Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11th September 2000 to 12th September 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

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
Chemical structure
Reference substance name:
Dipotassium heptafluorotantalate
EC Number:
240-986-1
EC Name:
Dipotassium heptafluorotantalate
Cas Number:
16924-00-8
Molecular formula:
F7Ta.2K
IUPAC Name:
Tantalate(2-), heptafluoro-, potassium (1:2)
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material: Potassium Fluorotantalate
- Physical state: Powder
- Storage condition of test material: Room temperature

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, UK
- Age at study initiation: At least 15 weeks
- Weight at study initiation: 3064g
- Housing: Individually in a metal cage.
- Diet: standard laboratory rabbit diet (Special Diet Services STANRAB (P) SQC pellet) ad libitum.
- Water: Water supplied ad libitum from mains water supply (Anglian Water).
- Acclimation period: 11 days prior to the start of the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 19 ± 2 ºC
- Humidity: 30 to 70%
- Photoperiod: 12 hours of artificial light (0600 -1800), 12 hours of darkness.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
Amount applied: 100mg
Duration of treatment / exposure:
100 mg of the test material was placed in the lower everted eyelid, which was gently held together for 1 second before being released. The other eye remained untreated.
Observation period (in vivo):
The test animal was observed one hour after administration and then at 24 hours post administration. Aided by the use of a hand light.
Number of animals or in vitro replicates:
1 male
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Irrigation was not performed.

SCORING SYSTEM:
The reaction was scored according to the Draize scale (1959) which is detailed below in the field " Any other information in materials and methods incl. tables" as table 1. Any lesion or reaction not covered by the scoring system was described.

TOOL USED TO ASSESS SCORE: hand-help lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1337
Time point:
other: 24 hours
Score:
5
Max. score:
8
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal: 1337
Time point:
other: 1 hour
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal: 1337
Time point:
other: 24 hours
Score:
7
Max. score:
7
Reversibility:
not specified
Irritant / corrosive response data:
Dulling of the cornea developing into corneal opacification (Grade 1) and iridial inflammation (Grade 1) was seen. The conjunctiva developed a beefy red colouration and swelling with lids more than half closed. Due to the severity of the ocular reaction the animal was sacrificed one day after dosing. Post-mortem testing revealed necrosis, blanching and heamorrhaging of the nictating membrane, blanching and necrosis of the conjunctivae and the stripping of epithelial cells form the cornea.
Other effects:
There were no other signs of toxicity or ill health in any test animal during the observation period.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test, the test material caused elicited corneal opacification, iridial inflammation and considerable conjunctival irritation. The test material therefore requires classification as an eye irritant.
Executive summary:

The eye irritation of the test material was determined in accordance with standardised guidelines OECD 405, EU Method B.5 and EPA OPPTS 870.2400. Approximately 100mg of the test material was applied directly into the eye of one rabbit, using the contralateral eye as a control; the rabbit was observed once at 1 hour post application and for the second time at 24 hours post application. The ocular reaction observed was so severe that no other animals were tested and the test animal was sacrificed one day after dosing. Elicited corneal opacification, iridial inflammation and considerable conjunctival irritation were observed.

Under the conditions of the study, the test material was considered to be of serious risk to the eyes. The test material requires classification as Irritating (Xi) with the risk phrase R41 "Risk of serious damage to eyes" under Directive 67/548/EEC. Under Regulation 1272/2208, the test material requires classification as "Eye Damage 1" with the hazard statement "H318: Causes serious eye damage".