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EC number: 692-793-0 | CAS number: 156487-12-6
- 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
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- Water solubility
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- Auto flammability
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- Additional physico-chemical information
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- Nanomaterial agglomeration / aggregation
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- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
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- Environmental data
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- 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
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- Toxicological Summary
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Endpoint summary
Administrative data
Description of key information
GLP compiant OECD 423 ATC Study: LD50 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:
- Aug 07, 2018 - Aug 21, 2019
- 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)
- 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, 33178 Borchen
- Age at study initiation: about 9 weeks
- Weight at study initiation: 166 g (range from 155 to 182 g).
- Fasting period before study: yes, overnight (17 hours before - 4 h after treatment)
- Housing: the rats were housed in an air-conditioned room of ca. 25 m² in the Institute of Toxicology in Macrolon cages type III with a shelter, placed on mobile racks. Animals were kept on conventional softwool granulate as bedding which was changed 2x per week.
- Diet: Provimi Kliba 3433.0, ad libitum
- Water: tap water from Makrolon drinking bottles, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.7 – 23.2
- Humidity (%): 43.2 – 58.5
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
Directly before the preparation the test metariel was solved in the vehicle using a shaking device (Vortex Genie) and and Ultra Turrax device.
The vehicle chosen was Methocel(R) K4M Premium solution
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - 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 and weighing:
The behaviour and general condition of all animals was monitored for at least 6 h after administration of the test material and then checked daily. All animals were weighed before treatment and on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part.
- Necropsy of survivors performed: yes, At the end of the experimental part, all surviving rats were sacrificed by an air carbon dioxide mixture and exsanguination after opening the abdominal vessels (Vena cava caudalis, Aorta abdominalis). All rats (survivors and rats found dead) were subjected to a gross pathological investigation and macroscopic findings were noted manually on a necropsy record sheet. - Statistics:
- Body weight data were recorded with the PC software "akudat", the statistical evaluation of the body weight were carried out with the software "Tox 511A", the body weight development of each rat and group was determined. The group mean value was calculated for each measurement.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Three out of six rats treated with 2000 mg/kg died on day 2 and 3 after the last observation. No mortality was seen after treatment with 300 mg/kg during the course of this study.
- Clinical signs:
- observations of tremors
- other: locomotor disturbance, dyspnea and tremor
- Body weight:
- lower than 10% body weight loss
- Remarks:
- Five out of six rats treated with 2000 mg/kg showed a decrease of the body weight on day 2. The body weight development of the surviving rats treated with 2000 mg/kg after day 2 was inconspicuous until experimental day 15. The body weight development of the rats treated with 300 mg/kg was inconspicuous throughout the study.
- Gross pathology:
- Necropsy revealed no findings in animals dosed with 300 mg/kg. Three out of six rats (no. 4,5,6) dosed with 2000 mg/kg showed macroscopic lesions as follows. All three rats showed dark-red discolorations in the fundus mucosa of the stomach (no histology correlate). In the intestines, multifocal to diffuse red discolorations were noted (no histology correlate); a firm content was found in the cecum (no histology correlate). Animal 4 showed dark-red discolorations in the thymus (acute hemorrhages). Animal no. 5 had a smaller spleen (marked lymphoid depletion) and animal no. 6 dark-red discolored kidneys (no histology correlate) and a wet abdominal fur (reddish fluid).
- Other findings:
- Histopathology examination of selected organs from rats dosed with 2000 mg/kg showed lesions in the urinary bladder, the hemo-lymphoid system (bone marrow, thymus, spleen), the liver, the small intestines and the lung. In the urinary bladder of all three rats (no. 4, 5, 6) dosed with 2000 mg/kg, moderate erosions of the mucosa (urothel) or a mild cytoplasmic vacuolation of the urothelium were seen. In addition, moderate submucosal located granulocytic infiltrates and acute focal hemorrhages were found. In the bone marrow, a moderate to marked decreased cellularity was seen. In the thymus of animal no. 4, severe lymphoid necrosis and acute hemorrhages were noted. The spleen showed marked to severe lymphoid depletion and lymphoid necrosis in all three animals. In the liver, a mild cytoplasmic vacuolation of periportal hepatocytes was found in all three rats. Animal no. 5 and 6 showed multifocal mucosa ulcerations and granulocytic infiltrates in the small intestines. All three rats showed lungs with acute blood congestion (most likely an agonal change).
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under the conditions of the present study, the LD50 value for the test item is expected to be between 300 - 2000 mg/kg after single oral administration in rats
Reference
The body weight development of rats is given in the following table:
Animal No. | Sex | Dose | Body weight in g on day | Body weight gain in g | |||||||
1 | 2 | 4 | 6 | 8 | 11 | 13 | 15 | Day 1 to 15 | |||
1 | Female | 2000 | 161 | 155 | 165 | 176 | 174 | 190 | 188 | 199 | +38 |
2 | Female | 2000 | 171 | 166 | 175 | 185 | 194 | 201 | 205 | 216 | +45 |
3 | Female | 2000 | 171 | 177 | 178 | 186 | 194 | 202 | 204 | 210 | +39 |
4* | Female | 2000 | 157 | 152 | - | - | - | - | - | - | - |
5** | Female | 2000 | 163 | 158 | - | - | - | - | - | - | - |
6** | Female | 2000 | 158 | 151 | - | - | - | - | - | - | - |
7 | Female | 300 | 162 | 175 | 177 | 184 | 182 | 191 | 190 | 197 | +35 |
8 | Female | 300 | 182 | 194 | 203 | 204 | 211 | 213 | 216 | 223 | +41 |
9 | Female | 300 | 169 | 184 | 189 | 197 | 197 | 199 | 205 | 208 | +39 |
10 | Female | 300 | 165 | 180 | 184 | 181 | 190 | 193 | 197 | 201 | +36 |
11 | Female | 300 | 173 | 188 | 190 | 195 | 199 | 203 | 201 | 208 | +35 |
12 | Female | 300 | 155 | 171 | 175 | 176 | 181 | 183 | 188 | 193 | +38 |
* died on day 3 after last observation; body weightpost mortem: animal no. 4: 147 g
** died on day 2 after last observation; body weight post mortem: animal no. 5: 152 g, animal no. 6: 146 g
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 300 - < 2 000 mg/kg bw
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 the provided information the substance is to be classified as acute toxicity category 4 according to the EU 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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