Registration Dossier
Registration Dossier
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EC number: 235-043-6 | CAS number: 12060-58-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 Nov - 22 Dec 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
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
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Swiss Federal Office of Public Health, 3003 Bern, Switzerland
Test material
- Reference substance name:
- Dilanthanum tricarbonate
- EC Number:
- 209-599-5
- EC Name:
- Dilanthanum tricarbonate
- Cas Number:
- 587-26-8
- IUPAC Name:
- dilanthanum tricarbonate
- Reference substance name:
- Lanthanum carbonate
- IUPAC Name:
- Lanthanum carbonate
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: 11 - 12 weeks (1 male & 2 females)
- Weight at study initiation: 2379 g (male), 2022 - 2064 g (females)
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): pelleted standard Provimi Kliba 3418 rabbit maintenance diet, ad libitum
- Water (e.g. ad libitum): community tap water from Füllinsdorf, ad libitum
- Acclimation period: 5 - 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 14 Nov 2005 To: 21 Nov 2005
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the right eye remained untreated and served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g as such
pH: 5 (1% w/w solution)
- Duration of treatment / exposure:
- 6 days (no removal of test substance)
- Observation period (in vivo):
- 6 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- - Removal of test system: no
- Scoring system: according to the numerical scoring system listed in Directive 2004/73/EC, at approximately 1, 24, 48, 72, 96 and 120 hours, as well as 6 days after instillation
- Tool used to assess score: Varta Cliptrix diagnostic-lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- corneal opacity
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.89
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- within 6 days
Any other information on results incl. tables
Table 1: Eye irritation scores - individual data
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0 / 1 / 1 |
0 / 0 / 0 |
2 / 2 / 2 |
1 / 1 / 2 |
24 h |
0 / 0 / 0 |
0 / 0 / 0 |
1 / 1 / 1 |
0 / 0 / 0 |
48 h |
0 / 0 / 0 |
0 / 0 / 0 |
1 / 1 / 1 |
0 / 0 / 0 |
72 h |
0 / 0 / 0 |
0 / 0 / 0 |
1 / 1 / 0 |
0 / 0 / 0 |
96 h |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 1 / 0 |
0 / 0 / 0 |
120 h |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 1 / 0 |
0 / 0 / 0 |
6 days |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
Average 24h, 48h, 72h |
0 / 0 / 0 |
0 / 0 / 0 |
1 / 1 / 0.67 |
0 / 0 / 0 |
In this study, Lanthanum carbonate is considered to be "not irritating" to the rabbit eye.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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