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EC number: 264-561-5 | CAS number: 63910-74-7
- 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
Acute oral toxicity:
The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the given test chemical. The LD50 value is >5000 mg/kg bw. The study concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- experimental data from various test chemicals
- Justification for type of information:
- Data is summarized based on the available information from various test chemicals.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- WoE report is based on 2 acute oral toxicity studies as- WoE 2 and WoE 3.
Acute oral toxicity test was carried out to study the effects of the test chemicals on rodents. - GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- other: 2. not specified 3. Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- 2. not specified
3. TEST ANIMALS
- Source: Geniron Biolabs Pvt. Ltd. Bengaluru
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 10 to 12 weeks
- Weight at study initiation: 176.24 g to 215.59 g
- Identification:By rat accession number. Identification of individual rats was by cage card and turmeric colour body markings. The rat accession number was allotted during the course of the study. The temporary body marking during acclimatization period was done with crystal violet.
- Fasting period before study: rats were fasted for approximately 16 to 18 hours
- Housing:Rats were housed individually in standard polysulfone cages (Size: L 425 x B 266 x H 185 mm), with stainless steel top grill
- Diet (e.g. ad libitum): Hypro Rat & Mice pellet feed, ad libitum
- Water (e.g. ad libitum): Deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier, Mumbai, ad libitum
- Acclimation period: The animals were acclimatized six days for G1-FTS, eight days for G1-STS, thirteen days for G2-FTS before treatment and and fifteen days for G2-STS.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 24°C
- Humidity (%): 65 to 67 %
- Air changes (per hr): air conditioned with adequate fresh air supply (between 13.1 and 13.2 air changes/hour).
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark cycle.
IN-LIFE DATES: From: 27 June 2018 To: 26 July 2018 - Route of administration:
- other: 2. oral: unspecified 3. oral: gavage
- Vehicle:
- other: 2. unchanged (no vehicle) 3. Milli-Q water
- Details on oral exposure:
- 2. not specified
3. VEHICLE
- Concentration in vehicle: 300 & 2000 mg/kg body weight.
- Amount of vehicle (if gavage):dose volume was 30 & 200 mg/ml body weight
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bodyweight - Doses:
- 2. 5000 mg/kg bw
3. G1 (FTS) - 300 mg/kg
G1 (STS) - 300 mg/kg
G2 (FTS) - 2000 mg/kg - No. of animals per sex per dose:
- 2. not specified
3. G1 (FTS) - 300 mg/kg - 3
G1 (STS) - 300 mg/kg - 3
G2 (FTS) - 2000 mg/kg - 3
G2 (STS) - 2000 mg/kg - 3 - Control animals:
- not specified
- Details on study design:
- 2. not specified
3. - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Clinical signs and pre-terminal deaths:At each step, the animals were observed five times on test day 1 (day of administration) i.e. at 30 minutes and four times at hourly intervals and once daily during days 2 to 15 post administration. Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern. Attention was directed to the observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma and all observed clinical signs were recorded.
- Body weights:The body weights were recorded on test day 1 (pre-administration), day 8 (7 days post administration) and day 15 (14 days post administration).
- Necropsy of survivors performed: yes, the rats surviving to the end of the observation period were euthanised by using isoflurane anaesthesia and subjected to detailed necropsy.
- Other examinations performed:Gross pathological findings were recorded and reported. Microscopic examination was not carried out as no gross pathological changes were observed. - Statistics:
- 2. not specified
3. not specified - Preliminary study:
- 2. not specified
3. not specified - Sex:
- not specified
- Dose descriptor:
- LD50
- Remarks:
- 2
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No Mortality was observed
- Sex:
- female
- Dose descriptor:
- LD50
- Remarks:
- 3
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality was observed
- Mortality:
- 2. No Mortality was observed in treated rats at 5000 mg/kg bw.
3. G1 - [300 mg/kg body weight - Treatment (FTS and STS)]: There were no pre-terminal deaths.
G2 - [2000 mg/kg body weight - Treatment (FTS and STS)]: There were no pre-terminal deaths. - Clinical signs:
- 2. not specified
3. G1 - [300 mg/kg body weight - Treatment (FTS and STS)]: There were no clinical sings.
G2 - [2000 mg/kg body weight - Treatment (FTS and STS)]: There were no clinical signs observed in any of the rats. - Body weight:
- 2. not specified
3. G1 - [300 mg/kg body weight - Treatment (FTS and STS)]: The body weights of all the rats increased throughout the observation period.
G2 - [2000 mg/kg body weight - Treatment (FTS and STS)]: The body weights of all the rats increased throughout the observation period. - Gross pathology:
- 2. not specified
3. There were no gross pathological changes at necropsy. - Other findings:
- 2. not specified
3. not specified - Interpretation of results:
- other: Not classified
- Conclusions:
- The test chemical cannot be classified for acute oral toxicity, as the LD50 value is >5000 mg/kg bw according to CLP regulation.
- Executive summary:
In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats for the given test chemical. The studies are summarized as below -
Acute oral toxicity study was conducted using test chemical in rats at the concentration of 5000 mg/kg bw. Animals were observed for mortality. No Mortality was observed at dose 5000 mg/kg bw. Hence, LD50 value was considered to be >5000 mg/kg bw, when rats were treated with test chemical via oral route.
The above study is supported with the data available in study report for the given test chemical. The acute oral toxicity study was conducted to assess the toxicological profile as per OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method) in Wistar rats. The dose formulation was prepared by using Milli-Q water and administered as a single oral gavage to overnight fasted (16 to 18 hours) three female rats (G1-FTS) at the dose of 300 mg/kg body weight. There were no clinical signs of toxicity and pre-terminal deaths observed. As all the rats survived at this step, the test was confirmed with three additional female animals with the same dose of 300 mg/kg body weight (G1-STS). There were no clinical signs of toxicity and pre-terminal deaths observed at this step. Based on the scheme - Annex 2c of the guideline OECD 423, the test was repeated at the dose of 2000 mg/kg body weight (G2-FTS). There were no clinical signs of toxicity observed. Hence, the test was confirmed with three additional female rats at the same dose of 2000 mg/kg body weight (G2-STS) as per the scheme - Annex 2c of the guideline OECD 423. There were no clinical signs of toxicity and pre-terminal deaths observed at this confirmatory test. Hence, the further dosing was stopped. The rats were observed for mortality and clinical signs for 14 days post treatment. Body weights were recorded prior to dosing on day 1 and again on days 8 and 15. Gross necropsy was performed for all the rats at termination. The body weight growth of all rats was unaffected by the test item. There were no gross pathological changes at necropsy, hence histopathology was not performed. Based on the results of the present study, the LD50 value for the given test chemical is considered to be >2000 mg/kg. The test item is “not classified (> 2000 mg/kg)” as per the criteria of CLP.
Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Data is Klimisch 2 and from handbook or collection of data.
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 oral toxicity:
In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats for the given test chemical. The studies are summarized as below -
Acute oral toxicity study was conducted using test chemical in rats at the concentration of 5000 mg/kg bw. Animals were observed for mortality. No Mortality was observed at dose 5000 mg/kg bw. Hence, LD50 value was considered to be >5000 mg/kg bw, when rats were treated with test chemical via oral route.
The above study is supported with the data available in study report for the given test chemical. The acute oral toxicity study was conducted to assess the toxicological profile as per OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method) in Wistar rats. The dose formulation was prepared by using Milli-Q water and administered as a single oral gavage to overnight fasted (16 to 18 hours) three female rats (G1-FTS) at the dose of 300 mg/kg body weight. There were no clinical signs of toxicity and pre-terminal deaths observed. As all the rats survived at this step, the test was confirmed with three additional female animals with the same dose of 300 mg/kg body weight (G1-STS). There were no clinical signs of toxicity and pre-terminal deaths observed at this step. Based on the scheme - Annex 2c of the guideline OECD 423, the test was repeated at the dose of 2000 mg/kg body weight (G2-FTS). There were no clinical signs of toxicity observed. Hence, the test was confirmed with three additional female rats at the same dose of 2000 mg/kg body weight (G2-STS) as per the scheme - Annex 2c of the guideline OECD 423. There were no clinical signs of toxicity and pre-terminal deaths observed at this confirmatory test. Hence, the further dosing was stopped. The rats were observed for mortality and clinical signs for 14 days post treatment. Body weights were recorded prior to dosing on day 1 and again on days 8 and 15. Gross necropsy was performed for all the rats at termination. The body weight growth of all rats was unaffected by the test item. There were no gross pathological changes at necropsy, hence histopathology was not performed. Based on the results of the present study, the LD50 value for the given test chemical is considered to be >2000 mg/kg. The test item is “not classified (> 2000 mg/kg)” as per the criteria of CLP.
Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.
Justification for classification or non-classification
Based on the above studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.
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