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Diss Factsheets
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EC number: 229-158-0 | CAS number: 6420-33-3
- 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
Endpoint summary
Administrative data
Description of key information
In an acute oral study, rats (5/sex) received the substance by oral gavage at 5000 mg/kg bw. No effects on mortality, bodyweight or macroscopy were found after the 14 day observation period. On day 1 of the test hunched posture, piloerection and diarrhea were observed. The LD50 is > 5000 mg/kg bw (Safepharm 1985).
Based on the information in an abstract from 1974 the dermal LD50 is > 4000 mg/kg bw
As the substance does not show toxicity in the acute oral toxicity study, further testing via the dermal route was waived.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 October 1985 to 19 November 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- no data on purity
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1981
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- no data on purity of the tested substance
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna Ltd, Wyton, Huntingdon UK
- Females (if applicable) nulliparous and non-pregnant: no data
- Age at study initiation: 5-8 weeks
- Weight at study initiation: males 172-200 g; females 172-183 g
- Fasting period before study: overnight until 2 hours post dosing
- Housing: 5/sex/polypropylene cage
- Diet: Rat and Mice Expanded Diet no 1 (Special Diet Srvices Ltd, Witham, Essex UK) ad libitum):
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22 °C
- Humidity (%): 40-65%
- Air changes (per hr): 15/hour
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 500 mg/mL
MAXIMUM DOSE VOLUME APPLIED: 10 mL
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 males + 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations:clinical signs and mortality : after 1 and 4 hours and daily thereafter
- Body weight: on day 0, 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- NA
- Preliminary study:
- Hunched posture, piloerection and diarrhea on day 1 at 2000 and 5000 mg/kg bw
No mortality - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- Hunched posture, piloerection and diarrhea on day 1
- Body weight:
- within normal ranges
- Gross pathology:
- no effects
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the substance tested the LD50 is >5000 mg/kg bw.
- Executive summary:
In an acute oral study, rats (5/sex) received the substance by oral gavage at 5000 mg/kg bw. No effects on mortality, bodyweight or macroscopy were found after the 14 day observation period. On day 1 of the test hunched posture, piloerection and diarrhea were observed. The LD50 is > 5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- worst case estimate as in the available studies limited information on purity is available
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1974
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
- Qualifier:
- no guideline followed
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- no data
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Duration of exposure:
- 4 hours
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 males
- Control animals:
- not required
- Details on study design:
- no data
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 4 000 mg/kg bw
- Based on:
- act. ingr.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the substance is > 4000 mg/kg bw
- Executive summary:
Five male rats received a single dose of 4000 mg/kg bw. The LD50 of the substance is > 4000 mg/kg bw, when corrected for purity of the tested substance
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 4 000 mg/kg bw
- Quality of whole database:
- Not assignable, but in absence of effects in the oral study no further testing via the dermal route is considered necessary
Additional information
Based on the information available the substance does not need to be classified for acute toxicity according to Regulation (EC) No 1272/2008.
Justification for classification or non-classification
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.