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EC number: 219-983-4 | CAS number: 2591-76-6
- 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
Link to relevant study records
- 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:
- 1997-02-04 to 1997-04-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Version / remarks:
- 1983
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- S. typhimurium and E. coli
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat liver S-9 mix
- Test concentrations with justification for top dose:
- Standard plate test: 20, 100, 500, 2500 and 5000 µg/plate
Preincubation test: Standard plate test: 20, 100, 500, 2500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle used: DMSO
- Justification for choice of vehicle: DMSO had been demonstrated to be suitable in bacterial reverse mutation tests and historical control data are available. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 2-AA
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with S9 mix (all tester strains)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- MNNG
- Positive control substance:
- other: N-methyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without S9 mix (TA 1535, TA100)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- NOPD
- Positive control substance:
- other: 4-nitro-o-phenylendiamine
- Remarks:
- without S9 mix (TA 98)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- AAC
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9 mix (TA 1537)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- ENNG
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without S9 mix (WP2 uvrA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) and preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 - 72 hours in the dark
NUMBER OF REPLICATIONS: 3
TOXICITY:
Toxicity detected by a
- decrease in the number of revertants
- clearing or diminution of the background lawn (= reduced his- or trp- background growth)
- reduction in the titer - 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. - Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No Precipitation of the test substance was found.
COMPARISON WITH HISTORICAL CONTROL DATA:
The number of revertants for all tester strains were within the historical control range.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In the standard plate test a slight decrease in the number of revertants was occasionally observed depending on the strain and test conditions at doses equal to or greater than 2500 µg/plate.
In the preincubation test bacteriotoxicity (reduced backgrown growth, decrease in the number of revertants, reduction in the titer) was observed from about 100 µg - 500 µg/plate onward. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Reference
Table 1: Preincubation Test
Dose/plate |
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
E. coli WP2 uvrA |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Negative control |
||||||||||
DMSO |
19 |
19 |
103 |
106 |
11 |
12 |
28 |
37 |
37 |
43 |
Test item |
||||||||||
20 µg |
18 |
16 |
97 |
102 |
10 |
9 |
29 |
33 |
34 |
31 |
100 µg |
16 |
11 |
97 |
82 |
10 |
7 |
25 |
27 |
32 |
26 |
500 µg |
11 |
9 |
94 |
82 |
9 |
8 |
20 |
23 |
27 |
21 |
2500 µg |
12 |
10 |
71 |
51 |
7 |
- |
14 |
20 |
21 |
15 |
5000 µg |
|
- |
- |
- |
- |
- |
10 |
9 |
15 |
7 |
Positive control |
||||||||||
5.0 µg MNNG |
1289 |
|
1091 |
|
|
|
|
|
|
|
2.5 µg 2-AA |
|
406 |
|
795 |
|
173 |
|
1050 |
|
|
100 µg AAC |
|
|
|
|
711 |
|
|
|
|
|
10 µg NOPD |
|
|
|
|
|
|
995 |
|
|
|
10 µg ENNG |
|
|
|
|
|
|
|
|
1216 |
|
60 µg 2-AA |
|
|
|
|
|
|
|
|
|
235 |
Table 2: Standard Plate Test
Dose/plate |
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
E. coli WP2 uvrA |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Negative control |
||||||||||
DMSO |
21 |
20 |
105 |
110 |
12 |
12 |
27 |
38 |
35 |
42 |
Test item |
||||||||||
20 µg |
20 |
17 |
107 |
123 |
9 |
10 |
33 |
|
40 |
47 |
100 µg |
17 |
16 |
105 |
123 |
12 |
13 |
26 |
|
34 |
46 |
500 µg |
16 |
16 |
108 |
105 |
7 |
10 |
27 |
|
39 |
45 |
2500 µg |
14 |
11 |
104 |
109 |
7 |
7 |
29 |
|
31 |
45 |
5000 µg |
11 |
10 |
104 |
85 |
6 |
7 |
22 |
|
29 |
41 |
Positive control |
||||||||||
5.0 µg MNNG |
1010 |
|
1368 |
|
|
|
|
|
|
|
2.5 µg 2-AA |
|
158 |
|
1195 |
|
135 |
|
845 |
|
|
100 µg AAC |
|
|
|
|
612 |
|
|
|
|
|
10 µg NOPD |
|
|
|
|
|
|
649 |
|
|
|
10 µg ENNG |
|
|
|
|
|
|
|
|
537 |
|
60 µg 2-AA |
|
|
|
|
|
|
|
|
|
250 |
DMSO: dimethyl sulfoxide
2 -AA: 2 -aminoanthracene
MNNG: N-methyl-N'-nitro-N-nitrosoguanidine
NOPD: 4 -nitro-o-phenylendiamine
AAC: 9-aminoacridine
ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Amest Test
In a reverse gene mutation assay in bacteria (BASF 1999, 40M0541/964338), strains TA 1535, TA 1537, TA 100, TA 98 of S. typhimurium and E. coli WP2 uvrA were exposed to the test item in DMSO at concentrations of 20, 100, 500, 2500 and 5000 µg/plate (standard plate test and preincubation test) in the presence and absence of mammalian metabolic activation (Aroclor-induced rat liver S-9 mix). No precipitation of the test substance was found and a bacteriotoxic effect was observed mainly in the preincubation test. An increase in the number of revertants was not observed in the standard plate test or in the preincubation test either without S-9 mix or after the addition of the metabolizing system. According to the results of the present study, the test substance is not mutagenic in the S. typhimurium/E. coli reverse mutation assay under the experimental conditions chosen.
Justification for selection of genetic toxicity endpoint
Only available study for this endpoint performed according to GLP and guideline citeria.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result based on this Ames test the substance is not considered to be classified for genetic toxicity under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.
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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