Silicate(2-), hexafluoro-, disodium, reaction products with lithium magnesium sodium silicate

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test carried out by GLP compliant laboratory to recognised validated methods by trained personnel

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

CBA

Sex:

female

Vehicle:

propylene glycol

Concentration:

From 5% to 25% by weight of the test substance in propylene glycol
25 microlitres of the suspension were applied daily for three consecutive days

No. of animals per dose:

Four mice per concentration
A control group of 4 mice were treated with propylene glycol alone

Positive control substance(s):

other: phenylacetaldehyde CAS122-78-1

Positive control results:

At a concentration of 2.5% in propylene glycol, the positive test substance, phenylacetaldehyde, which had been applied to five mice, showed a stimulation index of 18.43 and is known to be a skin sensitiser.

Parameter:

SI

Remarks on result:

other: At 5%w/w in propylene glycol = 0.77 (negative result) At 10%w/w in propylene glycol = 0.56 (negative result) At 25%w/w in propylene glycol = 0.61 (negative result)

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

The test material was considered to be a non-sensitiser under the conditions of the test

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

In addition to the negative test results, Laponite has been used for many years in personal care products at low concentrations to provide structure to formulations. In more than 30 years of use in these fields, no data has been found to indicate that this material leads to sensitisation in the general public.

Migrated from Short description of key information:
The study performed assessed the skin sensitisation potential of this substance in mice using the LLNA (Local Lymph Node Assay) to recommended guideline methodology. The test material was considered to be a non-sensitiser under the conditions of the test

Justification for classification or non-classification

Results of the skin sensitisation test (LLNA in mice) showed no indication that the material is a skin sensitiser.

Respirable exposure would not be an expected route for sensitisation for product uses and during the lifetime of the manufacturing facility where dust inhalation might be expected, there have been no incidences of operators developing respirable (or dermal) sensitisation to this substance.

Therefore it is concluded that this substance is not a sensitiser, neither dermal nor respirable.