Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 434-770-8 | CAS number: 55314-16-4
- 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:
- repeated dose toxicity: oral
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
- Limit test:
- yes
Test animals
- Species:
- other: Rat (Wistar)
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: Water (Milli-U)
- Details on oral exposure:
- Method of administration:
Daily gavage - Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
50 mg/kg/day: No treatment-related findings noted.
150 mg/kg/day: No treatment-related findings noted.
1000 mg/kg/day:
- Unscheduled death of 4 males and 2 females.
- Lethargy, muscle twitching, hunched posture, piloerection,
emaciated appearance, calm behaviour, and uncoordinated
movements (males), hunched and/or cramped posture and
emaciated appearance (females).
- Slightly low motor activity of the sole surviving group 4
male.
- Reduced body weight (gain) (males/females).
- Reduced (relative) food consumption (males).
Laboratory findings:
50 mg/kg/day: No treatment-related findings noted.
150 mg/kg/day: No treatment-related findings noted.
1000 mg/kg/day:
- Decreased white blood cell and lymphocyte counts,
prothrombin time and potassium values, increased neutrophil
counts, mean corpuscular haemoglobin concentration values,
bilirubin, cholesterol, total protein, sodium and albumin
levels in the one male which survived to study termination.
Alanine aminotransferase activitiys (by 64%) and bilirubin
levels (by 46%) were statistically significantly increased
in females.
Effects in organs:
50 mg/kg/day: No treatment-related findings noted.
150 mg/kg/day: No treatment-related findings noted.
1000 mg/kg/day:
-Apparently treatment-related findings observed at
necroscopy were thickened stomach (3/5 males) and
discoloured thymus in 4/5 males. Isolated instances of other
findings were observed but these were not considered to be
treatment-related.
-No clear treatment-related effect on organ weights were
noted in males. In females, absolute and relative liver
weights were increased by 22% and 38% respectively.
-The following findings were observed following a
histopathological assessment: atrophy of the testes (4/5),
lymphoid atrophy of the spleen in males (4/5), myleoid
hyperplasta at the sternum in 5/10 animals and lymphoid
atrophy of the thymus (5/5 males). All these findings were
reported at 1000 mg/kg/day.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 150 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 150 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Classified as: Not classified
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.