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EC number: 206-496-7 | CAS number: 350-03-8
- 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
Endpoint summary
Administrative data
Description of key information
Acute Toxicity oral: acute oral gavage study, Sprague-Dawley rats, m/f, 0.0312 mL/kg , 0.0442 ml/kg and 0.0625 mL/kg in 10% (v/v) in 0.25% methyl cellulose: LD50 = 57 mg/kg (males), LD50 = 51 mg/kg (females), Toxicity Cat. III
Acute Toxicity oral: acute oral gavage study, wild-trapped birds: LD50 values are for Agelaius phoeniceus (redwinged blackbird): 178 mg/kg bw; Sturnus vulgaris (European starling): 1000 mg/kg bw; Coturnix coturnix (Coturnix): 422 mg/kg bw; Passer domesticus (House sparrow): >1000 mg/kg bw
Acute Toxicity oral: acute oral study, rat: LD50 = 46 µl/kg
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: publication
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well-documented publication, which meets basic scientific principles
- Principles of method if other than guideline:
- The test article was administered by gavage as single doses to groups of young adult Harlan Sprague-Dawley rats (5/sex/group) at three dosage levels ranging from 0.0312 ml/kg to 0.0625 mL/kg.
- GLP compliance:
- not specified
- Test type:
- other: no information available
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Rats were fasted overnight (approximately 18 hours) before dosing
- Route of administration:
- oral: gavage
- Vehicle:
- other: 10% (v/v) in 0.25% methyl cellulose
- Doses:
- 0.0312 mL/kg , 0.0442 ml/kg and 0.0625 mL/kg.
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- The test article was administered by gavage as single doses to groups of young adult Harlan Sprague-Dawley rats (5/sex/group) at three dosage levels ranging from 0.0312 mL/kg to 0.0625 mL/kg. The rats were fasted overnight (approximately 18 hours) before dosing. Dosed rats were observed frequently for signs of toxic effects on the first day of the study and twice a day thereafter except for weekends when the rats were examined for survival. Individual body weights were recorded on the day of dosing, and at 7 and 14 days after dosing. After 14 days, all survivors were sacrificed. Necropsies were performed on all animals that died or were sacrificed.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 57 mg/kg bw
- Based on:
- not specified
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 51 mg/kg bw
- Based on:
- not specified
- Mortality:
- see table 1
- Clinical signs:
- other: Clinical signs included sluggishness, an unsteady gait, gasping, pale extremities, prostration, convulsions, emaciation, a red crust on the perinasal and periocluar fur, and blood in the urine.
- Gross pathology:
- Necropsy of rats that died revealed red and/or mottled lungs, red or brown stomachs, discolored intestines (yellow to red) and dark red livers. Survivors had no remarkable lesions
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The acute oral LD50 was reported as 57 mg/kg (males) and 51 mg/kg (females) in the rat.
- Executive summary:
The test article was administered by gavage as single doses to groups of young adult Harlan Sprague-Dawley rats (5/sex/group) at three dosage levels ranging from 0.0312 mL/kg to 0.0625 mL/kg. The rats were fasted overnight (approximately 18 hours) before dosing. Dosed rats were observed frequently for signs of toxic effects on the first day of the study and twice a day thereafter except for weekends when the rats were examined for survival. Individual body weights were recorded on the day of dosing, and at 7 and 14 days after dosing. After 14 days, all survivors were sacrificed. Necropsies were performed on all animals that died or were sacrificed.
The acute oral LD50 was reported as 57 mg/kg (males) and 51 mg/kg (females) in the rat .
Reference
Table 1 :
Dosage (mL/kg) | Number of rats dosed | Number of Deaths | Days to Death |
0.0625 | 5 M | 5 | 0,0,0,1,1 |
5 F | 5 | 0,1,1,1,1 | |
0.0442 | 5 M | 0 | - - |
5 F | 2 | 2,7 | |
0.0312 | 5 M | 0 | - - |
5 F | 0 | - - |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 51 mg/kg bw
- Quality of whole database:
- There are three studies available on acute oral toxicity, one Klimisch 2 on rats, and two Klimisch 4 on either wild birds and rats. The Klimisch 2 studies reveals very similar LD50 values for male and female rats, and the Klimisch 4 supporting study on rats reveals consistently a similar value. Hence, the result can be considered as sufficiently reliable as they are consistent and plausible, the tonnage-driven data requirements under REACH are fully met, and the database is of good quality.
Additional information
There are three studies available on acute oral toxicity. The most reliable one, assessed with Klimisch 2, which is the best documented, and closest to standard procedures and test animals. The obtained results are LD50 = 57 mg/kg (males), and LD50 = 51 mg/kg (females). Hence, this study should be chosen due to its reliability as the one used for risk assessment, and therein the LD50 value of the more sensitive sex out of precautionary reasons.
The acute oral study on birds may serve as supporting study, as birds are a non-standard species for this endpoint and less relevant for humans than mammals. Besides, the rather high LD50 values (Agelaius phoeniceus (redwinged blackbird): 178 mg/kg bw; Sturnus vulgaris (European starling): 1000 mg/kg bw; Coturnix coturnix (Coturnix): 422 mg/kg bw; Passer domesticus (House sparrow): >1000 mg/kg bw) compared to rats indicate that the chosen key value for risk assessment (LD50 = 51 mg/kg) does not underestimate the potential hazard arising from 3-Acetylpyridine.
The second Klimisch 4 supporting study on rats revealed a LD50 = 46 µl/kg. Taking into account the test item’s density of 1.11, this value corresponds to 51 mg/kg, which is the same value as derived from the key study. Hence, the available values for the more relevant species for human risk assessment are consistent, and there are no indications given that the LD50 = 51 mg/kg is not relevant or may underestimate the hazard arising from 3-Acetylpyridine. So, no data gaps were identified, and no additional testing is required, the tonnage-driven data requirements under REACH are fully met.
LD50
= 51 mg/kg falls in the range of 50 < Category 3 ≤ 300 as indicated by
Regulation (EC) No 1272/2008, and triggers the classification of the
test item as acute toxic Cat. 3.
Justification for selection of acute toxicity – oral endpoint
Most reliable study (Klimisch 2 vs. 4), best documented, and closest
to standard procedures and test animals.
Justification for classification or non-classification
The key value chosen for risk assessment is LD50 = 51 mg/kg, which falls in the range of 50 < Category 3 ≤ 300 as indicated by Regulation (EC) No 1272/2008, and triggers the classification of the test item as acute toxic Cat. 3.
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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