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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- EEC Directive 87/302/EEC, Annex V of the EEC Directive 67/548/EEC, Part B: Methods for determination of Toxivology "Sub-chronic Oral Toxicity Test: 90-days repeated oral doseusing rodent species". Official Journal of the European Communities No. L 133, May 1988.
OECD "Guidelines for Testing of Chemicals", Section 4, Health Effects, No. 408, "Repeated Dose 90-Day Oral ToxicityStudy in Rodents", Paris Cedex, September 1998. - GLP compliance:
- yes
- Limit test:
- no
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Polyethylene glycol 400
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Test duration: 90 days
- Frequency of treatment:
- Dosing regimen: 7 days/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Control
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Remarks:
- low dose
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Remarks:
- mid dose
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Remarks:
- high dose
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- From week 2 onwards, the majority of group (1000 mg/kg) males and females showed and increased incidence of slight to moderate post-dosing salivation.
In addition, an increased incidence of brown staining of the back and tail was exhibited by animals of high dose group. A higher incidence of salivation was also recorded for females of mid dose group (200mg/kg) particularly during weeks 5 to 10.
The remaining clinical signs recorded consisted of varying degrees of alopecia and skin lesions (scabs, wounds). These signs are commonly seen among gang housed rats dosed by oral gavage and were considered to be unrelated to the test article.
Staining (e.g. red/brown) of various parts of the body were common to some animals in most groups including the control group.
Other findings were only noted incidentally and at minimal severity without a relationship with treatment with the test compound. - Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Higher absolute and relative adrenal weights were recorded for males and females of group 4 (1000 mg/kg) of which the difference from control values attained a level of statistical significance for the females.
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Treatment associated alterations were present in the adrenal glands and mesenteric lymph nodes.
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- not examined
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
Target system / organ toxicity
- Key result
- Critical effects observed:
- not specified
- Lowest effective dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- System:
- endocrine system
- Organ:
- adrenal glands
Applicant's summary and conclusion
- Conclusions:
- Classified as: Not classified
- Executive summary:
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 consististing 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 for possible future analysis. At termination: clinical pathology, macroscopy and organ weights. Histopathology was performed on a selection of tissues.
From the results presented in this report, a No Observed Effect Level (NOEL) of 50 mg/kg/day was established for males, whereas a NOEL could not be defined for females. However, 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 adverce 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.
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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