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EC number: 203-115-6 | CAS number: 103-47-9
- 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 a GLP-study according to OECD TG 423 (acute toxic class method) with rats, the LD50 of the substance was determined as > 2000 mg/kg bw (reference 7.2.1 -1).
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:
- 2016-10-04 to 2016-10-20
- 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)
- Version / remarks:
- 17 December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: TOXI COOP ZRT. Cserkesz u. 90., 1103 Budapest, Hungary
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks
- Weight at study initiation: 198 - 204 g
- Fasting period before study: 1 day (water was available), food was returned 3 h after treatment
- Housing: group caging (3 rats/cage)
- Diet: ad libitum, ssniff® SM R/M-Z+H complete diet for rats and mice (ssniff Spezialdiäten GmbH, D-59494 Soest Germany)
- Water: ad libitum, tap water
- Acclimation period: 5-6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 30 - 70
- Air changes (per hr): above 10
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: standard vehicle
- Purity: aqua purificata Ph.Hg. VIII. from Parma Produkt Kft. (Batch no. 1606-5508)
MAXIMUM DOSE VOLUME APPLIED: 10 mL
CLASS METHOD
- Rationale for the selection of the starting dose: The starting dose was selected on the basis of the available information about the test item and similar substances. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females (3 per group)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed individually after dosing at least once during the first 30 minutes, then 1 h, 2 h, 3 h, 4 h after the treatment and twice each day for 14 days thereafter. The body weights were recorded on day 0 (just before the treatment), on day 7 and on day 15 with a precision of 1 g.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, external appearance, appearance of tissue and organs of cranial, thoracic and abdominal cavities
- Experimental design: The study was performed in two consecutive steps with three rats per step. - Statistics:
- not applicable
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death occurred at 2000 mg/kg bw single oral dose of the test item. All female rats in step 1 and step 2 survived until the end of the 14-day observation period.
- Clinical signs:
- other: No symptoms were observed throughout the 14-day post-treatment period at any groups of the female animals.
- Gross pathology:
- All animals survived until the scheduled necropsy on Day 15.
Severe hydrometra was detected in two animals of group 2 and in female of the group 1, as well. Hydrometra is physiological finding and connected to the cycle of the animal.
No further pathological changes were found during the macroscopic examination of animals. - Other findings:
- - Organ weights: not applicable
- Histopathology: not applicable
- Potential target organs: none
- Other observations: none - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test item was determined to be above 2000 mg/kg body weight by oral route in the rat.
- Executive summary:
A study according to OECD 423 was performed to assess the toxicity of test item when administered in a single dose to rats at one or more defined dose levels. The starting dose was selected on the basis of the available information about the test item and similar substances.
The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animal died in the first step at 2000 mg/kg bw dose level, so treatment with 2000 mg/kg bw was repeated on further three female rats. No animal died in the second step. Based on this the testing was terminated in accordance to the stopping criteria of Annex 2d of OECD Guideline No. 423.
Animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried out 15th day after the treatment in all animals.
No death occurred at 2000 mg/kg bw single oral dose of the test item. All female rats survived until the end of the 14-day observation period.
No symptoms were observed throughout the 14-day post-treatment period at any groups of the female animals.
The body weight development was undisturbed in all animals.
All organs of the animals treated with 2000 mg/kg bw proved to be free of treatment related gross pathological changes.
In conclusion, the LD50 of the test item was determined to be above 2000 mg/kg body weight by oral route in the rat.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The available study is of high quality and reliable without restrictions.
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
A study according to OECD 423 was performed to assess the toxicity of test item when administered in a single dose to rats at one or more defined dose levels. The starting dose was selected on the basis of the available information about the test item and similar substances.
The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animal died in the first step at 2000 mg/kg bw dose level, so treatment with 2000 mg/kg bw was repeated on further three female rats. No animal died in the second step. Based on this the testing was terminated in accordance to the stopping criteria of Annex 2d of OECD Guideline No. 423.
Animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried out 15th day after the treatment in all animals.
No death occurred at 2000 mg/kg bw single oral dose of the test item. All female rats survived until the end of the 14-day observation period.
No symptoms were observed throughout the 14-day post-treatment period at any groups of the female animals.
The body weight development was undisturbed in all animals.
All organs of the animals treated with 2000 mg/kg bw proved to be free of treatment related gross pathological changes.
In conclusion, the LD50 of the test item was determined to be above 2000 mg/kg body weight by oral route in the rat.
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Based on
available data on acute toxicity, the test item does not require
classification for acute toxicity via the oral route according to
Regulation (EC) No 1272/2008 (CLP), as amended for the fifteenth time in
Regulation (EU) No 2020/1182.
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