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EC number: 692-719-7 | CAS number: 882167-77-3
- 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:
- other information
- Study period:
- Apr 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- 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:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-chloro-N-methylpyridine-2-carboxamide hydrochloride (1:1)
- EC Number:
- 692-719-7
- Cas Number:
- 882167-77-3
- Molecular formula:
- C7 H7 Cl N2 O . Cl H
- IUPAC Name:
- 4-chloro-N-methylpyridine-2-carboxamide hydrochloride (1:1)
Constituent 1
Method
- Target gene:
- Histidine gene locus
Species / strain
- 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, 50, 160, 500, 1600, 5000 µg/plate
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide (TA 100 and TA 1535), 2-nitrofluoren (only TA 98), 4-nitro-1,2-phenylene diamine (only TA 1537), 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, TA 1537 and TA 98 this increase should be about twice that of solvent controls. 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
Results and discussion
Test resultsopen allclose all
- 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:
- cytotoxicity
- Remarks:
- strain-specific bacteriotoxic effect at 1600 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- strain-specific bacteriotoxic effect at 1600 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- strain-specific bacteriotoxic effect at 1600 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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:
- cytotoxicity
- Remarks:
- strain-specific bacteriotoxic effect at 1600 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: strain/cell type: TA 102, TA 1537
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Summary of results from the Salmonella mutagenicity assay (plate incorporation test) with non-purified 4-Chlor-PMA HCl (mean values of revertants per plate)
Dose (µg per plate) |
Without metabolic activation |
||||
|
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
TA 102 |
0 |
8 |
156 |
7 |
23 |
183 |
50 |
7 |
167 |
7 |
32 |
179 |
160 |
8 |
211 |
15* |
63* |
230 |
500 |
8 |
212 |
8 |
65* |
224 |
1600 |
4 |
189 |
7 |
145* |
279* |
5000 |
1 |
76 |
0 |
41 |
417* |
Positive control |
743* |
1234* |
76* |
1008* |
766* |
Dose (µg per plate) |
With metabolic activation (liver S9 mix) |
||||
|
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
TA 102 |
0 |
8 |
279 |
8 |
40 |
309 |
50 |
8 |
289 |
10 |
33 |
314 |
160 |
7 |
276 |
8 |
40 |
346 |
500 |
9 |
209 |
10 |
32 |
311 |
1600 |
5 |
216 |
22* |
41 |
297 |
5000 |
0 | 144 | 5 | 52 | 512* |
Positive control |
31* |
2339* |
77* |
1960* |
650* |
* = mutagenic effect
Doses up to and including 500 µg per plate did not cause any bacteriotoxic effects. At higher doses, the substance had a strain-specific bacteriotoxic effect. This range could be used up to 5000 µg per plate for assessment purposes, strain specifically. Substance precipitation did not occur.
Evidence of mutagenic activity of 4-Chlor-PMA HCl was seen. On Salmonella typhimurium TA 1537, TA 98 and TA 102, a biologically relevant increase was found in the mutant count compared to the corresponding solvent control. The lowest reproducible effective dose was 160 µg per plate for TA 1537 and TA 98 as well as 1600 µg per plate for TA 102. The Salmonella/microsome test thus showed the test item to have a mutagenic effect.
An independent repeat of the test using the preincubation modification was not performed, due to the positive response of the test item.
The positive controls sodium azide, 2-nitrofluoren, 4-nitro-1,2-phenylene diamine, mitomycin C and 2-aminoanthracene increased mutant counts to well over those of the solvent controls, and thus demonstrated the system's sensivity and the activity of the S9 mix.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive - Executive summary:
The mutagenic potential of 4-Chlor-PMA HCl (technical grade, not purified) 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 500 µg per plate did not cause any bacteriotoxic effects. At higher doses, the substance had a strain-specific bacteriotoxic effect. This range could be used up to 5000 µg per plate for assessment purposes, strain specifically. Substance precipitation did not occur. Evidence of mutagenic activity of 4-Chlor-PMA HCl was seen. On Salmonella typhimurium TA 1537, TA 98 and TA 102, a biologically relevant increase was found in the mutant count compared to the corresponding solvent control. The lowest reproducible effective dose was 160 µg per plate for TA 1537 and TA 98 as well as 1600 µg per plate for TA 102. The Salmonella/microsome test thus showed the non-purified test item to have a mutagenic effect.
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