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EC number: 213-034-8 | CAS number: 917-70-4
- 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 toxicity: oral
A K2 acute oral toxicity test was performed in male and female Sprague Dawley rats according to a guideline similar to OECD Guideline 401 (Cochran, 1950). This study was selected as key study, as the other available information came from a secondary source (considered K4)
Acute toxicity: inhalation:
no study available for this endpoint
Acute toxicity: dermal:
A K1 acute dermal toxicity test was performed in male and female Wistar rats following the OECD 402 Guideline (Bradshaw, 2013).
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Well documented, scientifically sound study with methods similar to OECD 401 with the following deviations: The number of deaths at each dose were not reported; the specific doses (mg/kg) were not provided; individual clinical observations, body weights, pathology were not reported; sex of the animals was not provided
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- The number of deaths at each dose were not reported; the specific doses (mg/kg) were not provided; individual clinical observations, body weights, pathology were not reported; sex of the animals was not provided
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: adult
- Weight at study initiation: between 200 and 300 g
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
Animals were maintained in air conditioned rooms. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50% suspension - Doses:
- The suspension was given in single doses by stomach tube. No further information on doses provided.
- No. of animals per sex per dose:
- 32 rats in total
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: All animals were observed for 10 days. An initial group of animals receiving the test substance were kept for 30 days to verify that if any significant mortality occurred after the tenth day.
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data - Statistics:
- The LD50 values were obtained from ten day mortality data by using the log-probability method.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 10 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: i.e. 4400 mg La/kg bw
- Mortality:
- No further details reported. No sex differences were noted.
- Clinical signs:
- other: No further details reported except that lanthanum acetate was found to be the least toxic of several lanthanum compounds tested (lanthanum chloride, lanthanum ammonium nitrate, lanthanum nitrate, lanthanum oxide and lanthanum sulfate.
- Gross pathology:
- No data
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 was calculated to be 10000 mg compound/kg bw (i.e. 4400 mg La/kg bw)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012/10/31 - 2012/11/21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP conditions according to with OECD Guideline No. 402 and EU Method B3.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 200 grams minimum
- Fasting period before study: No, free access to food and water was allowed throughout the study.
- Housing: The animals were housed in suspended solid-floor polypropylene cages furnished with woodflakes. The animals were housed individually during the 24-hour exposure period and in groups of up to four, by sex, for the remainder of the study.
- Diet: Free access to food was allowed throughout the study.
- Water: Free access to water was allowed throughout the study.
- Acclimation period: 5 days minimum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 – 25 degrees Celsius
- Humidity (%): 30 – 70%
- Air changes (per hr): At least 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of light/12 hours of dark - Type of coverage:
- semiocclusive
- Vehicle:
- arachis oil
- Details on dermal exposure:
- TEST SITE
- % coverage: Approximately 10% of the total body surface area
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated skin and surrounding hair were wiped with cotton wool moistened with arachis oil BP to remove any residual test item.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Constant volume or concentration used: Yes, 2000 mg/kg bw
- For solids, paste formed: Yes, an appropriate amount of test item to achieve a dose level of 2000 mg/kg was moistened with arachis oil BP. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- Five male and five females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Individual bodyweights were recorded prior to application on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: At the end of the study the animals were killed by cervical dislocation and gross necropsies conducted.
- Other examinations performed: clinical signs and dermal reactions - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: There were no signs of systemic toxicity.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- No erythema, eschar or oedema were noted throughout the study.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal LD50 was found to be greater than 2000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Acute toxicity: oral
Cochran et al. (1950) performed an acute oral toxicity study (gavage) in Sprague-Dawley rats similar to the OECD 401 test guideline, using a 50% suspension. After exposure to a single dose, all animals (32 in total) were observed for 10 days. An LD50 value of 10000 mg/kg bw (or 4400 mg La/ kg bw) was determined for male and female rats. This study is chosen as key study.
A K4 study based on a secondary source (Lewis 1995) from which the original reference is not available indicated an LD50 value of 32700 mg/kg bw.
Acute toxicity: inhalation
No data are available for this endpoint. However, no further testing is needed as 2 routes of exposure are already covered, according to REACH regulation (column 2, annex VIII, section 8.5). Furthermore, the substance is hygroscopic and forms aggregates. Therefore this study is not justified.
Acute toxicity: dermal
Bradshaw (2013) performed an acute dermal toxicity study (limit test) in Wistar rats similar to the OECD 402 test guideline and EU Method B.3, using a semi-occlusive cover. After 24h of exposure to a single dose (2000 mg/kg bw), all animals (5 males, 5 females) were observed for 14 days. No mortality occurred and no signs of systemic toxicity were observed. Therefore LD50 was defined to be higher than 2000 mg/kg bw for male and female rats.
Justification for selection of acute toxicity – oral endpoint
Only one K2 study available for this endpoint.
Justification for selection of acute toxicity – dermal endpoint
Only one K1 study available for this endpoint
Justification for classification or non-classification
Based on the results of the acute oral and dermal toxicity study and according to the criteria of the DSD and CLP Regulation, lanthanum acetate should not be classified as an acute oral or dermal toxicant.
No data were available to decide on the classification for the inhalation route.
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