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EC number: 605-495-2 | CAS number: 167948-98-3
- 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
The acute toxicity of the test item was determined in a GLP-study according to OECD Test Guideline 423 as LD50 > 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:
- November 11, 2002 - January 27, 2003
- 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:
- adopted on December 17th, 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- Commission Directive of 30th. July 1996 adapting to technical progress for the 22nd time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances
(Official Journal of the European communities No. L 248, September 30, 1996) - Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approx. 6 to 8 weeks
- Weight at study initiation :187 g (range from 160 to 202 g)
- Fasting period before study: 17 hours before until up to 4 hours after treatment
- Housing: separately in type III Makrolon cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22°C
- Humidity: 41 - 76%
- Photoperiod (hrs dark / hrs light): 12 hour light - 12 hour dark regime
IN-LIFE DATES: From: day 1 To: day 15 - Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle: 10 ml/kg
- Justification for choice of vehicle: well tolerated and established standard vehicle - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: day 1, 2, 4, 6, 8, 11, 13 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- The body weight data were recorded with the PC-program "AKUDAT". The statistical evaluations of the body weight were carried out with the PC-program "TOX 511 A". The body weight development of each rat and group was determined. The group mean value was calculated for each measurement and printed on tables.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All rats survived the observation period.
- Clinical signs:
- No signs of toxicity were detected in the 3 male and 3 female rats after treatment with 2000 mg/kg bw.
- Body weight:
- Body weight development of the treated rats was inconspicuous.
- Gross pathology:
- The gross pathological examination revealed no organ alterations.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the result of this study, it is concluded that the LD50 value of the substance is higher than 2000 mg/kg bw after oral treatment in rats.
- Executive summary:
The test item was tested for acute toxicity in rats after oral administration of 2000 mg/kg body weight. Directly before administration the test material was prepared with aqueous methylcellulose solution as the vehicle. This study was performed according to the "Acute toxic class method" (ATC) and fully compliant with OECD TG 423 (2001). No signs of toxicity were detected in the rats (3 males and 3 females) after treatment with 2000 mg/kg bw. There were no deaths during the course of the study. The gross pathological examination revealed no organ alterations. Based on the results of this study, it is considered that the test item has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg bw after oral treatment in rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study was conducted according to GLP and OECD guideline.
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 oral toxicity
The test item was tested for acute toxicity in rats after oral administration of 2000 mg/kg body weight. Directly before administration the test material was prepared with aqueous methylcellulose solution as the vehicle. This study was performed according to the "Acute toxic class method" (ATC) and fully compliant with OECD TG 423 (2001). No signs of toxicity were detected in the rats (3 males and 3 females) after treatment with 2000 mg/kg bw. There were no deaths during the course of the study. The gross pathological examination revealed no organ alterations. Based on the results of this study, it is considered that the test item has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg bw after oral treatment in rats.Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute oral toxicity, the test item is not classified for acute oral toxicity according to Regulation (EC) No 1272/2008 (CLP), as amended for the twelfth time in Regulation (EU) 2019/521.
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