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EC number: 807-813-7 | CAS number: 1298086-15-3
- 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
Oral:
One study on rats is available.
LD50 in rat was higher than 2000 mg/kg body weight (not disclosed, 2014).
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:
- From 22 Apr to 07 May 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study run to a method comparable with current guidelines
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER Labs
- Age at study initiation: 8 weeks old
- Weight at study initiation: between 169 g and 218 g
- Fasting period before study: an overnight
- Housing: Healthy female rats were housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week.
- Diet (e.g. ad libitum): Free access to foodstuff. Food was removed on D-1 and then redistributed 4 hours after the test item administration.
- Water (e.g. ad libitum): Free access to tap-water from public distribution system
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least ten changes
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (07:00 to 19:00) and twelve hours darkness - Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg
DOSAGE PREPARATION (if unusual): In the first and second step of the study, 2.0015 g and 2.0035 g of the test item, was weighed and dimethyl sulfoxide was added to two 10 mL volumetric flasks, respectively. The preparations were magnetically stirred to obtain a red solution just before the administration. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- Step 1: 3 female rats
Step 2: 3 female rats - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Systematic examinations were carried out every day to identify any behavioral or toxic effects on the major physiological functions during 14 days following the administration of the test item. The animals were weighed on day 0 (just before administering the test item) then on D2, D7, and D14.
- Necropsy of survivors performed: yes, On D14, the animals were anaesthetised with sodium pentobarbital and administration continue to fatal levels. Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. Those presenting macroscopic anomalies can be removed and preserved in view to microscopic examinations. - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: No clinical signs related to the administration of the test item were observed during the study.
- Gross pathology:
- The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat. In accordance with the OECD guideline No. 423, the LD50 cut-off of the test item may be considered to be higher than 5000 mg/kg body weight by oral route in the rat.
According to the criteria for classification, packaging and labeling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test item must not be classified, according to the criteria for classification, packaging and labeling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol or risk phrase is required.
In accordance with the Regulation (EC) No. 1272/2008, the test item must hat be classified. No signal word or hazard statement is required.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- 1 (reliable without restriction)
Additional information
Oral:
One study study is available which was conducted according to OECD Guideline 423 (not disclosed, 2014). The LD50 is higher than 2000 mg/kg body weight by oral route in Sprague-Dawley rats.
Justification for selection of acute toxicity – oral endpoint
Study run to a method comparable with current guidelines, with rats
Justification for classification or non-classification
Oral: rat LD50 > 2000 mg/kg bw (actual value > 2000 mg/kg bw);
Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.1.1, this substance should not be classified for acute oral toxicity.
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