Sodium zirconium lactate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

Part of research on methods to improve LLNA.
Lactic acid assessed (note lactic acid canbe used as a negative control in some methods)

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2011

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Principles of method if other than guideline:

As well as the standard method of using radioactivity to assess activity of the local lymph nodes, the research included asessment of cell counts in the lymph nodes

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Lactic acid

EC Number:

200-018-0

EC Name:

Lactic acid

Cas Number:

50-21-5

Molecular formula:

C3H6O3

IUPAC Name:

2-Hydroxypropanoic acid

Specific details on test material used for the study:

Work performed with lactic acid.
Lactic acid and lactates dissolve to form lactate ions and the acid is considered to be a suitable surrogate for assessment of the salt.

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

Temperature 20–24 °C and a relative humidity of 30–70%, with a 12 h light–dark cycle
Tap water and food were given ad libitum.

Study design: in vivo (LLNA)

Vehicle:

dimethyl sulphoxide

Concentration:

5.0, 10, 25 %

No. of animals per dose:

Three

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:

Positive

In vivo (LLNA)

Results

Key result

Parameter:

EC3

Value:

0

Remarks on result:

not determinable

Remarks:

No indication of positive effects

Any other information on results incl. tables

Lactic acid led to local skin irritation in the high and mid dose groups.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Lactic acid proved negative by both methods used for evaluation.
Substances known to be positive sensitisers gave positive responses as expected demonstrating validity of the work.