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Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study was selected as a key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment. The justification for read-across is attached in IUCLID5.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- Remarks:
- The study was conducted according to guideline in effect at time of study conduct.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Remarks:
- The study was conducted according to guideline in effect at time of study conduct.
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Details on test material:
- - Purity: not reported as such
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Crl:CD1(ICR)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10 weeks
- Weight at study initiation: 24-27 g
- Fasting period before study: yes; 3-4 hours prior to dosing
- Housing: singly in polycarbonate pans that contained bedding with enrichment (i.e., Shepherd’s™ Cob + PLUS™).
- Diet (e.g. ad libitum): ad libitum except for fasting period prior to dosing; food was returned to the mice approximately 1 hour after dosing
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26°C
- Humidity (%): 30-70%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: Not Reported
- Doses:
- 5000 mg/kg and 10000 mg/kg of the formulation.
- No. of animals per sex per dose:
- Three females, each at a dose level of 5000 mg/kg. One mouse was initially dosed. The remaining 2 mice were simultaneously dosed
2 days (at least 48 hours) later. An additional mouse was treated at a dose level of 10000 mg/kg of the formulation. - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: All animals were observed for mortality, signs of gross toxicity, and behavioural changes once during the first 30 minutes after dosing and 2 more times on the day of dosing, and once each day thereafter for 14 days after dosing.
-Frequency of weighing: prior to fasting and administration, and again on Days 7 and 14 (termination) following dosing.
- Necropsy of survivors performed: yes, on all animals at terminal sacrifice to detect grossly observable evidence of organ or tissue damage.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 other: mg/kg bw . Additionally, no mortality, clinical signs, or body weight losses were observed in a mouse dosed at 10000 mg/kg.
- Mortality:
- No deaths occurred.
- Clinical signs:
- The mice exhibited no clinical signs.
- Body weight:
- No biologically relevant body weight losses occurred after dosing.
- Gross pathology:
- No gross lesions were present in the mice at necropsy.
Any other information on results incl. tables
The aqueous dispersion of the test substance was administered directly without correction for active ingredients since the product does not exist as solids alone and is always transported and used as the aqueous dispersion. The material was not toxic via the oral route of exposure as evidenced by the LD50 of > 5000 mg/kg. Additionally, no mortality, clinical signs, or body weight losses were observed in a mouse dosed at 10000 mg/kg.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
LD50 (female mice) > 5000 mg/kg. Additionally, no mortality, clinical signs, or body weight losses were observed in a mouse dosed at 10000 mg/kg. - Executive summary:
A single dose of test substance was administered by oral gavage to 3 fasted female mice at a dose of 5000 mg/kg. One mouse was initially dosed. The remaining 2 mice were simultaneously dosed 2 days (at least 48 hours) later. An additional mouse was treated at a dose of 10,000 mg/kg. The mice were observed for mortality, body weight effects, and clinical signs for 14 days after dosing. All mice were necropsied to detect grossly observable evidence of organ or tissue damage. No deaths occurred. The mice exhibited no clinical signs or biologically relevant body weight losses during the study. No gross lesions were present in the mice at necropsy. Under the conditions of this study, the oral LD50 was greater than 5000 mg/kg for female mice based on the limit test conducted at 5000 mg/kg. Additionally, no mortality, clinical signs, or body weight losses were observed in a mouse dosed at 10,000 mg/kg.
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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