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Diss Factsheets
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EC number: 203-636-9 | CAS number: 108-99-6
- 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
Description of key information
non-sensitising
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- existing in vivo data which predates adoption of REACH and its supplemental regulations
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Information comes from a submission of a collection of acute toxicity data to the U.S. EPA, and provides little documentation. The studies use older protocols using guinea pigs; they predate the adoption of the REACH legislation and the development of the LLNA and in vitro methods.
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Precedes establishment of guideline and GLP. It is assumed that this scientific study was performed according to the accepted standards of its day.
- GLP compliance:
- no
- Type of study:
- other: guinea pig
- Justification for non-LLNA method:
- The studies use older protocols using guinea pigs; they predate the adoption of the REACH legislation and the development of the LLNA and in vitro methods.
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Assume 0 sensitised of at least 3 animals at 24 h reading
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The dermal sensitisation properties of the category substance pyridine were studied in the guinea pig, and pyridine was found to be a non-sensitiser. This read-across approach is valid for the purposes of classification and labelling, and for risk assessment. Additionally, appropriate risk management measures for a corrosive substance are protective of workers.
Reference
Not sensitising in guinea pigs.
As dermal irritation and toxicity of pyridine in guinea pigs was well studied and reported, it is anticipated that the dosage was appropriately chosen for this sensitisation study.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
3 -Methylpyridine was evaluated in a weight of evidence approach to sensitisation, relying on a category member, pyridine (CAS 110 -86 -3). Pyridine was found in a reputable industry laboratory to be non-sensitising in guinea pigs (Anonymous, Eastman Kodak Company, 1978. Pyridine was included in the validation data set for the ICCVAM Local Lymph Node Assay, and was found to be a weak sensitiser. The authors of the ICCVAM study noted that this positive result was unexpected, and may be due to high experimental doses associated with irritation. There is little human evidence that pyridine is a sensitiser. In accordance with the harmonized classifications of three of the category members according to Regulation (EC) No. 1272/2008, Annex VI, Indices # 613-002-00-7, 613 -036 -00 -2 (2 -methylpyridine) and 613 -037 -00 -8 (4 -methylpyridine), the registered substance, 3 -methylpyridine, is not classified as a dermal sensitiser.
Migrated from Short description of key information:
This substance is judged by a weight of evidence approach to be non-sensitising to the skin.
Justification for selection of skin sensitisation endpoint:
Experimental results on a read-across substance
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No data available
Migrated from Short description of key information:
There is no evidence of respiratory sensitisation.
Justification for classification or non-classification
Using data from a structurally similar substance in a chemical category, sensitisation was evaluated for 3 -methylpridine. The analogue, pyridine, is not sensitising in the guinea pig, nor has human experience demonstrated sensitisation in manufacturing plant workers. A local lymph node assay showed a weak positive which was unexpected to the authors, but this may be due to doses higher than usual. In the absence of firm data to the contrary, pyridine is a non-sensitiser.
There are harmonized classifications for three of the four members of the Pyidine and Pyridine Derivatives Category. In Regulation (EC) No. 1272/2008, Annex VI, none of the category members are classified as sensitisers: Pyridine (Index #613-002-00-7, 2-methylpyridine (Index # 613-036-00-2) and 4-methylpyridine (Index # 613-037-00-8). Similarly, we evaluate 3 -methylpyridine to be a non-sensitiser.
3 -Methylpyridine is corrosive to the skin and eyes. Risk managment measures are indicated for corrosion which will minimize skin contact and be sufficiently protective of workers regarding sensitisation.
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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