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EC number: 219-694-3 | CAS number: 2498-95-5
- 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 oral toxicity in rats of the test item was determined in an OECD guideline study. The LD50 was determined to be > 2000 mg/kg bw
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: animals of comparable weight (± 20% of the mean weight), mean weight: administration 1: 183.3 g, administration 2: 184.0 g
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum
- Housing: single housing in Makrolon cages, type III
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany; adlibitum (except during fasting period)
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 – 70
- Air changes (per hr): approx. 10
- Photoperiod (hrs light / hrs dark): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.) - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- FORM OF ADMINITRATION: Suspension
VEHICLE
- Concentration in vehicle: 20 g/100 mL
- Justification for choice of vehicle: a good homogeneity in water could not be guaranteed, because the test item preparation was a suspension
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION: The test item was prepared for each test group shortly before administration by stirring with a high speed homogenizer (Ultra-Turrax) and a magnetic stirrer. Additionally, the homogeneity of the test item preparation during administration was ensured by stirring with a magnetic stirrer.
CLASS METHOD
- Rationale for the selection of the starting dose: By request of the sponsor a starting dose of 2000 mg/kg bw was chosen in the first step with 3 female animals. Because no mortality occurred, 2000 mg/kg bw were administered to another group of 3 female animals in the second step. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 2 x 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality: A check for any dead or moribund animals was made at least once each workday
Body weight determination: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
Clinical observations: Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter
- Necropsy of survivors performed: yes; necropsy with gross-pathology examination was performed on the last day of the observation period after sacrifice by CO2-inhalation in a chamber with gradually increasing concentrations
- Other examinations performed: clinical signs, body weight - Statistics:
- Calculations were performed using Microsoft Excel 2003 and checked with a calculator.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality
- Mortality:
- No mortality occurred in both test groups.
- Clinical signs:
- other: In the first administration group impaired general state and piloerection were observed from hour 1 until hour 3 or 4 in all animals. In the second administration group no clinical signs were observed in all animals during clinical examination.
- Gross pathology:
- There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this study the median lethal dose of the test item after oral administration was found to be greater than 2000 mg/kg bw in rats.
- Executive summary:
In an acute oral toxicity study performed according to the Acute Toxic Class method, 2000 mg/kg bw of the test item (preparations in 0.5% CMC-solution) were administered by gavage to two test groups of three fasted female Wistar rats each.
The following test substance-related clinical observations were recorded, clinical signs occurred within the first 4 hours after administration:
2000 mg/kg (first test group):
- No mortality occurred
- Impaired general state in all animals
- Piloerection in all animals
2000 mg/kg (second test group):
- No mortality occurred
- No clinical signs were observed.
The body weights of both test groups increased within the normal range throughout the study period. There were no macroscopic pathological findings in all animals sacrificed at the end of the observation period. The acute oral LD50 was calculated to be greater than 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP guideline study
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
Oral:
In the key acute oral toxicity study performed according to the Acute Toxic Class method, 2000 mg/kg bw of the test item (preparations in 0.5% CMC-solution) were administered by gavage to two test groups of three fasted female Wistar rats each (BASF SE, 2015). The following test substance-related clinical observations were recorded, clinical signs occurred within the first 4 hours after administration:
2000 mg/kg bw (first test group): No mortality occurred; impaired general state in all animals; piloerection in all animals
2000 mg/kg bw (second test group): No mortality occurred; no clinical signs were observed
The body weights of both test groups increased within the normal range throughout the study period. There were no macroscopic pathological findings in all animals sacrificed at the end of the observation period. The acute oral LD50 was calculated to be greater than 2000 mg/kg bw.
A disregarded study with an aqueous solution of test item (10.8 g/100g active ingredient) was performed ot assess the acute oral toxicity in Wistar rats (OECD guideline 423). A single oral dose of the test material preparation in aqua bidest. was administered by gavage to a group of six fasted animals (three males and three females) at a dose level of 2000 mg/kg body weight. The animals did not show any signs of toxcicity. The expected body weight gain was observed in the course of the study. No mortality occurred. No abnormalities were noted at necropsy of animals sacrificed at the end of the study. Under the conditions of this study the median lethal dose of the test item after oral application was found to be greater than 2000 mg/kg body weight for male and female animals (BASF, 1998). The study was rated as disregarded study as it was only tested in a purity of 10.8 g/100 g active ingredient.
Justification for selection of acute toxicity – oral endpoint
GLP and guideline study
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 (CLP). As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008.
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