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EC number: 203-643-7 | CAS number: 109-06-8
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reliable with restrictions; acceptable, well- documented study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- Deviations:
- yes
- Remarks:
- 14 days of exposure, 14 days of recovery
- GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Reference substance name:
- 3-methylpyridine
- EC Number:
- 203-636-9
- EC Name:
- 3-methylpyridine
- Cas Number:
- 108-99-6
- IUPAC Name:
- 3-methylpyridine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Rats were eight weeks old and weighing between 211 to 240 g.
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- One group was exposed nose-only, six hours/day, five days/week for two weeks at a concentration of 290 ppm. One group was exposed simultaneously to air only. Five rats per group were sacrificed after the tenth exposure for pathologic examination and five rats per group were allowed to recover for 13 days post exposure.
- Duration of treatment / exposure:
- 6 hours/day, 5 days/week for 14 days.
- Frequency of treatment:
- Once daily, 6 hours/day, 5 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
290 ppm
Basis:
nominal conc.
- No. of animals per sex per dose:
- 10 per sex per group.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- 290 ppm is equivalent to 1105 mg/m3 of 3-methylpyridine, with a molecular weight of 93.
Examinations
- Observations and examinations performed and frequency:
- Rats were weighed and observed daily throughout the exposure and recovery periods, weekends excluded
- Sacrifice and pathology:
- Organs and tissues examined were the heart, lungs, nasal cavities, trachea, liver, pancreas, esophagus, stomach, duodenum, jejunum, ileum, cecum, colon, kidneys, urinary bladder, bone marrow (sternal), spleen, thymus, mesenteric lymph nodes, thyroid, testes, epididymides, adrenal glands, brain and eyes. Mean organ weights and organ-to-body ratios were calculated for the heart, lungs, liver, spleen, kidneys, testes and thymus.
- Other examinations:
- At the end of the exposure period, blood and urine samples were collected for clinical analysis. Urine samples were collected overnight from ten rats per group prior to the first exposure and after the ninth exposure and from five rats per group on the twelfth day of recovery. Samples were analyzed for volume, osmolality, pH, blood, sugar, protein, bilirubin, urobilinogen and ketone. Each specimen was noted for color and transparency and the sediment from each sample was examined microscopically. Tail blood samples were collected from ten rats per group prior to the first exposure and after the tenth exposure and from five rats per group on the thirteenth day of recovery. Samples were analyzed for erythrocyte count, hemoglobin concentration, mean corpuscular volume, platelet count, leukocyte count and relative numbers of neutrophils, band neutrophils, lymphocytes, atypical lymphocytes, eosinophils, monocytes and basophils. Hematocrit, mean corpuscular hemoglobin and mean corpuscular hemoglobin concentration were calculated from the erythrocyte data. In addition, serum activities of alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase and serum concentrations of urea nitrogen, creatinine, total protein and cholesterol were measured.
- Statistics:
- Least Significant Difference test and Dunnett’s test
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Rats exposed to 290 ppm of the test substance had elevated mean liver weights and liver-to-body weight ratios compared to controls. This change was absent after 13 days of recovery.
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- The only significant finding after exposure of male rats to 290 ppm of the test substance was elevated mean liver weights and liver-to-body weight ratios compared to controls. This effect resolved after 13 days of recovery. There were no significant findings on body weight, food consumption, haematology, clinical chemistry, gross or histopathology.
Effect levels
- Dose descriptor:
- NOAEC
- Effect level:
- > 290 ppm
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: see 'Remark'
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
An additional inhalation study of pyridine toxicity (Watanabe, et.al, 1979) is known to exist as part of the U.S.Voluntary HPV submission package on the Pyridine and Pyridine Derivatives Category (See: http://www.epa.gov/chemrtk/hpvis/hazchar/Category%20Pyr%20and%20Pyr%20Derivs_Sept2009.pdf.) However, legal access to refer to the findings of this study was not able to be arranged. A publically-available robust summary of the study is provided as an attachment here. The conclusion of this 1979 subchronic study is that the NOAEC in CD rats after a 6-month inhalation study (6 hr/day, 5 days/week) is >100 ppm or 323 mg/m3, the highest concentration tested. This is consistent with the NOAEC seen herein, in the shorter Chen and Krauss study, of 290 ppm or 1105 mg/m3.
This assessment from read-across from 3 -Methylpyridine (the registered substance), applies to all members of the chemical category. The category of pyridine and methyl pyridine derivatives is comprised of: pyridine, 2-methylpyridine, 3-methylpyridine and 4-methylpyridine. The basis of the category is structural similarity (based on the pyridine unsaturated ring structure) and similar physical properties, environmental fate and ecotoxicity, and mammalian toxicity. Similar toxicological properties derive from similar physical-chemical properties and common pathways of metabolism and elimination among all members of the category. This category is accepted by the U.S. Environmental Protection Agency (EPA).
Applicant's summary and conclusion
- Conclusions:
- Alpha picoline (2-methyl pyridine) is a member of a chemical category including pyridine and pyridine derivatives. The effect of 14-days of inhalatory exposure (nose-only) to 290 ppm (1105 mg/m3) of 3-methylpyridine in male rats was investigated. The only finding was an elevated mean liver weights and liver-to-body weight ratios compared to controls, which resolved after 13 days of recovery. The NOEC was greater than 1105 mg/m3. Reading-across from 3-methylpyridine to this substance is valid for the purposes of classification and risk assessment.
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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