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EC number: 269-929-9 | CAS number: 68391-11-7 The complex combination of polyalkylated pyridines derived from coal tar distillation or as high-boiling distillates approximately above 150°C (302°F) from the reaction of ammonia with acetaldehyde, formaldehyde or paraformaldehyde.
- 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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- - Name of test material: Pyridine, alkyl derivs.
Constituent 1
Method
- Target gene:
- Cultures of the histidine-dependent strains of Salmonella typhimurium were derived from cultures provided by Prof. Bruce Ames, University of California. The characteristics of the individual strains are as follows:
TA 1535: contains a histidine missense mutation but is also deficient in a DNA repair system (uvrB) and has a defective lipopolysaccharide coat on the cell wall. It is reverted by many agents causing base-pair substitutions, but is not sensitive to frameshift mutagens.
TA 1537: bears a histidine frameshift mutation. Like TA 1535, it is defective in a DNA repair system and lipopolysaccharide coat. It is sensitive to agents causing frameshift mutations involving insertion or deletion of a single base-pair.
TA 1538: contains another histidine frameshift mutation. Again it has a defective DNA repair system and lipopolysaccharide coat. It is reverted by agents causing deletion of two adjacent base-pairs (double frameshift mutations).
TA 100: is the same as TA 1535 but contains a resistance transfer factor conferring ampicillin resistance and increasing sensitivity to some mutagens (plasmid pKM 101). In addition to base-pair substitutions, it is also able to detect certain frameshift mutagens.
TA 98: is TA 1538 with the addition of the pKM 101 plasmid. It is reverted by a variety of mutagens, but not by simple alkylating agents causing base-pair substitutions.
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 100 and TA 98
- Details on mammalian cell type (if applicable):
- CULTURE
- Type and identity of media: Cultures of all organisms were prepared by overnight incubation of nutrient broth (Oxoid No.2) freshly inoculated from a frozen culture stock.
- Properly maintained: Yes
CHECKING OF TESTER STRAINS
New batches of frozen culture stocks, stored at -80 °C, are prepared at intervals from a central stock held in a liquid nitrogen refrigerator. Samples from each new batch are thawed at least 24 hours after freezing and checked for appropriate amino acid requirement and characteristic spontaneous reversion rate.
The Salmonella strains are checked by testing for growth inhibition in spot tests with:
- crystal violet inhibition zone > 14 mm in diameter when 10 ul of a 1 mg/mL crystal violet solution is spotted onto plate center indicates possession of the deep-rough (rfa) character.
- mitomycin C inhibition zone> 20 mm in diameter when 10 ul of a 0.1 mg/mL mitomycin C solution is spotted onto plate center indicates a defective DNA repair system (uvrB).
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver microsomal fractions
- Test concentrations with justification for top dose:
- Preliminary toxicity test 1: 5, 50, 500, 5000 ug/plate
Preliminary toxicity test 2: 2.5, 25, 250, 2500 ug/plate
Main test 1: 2.5, 7.9, 25, 79, 250 ug/plate
Main test 2: 15, 25, 50, 79, 150 ug/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Aceton, solutions were freshly prepared immediately before use
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- 9-aminoacridine
- sodium azide
- other: ampicillin
- Remarks:
- with and without S-9 mix where appropriate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- An aliquot (0.1 mL) of each concentration of test item was placed in a sterile tube. Molten, histidine-deficient top-agar (2 mL) and bacterial suspension (0.1 mL), maintained at 45 °C, was then added. The tubes were mixed by inversion and 0.5 mL rat liver microsomal preparation (S-9 mix) was added where appropriate. The tubes were again inverted to mix thoroughly and the contents poured onto plates containing solidified minimal medium (20 mL). Further plates were prepared without the inclusion of the test organisms to verify the sterility of the S-9 mix and the test material. A control series of plates was prepared to confirm the inability of acetone (0.1 mL) to induce reversion in the bacterial strains, and to provide a measure of the spontaneous mutation rates. Aliquots (0.1 mL) of a 1.0E-06 dilution of culture were spread on the surface of plates of complete medium to measure the viability and cell-density of each culture.
DURATION
- Exposure duration: 2 days
NUMBER OF REPLICATIONS: 2 independent occasions (main test 1 and main test 2) with 3 replicates each
DETERMINATION OF CYTOTOXICITY
- Present bacterial growth (background lawn)
- Slightly thin bacterial growth (background lawn)
- Thin bacterial growth (background lawn)
- Absent bacterial growth (background lawn) - Evaluation criteria:
- The test material may be considered to be positive in this test system if the following criteria are met:
The test material should have induced a reproducible, dose-related and significant increase in the revertant count in at least one strain of bacteria.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 100 and TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Thinning of the background lawn of non-revertant cells
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
- The lowest level of test item causing visible thinning of the background lawn of non-revertant cells was 250 ug per plate. This was therefore selected as the top exposure level for use in the first main test.
MAIN TEST
- Small, but dose-related, increases in reversion to prototrophy were obtained with the test item in strains TA 98 and TA 1538 in the presence of S-9 mix. Increases in revertant colony numbers over control counts reached 1.5- and 1.9-fold (TA 98) and 2.2- and 2.3-fold (TA 1538) in tests 1 and 2 respectively. Maximal increases were obtained at 79 ug/plate (50 ug/plate in test 2 with TA 1538). Inhibition of growth, observed as slight thinning of the background lawn of non-revertant cells, occurred in all strains following exposure to the test item at 250 ug per plate. - 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):
positive
It was concluded that the test item exhibited mutagenic activity under the conditions of the test, inducing frameshift mutations following metabolic activation. - Executive summary:
The test item was examined for mutagenic activity in five histidine-dependent auxotrophs of Salmonella typhimurium, strains TA 98, TA 1538, TA 100, TA 1535 and TA 1537, using pour-plate assays. The procedures used complied with EU Method B.13/14, OECD Guideline 471 (Reverse Bacteria Mutation Test) and EPA OPPTS 798.5265. Each test, in each strain, was conducted on two separate occasions.
The studies, which were conducted in the absence and presence of an activating system derived from rat liver (S-9 mix), employed a range of levels from 2.5 to 250 ug per plate on the first occasion of testing, selected following a preliminary toxicity test in strain TA 98, included solvent (ethanol) controls with and without S-9 mix. The levels employed on the second occasion of testing were from 15 to 150 ug per plate, selected to investigate an observed increase in revertant colony numbers.
Small, but dose-related, increases in reversion to prototrophy were obtained with the test item in strains TA 98 and TA 1538 in the presence of S-9 mix. Increases in revertant colony numbers over control counts reached 1.5- and 1.9-fold (TA 98) and 2.2- and 2.3-fold (TA 1538) in tests 1 and 2 respectively. Maximal increases were obtained at 79 ug/plate (50 ug/plate in test 2 with TA 1538). Inhibition of growth, observed as slight thinning of the background lawn of non-revertant cells, occurred in all strains following exposure at 250 ug per plate.
Marked increases in the number of revertant colonies were induced by the known mutagens benzo[a]pyrene, 2-nitrofluorene, 2-aminoanthracene, 9-aminoacridine and sodium azide when examined under similar conditions.
It was concluded that the test item exhibited weak mutagenic activity under the conditions of the test, inducing double frameshift mutations following metabolic activation.
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.
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