Optimized Strategies for Risk Assessment
of Industrial Chemicals through Integration
of Non-Test and Test Information


Endpoints in REACH

For the registration of chemicals within REACH, information regarding the following endpoints has to be submitted in the technical dossier.
For more details and dependence on the tonnage manufactured or imported see the following REACH overview.

Physicochemical information

7.1 State of the substance at 20 °C and 101,3 kPa
7.2 Melting/freezing point
7.3 Boiling point
7.4 Relative density
7.5 Vapour pressure
7.6 Surface tension
7.7 Water solubility
7.8 Partition coefficient n-octanol/water
7.9 Flash-point
7.10 Flammability
7.11 Explosive properties
7.12 Self-ignition temperature
7.13 Oxidising properties
7.14 Granulometry
7.15. Stability in organic solvents and identity of relevant degradation products
7.16. Dissociation constant
7.17. Viscosity

Toxicological information

8.1 Skin irritation or skin corrosion
8.1.1 In vivo skin irritation
8.2 Eye irritation
8.2.2 In vivo eye irritation
8.3 Skin sensitisation
8.4 Mutagenicity
8.4.1 In vitro gene mutation study in bacteria
8.4.2 In vitro cytogenicity study in mammalian cells or in vitro micronucleus study
8.4.3 In vitro gene mutation study in mammalian cells
8.5 Acute toxicity
8.5.1 By oral route
8.5.2. By inhalation
8.5.3. By dermal route
8.6. Repeated dose toxicity
8.6.1. Short-term repeated dose toxicity study (28 days)
8.6.2. Sub-chronic toxicity study (90-day)
8.6.3. Long-term repeated toxicity study (≥ 12 months)
8.6.4. Further repeated dose toxicity studies
8.7. Reproductive toxicity
8.7.1. Screening for reproductive/ developmental toxicity
8.7.2. Pre-natal developmental toxicity study
8.7.2. Developmental toxicity study
8.7.3. Two-generation reproductive toxicity study
8.8. Toxicokinetics
8.8.1. Assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from the relevant available information
8.9. Carcenogenicity
8.9.1. Carcinogenicity study

Ecotoxicological information

9.1 Aquatic toxicity
9.1.1 Short-term toxicity testing on invertebrates (preferred species Daphnia)
9.1.2 Growth inhibition study aquatic plants (algae preferred)
9.1.3. Short-term toxicity testing on fish
9.1.4. Activated sludge respiration inhibition testing
9.1.5. Long-term toxicity testing on invertebrates (preferred species Daphnia)
9.1.6. Long-term toxicity testing on fish: Fish early-life stage (FELS) toxicity test Fish short-term toxicity test on embryo and sac-fry stages Fish, juvenile growth test
9.2 Degradation
9.2.1 Biotic Ready biodegradability Simulation testing on ultimate degradation in surface water Soil simulation testing (for substances with a high potential for adsorption to soil) Sediment simulation testing (for substances with a high potential for adsorption to sediment)
9.2.2. Abiotic Hydrolysis as a function of pH.
9.2.3. Identification of degradation products
9.3. Fate and behaviour in the environment
9.3.1. Adsorption/desorption screening
9.3.2. Bioaccumulation in aquatic species, preferably fish
9.3.3. Further information on adsorption/desorption
9.3.4. Further information on the environmental fate and behaviour of the substance and/or degradation products
9.4. Effects on terrestrial organisms
9.4.1. Short-term toxicity to invertebrates
9.4.2. Effects on soil micro-organisms
9.4.3. Short-term toxicity to plants
9.4.4. Long-term toxicity testing on invertebrates
9.4.6. Long-term toxicity testing on plants
9.5 Effects on sediment organisms
9.5.1. Long-term toxicity to sediment organisms
9.6. Toxicity to birds
9.6.1. Long-term or reproductive toxicity to birds

OSIRIS Finished

The official end of the project was reached in September 2011. We thank all partners for their excellent cooperation. The public report giving an overview on the major achievements has been submitted to the European Commission. For legal reasons, please ask them in case you are interested in obtaining a copy. There are still OSIRIS related publications on their way. The OSIRIS publication page will still be updated, thus you may watch it regularly. However, this news column will no more be updated.

OSIRIS Models and Webtool

The OSIRIS webtool and ChemProp are publicly available

Webtool: ITS start
New users need to sign up for free to use the tool
Webtool: Online registration

A license agreement is necessary to obtain ChemProp
ChemProp: License agreement download

In general, information, downloads and links concerning software developed within OSIRIS can be found here:
Software overview