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Diss Factsheets
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EC number: 435-030-7 | CAS number: -
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- other: ICH Harmonised Tripartite Guideline S2A. Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals
- Qualifier:
- according to guideline
- Guideline:
- other: ICH Harmonised Tripartite Guideline S2B. Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 435-030-7
- EC Name:
- -
- Cas Number:
- 26452-81-3
- Molecular formula:
- C5H5N2OCl
- IUPAC Name:
- 4-chloro-6-methoxypyrimidine
- Test material form:
- other: solid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100, E. coli WP2 and WP2 uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital/beta-naphthoflavone-induced rat liver S9-mix
- Test concentrations with justification for top dose:
- 5000, 2500, 1000, 500, 200, 100 µg/plate
- Vehicle / solvent:
- - Vehicle/solvent used: DMSO
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- all Salmonella strains and E.Coli WP2 with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- strain E.Coli WP2 uvrA with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Daunomycin HCl
- Remarks:
- Strain: Salmonella TA98 without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Strain: E.Coli WP2 uvrA, without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- Strain: E.Coli WP2P, without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: acridine mutagen ICR 191
- Remarks:
- Strain: Salmonella TA1537, without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Strains: Salmonella TA1535 and TA100, without metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar plate incorporation; preincubation
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 3 days
NUMBER OF REPLICATIONS: tests performed in triplicate
DETERMINATION OF CYTOTOXICITY
- Method: not stated - Evaluation criteria:
- - Test data from individual experiments are considered valid if: a) the concurrent solvent control data are acceptable; b) the positive control data show unequivocal positive responses;
- Failure of one or more tester strain/S9 combinations does not invalidate the data for the remainder of a concurrent experiment.
- A positive response in a (valid) individual experiment is achieved when one or both of the following criteria are met: a) a statistically significant dose-related increase in the mean number of revertant colonies is obtained; b) a two-fold or greater increase in the mean number of revertant colonies (over that observed for the concurrent solvent control plates) which is statistically significant, is observed at one or more concentrations.
- A negative result in a (valid) individual experiment is achieved when: a) there is no statistically significant dose-related increase in the mean number of revertant colonies per plate observed for the test substance; and b) in the absence of any such dose response, no increase in colony numbers is observed (at any test concentration) which exceeds 2x the concurrent solvent control.
- For a positive response in an individual experiment to be considered indicative of an unequivocal positive, i.e. mutagenic, result for that strain/S9 combination, then the observed effect(s) must be consistently reproducible. - Statistics:
- An assessment of statistical significance was carried out using a one-tailed Student's t-test (Ehrenberg 1984). The corresponding probability for each dose level was derived by computer using the appropriate degrees of freedom.
Results and discussion
Test results
- 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:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- None - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
Under the conditions of this assay, the test substance gave a negative, i.e. non-mutagenic response in S.typhimurium strains TA1535, TA1537, TA98 and TA100 and E.coli strains WP2 and WP2 uvrA in both the presence and absence of S9-mix. - Executive summary:
In a GLP compliant bacterial mutagenicity assay (Ames test), performed according to OECD 471, using four Salmonella typhimurium strains (TA 1535, TA 1537, TA 98, and TA 100) and two E. Coli strains (WP2 and WP2 uvrA) the test substance was evaluated at concentrations of 100, 200, 500, 1000, 2500, and 5000 µg per plate in the presence and absence of rat liver derived metabolic activation system (S9-mix). In two separate experiments (one plate incorporation test and one pre-incubation test), the test substance did not induce any significant, reproducible increases in the observed numbers of revertant colonies in any of the strains used, either in the presence or absence of S9-mix.The sensitivity of the test system, and the metabolic activity of the S9-mix, were clearly demonstrated by the increases in the numbers of revertant colonies induced by positive control substances. It is concluded that, under the conditions of this assay, the test substance gave a negative, i.e. non-mutagenic response in S.typhimurium strains TA1535, TA1537, TA98 and TA 100 and E.coli strains WP2 and WP2 uvrA in both the presence and absence of S9-mix.
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