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Diss Factsheets
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EC number: 203-809-9 | CAS number: 110-86-1
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 225
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 555 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- no r-t-r.
- AF for dose response relationship:
- 3
- Justification:
- Less robust study (14 days duration) than 28- or 90-day
- AF for differences in duration of exposure:
- 6
- Justification:
- less than 28
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- accommodated in inhalation calculations
- AF for other interspecies differences:
- 2.5
- Justification:
- pharmacodynamic
- AF for intraspecies differences:
- 5
- Justification:
- individual
- AF for the quality of the whole database:
- 1
- Justification:
- adequate
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 0.33
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.14 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 7 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Absorbed through skin.
- AF for dose response relationship:
- 1
- Justification:
- DR shown in chronic toxicity study
- AF for differences in duration of exposure:
- 1
- Justification:
- 2-year lifetime study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- pharmadynamic
- AF for intraspecies differences:
- 5
- Justification:
- individual
- AF for the quality of the whole database:
- 1
- Justification:
- full dataset for oral toxicity
- AF for remaining uncertainties:
- 1
- Justification:
- no others
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.42 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 0.33
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
The chronic oral/dermal systemic DNEL is 0.14 mg/kg bw/d, based on a NOAEL of 7 mg/kg bw/d from the 2-year NTP chronic bioassay of pyridine in F344 rats, and an AF of 50.
A sub-acute inhalation study of beta-picoline (3-methylpyridine, a member of the Pyridine and pyridine derivatives category), of 14 days duration in rats (Chen and Krauss, 1984) was selected. The LOAEC was 290 ppm, equivalent to 1105 mg/m3. This was determined to be the NOAEC, because a 13 day recovery period demonstrated that effects on liver weight were completely reversible. To the NOAEC are applied two dose modifiers of 0.75 (to convert from a 6 h test exposure to an 8 h workday) and 0.67 (to convert from a resting activity level to an activity level of light exertion). This produces a modified dose descriptor of 555 mg/m3, to which is applied an AF of 225 (2.5 for interspecies (no allometric scaling factor is indicated (Table 8.4, ECHA TGD R.8, 2008)), 5 for intraspecies, 6 for duration, 1 for complete dataset, and 3 for a Dose-Response AF due to a less robust study design and pathology assessment in the 14 day study, compared to a 28-day study.) The DNEC is 2.5 mg/m3. This applies to all members of thePyridine and Pyridine Derivatives Category,an established category accepted by the U.S. Environmental Protection Agency. Category members include pyridine, 2-methylpyridine, 3-methylpyridine and 4-methylpyridine. In support of this DNEC are the results of an additional inhalation study of pyridine toxicity (Watanabe, et.al, 1979), part of the U.S.Voluntary HPV submission package on the Pyridine and Pyridine Derivatives Category, but to which legal access was not able to be obtained. A robust summary of the study is provided as an attachment in IUCLID5, and indicates 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. This results in a DNEC of 6.5 mg/m3, and suggests that the use of the Chen and Krauss study, with the selected AFs, provides values which are sufficiently conservative and valid for determining acceptable levels of exposure.
As pyridine is an irritant to the skin and eye, local effects will be evaluated in a qualitative manner. Risk management measures, such as gloves and goggles/safety glasses, are recommended to minimize the risk of adverse effects of local exposures to pyridine.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.6 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 450
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 276 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- no r-t-r
- AF for dose response relationship:
- 3
- Justification:
- DR Less robust study (14 days duration) than 28- or 90-day
- AF for differences in duration of exposure:
- 6
- Justification:
- less than 28-day duration
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- per ECHA guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- pharmacodynamic
- AF for intraspecies differences:
- 10
- Justification:
- individual variation
- AF for the quality of the whole database:
- 1
- Justification:
- adequate
- AF for remaining uncertainties:
- 1
- Justification:
- no others
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.07 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1 450
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 7 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no r-t-r
- AF for dose response relationship:
- 1
- Justification:
- DR seen in chronic toxicity study
- AF for differences in duration of exposure:
- 1
- Justification:
- 2-year lifetime study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- pharmacodynamic
- AF for intraspecies differences:
- 10
- Justification:
- individual
- AF for the quality of the whole database:
- 1
- Justification:
- full dataset
- AF for remaining uncertainties:
- 1
- Justification:
- no others
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.07 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 7 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no r-t-t
- AF for dose response relationship:
- 1
- Justification:
- DR seen in chronic toxicity study
- AF for differences in duration of exposure:
- 1
- Justification:
- 2-year lifetime study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- pharmacodynamic
- AF for intraspecies differences:
- 10
- Justification:
- individual
- AF for the quality of the whole database:
- 1
- Justification:
- full data set for oral exposure
- AF for remaining uncertainties:
- 1
- Justification:
- no others
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
There are no applications of pyridine or picolines involving the general population, to the knowledge of the manufacturer/importer. The oral DNEL is generated in order to assess risk for man via the environment. Any chemical exposure from the environment would to diluted material, not associated with eye irritation. While the general population may come in contact with pyridine as a component of cigarette smoke, food components or break-down products of flavours/food additives, or pharmaceuticals, these exposures are not derived from industrial sources of pyridine. They are outside the scope of REACH and are considered under the jurisdiction of other regulations. Risk assessment for the general population will not be considered here.
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.