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EC number: 270-219-6 | CAS number: 68413-47-8
- 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
The acute oral median lethal dose (LD50) of test material in the Sprague-Dawley CD strain rat was estimated as being greater than 2500 mg/kg bodyweight (SafePharm Laboratories, 2004).
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:
- 17 March 2004 – 11 May 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Specific details on test material used for the study:
- - Description: Light amber coloured, slightly viscous liquid
- Storage: Room temperature, in the dark - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: Eight to twelve weeks
- Weight at study initiation: 188 to 210 g
- Fasting period before study: An overnight fast immediately before dosing
- Housing: Suspended solid-floor polypropylene cages furnished with wood flakes
- Diet (e.g. ad libitum): Certified Rat and Mouse Diet (Code 5LF2) supplied by BCM IPS Limited, London, UK
- Water (e.g. ad libitum): Free Access to mains drinking water (tap water, ad libitum)
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): Fifteen changes per hour
- Photoperiod (hrs dark / hrs light): Twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
IN-LIFE DATES: From: 18 March 2004 To: 03 April 2004 - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Doses:
- 3 animals per dose
- No. of animals per sex per dose:
- 3 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for deaths or overt signs of toxicity ½, 1, 2, and 4 hours after dosing, and subsequently once daily for fourteen days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no unscheduled deaths.
- Clinical signs:
- other: Signs of systemic toxicity noted in three animals were hunched posture, diuresis, diarrhoea, and dehydration. These animals recovered six or seven days after dosing. The remaining three animals appeared normal throughout the study.
- Gross pathology:
- No abnormalities were noted at necroscopy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 for female Sprague Dawley CD strain rats was found to be greater than 2500 mg/kg body weight. The study was performed to the standardised guideline OECD 423, under GLP conditions.
- Executive summary:
The acute oral LD50 for female Sprague Dawley CD strain rats was found to be greater than 2500 mg/kg body weight.
No unscheduled deaths and no signs of systemic toxicity were noted during the observation period. All animals showed expected gains in body weight. No abnormalities were noted at necropsy.
The study was performed to the standardised guideline OECD 423, under GLP conditions.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 500 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Key study:
In an OECD Guideline 423 study, conducted according to GLP, the acute oral median lethal dose (LD50) of the test substance in the Sprague-Dawley CD strain rat was estimated as being greater than 2500 mg/kg bodyweight (SafePharm Laboratories, 2004).
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.