WS/T 326.2-2010 in English

Efficacy evaluation of toothpaste — Part 2: Guidelines for anti-caries efficacy evaluation

1 Scope

This part of WS/T 326 specifies the anti-caries efficacy evaluation and evaluation methods of the toothpaste.

This part is applicable to toothpaste products that are labeled to have an efficacy of anti-caries, and of which the physical and chemical properties, hygiene and safety indexes meet the corresponding national standards.

2 Normative references

The following referenced documents are indispensable for the application of this standard. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

GB/T 8372 Toothpaste
WS/T326.1 Efficacy evaluation of toothpaste—Part 1: General principles

3 Terms and definitions

For the purposes of this document, the terms and definitions given in WS/T326.1 apply.

4 Efficacy evaluation

4.1 Evaluation principles

a) The efficacy of anti-caries of fluoride toothpaste shall be verified according to the laboratory evaluation method in 5.1.

b) The efficacy of anti-caries of non-fluoride products shall be evaluated according to the clinical tests requirements in 5.2.

4.2 Efficacy determination

4.2.1 After the test, when the free fluoride or soluble fluoride content of fluoride toothpaste is ≥ 500mg/kg, the product has efficacy of anti-caries according to the laboratory evaluation method for efficacy of anti-caries in 5.1.

4.2.2 At the beginning of the test baseline, the middle of the test and the end of the test, the test group and the positive control group (fluoride toothpaste with total fluoride of 1,100mg/kg-1,450mg/kg in accordance with provisions of this standard, without other active ingredients) are statistically analyzed for the changes of increased value on each index and the change of each index between the two groups in each period according to the clinical test requirements for efficacy of anti-caries in 5.2. After statistical test, the indexes of the test group shall not be lower than those of the positive control group, and the product has efficacy of anti-caries.

Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Efficacy evaluation
5 Evaluation method