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EC number: 691-196-2 | CAS number: 5767-36-2
- 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:
- other information
- Study period:
- March 2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: guideline study with restriction (non-GLP)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine gene locus
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced male rat liver S9 mix
- Test concentrations with justification for top dose:
- 0, 16, 50, 158, 500, 1581, 5000 µg/plate (first test, +/-S9 mix, all strains)
0, 500, 1000, 2000, 3000, 4000, 5000 and 6000 µg/plate (repeat test, +/-S9 mix, all strains) - Vehicle / solvent:
- DMSO
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- Remarks:
- No solvent control was used since sufficient evidence was available in the literature and from testing laboratory experience, indicating that the solvents used had no influence on the spontaneous mutant counts of the used strains.
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide (only TA 1535), nitrofurantoin (only TA 100), 4-nitro-1,2-phenylene diamine (TA 1537 and TA 98), mitomycin C (only TA 102), 2-aminoanthracene (all strains).
- Remarks:
- The positive controls sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine and mitomycin C were only used without S9 mix; the positive control 2-aminoanthracene was only used with S9 mix.
- Details on test system and experimental conditions:
- METHOD: each concentration including the controls was tested in triplicate.
- Evaluation criteria:
- A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result. For TA 1535, TA 100 and TA 98 this increase should be about twice that of negative controls, whereas for TA 1537 at least a threefold increase should be reached. For TA 102 an increase of about 100 mutants should be reached. Otherwise, the result is evaluated as negative. However, these criteria may be overruled by good scientific judgment. In case of questionable results, investigations should continue, possibly with modifications, until a final evaluation is possible.
- Statistics:
- not specified
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- 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:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: strain/cell type: TA 98, TA 102
- Remarks:
- Migrated from field 'Test system'.
- Executive summary:
The mutagenic potential of the test material was evaluated in a Salmonella/microsome test with the S. typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 in the presence and absence of S9 mix according to OECD TG 471. Doses up to and including 6000 µg per plate did not cause any bacteriotoxic effects. Total bacteria counts remained unchanged and no inhibition of growth was observed. Evidence of mutagenic activity of the test material was seen. On Salmonella typhimurium TA 102 and TA 98, a biologically relevant increase was found in the mutant count compared to the corresponding negative control. Positive response was found only with S9 mix. For TA 100 there was a positive response without and with S9 mix, and the effect was comparable. The lowest effective dose was 4000 µg per plate for Salmonella typhimurium TA 102 and 6000 µg per plate for TA 100 and TA 98. The Salmonella/microsome test thus showed the test material to have a mutagenic effect.
Reference
Table 1: Summary of results from the Salmonella mutagenicity assay (first test) with 4 -Hydrazo-6 -morph-pyrimidin (mean values of revertants per plate)
Dose (µg per plate) |
Without metabolic activation |
||||
|
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
TA 102 |
0 |
9 |
110 |
9 |
24 |
245 |
16 |
5 |
98 |
6 |
28 |
234 |
50 |
9 |
107 |
6 |
25 |
228 |
158 |
8 |
116 |
5 |
25 |
235 |
500 |
7 |
114 |
6 |
29 |
186 |
1581 |
7 |
100 |
9 |
35 |
273 |
5000 |
7 |
217 |
10 |
41 |
318 |
Positive control |
1016 |
435 |
44 |
97 |
1397 |
Dose ( µg per plate ) |
With metabolic activation (liver S9 mix) |
||||
|
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
TA 102 |
0 |
7 |
191 |
10 |
38 |
350 |
16 |
9 |
177 |
7 |
31 |
309 |
50 |
6 |
148 |
6 |
34 |
277 |
158 |
5 |
121 |
10 |
36 |
336 |
500 |
12 |
150 |
7 |
48 |
378 |
1581 |
11 |
194 |
13 |
56 |
403 |
5000 |
14 | 311 | 17 | 84 | 518 |
Positive control |
84 |
2472 |
139 |
2253 |
1025 |
Table 2: Summary of results from the Salmonella mutagenicity assay (repeat test with additional concentrations) with 4 -Hydrazo-6 -morph-pyrimidin (mean values of revertants per plate)
Dose (µg per plate) |
With metabolic activation (liver S9 mix) |
||||
|
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
TA 102 |
0 |
10 |
146 |
9 |
38 |
333 |
500 |
6 |
148 |
10 |
40 |
340 |
1000 |
8 |
133 |
9 |
43 |
334 |
2000 |
7 |
166 |
12 |
59 |
327 |
3000 |
11 |
170 |
8 |
52 |
354 |
4000 |
16 |
210 |
13 |
56 |
457 |
5000 |
14 |
227 |
17 |
49 |
525 |
6000 |
18 |
291 |
20 |
68 |
534 |
Positive control |
71 |
2337 |
122 |
2305 |
1296 |
Dose ( µg per plate ) |
Without metabolic activation |
||||
|
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
TA 102 |
0 |
8 |
119 |
7 |
28 |
244 |
500 |
9 |
127 |
7 |
39 |
220 |
1000 |
10 |
123 |
6 |
24 |
226 |
2000 |
6 |
170 |
7 |
28 |
248 |
3000 |
9 |
157 |
7 |
38 |
191 |
4000 |
8 |
181 |
5 |
39 |
260 |
5000 |
7 |
208 |
9 |
44 |
285 |
6000 |
1150 |
245 |
8 |
46 |
284 |
Positive control |
84 |
366 |
58 |
89 |
1128 |
There was no indication of a bacteriotoxic effect of 4-Hydrazo- 6-morph-pyrimidin at doses of up to and including 6000 µg per plate. The total bacteria counts consistently produced results comparable to the negative controls, or differed only insignificantly. No inhibition of growth was noted as well.
Three of the five strains concerned revealed a relevant increase in mutant counts. Strains TA 100, TA 98 and TA 102 were affected. The findings for Salmonella typhimurium TA 100, TA 98 and TA 102 were confirmed by further repeat tests. The lowest dose at which this finding was observed was 4000 µg per plate for Salmonella typhimurium TA 102 and 6000 µg per plate for Salmonella typhimurium TA l 00 and T A 98. Positive findings for TA 98 and TA l02 were obtained only with S9 mix. Positive findings for TA l00 were obtained with and without S9 mix, the effects being comparable.
The positive controls sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine, mitomycin C and 2-aminoanthracene had a marked mutagenic effect, as was seen by a biologically relevant increase in mutant colonies compared to the corresponding negative controls.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Additional information
The mutagenic potential of the test material was evaluated in a Salmonella/microsome test with the S. typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 in the presence and absence of S9 mix according to OECD TG 471. Doses up to and including 6000 µg per plate did not cause any bacteriotoxic effects. Total bacteria counts remained unchanged and no inhibition of growth was observed. Evidence of mutagenic activity of the test material was seen. On Salmonella typhimurium TA 102 and TA 98, a biologically relevant increase was found in the mutant count compared to the corresponding negative control. Positive response was found only with S9 mix. For TA 100 there was a positive response without and with S9 mix, and the effect was comparable. The lowest effective dose was 4000 µg per plate for Salmonella typhimurium TA 102 and 6000 µg per plate for TA 100 and TA 98. The Salmonella/microsome test thus showed the test material to have a mutagenic effect.
Justification for selection of genetic toxicity endpoint
The second study is restricted to three Salmonella typhimurium L T2 mutants (strains TA 98; TA 100 and TA 102) which showed a positive response in a previous study (= rel 2, Ames, Herbold 2011)
Justification for classification or non-classification
Based on the available information (restricted to in vitro studies detecting gene mutations in bacteria) a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not required although the test result is positive.
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