Table of definitions for carcinogenic
Código SN02-E0021-I
VIEW:429 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(13) |
|
|
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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