Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 615-494-9 | CAS number: 71808-39-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Based on read-across following a category approach:
Oral: LD50 (rat) > 5000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Additional information
Justification for grouping of substances and read-across
In accordance with the specifications listed in Regulation (EC) No. 1907/2006 Annex XI, 1.5 Grouping of substances and read across, the similarity of category members has been shown to be justified based on the scope of variability and overlapping of composition, representative molecular structure, physico-chemical properties, tox-, ecotoxicological profiles and supporting Information by various validated QSAR methods. This information is given in further detail within the category justification for the grouping of chemicals and read-across (see IUCLID Section 13) for the dimerised fatty acids and its derivatives, and once more within the endpoint summary and discussion for Toxicokinetics.
For assessment of human health hazards of the category members, trends and similarities in toxicokinetic behaviour are most relevant. In particular, the molecular weight-dependent decrease in oral and dermal absorption and common metabolic pathways, which are explained by trends in molecular structure and common functional groups (monomers, dimers and trimers of similar long-chain fatty acids). This justifies the assumption that the toxicological profile of all category members is similar and effects or the lack of effects observed in toxicological studies of one ore more substances can also be expected and explained for the other substances in the category.
Therefore, in accordance with Annex XI, Item 1.5, of Regulation (EC) No 1907/2006, in order to avoid the need to test every substance for every endpoint, the category concept is applied for the assessment of human health hazards. Thus where applicable, human health effects are predicted from adequate and reliable data for reference substance(s) within the group by interpolation to other substances in the group (read-across approach).
All the available information from the substances within the category is taken into account for each endpoint to be assessed. Key studies are selected for assessment of the test substance and for read-across as to fulfil the requirements laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006, i.e. in all cases the results are adequate for the purpose of classification and labelling and/or risk assessment; have adequate and reliable coverage of the key parameters addressed in the corresponding test method referred to in Article 13(3); cover an exposure duration comparable to or longer than the corresponding test method referred to in Article 13(3) if exposure duration is a relevant parameter; and adequate and reliable documentation of the applied method is provided.
Discussion
There are no data available on the acute toxicity of fatty acids, C16-C18 and C18-unsaturated, dimerized upon oral, dermal or inhalative exposure. Therefore, assessment of acute toxicity was based on read-across from a group of structurally related substances within a category approach.
Oral
The acute oral toxicity of fatty acids, C18-unsaturated, dimers (CAS No. 61788-89-4) was tested in a study compliant with OECD Guideline 401 and under GLP conditions. The test material was administered by gavage to 5 male and 5 female Wistar rats at 5000 mg/kg bw. No mortalities and no signs of toxicity were observed during and at the end of the study (day 14 post-administration). The combined LD50 value for males and females was estimated to exceed 5000 mg/kg bw (Thouin, 1986).
In an earlier non-GLP study similar to OECD Guideline 401, the LD50 value for male and female Wistar rats given fatty acids, C18-unsaturated, dimers by gavage was determined to be greater than 18600 mg/kg bw. Transient sluggishness and slight diarrhoea were reported as clinical signs, which had diappeared at 24 h post-treatment (Spanjers, 1982).
The acute oral toxicity of fatty acids, C18-unsaturated, dimers, hydrogenated (CAS No. 68783-41-5) was tested in a study compliant with EU Method B.1 (Acute toxicity (oral)) under GLP conditions. The test material was administered by gavage to 5 male and 5 female Wistar rats at 5000 mg/kg bw. No mortalities and no signs of toxicity were observed during and at the end of the study (day 14 post-administration). Under the conditions used in this study, it was concluded that the test substance has no toxic effect when administered to the rat at a level of 5000 mg/kg bw. Thus, the LD50 value for males and females was estimated to be greater than 5000 mg/kg bw (Reijnders, 1988).
In another GLP-study conducted according to OECD Guideline 401, fatty acids, C18-unsaturated, dimers, hydrogenated were administered to 5 male and female Sprague-Dawley rats, respectively, by gastric force-feeding at a limit dose of 2000 mg/kg bw. There were no mortalities and no signs of toxicity after administration. Accordingly, the LD50 value was concluded to be greater than 2000 mg/kg bw (Saboureau, 1989).
In an earlier non-GLP study similar to OECD Guideline 401, the LD50 value for male and female Wistar rats given fatty acids, C18-unsaturated, dimers, hydrogenated by gavage was determined to be greater than 18800 mg/kg bw. Transient sluggishness and slight diarrhoea were reported as clinical signs, which had diappeared at 24 h post-treatment (Spanjers and Til, 1982).
In conclusion and based on read-across from structurally related substances, fatty acids, C16-C18 and C18-unsaturated, dimerized are not expected to induce systemic toxic effects after ingestion.
Dermal
No information is available on systemic toxicity after acute dermal exposure to fatty acids, C16-C18 and C18-unsaturated, dimerized or other members of the chemical category they belong to.
Based on the physicochemical properties (lipophilic substance with low water solubility) fatty acids, C16-C18 and C18-unsaturated, dimerized are expected to readily penetrate the stratum corneum, but partition into the epidermis, and thus dermal uptake, is likely to be low. Due to variations in the grade of saturation and type of dimeric structure, the molecular weight of fatty acids, C16-C18 and C18-unsaturated, dimerized is not restricted to a single value. However, the molecular weight of a C32-C36 fatty acid is estimated to be around 500 g/mol and above, hence too large for being dermally absorbed. Furthermore, taking into account the results of acute oral toxicity as well as skin and eye irritation studies conducted with other category members, no systemic toxic effects are expected after acute dermal exposure.
Inhalation
There are no data available on the acute toxicity upon inhalation exposure for fatty acids, C16-C18 and C18-unsaturated, dimerized or further members of the chemical category they belong to. However, in view of the very low vapour pressure of all category members, human exposure via inhalation is unlikely.
Potential acute inhalation exposure to aerosols of formulations intended for spray applications is expected to be low under normal conditions of use (s. CSR Chapter 9).
Justification for classification or non-classification
Based on read-across from structurally related substances within a category approach, the available data on the acute toxicity of fatty acids, C16-C18 and C18-unsaturated, dimerized is conclusive but not sufficient for classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.