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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.