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EC number: 701-340-9 | CAS number: -
- 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
Oral acute toxicity: LD50> 2000 mg/kg bw , key study with 6 female rats according to OECD Test Guideline 423.
Dermal acute toxicity: LD50> 2000 mg/kg bw, extrapolation from oral data.
Inhalation acute toxicity: LC50 > 50 mg/l, extrapolation from oral data.
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:
- From 16th June 2004 to 30th June 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD guideline 423. GLP study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan.
- Age at study initiation: 7 weeks
- Weight at study initiation: 183-190 g
- Fasting period before study: yes (from about 18 hours and 30 minutes from the evening of the day before administration to about 6 hours after administration)
- Housing: stainless-steel cages
- Diet (e.g. ad libitum): solid feed (CRF-1, Oriental Yeast Co., Ltd.), ad libitum.
- Water (e.g. ad libitum): free bottle of water intake tap water
- Acclimation period: 2 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23ºC
- Humidity (%): 55%
- Air changes (per hr): 12
- Photoperiod: 12 hrs dark / 12 hrs light (6 am to 6 pm) - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1% sodium carboxymethylcellulose solution
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 2 groups of 3 female rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1time/day
- Necropsy of survivors performed: yes - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed
- Clinical signs:
- other: No clinical signs
- Gross pathology:
- No autopsy findings for pathological damage.
- Other findings:
- Bluish feces in the 3 female rats of a group at 1st day after administration derived from the color of the test material.
- Interpretation of results:
- not classified
- Remarks:
- (EU criteria)
- Conclusions:
- The result was as follows: LD50 >2000 mg/kg bw
- Executive summary:
The aim of the test was to study the single dose oral toxicity of the test material according to OECD Test Guideline 423.
The test material was studied in 6 female rats (2 groups with 3 female rats per group) in a single dose oral toxicity test at 2000 mg/kg bw. On observation for general signs, only bluish feces, derived from the color of the test material, were noted. The result was as follows: LD50 >2000 mg/kg bw
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 001 mg/kg bw
- Quality of whole database:
- The study is a GLP compliant and has Klimisch score 1.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- other: extrapolation from results obtained by the oral route
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Extrapolation based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals.
- Principles of method if other than guideline:
- Extrapolation based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals.
- Dose descriptor:
- LC50
- Effect level:
- > 50 mg/L air
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the assumptions for the extrapolation from the acute oral toxicity data, the 4 -h LC50 would be greater than 10-50 mg/l.
- Executive summary:
From the available data on two acute oral toxicity studies, it is concluded that the oral LD50 for the substance is greater than 2000 mg/kg bw (study 1: no mortality was observed) and greater from 10000 mg/kg bw (study 2: mortality was observed). As recommended in the corresponding guidelines, where data from the oral route is being used as the starting point, if no data are available on oral bioavailability, it is appropriate to assume that 100% of an orally administered dose is systemically available. Since no data is available on inhalation absorption, the most precautionary default would be to assume 100% absorption by this route.
Based on this acute oral toxicity data, an oral NOAEL may be identified as greater than 10000 mg/kg bw. This NOAEL can be modified into an inhalation NOAEL using a route-to-route extrapolation based on the assumptions stated above. Taking into account an exposure of 4 hours for the acute inhalation toxicity study, the value of the oral LD50 is divided by the default physiological parameter under the allometric scaling principle which is approximately 0.2 m3/kg bw for rats. This extrapolation leads to a value of 10 mg/l (study 1) and 50 mg/l (study 2). Therefore, the 4 -h LC50 would be greater than 10 -50 mg/l.
Reference
Based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals, an extrapolation based on the acute oral toxicity data is calculated for the inhalation route.
From the available data on two acute oral toxicity studies, it is concluded that the oral LD50 for the substance is greater than 2000 mg/kg bw (study 1: no mortality was observed) and greater from 10000 mg/kg bw (study 2: mortality was observed). As recommended in the corresponding guidelines, where data from the oral route is being used as the starting point, if no data are available on oral bioavailability, it is appropriate to assume that 100% of an orally administered dose is systemically available. Since no data is available on inhalation absorption, the most precautionary default would be to assume 100% absorption by this route.
Based on this acute oral toxicity data, an oral NOAEL may be identified as greater than 10000 mg/kg bw. This NOAEL can be modified into an inhalation NOAEL using a route-to-route extrapolation based on the assumptions stated above. Taking into account an exposure of 4 hours for the acute inhalation toxicity study, the value of the oral LD50 is divided by the default physiological parameter under the allometric scaling principle which is approximately 0.2 m3/kg bw for rats. This extrapolation leads to a value of 10 mg/l (study 1) and 50 mg/l (study 2). Therefore, the 4 -h LC50 would be greater than 10 -50 mg/l.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 50 mg/m³ air
- Quality of whole database:
- The study has a Klimish score 2 and is adequate for assessment.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- other: extrapolation from results obtained by the oral route
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Extrapolation based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals.
- Principles of method if other than guideline:
- Extrapolation based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals.
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 mg/kg bw
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the assumptions for the extrapolation from the acute oral toxicity data, the dermal LD50 would be greater than 1000 mg/kg bw (study 1) and greater than 5000 mg/kg bw (study 2).
- Executive summary:
From the available data on two acute oral toxicity studies, it is concluded that the oral LD50 for the substance is greater than 2000 mg/kg bw (study 1: no mortality was observed) and greater from 10000 mg/kg bw (study 2: mortality was observed). As recommended in the corresponding guidelines, where data from the oral route is being used as the starting point, if no data are available on oral bioavailability, it is appropriate to assume that 50% of an orally administered dose is systemically available. Since no data is available on skin absorption, the most precautionary default would be to assume 100% absorption by this route although in reality very few substances will cross the skin to this extent. Therefore, based on these assumptions, the dermal LD50 would be greater than 1000 mg/kg bw (study 1) and greater than 5000 mg/kg bw (study 2).
Reference
Based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals, an extrapolation based on the acute oral toxicity data is calculated for the dermal route.
From the available data on two acute oral toxicity studies, it is concluded that the oral LD50 for the substance is greater than 2000 mg/kg bw (study 1: no mortality was observed) and greater from 10000 mg/kg bw (study 2: mortality was observed). As recommended in the corresponding guidelines, where data from the oral route is being used as the starting point, if no data are available on oral bioavailability, it is appropriate to assume that 50% of an orally administered dose is systemically available. Since no data is available on skin absorption, the most precautionary default would be to assume 100% absorption by this route although in reality very few substances will cross the skin to this extent. Therefore, based on these assumptions, the dermal LD50 would be greater than 1000 mg/kg bw (study 1) and greater than 5000 mg/kg bw (study 2).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 001 mg/kg bw
- Quality of whole database:
- The study has a Klimish score 2 and is adequate for assessment.
Additional information
Oral acute toxicity:
Key study: Study with 6 female rats (2 groups with 3 female rats per group) in a single dose oral toxicity test at 2000 mg/kg bw.
OECD Test Guideline 423.
The result was as follows: LD50 >2000 mg/kg bw.
Dermal acute toxicity:
Key study: Extrapolation from oral data.
From the available data on two acute oral toxicity studies, it is concluded that the oral LD50 for the substance is greater than 2000 mg/kg bw (study 1: no mortality was observed) and greater from 10000 mg/kg bw (study 2: mortality was observed). As recommended in the corresponding guidelines, where data from the oral route is being used as the starting point, if no data are available on oral bioavailability, it is appropriate to assume that 50% of an orally administered dose is systemically available. Since no data is available on skin absorption, the most precautionary default would be to assume 100% absorption by this route although in reality very few substances will cross the skin to this extent. Therefore, based on these assumptions, the dermal LD50 would be greater than 1000 mg/kg bw (study 1) and greater than 5000 mg/kg bw (study 2).
Inhalation acute toxicity:
Key study: Extrapolation from oral data.
From the available data on two acute oral toxicity studies, it is concluded that the oral LD50 for the substance is greater than 2000 mg/kg bw (study 1: no mortality was observed) and greater from 10000 mg/kg bw (study 2: mortality was observed). As recommended in the corresponding guidelines, where data from the oral route is being used as the starting point, if no data are available on oral bioavailability, it is appropriate to assume that 100% of an orally administered dose is systemically available. Since no data is available on inhalation absorption, the most precautionary default would be to assume 100% absorption by this route.
Based on this acute oral toxicity data, an oral NOAEL may be identified as greater than 10000 mg/kg bw. This NOAEL can be modified into an inhalation NOAEL using a route-to-route extrapolation based on the assumptions stated above. Taking into account an exposure of 4 hours for the acute inhalation toxicity study, the value of the oral LD50 is divided by the default physiological parameter under the allometric scaling principle which is approximately 0.2 m3/kg bw for rats. This extrapolation leads to a value of 10 mg/l (study 1) and 50 mg/l (study 2). Therefore, the 4 -h LC50 would be greater than 10 -50 mg/l.
Justification for selection of acute toxicity – oral endpoint
The study is of higher quality.
Justification for selection of acute toxicity – inhalation endpoint
Only one study available.
Justification for selection of acute toxicity – dermal endpoint
Only one study available.
Justification for classification or non-classification
Oral acute toxicity LD50> 2000 mg/kg: not classified.
Dermal acute toxicity LD50> 2000 mg/kg: not classified.
Inhalation acute toxicity LC50 > 10 -50 mg/l: not classified (inhalation of dusts)
Based on the available data, the substance is not classified for acute toxicity according to CLP Regulation (EC) No 1272/2008.
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