Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 10 Oct 1990 - 23 Jan 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- 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: 7 - 8 weeks (males), 10 - 11 weeks (females)
- Weight at study initiation: 167 - 186 g (males), 170 - 183 g (females)
- Fasting period before study: 15 - 17 hours before administration
- Housing: in groups of 5 in Type III Makrolon cages equipped with type S 8/15 low-dust wood granules (Rettemaier & Söhne Füllstoff-Fabriken, Ellwangen-Holzmühle, Germany) as bedding material
- Diet: Altromin 1324 Diet for Rats and Mice (Altromin GmbH and Co KG, Lage, 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: randomized lists generated by a computer program
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 22.5
- Humidity (%): 40 - 70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 10 Oct 1990 To: 23 Jan 1991
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 2 % v/v Cremophor EL in demineralized water
- Details on oral exposure:
- VEHICLE
- Amount of vehicle: 10 mL/kg bw - Doses:
- 50, 200, 300, 350, 400, 500, 600 mg/kg bw (males)
100, 200, 300, 350, 400, 500 mg/kg bw (females) - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: appearance and behavior were recorded several times in the day of administration, and at least once a day thereafter. Body weights were recorded before administration, on days 4 and 8 and then weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathological examination - Statistics:
- Not reported.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 504 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 372 - < 684
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 379 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 324 - < 445
- Mortality:
- Mortalities occurred at doses from 300 mg/kg bw. The LD50 was determined to be 504 mg/kg bw for males and 379 mg/kg bw for females. For details on mortality please see attached tabular results.
- Clinical signs:
- other: A dose of 50 mg/kg bw (males) and 100 mg/kg bw (females) was tolerated without symptoms. At higher doses apathy, staggering and spastic gait, labored breathing, reduced motility, spasmodic state (periodic in some cases), periodic tremors, soft feces and
- Gross pathology:
- No test substance-related gross pathological changes were observed in the animals which were sacrificed at the conclusion of the post-treatment observation period. The following findings were determined in animals which died during the post-treatment observation period: lung distended, mottled, dark; liver dark, bladder distended with clear urine.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The study was performed in accordance to OECD TG 401 under GLP conditions and is considered reliable. Under the conditions chosen, the acute oral LD50 was determined to be 504 mg/kg bw for male rats and 379 mg/kg bw for female rats. According to criteria of the CLP Regulation (EU) No. 1272/2008, classification of the test item for acute oral toxicity category 4 is needed.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
