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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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- 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 421 (Reproduction / Developmental Toxicity Screening Test)
- 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
- 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 8 weeks
- Weight at study initiation: 144-171 g (males) and 103-128 g (females) on arrival
- Housing: 2/cage initially in polypropylene cages with stainless steel grid bottoms. A few days prior to mating, males were transferred to individual grid-bottomed cages of similar design. Mated females were transferred to individual solid bottomed cages.
- Diet (e.g. ad libitum): Rat and Mouse Breeder Diet No. 3 SQC (Special Diets Services Ltd., 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 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.
- Details on mating procedure:
- - M/F ratio per cage: 1:1 within the same treatment group
- Length of cohabitation: Maximum of 7 consecutive nights
- Proof of pregnancy: vaginal plug/sperm in vaginal smear referred to as day 0 of gestation - 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 Weeks 3 and 6, triplicate samples of dosing formulation (1 mL) were taken immediately after preparation and stored at 4 ºC prior to analysis at Inveresk.
- Duration of treatment / exposure:
- Males = at least 4 weeks.
Females = treated until termination, commencing 2 weeks prior to mating, then through mating until termination after Day 4 of lactation. - Frequency of treatment:
- Once/day, 7 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 3, 15, or 60 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 10/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
- Parental animals: Observations and examinations:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Every day
BODY WEIGHT: Yes
- Time schedule for examinations: Once during the week prior to the commencement of dosing and once weekly up until Day 10 of the study, and then daily thereafter until termination (males). Once during the week prior to the commencement of dosing and weekly up until day 10 of the study, and then daily thereafter (females). On the day of detection of a positive mating sign (Day 0 of gestation) weights were recorded, followed by Days 7, 14, and 20 of gestation, and then Days 1 and 4 of lactation (where Day 0 = the day of parturition).
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: Visual inspection of the water bottles on a weekly basis throughout the study. - Oestrous cyclicity (parental animals):
- Not examined.
- Sperm parameters (parental animals):
- Not examined.
- Litter observations:
- The females were allowed to litter normally. The day on which parturition commenced was designated Day 0 of lactation. The number of live pups born and the number found dead in each litter was recorded as soon as possible after completion of parturition. The live pups were sexed, counted, examined for the presence of milk in the stomach and for any externally visible abnormalities daily until Day 4 of lactation.
- Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals following 4 weeks of treatment.
- Maternal animals: All surviving animals between Day 4 and Day 7 of lactation.
GROSS NECROPSY
- Gross necropsy consisted of internal examinations including the cranial, thoracic, and abdominal viscera.
HISTOPATHOLOGY / ORGAN WEIGHTS: Conducted on control and high-dose animals only. - Postmortem examinations (offspring):
- Pups were examined for externally visible abnormalities.
- Statistics:
- ANOVA, Kruskal-Wallis, analysis of covariance, and Disher's Eact Probability test were used.
- Reproductive indices:
- Reproductive indices that were examined included fertility index (males and females), gestation index, birth index, live birth index, and viability index.
- Offspring viability indices:
- Viability = Number of live pups on Day 4 of lactation ÷ Number of live pups on Day 0 of lactation.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- not examined
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS): At 60 mg/kg bw/ayd, there was a notable reduction in weight gain in both sexes following the first week of treatment. There was a marginal decrease in weight gain mid-gestation.
ORGAN WEIGHTS (PARENTAL ANIMALS): A statistically significant, dose-related increase in liver weights in both sexes was noted at 15 and 60 mg/kg bw/d.
GROSS PATHOLOGY (PARENTAL ANIMALS): Enlarged liver was noted in 3/10 males at 15 mg/kg bw/day and in 10/10 males at 60 mg/kg bw/day. The livers for these animals were not examined histologically.
OTHER FINDINGS (PARENTAL ANIMALS): Decreased food consumption was evident at 60 mg/kg bw/day following one week of treatment and was considered to be associated with the decreased faecal output noted in all animals.
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 3 mg/kg bw/day (actual dose received)
- Sex:
- male
- Basis for effect level:
- other: Based on statistically significant dose-related increases in liver weight at 15 and 60 mg/kg bw/day and an increase only in relative liver weights at 3 mg/kg bw/day.
- Dose descriptor:
- NOEL
- Effect level:
- 3 mg/kg bw/day (actual dose received)
- Sex:
- female
- Basis for effect level:
- other: Based on statistically significant dose-related increases in liver weights at 15 and 60 mg/kg bw/day.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 15 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: Based on a slight decrease in pup survival at the high-dose of 60 mg/kg bw/day.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
The NOAELs were 3 and 15 mg/kg bw/day in male and female parents and pups, respectively, following oral (gavage) administration of 2 -CP. |
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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