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EC number: 235-118-3 | CAS number: 12070-06-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2000-10-03 to 2000-12-18
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study. Tantalum used as read-across partner to Tantalum carbide
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tantalum
- EC Number:
- 231-135-5
- EC Name:
- Tantalum
- Cas Number:
- 7440-25-7
- IUPAC Name:
- tantalum(2+)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Ta MP STA-40 KD
- Physical state: grey powder
- Analytical purity: 99.9%
- Lot/batch No.: 20000804
- Storage condition of test material: romm temperature
- Expiry date: not advised, but assumed to be stable for six months from date of receipt
- Date of receipt: 2000-08-25
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd., Bicester, Oxon, England
- Age at study initiation: at least 12 weeks
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: individually in stainless steel cages with perforated floors
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 2
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the contralateral eye of each treated animal remained untreated
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
TREATMENT PROCEDURE
- The weight of the test material which when gently compacted occupied a volume of 0.1 mL exceeded 100 mg on all occasions. However, 100 mg only was placed in the lower everted lid of one eye of each animal. The eyelids were gently held together for one second before releasing. The contralateral eye remained untreated and served as a control. - Duration of treatment / exposure:
- The treated eyes were not washed following test material installation.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after installation
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not informed
SCORING SYSTEM: The reactions were scored in accordance with the numerical system outline in field "Any other information on materials and methods incl. tables".
TOOL USED TO ASSESS SCORE: Observation of the eyes was aided by the use of a handheld light.
OTHER: one animal was treated in advance of the other two, to ensure that if a severe response was produced, no further animals would be exposed
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No corneal damage was observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No lesions were observed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.1
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: Redness was seen in the eye of one male rabbit after 24 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No chemosis was observed
- Irritant / corrosive response data:
- No corneal damage or iridial inflammation was observed. Transient, hyperaemia of the blood vessels of the conjunctivae was seen in all animals, resolving completely by either one or two days after instillation.
- Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
Any other information on results incl. tables
| Table 1: Ocular reactions | ||||||
| Rabbit no. & sex | Region of eye | hours after instillation | ||||
| 1 | 24 | 48 | 72 | |||
| 1389 male* | Cornea | Density | 0 | 0 | 0 | 0 |
| Area | 0 | 0 | 0 | 0 | ||
| Iris | 0 | 0 | 0 | 0 | ||
| Conjunctiva | Redness | 1 | 0 | 0 | 0 | |
| Chemosis | 0 | 0 | 0 | 0 | ||
| 1456 male | Cornea | Density | 0 | 0 | 0 | 0 |
| Area | 0 | 0 | 0 | 0 | ||
| Iris | 0 | 0 | 0 | 0 | ||
| Conjunctiva | Redness | 1 | 1 | 0 | 0 | |
| Chemosis | 0 | 0 | 0 | 0 | ||
| 1457 male | Cornea | Density | 0 | 0 | 0 | 0 |
| Area | 0 | 0 | 0 | 0 | ||
| Iris | 0 | 0 | 0 | 0 | ||
| Conjunctiva | Redness | 1 | 0 | 0 | 0 | |
| Chemosis | 0 | 0 | 0 | 0 | ||
* Pilot animal
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusions, in this acute eye irritation/corrosion study according to OECD 405, the test item tantalum is considered to be non-irritating.
- Executive summary:
In a primary eye irritation study (OECD 405), 100 mg of tantalum (99.9%) was placed in the lower everted lid of one eye of each of three young adult New Zealand White rabbits (males). Animals were observed for 72 hours. Irritation was scored by the method of Draize. Only a very mild conjunctival reaction was observed, which was fully reversible within 1-2 days. Based on the results obtained from this study, tantalum is considered to be not an eye-irritant.
These tantalum data are used in a read-across approach for the assessment of the skin irritation potential of tantalum carbide.
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