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Diss Factsheets
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EC number: 944-550-8 | CAS number: -
- 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:
- march to december 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
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
Test material
- Test material form:
- other: Cream powder (84% w/w)
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: C202483
- Expiration date of the lot/batch: 31.05.2001
- Purity: 98.4%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: < -10 degrees C
- Solubility and stability of the test substance in the solvent/vehicle:
MI3 was homogeneous and stable in purified water for up to 6 hours after dose preparation.
Test animals
- Species:
- rat
- Strain:
- other: Han Wistar rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: 8 weeks
- Weight at study initiation: males: 193,8-228,9 g; females: 122,5-175 g
- Fasting period before study: not specified
- Housing: The animals were housed in a single, exclusive room, airconditioned (15 air changes/hour)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 4 weeks
DETAILS OF FOOD AND WATER QUALITY:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- purified water
- Details on oral exposure:
- Oral exposure by gavage
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analysis of the formulations for achieved concentration were performed in week 1. The analysis was performed by Covance and demonstrated that the formulations were accurately performed.
- Duration of treatment / exposure:
- 29 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Controls
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Remarks:
- low dose
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Remarks:
- intermediate dose
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Remarks:
- High dose
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- N/A
- Positive control:
- No
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily observation for signs of ill health
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly
Post dosing observations were performed daily during the first week of treatment (excluding Day 2, as functional obervational battery was being performed) at the following time intervals: immediately after dosing, 30 minutes, 1, 2 and 4 hours after dosing. For the remainder of the study, post dosing observations were recorded twice weekly
BODY WEIGHT: Yes
- Time schedule for examinations: Before treatment in the first day of dosing, at weekly intervals and before necropsy
FOOD CONSUMPTION:
- Food consumption was determined weekly and calculated as g food/animal/week
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: End of week 4
- Anaesthetic used for blood collection: Yes (fluothane)
- Animals fasted: Yes / No / Not specified
- How many animals:
- Parameters checked in table [No.?] were examined.
CLINICAL CHEMISTRY: Yes / No / Not specified
- Time schedule for collection of blood:
- Animals fasted: Yes overnight
- How many animals: all animals
- Parameters examined:
haemoglobin concentration
packed cell volume
mean cell haemoglobin
reticulocytes
platelet couunt
red blood cell count
mean cell volume
mean cell haemoglobin concentration
total and differential white cell count
and prothromnin time (in trisodium citrate anticoagulant)
URINALYSIS: Yes / No / Not specified
- Time schedule for collection of urine:
- Metabolism cages used for collection of urine: Yes / No / Not specified
- Animals fasted: Yes / No / Not specified
- Parameters checked in table [No.?] were examined.
NEUROBEHAVIOURAL EXAMINATION: Yes: FUNCTIONAL OBSERVATIONAL BATTERY (FOB):
- Time schedule for examinations: before initiation of treatment and once weekly thereafter.
- Dose groups that were examined: All animals
- Battery of functions tested: sensory activity / grip strength / motor activity (week 4)
IMMUNOLOGY:No
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes on control and high dose animals
HISTOPATHOLOGY: Yes on control and high dose animals - Statistics:
- Statistical analysis were perforned where appropriate.
Body weight gains, necropsy body weight, haematology, clinical chemistry, locomotor and FOB data were analysed using two-way analysis of variance (ANOVA). Pairwise comparison with control for each sex separately, were made using Dunnett’s test. For each sex separately, a regression test was performed to determine whether there was a dose response relationship. Non-parametric methods were used for clinical parameters with values above or below limit of detection. Levene’s test for equality of variance across groups, sexes and any interactions was also performed.
Organ weights were analysed using analysis of covariance (ANCOVA) and Dunnett’s test.
Significance level of p>0.05 was used. (p<0.01 for Levene's test)
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- 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 examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- effects observed, non-treatment-related
- Description (incidence and severity):
- Total group mean motor activity for females given 1000 mg/kg/day was slightly lower than controls. Landing foot display for males given 300 or 1000 mg/kg/day were slightly higher than controls.
Individual results for both landing footsplay and motor activity for the control and the treated groups were generally variable. This slight changes in footsplay and motor activity are therefore not considered to be related to treatment. - Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Liver weight for males given 1000 mg/kg/day and brain weight for females given 1000 mg/kg/day were slightly lower than controls, however, there were no clear sex or dosage-relationships. These findings are therefore considered to be fortuitous.
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Effect levels
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The administration of MI3 at doses of 100, 300 or 1000 mg/kg/day to Han Wistar rats for 28 days produced no evidence of toxicity and no effects which could be confidently attributed to treatment.
- Executive summary:
MI3 was administered to Han Wistar rats at doses of 100, 300 or 1000 mg/kg/day for 28 days. No evidence of toxicity and no effects which could be confidently attributed to treatment was observed.
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