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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
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- Density
- Particle size distribution (Granulometry)
- Vapour pressure
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- Endpoint summary
- Stability
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Terrestrial toxicity
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- 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

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 November 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented GLP study following OECD Guideline 437 with no deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Lanthanum(3+) acetate
- EC Number:
- 213-034-8
- EC Name:
- Lanthanum(3+) acetate
- Cas Number:
- 917-70-4
- Molecular formula:
- C2H4O2.1/3La
- IUPAC Name:
- lanthanum(3+) triacetate
Constituent 1
Test animals / tissue source
- Species:
- other: isolated bovine cornea
- Strain:
- other: not applicable
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Eyes from freshly slaughtered adult cattle as a by-product of normal operation
- Age at study initiation: 12-60 months
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration (if solution): 20% w/v of test item in 0.9% w/v sodium chloride solution
VEHICLE
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration (if solution): 0.9% w/v sodium chloride solution - Duration of treatment / exposure:
- 240 minutes
- Observation period (in vivo):
- At the end of the incubation period each cornea was examined for defects. Only corneas free of damage were used.
At the end of the exposure period the test item preparation and control items were removed from the anterior chamber and the cornea was rinsed three times with fresh complete MEM containing phenol red before a final rinse with complete MEM. The anterior and posterior chambers were refilled with fresh complete MEM. A post-treatment opacity reading was taken and each cornea was visually observed. The corneas were visually observed for macroscopic damage (eg pitting/sloughing) caused by the test item or controls. - Number of animals or in vitro replicates:
- 3 corneas per test item, positive control, and vehicle
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsed 3 times with fresh minimum essential medium (MEM) containing phenol red before a final rinse with complete MEM
- Time after start of exposure: 240 minutes
Scoring system: results from the two endpoints were combined to generate an In Vitro Irritancy score.
In Vitro Irritancy Score = mean opacity value + (15 x mean OD492 value)
A test item that induces an In Vitro Irritancy score >= 55.1 is considered on ocular corrosive or severe irritant.
TOOL USED TO ASSESS SCORE: Opacitometer/ fluorescein
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 60.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The positive control In Vitro Irritancy Score was within the range of 55.8 to 126.1. The positive acceptance criterion was therefore satisfied.
The corneas treated with the negative control item was clear post incubation (In Vitro Irritancy Score: 3.1).
In vivo
- Irritant / corrosive response data:
- In Vitro Irritancy score - test item: 60.7
In Vitro Irritancy score-negative control: 3.1, clear
In Vitro Irritancy score-positive control: 81.6. (Historical range 55.8-126.1, acceptable), cloudy
Any other information on results incl. tables
In Vitro Irritancy score - test item: 60.7
In Vitro Irritancy score-negative control: 3.1, clear
In Vitro Irritancy score-positive control: 81.6. (Historical range 55.8-126.1, acceptable), cloudy
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was found to be an ocular corrosive or severe irritant (In Vitro Irritancy score >/= 55.1).
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