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Directive 98/8/EC of the European Parliament and of the Council (repealed)Show full title

Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (repealed)

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Changes over time for: Division VI.

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Version Superseded: 01/09/2013

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EU Directives are published on this site to aid cross referencing from UK legislation. Since IP completion day (31 December 2020 11.00 p.m.) no amendments have been applied to this version.

VI.TOXICOLOGICAL AND METABOLIC STUDIESU.K.

6.1.Acute toxicityU.K.

For studies 6.1.1 to 6.1.3, substances other than gases shall be administered via at least two routes, one of which should be the oral route. The choice of the second route will depend on the nature of the substance and the likely route of human exposure. Gases and volatile liquids should be administered by the inhalation route.

6.1.1.OralU.K.
6.1.2.DermalU.K.
6.1.3.InhalationU.K.
6.1.4.Skin and eye irritation (3)U.K.
6.1.5.Skin sensitisationU.K.
6.2.Metabolism studies in mammals. Basic toxicokinetics, including a dermal absorption studyU.K.

For the following studies, 6.3 (where necessary), 6.4, 6.5, 6.7 and 6.8, the required route of administration is the oral route unless it can be justified that an alternative route is more appropriate

6.3.Short-term repeated dose toxicity (28 days)U.K.

This study is not required when a sub-chronic toxicity study is available in a rodent

6.4.Subchronic toxicityU.K.

90-day study, two species, one rodent and one non-rodent

6.5.Chronic toxicity (4)U.K.

One rodent and one other mammalian species

6.6.Mutagenicity studiesU.K.
6.6.1. In-vitro gene mutation study in bacteriaU.K.
6.6.2. In-vitro cytogenicity study in mammalian cellsU.K.
6.6.3. In-vitro gene mutation assay in mammalian cellsU.K.
6.6.4.If positive in 6.6.1, 6.6.2 or 6.6.3, then an in-vivo mutagenicity study will be required (bone marrow assay for chromosomal damage or a micronucleus test)U.K.
6.6.5.If negative in 6.6.4 but positive in-vitro tests then undertake a second in-vivo study to examine whether mutagenicity or evidence of DNA damage can be demonstrated in tissue other than bone marrowU.K.
6.6.6.If positive in 6.6.4 then a test to assess possible germ cell effects may be requiredU.K.
6.7.Carcinogenicity study (4)U.K.

One rodent and one other mammalian species. These studies may be combined with those in 6.5

6.8.Reproductive toxicity (5)U.K.
6.8.1.Teratogenicity test — rabbit and one rodent speciesU.K.
6.8.2.Fertility study — at least two generations, one species, male and femaleU.K.
6.9.Medical data in anonymous formU.K.
6.9.1.Medical surveillance data on manufacturing plant personnel if availableU.K.
6.9.2.Direct observation, e.g. clinical cases, poisoning incidents if availableU.K.
6.9.3.Health records, both from industry and any other available sourcesU.K.
6.9.4.Epidemiological studies on the general population, if availableU.K.
6.9.5.Diagnosis of poisoning including specific signs of poisoning and clinical tests, if availableU.K.
6.9.6.Sensitisation/allergenicity observations, if availableU.K.
6.9.7.Specific treatment in case of an accident or poisoning: first aid measures, antidotes and medical treatment, if knownU.K.
6.9.8.Prognosis following poisoningU.K.
6.10.Summary of mammalian toxicology and conclusions, including no observed adverse effect level (NOAEL), no observed effect level (NOEL), overall evaluation with regard to all toxicological data and any other information concerning the active substances. Where possible any suggested worker protection measures should be included in summary formU.K.

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