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EC number: 915-334-0 | 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
Key value for chemical safety assessment
Additional information
Justification for read-across
There are limited data available on the genetic toxicity of Reaction mass of octadecyl heptanoate and octadecyl octanoate (List No. 915-334-0). The assessment was therefore partly based on studies conducted with analogue substances as part of a read-across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13) and within Chapter 5.1 of the CSR.
Genetic toxicity (mutagenicity) in bacteria in vitro
List No. 915-334-0
The mutagenic potential of Reaction mass of octadecyl heptanoate and octadecyl octanoate was assessed in a bacterial reverse mutation assay (Ames test) and summarised in a review publication (Andersen (ed.), CIR Expert Panel, 1995). The study was performed similar to OECD guideline 471, but without the required TA 102 or E. coli strain according to the current OECD GL. S. typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 1538 were used in the plate incorporation assay in concentrations up to 5000 µg/plate, with and without metabolic activation. No details were given on the validity of the negative and positive controls, or on cytotoxicity. The test substance did not induce reversions in any of the S. typhimurium strains with or without metabolic activation. Due to the limited data on method and individual results, the study is not used for classification, but is included as part of the weight of evidence approach.
CAS 95912-86-0
An in vitro bacterial reverse mutation assay (Ames test) was performed with Fatty acids, C8-10, C12-18 alkyl esters (CAS 95912-86-0) (Banduhn, 1989). The study was performed equivalent to OECD guideline 471 and under GLP conditions, but without the required TA 102 or E. coli strain strain according to the current OECD GL. The plate incorporation method was applied using S. typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 1538 at concentrations up to 5000 µg/plate. Cytotoxicity was observed at 5000 µg/plate, with and without metabolic activation. The controls were valid. The test substance did not induce reversions in any of the S. typhimurium strains with or without metabolic activation.
CAS 2306-88-9
The mutagenic potential of Octyl octanoate (CAS 2306-88-9) was tested in a Salmonella typhimurium reverse mutation assay according to OECD guideline 471 and under GLP conditions (Wollny, 2000). The following strains were used: TA 1535, TA 1537, TA 100, TA 98 and TA 102. Tester strains were incubated with the test substance up to the limit concentration of 5000 µg/plate, with and without the addition of a metabolic activation system. Experiment I was carried out as a plate incorporation assay, while experiments II and III were performed as pre-incubation assays. No cytotoxicity of the test substance was observed. The controls were shown to be valid. Due to slightly induced numbers of revertant colonies for strain TA1535 without metabolic activation in the second experiment, a third experiment was carried out for strain TA1535 under the same conditions and at concentrations of 333, 1000, 2500 and 5000 µg/plate. No relevant increase in the number of revertant colonies occurred in the repeat experiment and the effect observed in the second experiment was considered to be biologically irrelevant.
Genetic toxicity (mutagenicity) in mammalian cells in vitro
CAS 26399-02-0
An in vitro mammalian cell gene mutation assay was performed with 2-ethylhexyl oleate (CAS 26399-02-0) according to OECD guideline 476 and under GLP conditions (Verspeek-Rip, 2010). Two independent experiments (with 3 or 24 hours of exposure) were performed in mouse lymphoma L5178Y cells in the absence and presence of metabolic activation (S9-mix) with test substance concentrations up to 100 μg/mL dissolved in ethanol. Precipitation was seen at concentrations of 100 µg/mL and higher. The negative control group was valid and within the range of historical control data. The positive control group was likewise valid. No significant increase in mutation frequency was observed.
Genetic toxicity in mammalian cells in vivo
EC 915-334-0
The potential for in vivo genetic toxicity of Reaction mass of octadecyl heptanoate and octadecyl octanoate was assessed in a micronucleus test performed according to OECD guideline 474 and under GLP conditions (Grötsch, 1993). 5 mice/sex/dose were administered a single dose of 500, 1500 and 5000 mg/kg bw test substance in corn oil by gavage. The animals were sacrificed 24 hours (vehicle control, 500, 1500 and 5000 mg/kg bw groups) and 48 hours (5000 mg/kg bw group) after dosing. Bone marrow cells from the femur were extracted, and 2 slides per animal were prepared and stained with a May-Grünwald and Giemsa solution. No systemic toxicity was observed up to and including the limit dose of 5000 mg/kg bw. There were two vehicle control groups with a 24-hour sampling time, while no vehicle control group with a 48-hour sampling time was included. The vehicle control groups were shown to be valid and within the range of historical control data. The positive control group was also valid. For the treatment groups with a 24-hour sampling time, no increase in the frequency of micronucleated polychromatic erythrocytes was observed in the isolated polychromatic erythrocytes and no decrease in the ratio of polychromatic to normochromatic erythrocytes was noted, compared with the vehicle control groups. For the 5000 mg/kg bw group with a 48-hour sampling time, all results were comparable to those of the other treatment groups and the vehicle control groups.
Overall conclusion for genetic toxicity
There is one reliable study on the in vivo genetic toxicity of the target substance Reaction mass of octadecyl heptanoate and octadecyl octanoate (List No. 915-334-0). Therefore, analogue read-across from source substances was applied from in vitro studies on gene mutations in bacterial cells and mammalian cells using 3 source substances. The results of the available in vitro and in vivo studies on target and source substances were negative.
Based on the available data and following the analogue approach, Reaction mass of octadecyl heptanoate and octadecyl octanoate is considered to be not mutagenic in vitro and not clastogenic in vivo.
Justification for selection of genetic toxicity endpoint
Hazard assessment is conducted by means of read-across from structural analogues. All available in vitro and in vivo genetic toxicity studies were negative. All available studies are adequate and reliable based on the identified similarities in structure and intrinsic properties between source and target substances and overall quality assessment (refer to the endpoint discussion for further details).
Short description of key information:
Genetic toxicity in vitro:
Ames test (OECD 471): negative with and without metabolic activation in S. typhimurium TA 1535, TA 1537, TA 100, TA 98, TA 1538 and TA 102
Gene mutation in mammalian cells (OECD 476): negative in L5178Y mouse lymphoma cells with and without metabolic activation
Genetic toxicity in vivo:
Micronucleus test (OECD 474): negative in mouse bone marrow cells
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “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. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to Reaction mass of octadecyl heptanoate and octadecyl octanoate (List No. 915-334-0), data will be generated from data for reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.
Therefore, based on the available data on the target substance and on analogue read-across approach, the results on genetic toxicity for the target and source substances do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore 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.
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