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EC number: 203-646-3 | CAS number: 109-09-1
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented, according to accepted guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 2-chloropyridine
- EC Number:
- 203-646-3
- EC Name:
- 2-chloropyridine
- Cas Number:
- 109-09-1
- Molecular formula:
- C5H4ClN
- IUPAC Name:
- 2-chloropyridine
- Details on test material:
- - Name of test material (as cited in study report): Pyridine, 2-Chloro
- Physical state: Colourless liquid
- Analytical purity: 99.7%
- Lot/batch No.: 2RC328562
- Expiration date of the lot/batch: 07 April 2004
- Stability under test conditions: Stability data indicates an 8-day shelf life
- Storage condition of test material: Stored in the dark at ambient room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, Kent, England
- Age at study initiation: Approximately 6 weeks
- Weight at study initiation: 79-94 g (males) and 70-86 g (females) at arrival
- Housing: 1/cage by sex and dose group in suspended polypropylene cages with stainless steel grid tops
- Diet (e.g. ad libitum): Rat and Mouse No. 1 Expanded SQC Diet (Special Diets Services Limited, Stepfield, Witham, Essex) ad libitum
- Water (e.g. ad libitum): Domestic mains water ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ºC ± 2 ºC
- Humidity (%): 50% ± 15%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours:12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- maize oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Prepared by adding appropriate weighed quantities of test item to measured volumes of a vehicle (maize oil) and mixing by manual inversion and sonication until visibly homogenous.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples of dosing formulations were analysed with regard to concentration and homogeneity. From day 1 formulations and during Week 4, triplicate samples of dosing formulation (1 mL) were taken immediately after preparation and stored in the dark at ambient temperature prior to analysis at Inveresk.
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- Once/day, 7 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 2, 10, or 45 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 5/sex/group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Doses were selected following evaluation of existing toxicological data.
- Positive control:
- Not required.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Once during the pre-treatment week and weekly thereafter.
BODY WEIGHT: Yes
- Time schedule for examinations: Twice during the week prior to commencement of dosing, and then daily from the start of dosing.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: Monitored by visual inspection of the water bottles on a weekly basis.
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: During pre-trial and after approximately 4 weeks of dosing.
- Dose groups that were examined: All control and high-dose animals.
HAEMATOLOGY: Yes
- Time schedule for collection of blood: During Week 4.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: During Week 4.
URINALYSIS: Yes
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: Once during the pre-treatment week (Week -1) and weekly thereafter
- Dose groups that were examined: All animals - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- "F-max" test, ANOVA, Student's t-test, Fisher's Exact Probability, and Kruskal-Wallis ANOVA were used.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY: No premature deaths at any dose level. At 45 mg/kg bw/day, subdued behaviour was observed in all animals on the first day of treatment. Other findings noted at the onset of treatment at this level included, but were not limited to, subdued behaviour, piloerection, irregular/slow respiration, clear discharge around eyes and partially closed eyes. The onset of all these signs generally occurred 2 hours after the dose and remained until the end of the working day when the last examination was made. In addition, at the 45 mg/kg bw/day level, salivation was evident in 5/5 males and 4/5 females, with staining around the mouth/muzzle in 4/5 males and 2/5 females.
BODY WEIGHT AND WEIGHT GAIN: At 45 mg/kg bw/d, weight loss was evident in all animals after one dose. From Day 2 of treatment, weight gain in both sexes was essentially comparable to that of the controls throughout the remainder of the study.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): At 45 mg/kg bw/d, there was a notable reduction in food consumption over Days 0to 4 of treatment in males and females; consumption thereafter was essentially similar to that of controls.
HAEMATOLOGY: A slight, statistically significant decrease in haemoglobin was noted in both sexes receiving 45 mg/kg bw/day. A marginal, but dose-related decrease in mean cell haemoglobin concentration in females attained statistical significance at 10 and 45 mg/kg bw/day. Red cell morphology generally demonstrated moderate to marked polychromasia, but in males treated at 45 mg/kg bw/day, marked polychromasia was seen in all animals.
CLINICAL CHEMISTRY: At 45 mg/kg bw/day, there was a statistically significant increase in total bilirubin and calcium in males. Increased total protein, albumin, and cholesterol levels achieved statistical significance in both sexes treated at 45 mg/kg bw/day and in males treated at 10 mg/kg bw/day.
NEUROBEHAVIOUR: Slight increases in piloerection (2/5 males and 2/5 females) and altered gait (4/5 males and 3/5 females) treated at 45 mg/kg bw/day. Slightly increased alertness was also observed in the arena especially in males at this level, but the opposite was true for the cage side observations. A slight, statistically significant increase was noted in the incidences of rearing in males treated at 45 mg/kg bw/day during Week 4 of the study and also a slight decrease in latency and a slight increase in number of sectors traversed.
ORGAN WEIGHTS: At 45 mg/kg bw/day, there was a statistically significant increase in liver weights in males and females and, at 10 mg/kg bw/day, an increase in liver weights was noted in females.
HISTOPATHOLOGY: NON-NEOPLASTIC: Centrilobular hypertrophy was noted in 1/5 males treated with 10 mg/kg bw/d and 4/5 males and 4/5 females treated with 45 mg/kg bw/d.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 2 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: Based on increases in plasma levels of total bilirubin, albumin, and cholesterol, as well as an increase in centrilobular hypertrophy and increased liver weight at 10 and 45 mg/kg bw/day.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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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