Sodium zirconium lactate

Endpoint summary

Description of key information

No skin irritation was observed in in-vivo testing.

Slight reversible eye irritation was seen in one animal during an in-vivo test.

Testing was performed in the US in 1994 on a 25% actives commercial grade solution. The absence of adverse effects indicates that classification is not required, although if isolated from water, the pure substance may cause mild irritant effects.

The substance is typically manufactured and supplied in water.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

6-rabbits for US

GLP compliance:

not specified

Specific details on test material used for the study:

Commercial grade material used at ca 25% solids

Species:

rabbit

Strain:

New Zealand White

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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.

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

Specific details on test material used for the study:

Commercial grade material with ca 25% actives

Species:

rabbit

Strain:

New Zealand White

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)