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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 424-060-6 | CAS number: 6364-17-6
- 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)
- Rationale for reliability incl. deficiencies:
- other: Meets the criteria for classification as Reliable without restriction according to Klimisch et al (1997)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Version / remarks:
- Annex V
- GLP compliance:
- yes
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- other: Rat CD
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: 1% aqueous methylcellulose
- Details on oral exposure:
- Method of administration:
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 150 mg/kg bw/day
Male: 5 animals at 15 mg/kg bw/day
Male: 5 animals at 1.5 mg/kg bw/day
Male: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 15 mg/kg bw/day
Female: 5 animals at 1.5 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
One female receiving 150 mg/kg/day died during Week 1 of
treatment. The death of this animal was attributed to
treatment with the test substance. One control female died
during the routine bleed in Week 4 of treatment; the death
of this animal was incidental.
Black staining of the cage tray paper was seen in animals
receiving 150 mg/kg/day during Weeks 1 and 2 of treatment.
Pallor of the skin was seen in mose males and females
receiving 150 mg/kg/day.
Overall bodyweight gain , food consumption and food
conversion efficiency was low in males receiving 150
mg/kg/day in comparison with the controls. A less marked
effect on weight gain was seen from Week 2 in males
receiving 1.5 or 15 mg/kg/day.
In comparison with the controls, water consumption was high
in females receiving 15 mg/kg/day and in all animals
receiving 150 mg/kg/day.
Laboratory findings:
Markedly low packed cell volumes, haemoglobin concentrations
and erythricyte counts, slightly low mean cell haemoglobin
concentrations, slightly high mean cell haemoglobin content
and high mean cell volumes were seen in animals receiving
150 mg/kg/day. Macrocytes, polychromasia and anisocytosis
were also seen in animals receiving 150 mg/kg/day.
Markedly high bilirubin, high cholestrol and high protein
concentrations were seen in animals receiving 150 mg/kg/day;
slightly high albumin concentrations were seen in males
receiving 150 mg/kg/day.
Effects in organs:
Analysis of organ weights revealed high spleen weights in
animals receiving 150 mg/kg/day, high liver weights in
females which received 1.5 or 15 mg/kg/day and males and
females given 150 mg/kg/day and high kidney weights
(absolute or bodyweight relative) in most treated groups.
Amongst animals receiving 150 mg/kg/day macroscopic
examination showed dark thyroid s, dark kidneys, swollen or
dark spleens and pale skin. Dark thyroids were also seen in
females receiving 50 mg/kg/day.
Periacinar hepatocytic hypertrophy was seen in males and
females given 150 mg/kg/day; extramedullary haemopoiesis in
the liver was seen in females given 150 mg/kg/day. An
increase in incidence and severity of proximal tubular
vacuolation and necrosis was seen in the kidneys of treated
females and in two males given 150 mg/kg/day. Congestion and
haemosiderosis of the spleen was seen in males and females
given 150 mg/kg/day. Follicular hyperplasia of the thyroid
was seen in males and females given 150 mg/kg/day. Brown
pigment deposition was seen in the Kupffer cells of the
liver, tubular epithelium of the kidney and follicular cells
and follicular colloid of the thyroid in males and females
given 150 mg/kg/day; brown pigment in follicular cells of
the thyroid only was seen in males and females given 15
mg/kg/day.
Effect levels
- Dose descriptor:
- NOAEL
- Remarks:
- toxicity observed at lowest dose
- Sex:
- male/female
- Basis for effect level:
- other: Observations of a minimal nephrotoxic change in a single female given 1.5 mg/kg/day prevented the establishment of a No-Observed -Effect-Level in this study
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Observations of a minimal nephrotoxic change in a single female given 1.5 mg/kg/day prevented the establishment of a No-Observed -Effect-Level in this study
Applicant's summary and conclusion
- Conclusions:
- Classified as: Xn - harmful
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.