Silicic acid, aluminum calcium sodium salt

Skin sensitisation

Administrative data

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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

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)

Test material

Test material information

Constituent 1

Reference substance name:

Silicic acid, aluminium, calcium, sodium salt

IUPAC Name:

Silicic acid, aluminium, calcium, sodium salt

Constituent 2

Reference substance name:

Silicic acid, aluminum calcium sodium salt

EC Number:

215-685-3

EC Name:

Silicic acid, aluminum calcium sodium salt

Cas Number:

1344-01-0

Molecular formula:

3.0-3.9 SiO2 . Al2O3 . 0.4-0.6 CaO . 0.4-0.6 Na2O . nH2O

IUPAC Name:

aluminium(3+) calcium sodium tris(oxosilanebis(olate))

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Sample Name: Silicic acid, aluminium calcium sodium salt (Silton JC-30)
Sample Description: White powder
Batch Number: TSM 12/21
Purity: 99%
Expiry Date: 7th June 2013

In vivo test system

Test animals

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.

Study design: in vivo (LLNA)

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)

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

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

Results 2

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

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.