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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4 hours exposure
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:
US Study performed 1994 with 6 rabbits.
Well documented, but 25% commercial grade solution used for testing

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 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
6-rabbits for US
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 used at ca 25% solids

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 ml, undiluted as supplied (ie 25% actives)
Duration of treatment / exposure:
4 hours
Observation period:
Up to 72 hours (all animals with no score at this point)
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 1 animal
Time point:
other: 1 hour
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: All animals
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not relevant
Irritation parameter:
edema score
Basis:
animal: All animal
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not relevant
Irritant / corrosive response data:
Only one animal showed a slight effect at 1 hour after removal of dressings. This resolved prior to next observation at 24 hours.
No other animals showed any adverse effect.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Although it was uncessary to use 6 animals, the work was performed in accordance with common practice in the US at this period.
Only slight transitory effects were seen in one animal 1 hour after removal of dressings.
The material tested was as supplied as ca 25% actives. The very low irritation of the 25% solution would suggest that the substance need not be classified as irritating to the skin.
The pH of the material was unknown, but current production is for pH 6 - 7.