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EC number: 246-788-1 | CAS number: 25279-09-8
- 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
Acute oral toxicity: Key study: OECD Guideline 420. GLP study. The acute oral median lethal dose (LD50) of test item in Wistar rats was found to be greater than 2000 mg/kg body weight.
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:
- 02 January 2018 - 02 February 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- RccHan: WIST
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Jai Research Foundation
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: 164.6-188.2 g
- Fasting period before study: Overnight and until 3 h post dosing.
- Housing: Two rats per cage.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 6-11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23 ºC
- Humidity (%): 49-67 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 (lights hours 06:00 h – 18:00 h) - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 0.44 mL
DOSAGE PREPARATION (if unusual): Individual dose volume was adjusted according to body weight and dose level and density (852.7 mg/mL). - Doses:
- Sighting test: 300 and 2000 mg/kg bw
Main test: 2000 mg/kg bw - No. of animals per sex per dose:
- Sighting test: 2 rats
Main test: 4 rats - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Signs of toxicity: 0.5, 1, 2, 3, 4 and 6 h post-administration
Morbidity and mortality: twice a day thereafter
Clinicals signs: Once a day
Weighing: Days 0, 7 and 14
- Necropsy of survivors performed: yes (external examination and opening of the abdominal and thoracic cavities) - Preliminary study:
- A sighting study was conducted using two animals; the first animal was dosed at the dose level of 300 mg/kg body weight. As no toxic sign or mortality was observed at this dose level, another animal was dosed at the higher dose level of 2000 mg/kg body weight. Nno toxic sign or mortality was observed.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No clinical sign was observed.
- Clinical signs:
- other: No clinical sign was observed.
- Gross pathology:
- External examination of terminally sacrificed rats did not reveal any abnormality of pathological significance.
Visceral examination of terminally sacrificed rats did not reveal any lesion of pathological significance. - Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The acute oral median lethal dose (LD50) of test item in Wistar rats was found to be greater than 2000 mg/kg body weight.
- Executive summary:
An acute oral toxicity test was performed according to OECD Guideline 420 (GLP study). A sighting study was conducted using two animals; the first animal was dosed at the dose level of 300 mg/kg body weight. As no toxic sign or mortality was observed at this dose level, another animal was dosed at the higher dose level of 2000 mg/kg body weight. As no toxic sign or mortality was observed, a main study (limit test) was conducted by dosing further four animals at the same dose level. No toxic signs or mortality was observed in main study conducted at the dose level of 2000 mg/kg body weight. There were no treatment-related mortality, clinical sign, changes in body weight or necropsy findings recorded. The acute oral median lethal dose (LD50) of test item in Wistar rats was found to be greater than 2000 mg/kg body weight
Reference
Dose (mg/kg bw) |
Study |
Rat N° |
Volume of Dose Administered (mL) |
Body Weight (g) on Day |
Percent Body Weight Change on Day |
|||
0 |
7 |
14 |
7 |
14 |
||||
300 |
Sighting |
1 |
0.06 |
164.6 |
180.4 |
208.2 |
9.6 |
26.5 |
2000 |
Sighting |
2 |
0.40 |
170.4 |
195.4 |
209.2 |
14.7 |
22.8 |
Main |
3 |
0.44 |
188.2 |
211.1 |
221.2 |
12.2 |
17.5 |
|
4 |
0.43 |
185.1 |
200.5 |
214.5 |
8.3 |
15.9 |
||
5 |
0.44 |
188.1 |
225.4 |
232.8 |
19.8 |
23.8 |
||
6 |
0.42 |
180.2 |
202.1 |
216.4 |
12.2 |
20.1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- One study available with a Klimisch score of 1.
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
Justification for classification or non-classification
Based on available information (LD50 oral > 2000 mg/kg bw), the substance is not classified for acute toxicity according to CLP Regulation (EC) no. 1272/2008.
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.
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