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EC number: 274-625-4 | CAS number: 70495-37-3
- 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 according to OECD Guideline 423 an LD50 of >2000 mg/kg bw was determined for the test item when administered as a single dose by oral gavage to female Sprague Dawley 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
- 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:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-house bred
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: 165.26 to 173.82 g
- Housing: Three animals were housed in standard polypropylene cage (Size: L 430 x B 285 x H 150 mm) with stainless steel mesh top grill having facilities for holding pelleted feed and drinking water in water bottle fitted with stainless steel sipper tube. Clean sterilized paddy husk was provided as bedding material.
- Diet: ad libitum (altromin Maintenance diet for rats and mice 1324 manufactured by Altromin Spezialfutter GmbH & Co. KG)
- Water: ad libitum
- Acclimation period: Healthy young adult animals used for Step-I, Step-I confirmation, Step-II and Step-II confirmation were acclimatized for five, six, nine and eleven days respectively to laboratory condition prior to treatment and were observed for clinical signs once daily. Veterinary examination of all the animals was performed on the day of receipt and on 5th day of acclimatization.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.6 to 23.4
- Humidity (%): 45 to 65
- Air changes (per hr): 12 to 15
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 and 200 mg/mL
- Amount of vehicle: 10 mL
- Justification for choice of vehicle: Distilled water is universally accepted and routinely used vehicle in oral toxicity studies.
- Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 female animals per step
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual animal body weight was recorded at receipt, on day 1 (before test item administration) and on day 8 and 15 during the observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None.
- Clinical signs:
- other: No clinical signs of toxicity were observed.
- Gross pathology:
- No gross pathological changes were observed in any of the animals at 300 mg/kg and 2000 mg/kg body weight.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study the LD50 of the test item is >2000 mg/kg bw when administered as a single dose by oral gavage to female Sprague Dawley rats according to OECD 423.
- Executive summary:
The test item was evaluated for acute oral toxicity in Sprague Dawley rats according to OECD Guideline 423. A starting dose of 300 mg/kg body weight was selected from the fixed dose levels of 5, 50, 300 and 2000 mg/kg body weight since the LD50 for test item is not available. A total of 12 females (3 females for each Step-I, Step-I confirmation, Step-II and Step-II confirmation) were used for the experiment. All the animals of Step-I and Step-I confirmation were administered with 300 mg/kg body weight of the test item. Step II and Step-II confirmation were administered with 2000 mg/kg body weight of the test item through oral route. All the animals were observed for clinical signs of toxicity and mortality at 20 to 30 min, 1 hr (±10 mins), 2 hrs (±10 mins), 3 hrs (±10 mins) and 4 hrs (±10 mins) post dosing on Day 1 and once daily thereafter for clinical signs of toxicity and twice daily for mortality during the 14 days observation period. Body weight was recorded on Day 1 before test item administration and on day 8 and 15 during the observation period. At the end of observation period, all the surviving animals were humanely sacrificed under carbon dioxide asphyxiation, subjected to necropsy and gross pathological examination. No clinical signs of toxicity or mortality were observed in any of the animals dosed at 300 mg/kg and 2000 mg/kg body weight. No changes were observed in body weight and percent change in body weight with respect to day 1. All the animals revealed physiologically normal increase in the body weight. No gross pathological changes were observed in any of the animals at 300 mg/kg and 2000 mg/kg body weight.
Based on the findings of this study the acute oral LD50 of the test item is > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no 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
The test item was evaluated for acute oral toxicity in Sprague Dawley rats according to OECD Guideline 423. A starting dose of 300 mg/kg body weight was selected from the fixed dose levels of 5, 50, 300 and 2000 mg/kg body weight since the LD50 for test item is not available. A total of 12 females (3 females for each Step-I, Step-I confirmation, Step-II and Step-II confirmation) were used for the experiment. All the animals of Step-I and Step-I confirmation were administered with 300 mg/kg body weight of the test item. Step II and Step-II confirmation were administered with 2000 mg/kg body weight of the test item through oral route. All the animals were observed for clinical signs of toxicity and mortality at 20 to 30 min, 1 hr (±10 mins), 2 hrs (±10 mins), 3 hrs (±10 mins) and 4 hrs (±10 mins) post dosing on Day 1 and once daily thereafter for clinical signs of toxicity and twice daily for mortality during the 14 days observation period. Body weight was recorded on Day 1 before test item administration and on day 8 and 15 during the observation period. At the end of observation period, all the surviving animals were humanely sacrificed under carbon dioxide asphyxiation, subjected to necropsy and gross pathological examination. No clinical signs of toxicity or mortality were observed in any of the animals dosed at 300 mg/kg and 2000 mg/kg body weight. No changes were observed in body weight and percent change in body weight with respect to day 1. All the animals revealed physiologically normal increase in the body weight. No gross pathological changes were observed in any of the animals at 300 mg/kg and 2000 mg/kg body weight.
Based on the findings of this study the acute oral LD50 of the test item is > 2000 mg/kg bw.
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 toxicity, the test item is not classified for acute oral toxicity according to Regulation (EC) No 1272/2008 (CLP), as amended for the fifteenth time in Regulation (EU) No 2020/1182.
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