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EC number: 214-333-6 | CAS number: 1121-60-4
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 August - 04 October 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom
- Limit test:
- no
Test material
- Reference substance name:
- Pyridine-2-carbaldehyde
- EC Number:
- 214-333-6
- EC Name:
- Pyridine-2-carbaldehyde
- Cas Number:
- 1121-60-4
- Molecular formula:
- C6H5NO
- IUPAC Name:
- pyridine-2-carbaldehyde
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report) : Pyridine-2-aldehyde
- Physical state : light yellow liquid
- Analytical purity : no data
- Lot/batch No. : 0610404
- Storage condition of test material : room temperature , in the dark until 31 July 2001 , thereafter approximately 4°C , under nitrogen , in the dark.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley Crl:CD® (SD) IGS BR strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source : Charles River (UK) Ltd, Margate, Kent
- Age at study initiation : 8 - 12 weeks
- Weight at study initiation : male : 281-324g , female : 221-252g
- Fasting period before study : no
- Housing : The animals were housed in groups of five by sex in solid-floor polypropylene cages with stainless steel lids, furnished with softwood flakes (Datesand Ltd., Cheshire, UK) and provided with environmental enrichment aids: wooden chew blocks (B & K Universal Ltd, Grimston, Hull,UK) and cardboard “fun tunnels” (Datesand Ltd., Cheshire, UK))
- Diet : Rat and Mouse Expanded Diet No.1 (Special Diets Services Limited, Witham, Essex, UK) , ad libitum with exception of the exposure period
- Water : mains drinking water ,ad libitum with exception of the exposure period
- Acclimation period : at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C) : 21°C , +/-2°C
- Humidity (%) : 55% , +/-15%
- Air changes (per hr) : at least 15
- Photoperiod (hrs dark / hrs light) : 12/12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: Compressed air , supplied by means of an oil free compressor and passed through a water trap and respiratory quality filters
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus : glass concentric jet nebuliser (Radleys, Saffron Walden, Essex, UK) located at the top of the exposure chamber. The nebuliser was connected to a glass syringe attached to an infusion pump, which provided a continuous supply of test material under pressure, and to a metered compressed air supply.
- Exposure chamber volume : approximately 30l
- Method of holding animals in test chamber : Each rat was individually held in a tapered, polycarbonate restraining tube fitted onto a single tier of the exposure chamber and sealed by means of a rubber ‘O’ ring .
- Source and rate of air :Compressed air . Chamber air flow rates ranged from 20 to 28 L/min dependent on concentration, providing 40 to 56 air changes per hour .
- Method of conditioning air : Compressed air was supplied by means of an oil free compressor and passed through a water trap and respiratory quality filters.
- System of generating particulates/aerosols : The test material was aerosolised using a glass concentric jet nebuliser (Radleys, Saffron Walden, Essex, UK)
- Method of particle size determination : The particle size of the generated atmosphere inside the exposure chamber was determined three times during each exposure period using a Marple Personal Cascade Impactor (Schaefer Instruments Ltd, Oxon., UK). This device consisted of six impactor stages (9.8, 6.0, 3.5, 1.55, 0.93 and 0.52 μm cut points) with stainless steel collection substrates and a back up glass fibre filter, housed in an aluminium sampler. The sampler was temporarily sealed in a sampling port in the animals’ breathing zone and a suitable, known volume of exposure chamber air was drawn through it using a vacuum pump . The collection substrates and backup filter were weighed before and after sampling and the weight of test material, collected at each stage, calculated by difference
- Treatment of exhaust air : The extract from the exposure chamber passed through a ‘scrubber’ trap and was connected with a high efficiency filter to a metered exhaust system
- Temperature, humidity, pressure in air chamber : The temperature and relative humidity inside the exposure chamber were measured by an electronic thermometer/humidity meter (Hanna Instruments Ltd, Beds., UK) located in a vacant port in the animals’ breathing zone of the chamber and recorded every thirty minutes throughout the four-hour exposure period .The chamber was maintained under negative pressure.
TEST ATMOSPHERE
- Brief description of analytical method used : The actual chamber concentration was measured at regular intervals during each exposure period . The gravimetric method used employed glass fibre filters (Gelman type A/E 25 mm) placed in a filter holder. The holder was temporarily sealed in a vacant port in the exposure chamber in the animals’ breathing zone and a suitable, known volume of exposure chamber air was drawn through the filter using a vacuum pump . Each filter was weighed before and after sampling in order to calculate the weight of collected test material. The difference in the two weights, divided by the volume of atmosphere sampled, gave the actual chamber concentration . The nominal chamber concentration was calculated by dividing the mass of test material used by the total volume of air passed through the chamber.
- Samples taken from breathing zone: yes
VEHICLE
- Concentration of test material in vehicle : mean achieved atmosphere concentrations : 0.74 , 1.89 and 5.23 mg/l
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution:
- Dose group 1 (Atmosphere concentration : 5.23 mg/l) : MMAD = 1.61 µm ; GSD = 1.51 ; Predicted amount less than 4µm = 98.6%
- Dose group 2 (Atmosphere concentration : 1.89 mg/l) : MMAD = 3.16 µm ; GSD = 1.99 ; Predicted amount less than 4µm = 63.4%
- Dose group 3 (Atmosphere concentration : 0.74 mg/l) : MMAD = 2.30 µm ; GSD = 1.99 ; Predicted amount less than 4µm = 78.8% - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- mean achieved atmosphere concentrations : 0.74 , 1.89 and 5.23 mg/l
- No. of animals per sex per dose:
- 5 males/5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration : 14 days
- Frequency of observations and weighing : All animals were observed for clinical signs at hourly intervals during exposure, immediately on removal from the restraining tubes at the end of exposure, one hour after termination of exposure and subsequently once daily for up to fourteen days . Individual bodyweights were recorded prior to treatment on the day of exposure and on Days 7 and 14 or at death
- Necropsy of survivors performed : yes - Statistics:
- Using the mortality data obtained, an estimate of the acute inhalation median lethal concentration (LC50) and 95% confidence limits of the test material were calculated using validated toxicity data analysis software (ToxCalc v5.0 (Tidepool Scientific Software, McKinleyville, Ca, USA)). The female and all-animal LC50’s were calculated by the Maximum Likelihood Regression Method (Finney, 1971) whilst the male LC50 was calculated by the Trimmed Spearman-Karber Method (Hamilton et al, 1977).
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 0.8 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: 95% confidence limit not calculable
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 2.53 mg/L air (analytical)
- Based on:
- test mat.
- 95% CL:
- >= 1.65 - <= 3.87
- Exp. duration:
- 4 h
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- 0.23 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: 95% confidence limit not calculable
- Mortality:
- see Table 1 at "Overall remarks, attachments"
- Clinical signs:
- other: Signs of hunched posture, pilo-erection and red/brown staining around the snout are commonly seen in animals for short periods on removal from the chamber following 4-hour inhalation studies. Wet fur and fur stained by test material are commonly recorded
- Body weight:
- One male and two females showed reduced bodyweight development during Week 1 but normal bodyweight development was noted for most surviving animals during the study.
- Gross pathology:
- With the exception of an isolated instance of dark foci of the lungs, no macroscopic abnormalities were detected amongst surviving animals at terminal kill.
For animals that died or were humanely killed during the course of the study, the following abnormalities were detected:
Lungs – enlarged, pale, abnormally red, abnormally dark;
Liver – dark, accentuated lobular pattern;
Stomach – gaseous distension.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The study was performed according to the OECD TG403 without deviations and therefore considered to be of the highest quality (reliability Klimisch 1). The validity criteria of the test system are fulfilled.
The acute inhalation median lethal concentrations (LC50) and 95% confidence limits of Pyridine-2-aldehyde in the Sprague-Dawley Crl:CD® (SD) IGS BR strain rat, were estimated to be:
All animals : 0.80 (non-calculable) mg/l
Males only : 2.53 (1.65 – 3.87) mg/l
Females only : 0.23 (non-calculable) mg/l
An aerosol has been tested and hence, for classification the following criteria for dusts and mists are applicable:
Category 1 LC50 < 0.05 mg/L
Category 2 0.05 mg/L < LC50 ≤ 0.5 mg/L
Category 3 0.5 mg/L < LC50 ≤ 1.0 mg/L
Category 4 1.0 mg/L < LC50 ≤ 5.0 mg/L
Taking into account the lowest LC50 (all animals) of 0.8 mg/L, the substance has to be classified as Acute Tox. 3 for inhalation. - Executive summary:
The acute inhalation toxicity of the test material was investigated in rats of both sexes. The test was conducted according to OECD Guidelines for Testing of Chemicals (1981) No. 403 “Acute InhalationToxicity”" referenced as Method B2 in Commission Directive 92/69/EEC “Acute Toxicity-Inhalation” (which constitutes Annex V of Council Directive 67/548/EEC). Groups of ten Sprague-Dawley Crl:CD® (SD) IGS BR strain rats (five males and five females) were exposed to an aerosol atmosphere. The animals were exposed for four hours using a nose only exposure system, followed by a fourteen day observation period. The mean achieved atmosphere concentrations and the corresponding mortalities were as follows:
Group Number
Atmosphere Concentration
Deaths
Mean Achieved (mg/L)
Nominal (mg/L)
Male
Female
Total
1
5,23
48,0
5/5
5/5
10/10
2
1,89
17,5
1/5
4/5
5/10
3
0,74
12,0
2/5
4/5
6/10
Clinical Observations: Common abnormalities noted during the study included decreased and/or increased respiratory rate, wet fur, hunched posture and pilo-erection. There were frequent occurrences of laboured respiration, noisy respiration, red/brown staining around the snout and pallor of the extremities and several instances, particularly at the highest concentration, of corneal opacity, severe ataxia, gasping respiration and fur staining by test material. The following observations were seen sporadically: ataxia, coma, cyanosis, hypothermia, lethargy, tremors, clonic convulsions, loss of righting reflex and red/brown staining of the head. One male and two females showed reduced bodyweight development during Week 1 but normal bodyweight development was noted for most surviving animals during the study.
With the exception of an isolated instance of dark foci of the lungs, no macroscopic abnormalities were detected amongst surviving animals at terminal kill.
For animals that died or were humanely killed during the course of the study, the following abnormalities were detected :
Lungs – enlarged, pale, abnormally red, abnormally dark;
Liver – dark, accentuated lobular pattern;
Stomach – gaseous distension.
The acute inhalation median lethal concentrations (LC50) and 95% confidence limits of Pyridine-2-aldehyde in the Sprague-Dawley Crl:CD® (SD) IGS BR strain rat, were estimated to be:
All animals : 0.80 (95% confidence limit non-calculable) mg/l
Males only : 2.53 (95% confidence limit : 1.65 – 3.87) mg/l
Females only : 0.23 (95% confidence limit non-calculable) mg/l
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