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EC number: 401-310-2 | CAS number: 93912-64-2
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- 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: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Frequency of treatment:
- daily, 7 days a week
- No. of animals per sex per dose:
- Male: 8 animals at 40 mg/kg bw/day
Male: 8 animals at 200 mg/kg bw/day
Male: 16 animals at 1000 mg/kg bw/day
Female: 8 animals at 40 mg/kg bw/day
Female: 8 animals at 200 mg/kg bw/day
Female: 16 animals at 1000 mg/kg bw/day - Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- at the high and medium dose
- Food consumption and compound intake (if feeding study):
- no effects observed
- Ophthalmological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- blue discoloration of the eye at the highest dose
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- only at the high dose
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- only at the hogh dose(male)
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- blue discolouration
- Histopathological findings: non-neoplastic:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical biochemistry
- clinical signs
- gross pathology
- Critical effects observed:
- not specified
Reference
MORTALITY AND CLINICAL SIGNS
The animals from the high-dose group exhibited a bluish discoloration of the faeces, skin and eyes. Blue discoloration of the skin was observed up to the 12th day, the blue discoloration of the eyes was not reversible. Up to the end of the treatment period a (non-significant) reduced body weight was observable among the male animals from the medium and high-dose groups. The body-weight gain was temporarily (on day 16) significantly reduced in both of the dose groups. The feed consumption of the treated animals did not differ from that found in the controls.
CLINICAL CHEMISTRY
Clinico-chemically, increased total cholesterol and phospholipid values as well as increased ASAT activity were revealed for the male animals from the high-dose group. Among the female animals, the alpha-1-globulin values were elevated. At the end of the follow-on observation period, these clinico-chemical values were located within the normal range once more.
GROSS PATOLOGY
At the high dose, at the end of treatment, reduced absolute and relative thymus weights were determined in both of the sexes. At the end of the follow-on observation period, increased relative thymus weights occurred among the high-dose males. Post-mortem examination revealed blue discoloration of the kidneys (in particular in the case of the cortex region) in all of the treated animals as well as blue discoloration of the mesenteric lymph nodes and testes of numerous animals from the medium and high-dose groups. Discoloration, which was still present in the majority of the organs at the end of the follow-on observation period, but not, however, in the thymus, tongue and intestines, was also observed in other organs (salivary glands, thymus, mandibular lymph nodes, tongue, stomach, small intestine, large intestine, pancreas, epididymides, ovaries, uterus, subcutis). One male from each of the dose groups as well as a high-dose female additionally exhibited blue discoloration of the lung.
Microscopically, eosinophilic inclusions in the tubular epithelia were determined in almost all of the males from all of the dose groups and from the control. At the high dose, the severity of this finding was greater than in the case of the controls. After the recovery period no difference was detected in the frequency or the degree of severity of these findings. No further treatment-related, pathohistological changes were established in the macroscopically discoloured organs. The eyes, brain, spinal marrow and peripheral nerve were examined histologically in the control and high-dose group. They did not exhibit any treatment-related changes.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
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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