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EC number: 202-864-6 | CAS number: 100-55-0
- 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
Acute oral toxicity:
The LD50 value of the test item was determined to be higher than 2000 mg/kg after single oral administration in female rats.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5 May 2017 - 6 September 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI (Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: 9 weeks
- Weight at study initiation: 155 - 183 g
- Housing: individually in type III Makrolon*1 cages with a shelter on softwood bedding material and a play tunnel
- Diet: ad libitum, V1534, ssniff Spezialdiaten GmbH, Germany)
- Water, ad libitum, community water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.8 - 23.3
- Humidity (%): 38.1 - 78.6 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- CLASS METHOD
- Rationale for the selection of the starting dose: existing information concerning the toxic potential of pyridine (Smyth, 1951 and Anderson, 1987) - Doses:
- 300 mg/kg bw and 2000 mg/kg bw
- No. of animals per sex per dose:
- 300 mg/kg bw: 2 x 3
2000 mg/kg bw: 6 - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations once daily, weighing on day 1 (before treatment), 2, 4, 6, 8, 11, 13 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, pathology - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was seen.
- Clinical signs:
- All rats treated with 2000 mg/kg bw showed locomotor disturbance and piloerection on day 1 which started 2 hours after treatment.
- Body weight:
- There were no effects on the body weight development throughout the study.
- Gross pathology:
- No organ alterations were identified during the gross pathological examination.
- Other findings:
- No other findings.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 value of the test item was determined to be higher than 2000 mg/kg bw after single oral administration in female rats.
- Executive summary:
The objective of the study according to OECD guidline 423 was to identify potential toxic effects of the test item after single oral administration to rats in a stepwise procedure. The study was started with 300 mg/kg bw in 3 female rats, continued with further 3 females treated with 300 mg/kg bw. Due to the fact, that no mortality was seen after treatment with 300 mg/kg bw, 6 further females were treated with 2000 mg/kg bw. Mortality and clinical signs were monitored for at least 6 hours after administration and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period, all surviving rats were sacrificed and subjected to a detailed necropsy.
No mortality occurred during the course of this study. All rats treated with 2000 mg/kg bw showed locomotor disturbance and piloerection on day 1 which started 2 hours after treatment. The body weight development was inconspicuous throughout the study.The gross pathological examination revealed no organ alterations. The LD50 value of the test item was determined to be higher than 2000 mg/kg bw after single oral administration in female rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral toxicity:
The objective of the study according to OECD guidline 423 was to identify potential toxic effects of the test item after single oral administration to rats in a stepwise procedure. The study was started with 300 mg/kg in 3 female rats, continued with further 3 females treated with 300 mg/kg. Due to the fact, that no mortality was seen after treatment with 300 mg/kg, 6 further females were treated with 2000 mg/kg. Mortality and clinical signs were monitored for at least 6 hours after administration and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period, all surviving rats were sacrificed and subjected to a detailed necropsy.
No mortality occurred during the course of this study. All rats treated with 2000 mg/kg showed locomotor disturbance and piloerection on day 1 which started 2 hours after treatment. The body weight development was inconspicuous throughout the study.The gross pathological examination revealed no organ alterations. The LD50 value of the test item was determined to be higher than 2000 mg/kg after single oral administration in female rats.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. Based on this data, the substance is not considered not to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EC) No 2017/776.
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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