Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 603-290-2 | CAS number: 128625-52-5
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
The LD50 value was determined to be between 300 and 2000 mg/kg after single oral administration in female rats (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:
- July 29, 2019 - September 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)
- Version / remarks:
- December 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI (Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: 9 weeks
- Fasting period before study: yes
- Housing: group-housed in type IV Makrolon cages; one day before treatment,rats were single-housed in type II Makrolon cages
- Diet: ad libitum, V1534, ssniff Spezialdiäten GmbH, Germany
- Water: ad libitum, tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 45-65
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.25% aqueous hydroxypropylcellulose (Methocel)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
CLASS METHOD
- Rationale for the selection of the starting dose: Due to the fact, that no information concerning the toxic potential of the test item is available, the study started in 3 females with 300 mg/kg bw. - Doses:
- 300 mg/kg bw (starting dose)
2000 mg/kg bw - No. of animals per sex per dose:
- 3 (females)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: recorded directly before treatment (day 1) and on days 2, 4, 6, 8,11,13 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was seen after treatment with 300 mg/kg during the course of this study. All three rats treated with 2000 mg/kg were killed in moribund condition 4 hours after treatment.
- Clinical signs:
- other: No clinical signs of toxicity were observed in all rats treated with 300 mg/kg. All rats treated with 2000 mg/kg showed locomotor disturbance, abdominal or lateral position and dyspnea.
- Gross pathology:
- The gross pathology examination revealed no findings in animals dosed with 300 mg/kg. The animals at 2000 mg/kg exhibited a dark red or dark grey discoloration of the lung.
- Other findings:
- The histopathology examination of the lungs of the animals dosed with 2000 mg/kg revealed in all animals blood congestion and in two animals mild acute alveolar hemorrhages and a perivascular edema.
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The test item has acute toxic potential under the conditions of the present study, and the LD50 value was between 300 and 2000 mg/kg bw after single oral administration in female rats.
- Executive summary:
An acute oral toxicity study with the test item was performed according to the Acute-Toxic-Class Method and OECD Guideline 423. The study was started with 300 mg/kg in 3 female rats where no mortality was seen, and continued with further 3 females treated with 300 mg/kg. Due to the fact, that no mortality was seen in animal after treatment with 300 mg/kg, 3 further females were treated with 2000 mg/kg.
Mortality and clinical signs were monitored for at least 6 hours after administration and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period, all surviving rats were sacrificed and subjected to a detailed necropsy. No mortality was seen after treatment with 300 mg/kg during the course of this study. All three rats treated with 2000 mg/kg were killed in moribund condition 4 hours after treatment. No clinical signs of toxicity were observed in all rats treated with 300 mg/kg. All rats treated with 2000 mg/kg showed locomotor disturbance, abdominal or lateral position and dyspnea. In 2 out of 3 rats incomplete eyelid closure was seen. The body weight development of the rats treated with 300 mg/kg was inconspicuous throughout the study. The gross pathology examination revealed no findings in animals dosed with 300 mg/kg. The animals at 2000 mg/kg exhibited a dark red or dark grey discoloration of the lung. The histopathology examination of the lungs of the animals dosed with 2000 mg/kg revealed in all animals blood congestion and in two animals mild acute alveolar hemorrhages and a perivascular edema. Under the conditions of the present study, the LD50value is expected to be between 300 - 2000 mg/kg after single oral administration in rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 300 mg/kg bw
- Quality of whole database:
- OECD TG 423
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
An acute oral toxicity study with the test item was performed according to the Acute-Toxic-Class Method and OECD Guideline 423.The study was started with 300 mg/kg in 3 female rats where no mortality was seen, and continued with further 3 females treated with 300 mg/kg. Due to the fact, that no mortality was seen in animal after treatment with 300 mg/kg, 3 further females were treated with 2000 mg/kg.
Mortality and clinical signs were monitored for at least 6 hours after administration and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period, all surviving rats were sacrificed and subjected to a detailed necropsy. No mortality was seen after treatment with 300 mg/kg during the course of this study. All three rats treated with 2000 mg/kg were killed in moribund condition 4 hours after treatment. No clinical signs of toxicity were observed in all rats treated with 300 mg/kg. All rats treated with 2000 mg/kg showed locomotor disturbance, abdominal or lateral position and dyspnea. In 2 out of 3 rats incomplete eyelid closure was seen. The body weight development of the rats treated with 300 mg/kg was inconspicuous throughout the study. The gross pathology examination revealed no findings in animals dosed with 300 mg/kg. The animals at 2000 mg/kg exhibited a dark red or dark grey discoloration of the lung. The histopathology examination of the lungs of the animals dosed with 2000 mg/kg revealed in all animals blood congestion and in two animals mild acute alveolar hemorrhages and a perivascular edema. Under the conditions of the present study, the LD50value is expected to be between 300 - 2000 mg/kg after single oral administration in rats.
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 oral toxicity, the test item is classified as
acute toxic cat 4 H302 according to Regulation (EC) No 1272/2008 (CLP), as
amended for the fifteenth time in Regulation (EU) No 2020/1182.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)