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Diss Factsheets
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EC number: 700-351-6 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 September 2008 - 07 November 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study; well documented study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Test material form:
- solid
- Details on test material:
- - Appearance/physical state: Black lumps
- Storage conditions: Room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Source: Charles River Deutschland, Sulzfeld, Germany.
-Age at study initiation: approx. 8~10 weeks
-Weight at study initiation: Body weight variation did notexceed +/-20% of the sex mean.
-Fasting period before study: Food was withheld overnight (for a maximum of 20 hours) prior to dosing until 3-4 hours after administration of the test substance.
-Housing: Group housing of 3 animals per cage in labeled Macrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom)..
-Diet: Free access to pelleted rodent diet (SM RIM-Z from SSNIFFB Spezialdiaten GmbH, Soest, Germany).
-Water: free access to tap-water.
-Acclimation period: Acclimatization period was at least 5 days before start of treatment under laboratory conditions.
ENVIRONMENTAL CONDITIONS
-Temperature (C): 19.5 -21.3 C
-Humidity (%): 30-70% (actual range: 37 -74%)
-Air changes: 15 air changes per hr
-Photoperiod: 12 hours artificial fluorescent light and 12 hours darkness per day.
IN-LIFE DATES: Start: 23 September 2008; Completion: 07 November 2008.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30, and 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: The vehicle was selected based on trial formulations performed at NOTOX and on test substance data supplied by the sponsor.
- Lot/batch no. (if required): No data available.
- Purity: No data available.
MAXIMUM DOSE VOLUME APPLIED: 10mL/Kg
DOSAGE PREPARATION (if unusual): the formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of the vehicle. The concentration of the test substance in vehicle was varied to allow constant dosage volume in terms of mL/kg body weight.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: the toxicity of the test substance was assessed by stepwise treatment of groups of 3 females. The first group was treated at a dose level of 2000 mg/kg. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups. - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 12 Females, each dose group consisted of 3 animals.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
-Motility/viability: twice daily. The time of death was recorded as precisely as possible.
-Body weights: Days 1 (pre-administration), 8 and 15 and at death.
-Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: None. - Statistics:
- No statistical analysis was performed.
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 500 mg/kg bw
- Mortality:
- Five females in the high dose group were found dead on Days 9. 12 or 13. No further mortality occurred.
- Clinical signs:
- Clinical signs observed during the study period were as follows:
2000 mg/kg group: lethargy, hunched posture, watery discharge of the eyes, uncoordinated movements, ptosis, piloerection, lean appearance and/or hypothermia were noted in all animals during the observation period.
300 mg/kg group: hunched posture and piloerection were noted in all animals between
Days 1 and 7. - Body weight:
- The mean body weight gain shown by the animals at 300 mg/kg over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
- Gross pathology:
- Emaciation, dark red discoloration of the thymus and reduced size of the thymus was noted in one surviving animal at 2000 mg/kg. One animal, which was found dead, showed irregular surface of the forestomach. All animals found dead showed beginning or advanced autolysis.
No abnormalities were found at macroscopic post mortem examination of the animals at 300 mg/kg. - Other findings:
- - Organ weights: No data available.
- Histopathology: No data available.
- Potential target organs: No data available.
- Other observations: No data available.
Any other information on results incl. tables
Results are shown in the attachments.
Table 1: Mortality
Table 2: Clinical signs
Table 3: Body weights
Table 4: Macroscopic findings
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The oral LD50 value of the test substance in Wistar rats was established to be within the range of 300- 2000 mg/kg body weight. According to the OECD 423 test guideline the LD50 cut-off value was considered to be 500mg/kg body weight.
- Executive summary:
In an acute oral toxicity study, the oral LD50value of the test substance in Wistar rats was established to be within the range of 300- 2000 mg/kg body weight. According to the OECD 423 test guideline the LD50 cut-off value was considered to be 500mg/kg body weight.
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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