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Toxicological information

Eye irritation

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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:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Swiss Federal Office of Public Health, 3003 Bern, Switzerland

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

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

Slight ocular discharge was noted in all animals at 1-hour reading. Slight white remnants of the test item were observed in the eye or conjunctival sac of all animals 1 hour after treatment. The body weights of all rabbits were considered to be within the normal range of variability.

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