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EC number: 261-619-1 | CAS number: 59130-69-7
- 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
A 28 -day study (BASF, 1993) with the structural analogue Fatty acids, C8 -10, C12 -18 -alkyl esters is available, where no adverse effects were found revealing a NOAEL of 1000 mg/kg bw (highest dose tested).
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable subacute toxicity study (Klimisch score 2), and is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.6, of Regulation (EC) No 1907/2006.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for grouping of substances and read-across
There are no data available for repeated dose toxicity of Hexadecyl 2-ethylhexanoate (CAS No. 59130-69-7). In order to fulfil the standard information requirements set out in Annex IX in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted.
In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).
Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, 1.5, of Regulation (EC) No 1907/2006, whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.
Repeated dose toxicity
CAS |
59130-69-7 |
95912-86-0 |
Chemical name |
Hexadecyl 2-ethylhexanoate |
Fatty acids, C8-10, C12-18-alkyl esters |
MW |
368.7 g/mol |
312.53-424.74 g/mol |
Repeated dose toxicity, oral |
RA: CAS 95912-86-0 |
NOAEL: 1000 mg/kg bw |
Repeated dose toxicity, inhalation |
- |
- |
Repeated dose toxicity, dermal |
- |
- |
The above mentioned substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information is used to predict the same endpoints for Hexadecyl 2-ethylhexanoate (CAS No. 59130-69-7).
A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
Discussion
Toxicity after long-term exposure is assessed by use of a subacute oral toxicity study with Fatty acids, C8-10, C12-18-alkyl esters, which was performed in male and female Wistar rats similar to OECD guideline 407 under GLP conditions (Pittermann, 1993). Rats were allocated to main control and treatment (10 rats per group) and satellite control and treatment (5 rats per group) groups. The rats were dosed with 100, 300, and 1000 mg/kg bw of the test substance by oral gavage. They were dosed once daily, 5 days/week for 28 days, resulting in 23-24 doses in total. There was no substance-related mortality and no clinical signs were observed during the study period. No effect on body weight gain was observed. Food and water consumption were similar in the control and treatment groups. Ophthalmoscopic examination revealed no effects. The males administered 1000 mg/kg bw/day had a significant increase in the level of leucocytes with segmented nuclei. As this effect was only observed in one sex and there were no other haematologic or histopathologic effects, this was not considered to be a treatment-related effect. No treatment-related effects on organ weights and clinical chemistry were observed. 1/10 females administered 1000 mg/kg bw/day had severe oedema in the forestomach and 1/10 had thickening of the forestomach mucosa. No other effects were noted during necropsy. Histopathology revealed that 4/10 males and 2/10 females in the 1000 mg/kg bw/day group had oedema in the mucosa of the forestomach, and the 2 females also had ulcerations. The findings in the forestomach were probably compound-related, however, humans do not have a forestomach and this effect is therefore not relevant to human exposure. As none of the animals in the satellite group had effects on the forestomach, this is considered to be a reversible effect. In conclusion, no adverse effects were observed after treatment of Wistar rats with up to 1000 mg/kg bw Fatty acids, C8-10, C12-18-alkyl esters. Thus, a NOAEL of 1000 mg/kg bw was deduced.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
There is only one study available.
Justification for classification or non-classification
According to DSD (67/548/EEC) or CLP (1272/2008/EC) classification criteria for repeated dose toxicity, no classification is required.
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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