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Note for Guidance for Food Contact Materials
Page 57 of 126
8.1.1 Gene mutation in bacteria:
According to the EC Method B.13/14 and
the OECD Guideline 471.
It has to be noted that, the bacterial reverse
mutation test may not be appropriate for the
evaluation of certain classes of chemicals,
for example highly bactericidal compounds
(e.g. certain antibiotics). In such cases,
mammalian mutation tests may be more
appropriate.
Ref:
8.1.2 In vitro mammalian cell gene
mutation test:
According to the EC Method B.17 and the
OECD Guideline 476.
Ref:
8.1.3 In vitro mammalian chromo-
some aberration test :
According to the EC Method B.10 and the
OECD Guideline 473.
Ref:
8.1.4 Other
information:
If any of the above tests yields a positive or
equivocal result, further mutagenicity tests,
including in vivo assays, may be required to
elucidate the genotoxic potential of the
substance. The choice of supplementary
test(s) is decided case by case, on the basis
of the results obtained and other relevant
information.
Ref:
8.2 General
toxicity
8.2.1
Subchronic (90d) oral
toxicity:
According to the EC Method B.26 and the
OECD guideline 408.
Ref:
8.2.2 Chronic
toxicity/
carcinogenicity:
According to the EC Method B.33 and the
OECD guideline 453.
Ref:
8.2.3 Reproduction/teratogenicity:
According to the EC Methods B.34B.35 and
the OECD guidelines 421-422.
Ref:
8.2.4 Other
information:
Set out any other information that may be
relevant for evaluation, e.g. acute or subacute
(28d) toxicity, dermal and inhalation effects
should be provided when available.
Ref:
8.3 Metabolism

8.3.1 Absorption,
distribution,
biotransformation and
excretion:
Give any relevant information when available.
Ref: