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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
Two rabbits tested following US guidelines from 1994.
A 25% commercial grade material was tests, but in view of the absence of significant effects, it is considered adequate to conclude that the substance is not irritating to eyes.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Only 2 animals tested. Method considered valid in 1994.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium zirconium lactate
EC Number:
239-570-2
EC Name:
Sodium zirconium lactate
Cas Number:
15529-67-6
Molecular formula:
C3H6O3xZr
IUPAC Name:
sodium zirconium lactate
Test material form:
solid
Specific details on test material used for the study:
Commercial grade material with ca 25% actives

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.01 ml applied unchanged
Observation period (in vivo):
Observation period for 3 days.
Number of animals or in vitro replicates:
Two animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: All animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal: All animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
chemosis score
Basis:
animal: All animals
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
One animal showed conjuntival rednees for 48 hours and chemosis immediately after treatment (resolved within 24 hours).
The second animal (unwashed eye) showed no adverse effects.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Although only two animals were tested, it canbe concluded that the material was not irritating to the eye.
The commercial grade material with ca 25% actives was tested, but in view of the low level of effect seen, it can be concluded that the substance is unlikely to be irritating to the eye.
The pH of the tested material is not known, but the current production material has pH 6 - 7.