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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:
1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Acute toxicological evaluation of lanthanum oxide
Author:
Lambert C E, Barnum E C, Shapiro R
Year:
1993
Bibliographic source:
Journal of the American College of Toxicology, 12 (6), 622

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Draize HH, Woodward G, Calveny HO, Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J. Pharmacol. Exp. Ther. 83, 377-390, 1944
Principles of method if other than guideline:
0.1 g of the test material wa instilled into the left eye of 6 New Zealand White Rabbits. Three of the treated eyes were rinsed with saline 30 seconds post-istillation. Eyes were examined at 24, 48 and 72 h by the method of Draize.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No data reported

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: right eyes served as controls
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
30 seconds and 72 h
Observation period (in vivo):
24, 48, 72 h
Number of animals or in vitro replicates:
6, eyes o 3 animals rinsed after 30 seconds
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): in 3 animals 30 seconds after instillation of the test substance, in 3 animals no washing
.


SCORING SYSTEM: Draize

.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Remarks:
unwashed
Basis:
mean
Time point:
other: 24 hours
Score:
13
Max. score:
110
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: The effect was almost reversible after 72 h
Irritation parameter:
overall irritation score
Remarks:
washed
Basis:
mean
Time point:
other: 24 h
Score:
9
Max. score:
110
Reversibility:
fully reversible within: 72 h
Irritation parameter:
overall irritation score
Remarks:
unwashed
Basis:
mean
Time point:
other: 48 h
Score:
3.7
Max. score:
110
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: see 24 h value
Irritation parameter:
overall irritation score
Remarks:
washed
Basis:
mean
Time point:
other: 48 h
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 72 h
Irritation parameter:
overall irritation score
Remarks:
unwashed
Basis:
mean
Time point:
other: 72 h
Score:
0.7
Max. score:
110
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: see 24 h time point
Irritation parameter:
overall irritation score
Remarks:
washed
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
110
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
The test substance was considered midly and minimally irritating to rabbit unwashed and washed eyes respectively.
Other effects:
No data reported.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Draize
Conclusions:
Under the conditions of the test and according to the reported Draize scores the substance was mildly irritating to rabbit eyes (unwashed). With that low irritaiton score the EU classification criteria for irritancy to eyes are not met.
Executive summary:

In a primary eye irritation study (Lambert CE, 1993),

0.1 g of the test substance (purity unknown) was instilled to the left eye of 3 New Zealand White Rabbits without rinsing and 3 rabbits with rinsing after 30 seconds. The animals were then observed for 3 days and the irritation reaction scored according to the method of Draize. According to the scale of Draize mean irritation scores for unrinsed eyes were 13, 3.7 and 0.7 after 24, 48 and 72 h respectively and for the rinsed eyes 9, 2 and 0 (maxium score: 110). It was concluded that the substance is mildly iritating to the unwashed eye and minimally irritating when washed after 30 seconds. Based on the irritation score, the EU classification criteria for irritancy to eyes are not met.