Registration Dossier

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:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: US CFR guideline study, pre-GLP, with limited reporting.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Unnamed
Year:
1974
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2002
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1974

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: CFR 21, part 191 12 (revised as of April 1, 1973)
Deviations:
no
GLP compliance:
no
Remarks:
(prior to GLP)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Palladium (II) oxide
- Substance type: No data
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Albino rabbits with no known ocular abnormalities.

Test system

Vehicle:
not specified
Controls:
other: The left eye of each animal served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg (deposited on the eye surface)
Duration of treatment / exposure:
Presumably the observation period
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE: Not removed

SCORING SYSTEM: No data

TOOL USED TO ASSESS SCORE: No data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Number of animals showing irritant reactions
Basis:
other: Total number of test animals
Time point:
other: 24 hours
Score:
0
Max. score:
6
Reversibility:
other: Not applicable
Irritation parameter:
other: Number of animals showing irritant reactions
Basis:
other: Total number of test animals
Time point:
other: 48 hours
Score:
0
Max. score:
6
Reversibility:
other: Not applicable
Irritation parameter:
other: Number of animals showing irritant reactions
Basis:
other: Total number of test animals
Time point:
other: 72 hours
Score:
0
Max. score:
6
Reversibility:
other: Not applicable
Irritant / corrosive response data:
No corrosive conjunctival lesions or severe inflammation of the cornea and anterior chamber of the eyes
Other effects:
In one animal, the test material was still present in the conjunctival sac at the end of the observation period, but was completely covered with a thick mucous material.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to an expert review of an unpublished eye irritation study, conducted to US guidelines (CFR 21, part 191 12), a single instillation of palladium monoxide (100 mg) to the eyes of six rabbits produced no signs of irritation.
Executive summary:

According to an expert review of an unpublished eye irritation study, conducted to US test guidelines (CFR 21, part 191 12), palladium monoxide (100 mg) was instilled into one eye of each of six rabbits. The other eye remained untreated and acted as the control. The treated eye was then assessed for ocular inflammation 24, 48 and 72 hr after application. No reaction was noted in any of the six animals, indicating that the test material was not irritating.

 

Based on the results of this study, palladium monoxide should not be classified for eye irritation according to EU CLP criteria (EC 1272/2008).