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EC number: 428-040-8 | CAS number: 138261-41-3
- 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:
- 08 - 22 Sep 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- adopted 1981
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 428-040-8
- EC Name:
- -
- Cas Number:
- 138261-41-3
- Molecular formula:
- C9H10ClN5O2
- IUPAC Name:
- 2-chloro-5-{[2-(nitroimino)imidazolidin-1-yl]methyl}pyridine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: laboratory animal breeder Winkelmann, Borchen, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 160 - 210 g
- Fasting period before study: not reported
- Housing: animals were housed in groups of 5 in Makrolon cages type III with low-dust wood granulate type 8/15 (Ssniff Co, Soest, Germany) for bedding material.
- Diet: Altromin 1324 Diet for rats and mice (Altromin GmbH, Lange, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
- Method of randomisation in assigning animals to test and control groups: randomizing lists produced by a computer program were used
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): approximately 50
- Air changes (per hr): approximately 10
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 08 Sep 1987 To: 22 Sep 1987
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- > 10.6 - <= 20 µm
- Geometric standard deviation (GSD):
- > 1.82 - <= 2.15
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: PVC inhalation chamber
- Exposure chamber volume: approximately 20 L
- Method of holding animals in test chamber: animals were confined to plexiglass exposure tubes matching the animals sizes
- Source and rate of air (airflow): see 'any other information on materials and methods incl tables' section for further information
- Method of conditioning air: in-line VIA compressed air dryer type A110, i.e. water, dust and oil were removed
- System of generating particulates: Bayer Dust Generator (see 'any other information on materials and methods incl tables' for further description)
- Method of particle size determination: aerodynamic particle sizer with laser velocimeter (TSI-APS 3300)
- Treatment of exhaust air: purified using an absolute filter
- Temperature, humidity, pressure in air chamber: 22 - 25 °C, 5 - 34 %, not reported
TEST ATMOSPHERE
- Brief description of analytical method and equipment used: gravimetrical evaluation of 10 - 50 L of air using filters (SM 11106, pore size 0.45 µm)
- Samples taken from breathing zone: yes
- Particle size distribution: number of particles < 5 µm: 71 % (1.22 mg/L air), 65 % (2.57 mg/L air), 70 % (5.32 mg/L air)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 10.6 µm, 1.82 µm (1.22 mg/L air), 14.2 µm, 1.92 µm (2.57 mg/m³ air), 20.0 µm, 2.15 µm (5.32 mg/L air) - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Remarks on duration:
- 1 x 4h (dust)
- Concentrations:
- 1.22, 2.57, and 5.32 mg/L air (dust)
- No. of animals per sex per dose:
- 5 for treatment groups and 10 for air control
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weights were recorded before exposure and on day 3, 7 and 14 (1 x 4h). Appearance and behavior were assessed several times on the day of exposure, but not during exposure.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology, gross pathological examination, organ weights - Statistics:
- Please refer to 'any other information on materials and methods incl. tables' section.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.32 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: difficult breathing, reduced motility and piloerection, slight tremors.
- Remarks:
- Doses up to 1.22 mg/L air were tolerated without symptoms by both sexes. At 2.57 mg/L air difficult breathing, reduced motility and piloerection and additionally at 5.32 mg/L air slight tremors were observed.
- Body weight:
- No effect on body weight was noted during the course of the study
- Gross pathology:
- Gross pathological examination revealed no substance-related findings.
- Other findings:
- No obvious treatment-related effects on relative organ weight were noticed for liver and lung.
Histopathological examination of lung and liver exhibited no signs of treatment-related changes.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- The study is in accordance with OECD 403, was performed under GLP conditions and is considered to be valid and reliable. Under the conditions chosen, the acute inhalation LC50 was determined to be >5.32 mg/L air (dust; 1x4h) in male and female rats. According to criteria of the CLP Regulation (EU) No. 1272/2008, classification of the test item for acute inhalation toxicity is not required.
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