Registration Dossier
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EC number: 217-316-1 | CAS number: 1809-19-4
- 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

Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- other: range-finding study
- Type of information:
- other: read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Study period:
- 31 August to 14 September, 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- NTP Study, very reliable source
- Justification for type of information:
- Justification for Read Across is provided in Section 13 of IUCLID
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: range-finding study
- Deviations:
- not applicable
- Principles of method if other than guideline:
- 2.5 mL/kg bw/day of test item in 1 % (v/v) corn oil was administered to groups of 5 male and 5 female Fischer 344 rats via oral gavage for 15 days at doses of 250, 500, 1000, 2000, 3000 mg/kg bw/day, alongside a vehicle control group. Animals were checked two times per day for signs of moribundity and mortality; moribund animals were killed. Initial (day 0) but not final body weights were taken. Necropsy was performed on all animals, except those autolyse/cannibalised.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Source Chemical 01
- IUPAC Name:
- Source Chemical 01
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Age at study initiation: 43 days
- Weight at study initiation: male 116-130 g, females 91-95 g
- Housing: 5 per cage, Polycarbonate cage with Ab-Sorb-Dri hardwood chips
- Diet: Purina Lab Chow, ad libitum
- Water: Acidified with HCl (pH 2.6) tap water; available ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
Not reported.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Justification for use and choice of vehicle: the vehicle was chosen because of the potential for chemical hydrolysis in water.
- Concentration in vehicle: 1% w/w
- Dose (vol): 2.5 mL/kg
- Highest rat dose undiluted: 3000 mg/kg. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analyses for the test item in corn oil were performed on every eighth dose mixture to confirm that the correct concentrations were administered to the test animals. The method of analysis involved a methanolic extraction as a purification step and a gas chromatographic assay as a quantitation step.
- Duration of treatment / exposure:
- 15 days
- Frequency of treatment:
- 15 consecutive days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5 per sex per doses
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Animals were checked two times per day for signs of moribundity and mortality; moribund animals were killed. Initial (day 0) but not final body weights were taken.
Examinations
- Sacrifice and pathology:
- Necropsies were performed on all animals, except those excessively autolysed or cannibalised.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Other effects:
- not examined
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: clinical signs; mortality
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
All rats receiving 1000, 2000, or 3000 mg/kg/day, and 4/5 males and 2/5 females that received 500 mg/kg, died before the end of the study. Rats receiving 500 mg/kg/day or more were inactive after dosing. There were no dose-related findings at necropsy.
Applicant's summary and conclusion
- Conclusions:
- NOAEL (sub-acute, rat) = 250 mg/kg bw/day
LOAEL (sub-acute, rat) = 500 mg/kg bw/day (based on mortality) - Executive summary:
Sub-acute toxicity of the substance was evaluated in a dose range finding study. 2.5 mL/kg bw/day of test item in 1 % (v/v) corn oil was administered to groups of 5 male and 5 female Fischer 344 rats via oral gavage for 15 days at doses of 250, 500, 1000, 2000, 3000 mg/kg bw/day, alongside a vehicle control group. Animals were checked two times per day for signs of moribundity and mortality; moribund animals were killed. Initial (day 0) but not final body weights were taken. Necropsy was performed on all animals, except those autolyse/cannibalised.
All animals receiving either 1000, 2000 or 3000 mg/kg bw/day, plus and 4/5 males and 2/5 females receiving 500 mg/kg bw/day, died before the end of the study period. No mortality occurred in the low-dose group receiving 250 mg/kg bw/day. There were no dose-related findings at necropsy. Based on mortality, the NOAEL for sub-acute toxicity may be considered 250 mg/kg bw/day. The findings of this study were used to set the doses for a subsequent sub-chronic toxicity study.
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