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EC number: 435-780-5 | 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
Endpoint summary
Administrative data
Description of key information
Acute oral LD50 > 5000 mg/kg bw, EU Method B.1, OECD 401, rat (male/female), Jones & Collier (1987)
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:
- 29 April to 27 May 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna (U.K.) Limited, Wyton, Huntingdon, Cambridgeshire
- Age at study initiation: ca. 5 - 8 weeks
- Weight at study initiation: males: 211 - 234 g; females: 161 - 181 g
- Fasting period before study: yes (overnight before dosing and ca. 2 hours after dosing)
- Housing: animals were housed in groups of up to 5 by sex in solid-floor polypropylene cages with sawdust bedding
- Diet: ad libitum (Rat and Mouse Expanded Diet No. 1, Special Diet Services Ltd)
- Water: ad libitum
- Acclimation period: 5 days (minimum)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22 °C
- Humidity (%): 55 - 68 %
- Air changes (per hr): ca. 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 5.77 mg/kg bw
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for mortality and overt signs of toxicity 1 and 4 hours after dosing and subsequently once daily for 14 days. Bodyweights were recorded on the day of dosing (day 0) and on days 7 and 14.
- Necropsy of survivors performed: yes - Preliminary study:
- None of the animals died during the preliminary study and subsequently, the top dose of 5000 mg/kg bw was selected for the main study.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None of the animals died during the study period.
- Clinical signs:
- other: No signs of systemic toxicity were noted during the study period. All animals showed expected gains in bodyweight over the study period.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, the acute oral LD50 of the test material was determined to be in excess of 5000 mg/kg bw.
- Executive summary:
The acute oral toxicity of the test material was evaluated in a study which was conducted under GLP conditions and in accordance with the standardised guidelines EU Method B.1 and OECD 401.
During the study, the test material was administered by oral gavage to one group of five male and five female Sprague-Dawley rats at 5000 mg/kg bw. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing. All animals were subject to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice on day 15.
None of the animals died during the study and no clinical signs were noted. The mean body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain. Furthermore, no abnormalities were found at macroscopic post mortem
examination of the animals.
Therefore, under the conditions of the study, the oral LD50 value of the test material in male and female Sprague-Dawley rats was in excess of 5000 mg/kg bw, the highest permissible dose level tested.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The available study was conducted under GLP conditions and in accordance with standardised guidelines. The study was assigned a reliability score of 1; the overall quality of the database is good.
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
Acute toxicity oral:
The acute oral toxicity of the test material was evaluated in a study which was conducted under GLP conditions and in accordance with the standardised guidelines EU Method B.1 and OECD 401.
During the study, the test material was administered by oral gavage to one group of five male and five female Sprague-Dawley rats at 5000 mg/kg bw. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing. All animals were subject to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice on day 15.
None of the animals died during the study and no clinical signs were noted. The mean body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain. Furthermore, no abnormalities were found at macroscopic post mortem
examination of the animals.
Therefore, under the conditions of the study, the oral LD50 value of the test material in male and female Sprague-Dawley rats was in excess of 5000 mg/kg bw, the highest permissible dose level tested.
Justification for classification or non-classification
The substance does not fulfil the classification criteria for acute toxicity according to European Regulation (EC) No 1272/2008.
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