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Diss Factsheets
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EC number: 936-831-9 | CAS number: -
- 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
LLNA (OECD 429; RCC 848427,2003) = sensitizing
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
According to regulation (EC) No 1907/2006, Annex XI, paragraph 1.5., substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or "category" of substances. Environmental effects or environmental fate may be predicted from data for reference substance(s) within the group by interpolation to other substances in the group (read-across approach).
The source (CAS 376588-17-9) and target (EC 936-831-9) substance share identical structural elements, the only difference being the length of the carbon chain at the ester function. The source chemical is esterified with stearic acid (C18), whereas the target compound is a mixture of stearate (C18) and palmitate (C16), with the stearate version accounting for about 60% of the chemicals present in the target compound. Therefore, 60% of the target compound are identical with the source chemical and the remaining molecules of the target compound are nearly identical with the only difference being the chain length at the ester group. It is expected that the structural difference between the octadecanoate and the hexadecanoate does not affect the physico-chemical properties, the toxicological and ecotoxicologocal profile as well as the environmental fate. Both substances are characterized by similar values for water solubility, vapor pressure and log POW. Furthermore, it can be assumed that the degradation products of CAS 376588-17-9 are very similar to the degradation products of the mixture containing the octadecanoate and the hexadecanoate. In addition, both substances triggered comparable (eco)toxicological effects. Therefore read-across to CAS 376588-17-9 is scientifically justified for physico-chemical properties, the toxicological and ecotoxicologocal profile as well as environmental fate. For more information on the read-across approach, please refer to the Chapter 13 (attached read-across justification).
The sensitization potential was evaluated in a GLP compliant guideline study according to OECD 429 (RCC, 848427, 2003) with the source substance. The substance was found to be a skin sensitizer.
Key information:
According to the analogues approach, no additional information is needed to conclude on the senitizing potential of the registered substance. The registered substance according to the CLP Regulation (EC) No. 1272/2008 as skin sensitizer in Cat 1B / H317.
According to the Potency categorization suggested in Chapter R.8 of ECHA Guidance on information requirements and chemical safety assessment (November 2012), the test substance is assumed to be a moderate sensitizer. As the test substance is contained in finished articles below the limits identified in Article 14(2) of REACH, in fact it is lower than 1% (ECHA GD chapter R7c, March 2020) no risk assessment has to be performed. This is supported by additional product tests, which showed that the test substance was not sensitizing when tested up tp 10% in PP.
Additional information: product testing with the source chemical
Several product tests were performed. The test substance (CAS 376588-17-9) was found to be not sensitizing in the following LLNA (OECD 429) tests:
- RCC 850009. 5% test substance in PP/190°C. (Concentrations:2.5, 5, 10% in Acetone:olive oil (4:1))
- RCC 850010. 5% test substance in PP/175°C. (Concentrations:2.5, 5, 10% in Acetone:olive oil (4:1))
- RCC 850012. 10% test substance in PP/175°C. (Concentrations:1, 2.5, 5% in Acetone:olive oil (4:1))
According to the analogues approach, it is assumed that the target chemical is also not sensitizing when tested in 5% and 10% in PP.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified as sensitizing to skin under Regulation (EC) No. 1272/2008.
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.
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