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Diss Factsheets
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EC number: 422-310-9 | CAS number: 114772-53-1
- 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:
- supporting study
- Study period:
- not declared
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: The study was provided us by ECHA under the 12 years rule. Available data contain scanty study details: the limited amount of information and the lack of the full study report do not allow a proper reliability assessment.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Deviations:
- not specified
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- EC 422-310-9 (identity was verified by ECHA while providing us with information in response to our inquiry)
- IUPAC Name:
- EC 422-310-9 (identity was verified by ECHA while providing us with information in response to our inquiry)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: methylcellulose (0.5%)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Test duration: 28
- Frequency of treatment:
- 7 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 mg/kg bw/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
15 mg/kg bw/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
50 mg/kg bw/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
150 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 15 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 15 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at150 mg/kg bw/day - Control animals:
- yes
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- At intermediate (50 mg/kg) and high (150 mg/kg) doses, animals showed movement and postural disorders, piloerection, hair loss, and decrease in body weight.
In a dose-dependent manner, in all males and females a decrease in body weight and in food consumption was observed. In both males and females treated with the highest dose (150 mg/kg) and with the intermediate dose (50 mg/kg), water consumption was increased in the first two weeks of the study; the effect persisted in males.
In males treated with the highest dose (150 mg/kg) the following laboratory changes were observed: reduced alkaline phosphatase levels, increased AST levels, reduced beta-globulin, glucose, potassium, calcium and phosphate levels, increased albumin:globulin ratio. In females treated with the highest dose (150 mg/kg) the following laboratory changes were observed: reduced glucose levels, increased creatinine and BUN levels.
At intermediate (50 mg/kg) and high (150 mg/kg) doses, animals body weight was reduced. In 1 female in the intermediate dose group and in 1 female in the high dose group, uterus size was reduced: micorscopic examination confirmed the presence of moderate atrophy.
In treated animals, absolute and relative weights of epidydimes, prostate, seminal vesicles and ovaries were reduced. Other organs showed changes (increase or reduction) in their absolute and relative weight. In all dosage groups, micorscopic examination showed signs of chronic myocarditis in both males and females, and degeneration of tubular epitelium in males testes. Histopathological examination was not performed for the other sexual organs nor for ovaries.
Effect levels
- Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, study results indicate that the substance should be classified as following for its effects after repeated exposure:
- DSD: T R48/25, Xn R62
- GHS: STOT RE 1 H372, Repr 2 H361
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