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Toxicological information

Eye irritation

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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:
2000
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

Constituent 1
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

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.