3.4 Data on mammalian toxicity (Procedure (G9),
paragraph 4.2.1.2)
3.4.1 General
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For proprietary experimental data
the applied test method should be specified.
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For each
toxicological endpoint, the quality of the available data and the
implications of the results should be briefly discussed.
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3.4.2 Acute toxicity
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Lethal or limit dose
information, exposure route, species.
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3.4.3 Effects on skin and eye
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Application form/concentration
tested, severity and reversibility of effect, species or in vitro
model.
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If tests have not
been carried out on account of extreme pH or known or suspected corrosive
properties this should be clearly stated and supporting information
provided.
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3.4.4 Repeated-dose toxicity
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NOAEL or LOAEL, dose
range tested, most sensitive effect observed (target organ), test
duration, exposure route, species, and sex.
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3.4.5 Chronic toxicity
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NOAEL or LOAEL, dose
range tested, most sensitive effect observed (target organ), test
duration, exposure route, species, and sex.
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3.4.6 Developmental and reproductive toxicity
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NOAEL or LOAEL for
systemic parental toxicity, effects on reproduction, and developmental
effects, dose range tested, most sensitive effect observed, test
duration, exposure route, and species.
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3.4.7 Carcinogenicity
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NOAEL or LOAEL for tumour and
non-tumour effects, dose range tested, most sensitive effect observed,
test duration, exposure route, species, and sex.
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If available
carcinogenicity classifications are cited, a full verbal description of
the relevant classification should be provided as well as the year of the
last assessment. It is not appropriate to cite carcinogenicity
classifications that have been outdated by more recent relevant
experimental data.
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3.4.8 Mutagenicity/Genotoxicity
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Experimental model,
dose range tested.
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3.4.9 Toxicokinetics
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