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EC number: 410-510-9 | CAS number: 86753-82-4
- 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
Endpoint summary
Administrative data
Description of key information
The test substance was administered daily for at least 90 days by oral gavage to SPF-bred Wistar rats. One control group and three treated groups were used. each consisting of 10 males and 10 females. The following parameters were evaluated: Clinical signs, functional observations, body weight, food consumption and opthalmoscopy. Urine and faeces samples were collected in week 13. At termination: clinical pathology, macroscopy and organ weights. Histopathology was performed on a selection of tissues.
Since the findings in the adrenal cortex were also seen in one of the control females, the histiocytosis in the mesenteric lymph nodes was not accompanied by adverse tissue reaction and the post dosing salivation considered due to the bad taste of the substance, a No Observed Adverse Effect Level (NOAEL) of 200 mg/kg/day may be considered for males and females.
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:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V - method B.7
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- 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 0 mg/kg bw/dayMale: 5 animals at 50 mg/kg bw/dayMale: 5 animals at 250 mg/kg bw/dayMale: 5 animals at 1000 mg/kg bw/dayFemale: 5 animals at 0 mg/kg bw/dayFemale: 5 animals at 50 mg/kg bw/dayFemale: 5 animals at 250 mg/kg bw/dayFemale: 5 animals at 1000 mg/kg bw/day
- Details on results:
- Clinical observations:There were no mortalities or clinical observations seenduring the study that could be attributed to administrationas Substance H109368Laboratory findings:Changes considered to be related to treatment were recordedfor animals receiving 1000mg/kg/day. Slight reductions ingroup mean haemoglobin, haematocrit and red cell count wereseen for males and females. minor reductions in group meanplasma triglyceride levels for males and increases in plasmaaspartate transaminase and/or alanine transaminaseactivities for males and/or females were possiblyindicative of a mild hepatic response, althoug this couldnot be correlated with histopathological changeEffects in organs:Pathological changes included mononuclear cell infiltrationin the kidney, adrenal gland, heart and liver, and anincrease in extramedullary haemopoiesis of the spleen. Thetoxicological significance of these findings is uncertain.Organ weight parameters were not affected.
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 250 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Critical effects observed:
- not specified
- Conclusions:
- Classified as: Not classified
- Executive summary:
Changes considered to be related to treatment were recorded for animals receiving 1000mg/kg/day. The no-observed effect level for the substance in the rat is therefore 250mg/kg/day for males and females, following daily oral administration over a 28 -day period.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- reliable
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated oral toxicity:
An OECD test guideline and GLP-compliant 90-day toxicity study was performed with test item in Wistar rats. Groups of 10 male and 10 female rats received 0, 50, 200 and 1000 mg/kg/day by oral gavage in polyethylene glycol 400 for 90 days. The No-observed-adverse-effect level (NOAEL) of test item was 200 mg/kg bw/day in both sexes.
This study is supported by a 28 day oral dosing study (GLP-compliant) in Wistar rats (Alpk:APfSD). Groups of 5 male and 5 female rats received 0, 50, 250 and 1000 mg/kg/day by oral gavage in corn oil for 28 days. The No-observed-adverse-effect level (NOAEL) of test item was 250 mg/kg bw/day in both sexes.
Repeated dermal toxicity:
The dermal route was waived; substance is not classified for this endpoint. The substance is considered not to exert any local or systemic adverse effects.
Repeated inhalation toxicity:
The inhalation route was waived; substance is not classified for this endpoint. When aerosolized in respirable form; when aerosolized in respirable form, the substance is considered likely to behave like an inert dust.
Justification for classification or non-classification
not classified
Criteria for SOTS classification not met.
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