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EC number: 454-190-9 | CAS number: 324763-51-1
- 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: GLP - Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- ARC Seibersdorf research GmbH
- Limit test:
- no
Test material
- Details on test material:
- - Physical state: white solid
- Analytical purity: 98.4%
- Lot/batch No.: 0424
- Storage condition of test material: in refrigerator, storage in the dark but may be used under light.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelman GmbH, Borchen, Germany
- Age at study initiation: 6 weeks
- Mean weight at study initiation: males: 170.1 g, females: 127.2 g
- Fasting period before study: no
- Housing: group caging (2 or 3 animals of one group and one sex per cage), the first 3 animals of a group and the second 2 animals of a group are housed together
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): average of 21.9
- Humidity (%): avarage of 41.1
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Preparations of the test substance were made freshly every day shortly before the administration to the animals. Appropriate preparations were made to allow a uniform dose volume for all groups. - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily, 7 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 316, 1000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The doses chosen are derived from and based on the results of the dose range finding study. Groups of 5 male and 5 female rats each were given 100 or 316 or 1000 mg test substance in 10 mL water orally once a day for 7 consecutive days. All animals survived until the terminal sacrifice. There were no treatment related observations in life; the body weights and the feed consumption were not notably affected. All animals were found to be grossly normal at post mortem examination. The high dose in the main study shall induce a clear toxicity, but no or at most isolated mortality. A dose of 1000 mg per kg b.w. will not be exceeded as high dose and is thus chosen as high dose. The low dose shall induce no toxic effect. It was set at 10 % of the high dose. The mid dose is interpolated geometrically.
- Rationale for selecting satellite groups: to observe the reversibility or persistence of the test substance induced lesions
- Post-exposure recovery period in satellite groups: 15 days
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: days: -1, 7, 14, 21, 27: all animals of all groups and days 35 and 41: all animals of the satellite groups
BODY WEIGHT: Yes
- Time schedule for examinations: day 1 to 28: once a week, all animals; days 35 and 42: satellite groups
FOOD CONSUMPTION: determined per cage in weekly intervals in all animals
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: day 29 from all animals except satellite groups; satellite groups: all animals on day 43
- Anaesthetic used for blood collection: Yes: slight ether anaesthesia
- Animals fasted: Yes
- How many animals: all
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: same as haematology
- Animals fasted: Yes
- How many animals: same as haematology
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: on day 27 and day 41
- Dose groups that were examined: all animals on day 27, on day 41 all animals of satallite groups
- Battery of functions tested: sensory activity / grip strength / motor activity - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- Analysis of variance: used for all data with means and standard deviations determined
Scheffé test: used for comparison of more than two groups
t-test: all data with means and standard deviations determined, for comparison of two groups only
H-test of Kruskal and Wallis followed by the test of Nemenyi: used for counted events with scoring or in cases where the requirements for the analysis of variance were not fulfilled
χ2-test: used for counted events
Fisher's exact test: used for counted events, if the χ2-test was not applicable
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY: There was no test substance related mortality, all animals survived until their scheduled sacrifice. Signs of reduced well-being were noted shortly after dosing in the high dosed animals. Otherwise no test substance related effects were noted.
BODY WEIGHT AND WEIGHT GAIN: The body weight gain of the high dosed recovery group males was significantly reduced in the first two weeks of dosing. No test substance related effects were noted in the body weights themselves or in the feed consumption.
HAEMATOLOGY & CLINICAL CHEMISTRY:
Platelet count (males) - high dose - significant increase
Lymphocytes (females) - high dose, after recovery - significant decrease
Alkaline phosphatase (females) - high dose, after recovery - significant increase
The changes in platelet count may be due to the test substance, while both the differences in lymphocyte count and in alkaline phosphatase are of equivocal relevance.
NEUROBEHAVIOUR: There were no differences between a dosed group and the corresponding control group noted at the functional observations or at the determinations of the grip strength. All observations made are in accordance with a normal behavioural pattern of the strain of rats used.
ORGAN WEIGHTS: There were no significant differences in the organ weights.
GROSS PATHOLOGY & HISTOPATHOLOGY: There were no significant differences nor any test substance related alterations noted.
OTHER FINDINGS: Satellite groups: There were a few scattered significant differences noted at the end of the satellite period. None of them can be attributed to the test substance, as to the lack of corresponding alterations at the end of the dosing period. None of the test substance related effects, noted during or at the end of the dosing period, persisted until the end of the recovery period.
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 316 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Marginally decreased body weight gain and isolated haematological alterations in the high dose treatment are considered as not adverse.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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.
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