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EC number: 430-610-6 | CAS number: 226996-19-6
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 96/54/EG, B.7; OECD 407 (1995)
- GLP compliance:
- yes
- Limit test:
- no
Test material
Constituent 1
Test animals
- Species:
- other: rat, Crl:CD(SD) IGS BR
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- corn oil
- Details on oral exposure:
- Method of administration:
Oral gavage - Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 15, 150, 400 mg/kg/day
Basis:
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 15 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 5 animals at 400 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 15 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 400 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
There were no deaths during the study.
Poor clinical condition, characterized mainly by abnormal
gait, loss of body tone and piloerection, was noted among
animals receiving 400 mg/kg bw/d during Week 1; with
piloerection also noted during the final two weeks of
treatment. In addition hair loss, occurring mainly among
animals receiving 400 mg/kg bw/d, was noted during the
treatment period.
During the first week of treatment, body weight gain was
significantly decreased (by approximately 40 %) and food
consumption was reduced by 26 % and 14 % in males and
females respectively, receiving 400 mg/kg bw/d, in
comparison with controls. Subsequently they were decreased
among males only receiving 150 or 400 mg/kg bw/d during
Weeks 2 to 4 of treatment.
The food conversion efficiencies for both sexes receiving
400 mg/kg bw/d and for males receiving 150 mg/kg bw/d were
slightly lower than their respective controls during the
four week treatment period.
No behavioral changes that were considered to be indicative
of neurotoxicity were observed.
Laboratory findings:
The hematology investigations did not reveal any findings
that were considered to be related to treatment.
The blood chemistry investigations revealed significantly
increased alanine amino-transferase levels among both sexes
receiving 400 mg/kg bw/d and in males receiving
150 mg/kg bw/d, together with aspartate amino-transferase
levels in both sexes receiving 400 mg/kg bw/d. Significantly
higher total cholesterol levels, which followed a dosage
related trend, were noted among all treated female groups.
In addition slightly increased potassium values for both
sexes, urea levels in males and creatinine levels in females
were also noted for animals receiving 400 mg/kg bw/d.
Effects in organs:
Liver weights among females receiving 400 mg/kg bw/d were
statistically, significantly increased after adjustment for
terminal body weight, when compared with control.
Examination of all animals killed at the end of 4 weeks of
treatment revealed an increased incidence of hair loss in
both sexes and gaseous distension of the caecum in females,
among rats treated with 400 mg/kg bw/d, compared with none
in the controls.
The microscopic examination of animals killed after 4 weeks
of treatment, revealed no treatment related changes in the
tissues examined.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 15 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 15 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:
- Treatment at 15 mg/kg/day represents the NOAEL (however, findings not considered as being adverse, e.g. food consumption, body weight gains and blood chemistry parameters). In addition, no treatment related microscopical changes were observed among tretated animals and treatment at 150 and 400 mg/kg/day over the 4-wk treatment period. Thus 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.
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