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EC number: 276-586-9 | CAS number: 72319-18-7
- 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 LD50 for acute oral toxicity of the substance was determined to be between 300 and 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
- Study period:
- 31 May 2016 to 29 June 2016
- 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
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 30 May 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- December 2002
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nousan No. 8147
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Test item No.: 16/0122-1
- Batch identification: Lot 4030158820
- Expiry date: March 2018
- Content: 100 g/100 g
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
OTHER SPECIFICS
- Physical state / color: Solid / violet to sparkling dark blue - Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI (Han) SPF
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: Animals were of comparable weight (± 20% of the mean weight, experiment 1: 178.7 g, experiment 2: 176.7, experiment 3: 176.3 g)
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: Makrolon cage, type III, Single housing
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water: Tap water ad libitum
- Bedding: H 15005-29; Ssniff, Spezialdiäten GmbH (Experimental Animal Diets Inc., 59494 Soest, Germany)
- Enrichment: Wooden gnawing blocks (Type NGM E-022) ; ABEDD® LAB & VET Service GmbH, Hasnerstraße 84/6; 1160 Wien – Austria
- Acclimation period: Acclimatization period of at least 5 days before the beginning of the experimental phase; during the acclimatization period, the animals were accustomed to the environmental conditions of the study and to the diet.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 (fully air-conditioned rooms)
- Humidity (%): 30 – 70
- Air changes (per hr): Approx. 10
- Photoperiod (hrs dark / hrs light): 12/12 (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.) - Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% solution of CMC (sodium carboxymethylcellulose, Dow Wolff Cellulosics GmbH) in deionized water
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: A good homogeneity in water could not be guaranteed, because the test item preparation was a suspension. Therefore a 0.5% solution of CMC in deionized water was applied.
DOSAGE PREPARATION
- Form of administration: Suspension
- Test item preparation (for all doses): The test item preparation for each test group was produced shortly before administration by stirring with a high speed homogenizer (Ultra-Turrax) and a magnetic stirrer.
- Homogenization until end of each administration period: The homogeneity of the test item preparation during administration was ensured by stirring with a magnetic stirrer.
FORM AS APPLIED IN THE TEST
Suspension - Doses:
- EXPERIMENT 1
2000 mg/kg bw
EXPERIMENT 2 and Experiment 3
300 mg/kg bw - No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Observation period: 14 days
- 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.
- Mortality: A check for any dead or moribund animals was made at least once each workday; these records are archived by Bioassay.
- Pathology: 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. Necropsy of all animals that died as early as possible after death.
- Histology: No histological examinations were performed. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- EXPERIMENT 1
All animals died at hour 3 after administration
EXPERIMENT 2 and 3
No mortality occurred - Clinical signs:
- other: EXPERIMENT 1 - Impaired general state was noted in two animals from hour 0 until hour 1 after administration. Thereafter poor general state was noted in these animals at hour 2. Piloerection was seen in these animals from hour 0 until hour 2. - In the th
- Gross pathology:
- EXPERIMENT 1
The following macroscopic pathologic findings were observed in the animals that died: Red discoloration of the stomach contents, red discoloration of the small intestine contents and dark spotted liver.
EXPERIMENT 2 and 3
There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period. - Interpretation of results:
- Category 4 based on GHS criteria
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
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 toxicity: oral
In a GLP compliant acute oral toxicity study performed according to OECD guideline 423 (Acute Toxic Class method), doses of 2000 and 300 mg/kg bw of the test substance (preparations in 0.5% sodium carboxymethylcellulose-solution) were administered by gavage to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 3 females, 300 mg/kg bw in two times 3 females). All animals died at hour 3 after administration of 2000 mg/kg bw. In this test group, test-substance related clinical signs included impaired general state, piloerection, staggering and red discoloured defecation. Macroscopic pathologic observations in these animals were red discoloration of the stomach contents and of the small intestine contents, and dark spotted liver. No mortality occurred in the 300 mg/kg bw test groups. Red discoloured defecation and red discoloured urine were noted from study day 1 till study day 3. There were no macroscopic pathological findings in the surviving animals sacrificed at the end of the observation period. The LD50 was determined to be between 300 and 2000 mg/kg bw.
Justification for classification or non-classification
Based on the available information the substance needs to be classified as acute toxic 4, H302: Harmful if swallowed in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. (EC) 1272/2008.
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