4.3.2. Classification criteria for substances

the degradation half-life in marine water is higher than 60 days;

the degradation half-life in fresh or estuarine water is higher than 40 days;

the degradation half-life in marine sediment is higher than 180 days;

the degradation half-life in fresh or estuarine water sediment is higher than 120 days;

the degradation half-life in soil is higher than 120 days.

the long-term no-observed effect concentration (NOEC) or ECx (e.g. EC10) for marine or freshwater organisms is less than 0,01 mg/l;

the substance meets the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B, or 2) according to Sections 3.5, 3.6 or 3.7;

there is other evidence of chronic toxicity, as identified by the substance meeting the criteria for classification: specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Section 3.9;

the substance meets the criteria for classification as endocrine disruptor (category 1) for humans or the environment according to Sections 3.11 or 4.2.

the degradation half-life in marine, fresh or estuarine water is higher than 60 days;

the degradation half-life in marine, fresh or estuarine water sediment is higher than 180 days;

the degradation half-life in soil is higher than 180 days.

results from simulation testing on degradation in surface water;

results from simulation testing on degradation in soil;

results from simulation testing on degradation in sediment;

other information, such as information from field studies or monitoring studies, provided that its suitability and reliability can be reasonably demonstrated.

results from a bioconcentration or bioaccumulation study in aquatic species;

other information on the bioaccumulation potential, provided that its suitability and reliability can be reasonably demonstrated, such as:

information on the ability of the substance to biomagnify in the food chain, where possible expressed by biomagnification factors or trophic magnification factors.

results from long-term toxicity testing on aquatic invertebrates;

results from long-term toxicity testing on fish;

results from growth inhibition study on algae or aquatic plants;

the substance meeting the criteria for classification as carcinogenic in Category 1A or 1B (assigned hazard statements: H350 or H350i), germ cell mutagenic in Category 1A or 1B (assigned hazard statement: H340), toxic for reproduction in Category 1A, 1B or 2 (assigned hazard statements: H360, H360F, H360D, H360FD, H360Fd, H360fD, H361, H361f, H361d or H361fd), specific target organ toxic after repeated dose in Category 1 or 2 (assigned hazard statements: H372 or H373);

the substance meeting the criteria for classification as endocrine disruptor (Category 1) for human health or the environment (assigned hazard statements: EUH380 or EUH430);

results from long-term toxicity testing on terrestrial organisms; invertebrates and plants;

results from long-term toxicity testing on sediment organisms;

results from long-term or reproductive toxicity testing with birds;

other information, provided that its suitability and reliability can be reasonably demonstrated.

in vivo studies or other studies (e.g. in vitro, in silico studies);

information from the application of the category approach (grouping, read-across);

data from analogue substances using structure-activity relationships (SAR), informing about P, vP, B, vB and T properties;

results of monitoring and modelling;

human experience such as occupational data and data from accident databases;

epidemiological and clinical studies;

well documented case reports, peer-reviewed published studies and observations;

any additional acceptable data.

Indication of P or vP properties:

Indication of B or vB properties:

Indication of T properties: