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EC number: 831-167-5 | CAS number: 2126827-44-7
- 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
In an acute oral toxicity study, the substance was administered to female Wistar Han rats in a single dose by oral gavage at 300 (3 animals) and 2000 (6 animals) mg/kg body weight. All animals survived in the highest dose group of 2000 mg/kg body weight. The substance did not cause death or evident signs of toxicity. During the observation period of 15 days, no other signs of intoxication, change of health, nor any other adverse reactions were seen. Macroscopic examination of the animals at the end of the study did not reveal treatment-related changes. The LD50 of the substance is considered to be greater than 2000 mg/kg bw after single oral administration to female rats.
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:
- 27th February 2019 - 11th April 2019
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- EC No 440/2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Guidelines
- Version / remarks:
- 2000, including the most recent versions.
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Specific details on test material used for the study:
- Batch (Lot) Number: 2715/18/01
Expiry date: 01 July 2020 (expiry date)
Physical Description: Dark green solid
Purity/Composition: 99%
Storage Conditions: At room temperature protected from light
Test item handling: Use amber glassware or wrap container in aluminum foil - Species:
- rat
- Strain:
- other: Wistar Han
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: Young adult animals (approximately 9-10 weeks old)
- Weight at study initiation: 161 to 187 g
- Fasting period before study: Overnight (a maximum of 20 hours) prior to dosing and until 3-4 hours after administration fo the test item. Water was available.
- Housing: Polycarbonate cages (Makrolon MIV, 18cm height). Maximum of 3 animals (same sex and dose group) per cage.
- Diet: Pelleted rodent diet (SM R/M-Z), ad libitum
- Water: Municipal tap-water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Target - 18 to 24 °C; Actual daily mean - 21 °C
- Humidity (%): Target - 40 to 70%; Actual daily mean – 38 to 52%
Note: the humidity levels were outside of the target range occasionally for 3 days with a minimum of 38%. No noticeable effects on the clinical condition of the animals were observed.
- Air changes (per hr): 10 or more changes per hour with 100% fresh air.
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
IN-LIFE DATES:
From: 27th February, 2019 (experimental start date)
To: 11th April, 2019 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Remarks:
- Specific gravity: 0.92
- Details on oral exposure:
- Single oral dose VEHICLE
- Concentration in vehicle: 100% - corn oil used neat.
- Amount of vehicle (if gavage): Appropriate volumes to give a dose volume of 10 mL/kg body weight
- Justification for choice of vehicle: Trial prepatations were undertaken to select the suitable vehicle and to establish a suitable formulation procedure.
- Purity: 100%
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight - Doses:
- 300 and 2000 mg/kg body weight
- 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: Day 1 (predose), Day 8, and Day 15
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weights, macroscopic examination - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 300 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- At 300 mg/kg, hunched posture was noted for all animals on Day 1. Green discolouration of the faeces was noted in all animals between Days 2 and 5, which was considered to be caused by the staining properties of the substance. No mortality occurred.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- Hunched posture and/or piloerection were noted for the animals on Days 1 and/or 2. Green discolouration of the faces was noted in all animals between Days 2 and 5, which was considered to be caused by the staining properties of the substance.No mortality occurred.
- Mortality:
- All (6/6 females) animals survived the limit dose of 2000 mg/kg body weight.
- Clinical signs:
- other: At 300 mg/kg, hunched posture was noted for all animals on Day 1. At 2000 mg/kg, hunched posture and/or piloerection were noted for the animals on Days 1 and/or 2. Green discolouration of the faces was noted in all animals between Days 2 and 5, which was
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 in an acute toxicity study conducted on the substance in female rats administered via gavage is >2000 mg/kg bw.
- Executive summary:
In a reliable in vivo acute oral toxicity study conducted in accordance to OECD guideline 423, the substance was administered to female Wistar Han rats in a single dose by oral gavage at 300 (3 animals) and 2000 (6 animals) mg/kg body weight. All (6/6 females) animals survived in the highest dose group of 2000 mg/kg body weight. The substance did not cause death or evident signs of toxicity. During the observation period of 15 days, no other signs of intoxication, change of health, nor any other adverse reactions were seen. Macroscopic examination of the animals at the end of the study did not reveal treatment-related changes. The LD50 of the substance is considered to be greater than 2000 mg/kg body weight after single oral administration to female Wistar Han rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Sufficient to address requirements.
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 findings of a reliable acute oral toxicity study conducted on the substance, classification of the substance is not justified.
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