Table of definitions for carcinogenic

Código SC1-E2000-I

VIEW:69 DATA:2020-03-20

 

A product has its carcinogenic strength stipulated by evidence, which may occur in humans in animals, and in chemical analyzes. This evidence demarcates the magnitude of the risk of getting the disease.

Integration of streams of evidence in reaching overall classifications (the evidence in bold italic represents the basis of the overall evaluation)

 

Stream of evidence

Classification based on strength of evidence

Evidence of cancer in humansa

Evidence of cancer in experimental animals

Mechanistic

evidence

Sufficient

Not necessary

Not necessary

Carcinogenic to humans (Group 1)

Limited or Inadequate

Sufficient

Strong (b)(1) (exposed humans)

 

Limited

Sufficient

Strong (b)(2-3), Limited, or Inadequate

Probably carcinogenic to humans (Group 2A)

Inadequate

Sufficient

Strong (b)(2) (human cells or tissues)

 

Limited

Less than Sufficient

Strong (b)(1-3)

 

Limited or Inadequate

Not necessary

Strong (a) (mechanistic class)

 

Limited

Less than Sufficient

Limited or Inadequate

Possibly carcinogenic to humans (Group 2B)

Inadequate

Sufficient

Strong (b)(3), Limited, or Inadequate

 

Inadequate

Less than Sufficient

Strong b(1—3)

 

Limited

Sufficient

Strong (c) (does nob operate in humans)b

 

Inadequate

Sufficient

Strong (c) (does notb operate in humans)

Not classifiable as to its carcinogenicity to humans (Group 3)

 

All other situations not listed above

a Human cancer(s) with highest evaluation

b The strong evidence that the mechanism of carcinogenicity in experimental animals does not operate in humans must specifically be for the tumour sites supporting the classification of sufficient evidence in experimental animals.

Preamble-2019.pdf




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