILITY
Test substance precipitation was found from about 500 pg/plate onward .
Reference
Table: Standard Test (average result of 3 plates, respectively)
Concentration [µg/plate] |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
E. coli WP2 uvrA |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Solvent control (DMSO) |
18 |
19 |
10 |
11 |
31 |
38 |
114 |
128 |
36 |
36 |
20 |
20 |
17 |
9 |
10 |
21 |
30 |
96 |
116 |
25 |
45 |
100 |
18 |
18 |
8 |
12 |
20 |
43 |
91 |
113 |
29 |
43 |
500 |
17 |
15 |
5 |
11 |
20 |
25 |
98 |
86 |
25 |
34 |
2500 |
11 |
11 |
4 |
5 |
13 |
16 |
58 |
24 |
25 |
37 |
5000 |
11 |
7 |
3 |
1 |
12 |
5 |
62 |
16 |
25 |
35 |
Positive control |
647 |
165 |
601 |
103 |
1081 |
580 |
619 |
722 |
550 |
225 |
Table: Preincubation test (average result of 3 plates, respectively)
Concentration [µg/plate] |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
E. coli WP2 uvrA |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Solvent control (DMSO) |
17 |
17 |
9 |
13 |
25 |
35 |
108 |
109 |
36 |
29 |
Test item |
|
|||||||||
4 |
19 |
17 |
8 |
12 |
21 |
35 |
105 |
105 |
37 |
25 |
20 |
16 |
16 |
5 |
11 |
20 |
30 |
60 |
89 |
33 |
23 |
100 |
13 |
16 |
4 |
10 |
15 |
25 |
56 |
81 |
27 |
27 |
500 |
12 |
11 |
1 |
5 |
12 |
20 |
31 |
59 |
26 |
25 |
2500 |
8 |
6 |
2 |
1 |
10 |
9 |
49 |
14 |
24 |
19 |
Positive control |
|
|||||||||
MNNG |
1093 |
|
|
|
|
|
1190 |
|
|
|
2-AA |
|
178 |
|
104 |
|
561 |
|
622 |
|
220 |
AAC |
|
|
632 |
|
|
|
|
|
|
|
NOPD |
|
|
|
|
990 |
|
|
|
|
|
CONGOR. |
|
|
|
|
|
370 |
|
|
|
|
BENZID |
|
|
|
|
|
579 |
|
|
|
|
4-NQO |
|
|
|
|
|
|
|
|
519 |
|
MNNG: N-methyl-N'-nitro-N-nitrosoguanidine
2 -AA: 2-aminoanthracene
AAC: 9-aminoacridine
NOPD: 4 -nitro-o-phenylendiamine
4 -NQO: 4 -Nitroquinoline-N-oxide
BENZID: Benzidine
CONGOR.: Congo red
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Genetic toxicity in vitro:
In a reverse gene mutation assay in bacteria (Ames-test), strains TA 1535, TA 100, TA 1537 and TA 98 of Salmonella typhimurium and strain WP2 uvrA of E. coli were exposed to the test substance at concentrations of 20, 100, 500, 2500 and 5000 µg/plate (BASF, 2000). Standard plate test and preincubation test both were conducted with and without metabolic activation (Aroclor induced rat liver S-9 mix). The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background. Based on the available information, the test substance is not mutagenic in the Ames test under the selected experimental conditions.
Justification for classification or non-classification
Based on the available information classification for genetic toxicity is not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.
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.