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EC number: 205-516-1 | CAS number: 141-97-9
- 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
- Study period:
- February 1990 - April 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Test material form:
- other: non-viscous clear liquid
- Details on test material:
- - Name of test item in the report: P0010
- Appearance: colorless liquid
- Storage: at room temperature
Constituent 1
- Specific details on test material used for the study:
- - Batch-no.: 157
- Storage: room temperature
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- the rodent species is acceptable to the regulatory authorities and has documented susceptibility to a wide range of toxic substances. Background data of the strain are available at the testing facility. There are no known contra-indications to its use.
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: IFFA Credo, L'Arbresle, France
- Age at study initiation: 6 weeks
- Weight at study initiation: males 172-197.9 g / females 141.5-174.2 g
- Housing: gang housing (groups of 5 animals)
- Acclimation period: 7 days
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- ROUTE AND METHOD OF ADMINISTRATION
- Route: oral
- Justification of the route: potential human exposure is by the oral route
- Volume of administration: 10 ml/kg/day
- Individual dose volumes were calculated weekly using the most recent body weight
- Method of administration: gavage, using a metal cannula - Vehicle:
- water
- Remarks:
- distilled
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
- Solution of the test article in the vehicle at the concentrations of 5, 22.5 and 100 mg/ml
- Stabilify of the test article in the vehicle: determined over 24 hours for the lowest and highest concentrations. The analyses were carried out at test lab
- Frequency of preparation: daily
- Storage: at room temperature, protected from light
- Analysis of formulation: a sample from each preparation (including control group) was taken at weeks 1 and 4 - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Stability/homogeinity was determined for the lowest and highest dose concentrations by Gas chromatography (GC):
- Apparatus: Varian 3400 with autosampler
- Detector: FID
- Column: OV101, 15 m x 0.53 mm
- Injection volume: 1 ul
- Gas: nitrogen 10 ml/min
- Temperature: injector: 210°C / detector 260°C / column oven 70°C
- Test sample: dosing solutions were dissolved in acetone
The test item was found to be stable at room temperature over 24 hours. - Duration of treatment / exposure:
- Duration:
- males and females killed at week 4 : 29 days
- males and females killed at week 6 : 28 days
For animals killed at week 4, treatment continued until the day before necropsy. - Frequency of treatment:
- Once daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 225 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 60 animals were used in this study:
- 0 mg/kg/day: 20 (5 males/5 females for treatment period PLUS 5 males/5 females for recovery period)
- 50 mg/kg/day: 10 (5 males/5 females)
- 225 mg/kg/day: 10 (5 males/5 females)
- 1000 mg/kg/day: 20 (5 males/5 females for treatment period PLUS 5 males/5 females for recovery period) - Control animals:
- yes
- Details on study design:
- Dose selection rationale:
The high dose level of 1000 mg/kg/day is the maximal dose recommended by the OECD and EEC guidelines. The low dose level is expected to be a noobservable effect level and the intermediate dose level of 225 mg/kg is close to the geometric mean between the low and high dose levels. - Positive control:
- no positive control tested
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Animals were observed daily, before and at least once after dosing, Full clinical observation was performed weekly.
BODY WEIGHT: Yes
- Time schedule for examinations: Individual body weights were recorded weekly
FOOD CONSUMPTION:
- Food consumption was measured weekly for each cage from the first week of treatment
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: Once pretest and at week 4
- Examination: All animals; Direct and indirect ophthalmoscopy, a mydriatic agent (tropicamidel was instilled in to the eyes before examination
HAEMATOLOGY/CLINICAL CHEMISTRY: Yes
- Animals examined and frequency : 5 animals for each sex/group at week 4
- Samples: blood was withdrawn from the retro-orbital sinus following light ether anaesthesia on overnight fasted animals (about 16 hours). Bone marrow smears were prepared at scheduled necropsy for all animals killed at week 4. In consideration of the results for other parameters examined during the study.
URINALYSIS: Yes
- Collected in metabolism cages (approximately 16 hours) from animals deprived of food and water but receiving 20 ml/kg of mains water by gavage before being placed in the metabolism cages
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
At weeks 4 and 6, the animals were necropsied after randomisation. The animals were weighed before necropsy. The animals were killed by carbon dioxide inhalation and exsanguination. All animals were submitted to full necropsy procedures including examination of :
- the external surface
- ail orifices
- the cranial cavity
- the carcass
- the external surface of the brain and of samples of the spinal cord
- the thoracic, abdominal and pelvic cavities and viscera
- the cervical tissues and organs
HISTOPATHOLOGY: Yes
All organs/tissues sampled were fixed and preserved in 10% neutral formalin with the following exception: bone marrow smears fixed in methanol. All sections were stained with haematoxylin and eosin.
Histopathological examinations were performed on all organs/tissues. For all animals in groups 1 (control) and 4 (high dose) at week 4. In each group, histopathological examination was performed for all gross lesions except those for which the diagnosis was judged unnecessary for the outcome of the study by the pathologist. - Other examinations:
- none
- Statistics:
- no data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- In week 2, approximately half the high dose animals (group 4) were salivating immediately after dosing. In weeks 3 and 4, this observation was present in all high dose animals. Salivation is seen occasionally in studies of this type (gavage) and probably represents a local reaction to the test article. It is considered not to represent systemic toxicity.
- Mortality:
- no mortality observed
- Description (incidence):
- There were no deaths.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- There were no biologically significant differences between the groups in the amount of body weight gained.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- The differences in food consumption between the groups were small and not considered to be treatment-related. Food conversion ratios were similar in all groups.
- Food efficiency:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects observed.
- Water consumption and compound intake (if drinking water study):
- not specified
- Description (incidence and severity):
- No treatment-related effects observed.
- Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- There were no eye lesions. The data have therefore not been tabulated.
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- There were no differences between the groups to indicate an effect of treatment on the haematological parameters.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- The clinical chemistry profiles of the treated animals were similar to the controls.
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects observed.
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- The few microscopic findings were considered to be of agonal or incidental origin (i.e. pulmonary haemorrhage). There were no treatment-related microscopic findings.
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- There were no treatment-related neoplastic histopathological findings noted.
- Other effects:
- not examined
- Details on results:
- see above
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- behaviour (functional findings)
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- gross pathology
- haematology
- histopathology: neoplastic
- mortality
- ophthalmological examination
- organ weights and organ / body weight ratios
- urinalysis
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- behaviour (functional findings)
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- gross pathology
- haematology
- histopathology: neoplastic
- mortality
- ophthalmological examination
- organ weights and organ / body weight ratios
- urinalysis
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
- Organ:
- other: no organ toxicity observed
Applicant's summary and conclusion
- Conclusions:
- The test item did not show any mortality, clinical signs or effects on organs and food consumption. There were also neither abnormalities in the hematological and biochemical parameters nor treatment-related macroscopic and microscopic findings.
- Executive summary:
The study was performed 1991 under GLP according to OECD-guideline no. 407. Appropriate dose levels were evaluated in a DRF study. Application route was gavage, in the main study dose levels were 0, 50, 225 and 1000 mg/kg/day. Ten males and ten females were used at 0 and 1000 mg/kg/day, whereas five animals of each sex were killed at the end of treatment and the other five males and females were further observed throughout a two weeks recovery period. At 50 and 225 mg/kg/day, five animals of each sex were used per dose group. No treatment-related effects were observed, therefore the NOEL was found to be 1000 mg/kg/day.
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