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Diss Factsheets
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EC number: 481-830-4 | CAS number: 3687-22-7
- 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:
- other: SNIF
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
Data source
Referenceopen allclose all
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 008
- Reference Type:
- other: SNIF#001-4.2.10-01
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V.
- GLP compliance:
- yes
- Limit test:
- no
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Method of administration:
Dietary admixture - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
100 mg/kg bw/day
Basis:
no data
- Remarks:
- Doses / Concentrations:
300 mg/kg bw/day
Basis:
no data
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw/day
Basis:
no data
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 100 mg/kg bw/day
Male: 5 animals at 300 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 100 mg/kg bw/day
Female: 5 animals at 300 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day - Control animals:
- yes, plain diet
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
Achieved dosage
The mean achieved dosages corresponded to approximately 9,
27 and 90 mg/kg/day at 100, 300 and 1000 ppm respectively.
Mortality
No unscheduled deaths occurred during the study.
Clinical signs
Bright yellow urine was noted in all test item-treated
animals. At 1000 ppm, all the animals showed yellowish coat.
In absence of other observations (at clinical pathology and
histopathology), this variation was most probably related
to the test item/metabolite excretion.
Functional Observation Battery
Except for the yellowish coat and bright yellow urine
already noted during the weekly clinical signs session, no
test item treatment-related changes were noted in the
autonomy, physiology or neurotoxicology parameters. No
differences of toxicological significance were seen in motor
activity.
Body weight
At 1000 ppm, during the first week of dosing, males gained
18% and females 36% less weight than controls. This resulted
in a slightly lower female mean body weight gain over the
whole dosing period (-18%), which was most probably related
to the slightly low food consumption.
Food consumption
At 1000 ppm, from days 1 to 4, males ate 11%, p < 0.01 and
females 16%, p < 0.01 less food than controls. After this
transient observation, food consumption was comparable to
control values.
Laboratory findings:
Hematology and blood biochemistry
No test item treatment-related effects were noted at any
concentration tested.
Effects in organs:
Organ weights
At 1000 ppm, when compared to controls, statistically
significant higher relative liver weight (+16%) was noted in
males. This difference did not correlate with any
macroscopic and microscopic findings or blood biochemical
changes, and thus was considered to be of minor
toxicological importance.
Macroscopic post-mortem examination
At 1000 ppm, yellow hair was noted in all rats.
Microscopic examination
3/5 and 2/5 males, respectively treated at 300 and 1000 ppm
showed sporadic necrotic germ cells in the testes; another
(1/5) male at 1000 ppm had vacuolated Sertoli cells together
with a few sloughed in epididymis. Although the severity of
these changes, which can be found sporadically in untreated
rats, was minimal to slight and poorly dose-related, a
relationship to treatment with the test item could not be
excluded.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 100 ppm
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: The NOAEL (No Observed Adverse Effect Level) was identified at 100 ppm (equivalent to 9 mg/kg/day) in the males.
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 ppm
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: The NOAEL (No Observed Adverse Effect Level) was identified at 1000 ppm (equivalent to 90 mg/kg/day) in females.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
EU guidelines indicating that R48 should be applied cite 'severe organ damage' such as 'widespread or severe necrosis' (Directive 2001/59/EC, Annex 6, page 276). As the effects seen in this study were neither severe nor widespread, in isolation they were considered insufficient to justify assignment of R48.
Applicant's summary and conclusion
- Conclusions:
- 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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