Silicic acid, aluminum calcium sodium salt

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: Study was conducted by a GLP accredited laboratory using OECD Testing Guideline 429.

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:

other: CBA/CaCrl

Sex:

female

Details on test animals and environmental conditions:

The test was carried out on Nulliparous, non-pregnant female CBA/CaCrl strain mice. The sex and strain of mouse has been selected for this study in conformance with the design of the validated test method (OECD Guidelines for Testing of Chemicals Method 429, adopted 24 April 2002). Animals in the main study were in a body weight range of 16.9 to 20.5 g on the day before dosing commenced. Individual body weights were within ± 20% of the mean body weight for mice on the study. Based on information from the supplier the mice were approximately 8 to 10 weeks old on Day 1.

Vehicle:

dimethyl sulphoxide

Concentration:

10, 25 and 50 % w/v

No. of animals per dose:

4

Positive control substance(s):

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

mercaptobenzothiazole (CAS No 149-30-4)

Parameter:

SI

Remarks on result:

other: 10% w/v: 0.8 25% w/v: 1.2 50% w/v: 1.3

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Vehicle Control: 1794 DPM 10% w/v: 1448 DPM 25% w/v: 2141 DPM 50% w/v: 2324 DPM

Sample Identity	Number of sites yielding lymph nodes	Disintegrations per minute* (DPM)	Disintegrations per minute per node (DLM)	Stimulation Index (SI)
Scintillation fluid with 5% w/v trichloroacetic acid	-	48	-	-
Vehicle control	8	1794	224	-
Test article, 10% w/w	8	1448	181	0.8
Test article, 25%	8	2141	268	1.2
Test article, 50%	8	2324	291	1.3

 

* All scintillation counts corrected for the blank

SI = Test group DLM value / Control group DLM value

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The Stimulation Index (SI) recorded for the test sample was 0.8 (10% w/v test sample), 1.2 (25% w/v test sample) and 1.3 (50% w/v) test sample. These values do not meet the criteria for classifying the substance as a skin sensitiser according to EU CLP criteria.

Executive summary:

The skin sensitisation potential of the substance was tested in accordance with the OECD Guideline for Testing of Chemicals 429. Groups of four female CBA/CaCrl mice were subjected to topical applications of vehicle or of one of the test formulations (at concentrations of 10, 25 or 50% w/v) to the outer aspect of the auditory pinnae once daily on Days 1, 2 and 3. The Stimulation Index (SI) recorded for the test sample was 0.8 (10% w/v test sample), 1.2 (25% w/v test sample) and 1.3 (50% w/v) test sample. These values do not meet the criteria for classifying the substance as a skin sensitiser according to EU CLP criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

A study was conducted on the registered substance to determine the skin sensitisation potential of the substance. The skin sensitisation potential of the substance was tested in accordance with the OECD Guideline for Testing of Chemicals 429. Groups of four female CBA/CaCrl mice were subjected to topical applications of vehicle or of one of the test formulations (at concentrations of 10, 25 or 50% w/v) to the outer aspect of the auditory pinnae once daily on Days 1, 2 and 3. The Stimulation Index (SI) recorded for the test sample was 0.8 (10% w/v test sample), 1.2 (25% w/v test sample) and 1.3 (50% w/v) test sample. These values do not meet the criteria for classifying the substance as a skin sensitiser according to EU CLP criteria.

Migrated from Short description of key information:
The registered substance is not sensitising to skin.

Justification for selection of skin sensitisation endpoint:
Study was conducted on the registered substance according to GLP standards and using OECD Testing Guideline 429.

Justification for classification or non-classification

The registered substance did not show skin sensitisation potential.