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EC number: 238-510-2 | CAS number: 14507-19-8
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 October 2012 - 21 November 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Lanthanum trihydroxide
- EC Number:
- 238-510-2
- EC Name:
- Lanthanum trihydroxide
- Cas Number:
- 14507-19-8
- Molecular formula:
- H3LaO3
- IUPAC Name:
- lanthanum trihydroxide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Description: Yellow powder
Storage Conditions: Room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: RccHan:WIST.
- Age at study initiation: 8 - 12 weeks.
- Weight at study initiation: At the start of the study the animals weighed at least 200 g. The weight variation did not exceed ± 20 % of the mean weight for each sex, with the exception of on male, which was heavier than all the others.
- Fasting period before study: No.
- Housing: The animals were housed in suspended solid-floor polypropylene cages furnished with woodflakes, individually during the exposure period and in groups of up to four, by sex, for the remainder of the study.
- Diet (e.g. ad libitum): ad libitum access to rodent diet.
- Water (e.g. ad libitum): Free access to mains drinking water.
- Acclimation period: At least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 30 - 70 % (relative)
- Air changes (per hr): At least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): lighting was controlled by a time switch to give twelve hours continuous light (0600 to 1800) and twelve hours darkness.
IN-LIFE DATES: From: 31 October 2012 To: 21 November 2012
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: moistened with distilled water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: The back and flanks clipped free of hair.
- % 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 was wiped with cotton wool moistened with distilled water.
- Time after start of exposure: After the 24 hour exposure period, following the removal of the semi-occlusive dressing.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bodyweight.
VEHICLE
- Amount(s) applied: The test material was moistened with distilled water prior to application. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- not required
- Details on study design:
- - Treatment schedule: In the absence of data suggesting toxicity, one male and one female were initially treated at a dose level of 2000 mg/kg. These animals remained in individual housing following exposure. As no mortalities were noted, a further group of animals (four males and four females) was similarly treated with the test material at a dose level of 2000 mg/kg bodyweight to give a total of five males and five females.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily. Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: Yes. At the end of the study the animals were killed by cervical dislocation and subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
- Other examinations performed: After removal of the dressings and subsequently once daily, the test sites were examined for evidence of primary irritation and scored according to the Draize scale:
Erythema and Eschar Formation Value
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) to slight eschar formation (injuries in depth) 4
Oedema Formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4
Any other skin reactions, if present were also recorded.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There was no mortality.
- Clinical signs:
- other: Dehydration was noted in one male one day after dosing. No other signs of systemic toxicity were noted.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- DERMAL REACTIONS
Off white residual test material was noted at the test site of one male.
Very slight erythema (score of 1) was noted at the test site of one female three to five days after dosing. There were no signs of dermal irritation noted in the remaining animals.
Any other information on results incl. tables
Table 1: Individual Bodyweights and Weekly Bodyweight Changes
Animal Number and Sex |
Bodyweight (g) at Day |
Bodyweight Change (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
|
1-0 Male 3-0 Male 3-1 Male 3-2 Male 3-3 Male |
254 301 223 247 222 |
266 312 231 261 226 |
301 321 243 285 241 |
12 11 8 14 4 |
35 9 12 24 15 |
2-0 Female 4-0 Female 4-1 Female 4-2 Female 4-3 Female |
241 210 210 203 200 |
219 209 219 209 209 |
216 214 228 219 222 |
5 -1 9 6 9 |
-3 5 9 10 13 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to EU criteria
- Conclusions:
- The LD50 of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight and as such requires no classification in accordance with EU criteria.
- Executive summary:
The acute dermal toxicity potential of the test material was assessed in a limit test conducted in the Wistar strain rat in accordance with the standardised guidelines OECD 402 and EU Method B.3.
Initially, two animals (one male and one female) were given a single, 24 hour, semi-occluded dermal application of the test material to intact skin at a dose level of 2000 mg/kg bodyweight. Based on the results of the initial test, a further group of eight animals (four males and four females) was similarly treated. Clinical signs and bodyweight development were monitored during the 14 day observation period. All animals were subjected to gross necropsy.
There were no deaths and no signs of systemic toxicity, though one male animal was dehydrated one day after dosing. Furthermore, the animals showed the expected gains in bodyweight with the exception of one female which showed minimal bodyweight loss during the first week but expected gain in bodyweight during the second week and one female which showed expected gain in bodyweight during the first week but minimal bodyweight loss during the second week.
The only dermal irritation observed was very slight erythema (score of 1) in one female animal three to 5 days after dosing. No abnormalities were noted at necropsy.
The LD50 of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight and as such requires no classification in accordance with EU criteria.
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