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EC number: 292-932-1 | CAS number: 91031-31-1
- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Negative results in Salmonella typhimurium TA 98, TA 100, TA 1535 and TA 1537, with and without metabolic activation (OECD 471, GLP).
Negative results in mammalian chromosomal aberration test with Chinese hamster lung cells (OECD 473, GLP, category approach).
Negative results in mammalian cell gene mutation tests using Chinese hamster ovary cells, with and without metabolic activation (OECD 476, GLP).
The hazard assessment is based on the data currently available. Pursuant to ECHA decision on a compliance check CCH-D-2114551285-49-01/F new studies with the registered substance will be conducted in the future. The finalised studies will be reported in an updated dossier until 22 July 2024 and the hazard assessment will be re-evaluated accordingly.
For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
Negative results in mammalian erythrocyte micronucleus test in vivo (OECD 474, GLP, category approach).
The hazard assessment is based on the data currently available. Pursuant to ECHA decision on a compliance check CCH-D-2114546559-35-01/F new studies with the registered substance will be conducted in the future. The finalised studies will be reported in an updated dossier until 22 July 2024 and the hazard assessment will be re-evaluated accordingly.
For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The hazard assessment is based on the data currently available. Pursuant to ECHA decision on a compliance check CCH-D-2114546559-35-01/F new studies with the registered substance will be conducted in the future. The finalised studies will be reported in an updated dossier until 22 July 2024 and the hazard assessment will be re-evaluated accordingly.
For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.
Genetic toxicity in vitro
Data Matrix
(a) Category members subject to the REACh Phase-in registration deadline of 31 May 2013 are indicated in bold font.
(b) Substances that are either already registered under REACh or not subject to the REACh Phase-in registration deadline of 31 May 2013 are indicated in normal font.
(c) Original data is not available.
For all category members registered under REACh a full data set for each endpoint is provided. For substances not subject to the current REACh Phase-in registration, lack of data for a given endpoint is indicated by "--".
Genetic toxicity (mutagenicity) in bacteria in-vitro
CAS 627-83-8
A bacterial gene mutation assay (Ames test) was performed with ethylene distearate following OECD guideline 471 and in compliance with GLP (Grötsch, 1996). The plate incorporation procedure was performed with Salmonella typhimurium strains TA 100, TA 1535, TA 1537 and TA 98 in the absence and presence of metabolic activation (Aroclor 1254-induced rat liver S9-mix). Two independent experiments were conducted each in triplicates at concentrations from 8 to 5000 µg/plate (vehicle: DMSO). No increase in the number of revertant colonies was noted in any of the bacterial strains, with and without metabolic activation system. No cytotoxicity was observed up to the highest dose tested. The included positive and negative controls showed the expected results, however instead of the solvent control DMSO, water was included as negative control substance. Under the conditions of the study, the test substance did not induce mutations in the bacterial mutation assay in the absence and presence of a metabolic activation system in any of the strains tested.
CAS 68583-51-7
Two bacterial gene mutation assays were performed with Decanoic acid, mixed diesters with octanoic acid and propylene glycol following OECD guideline 471 and in compliance with GLP (Banduhn, 1991a; Ebert, 1995). The strains Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537 and TA 1538 were tested in two independent experiments according to the plate incorporation procedure at concentrations from 8 to 5000 µg/plate (vehicle: suspension medium Tween 80/bidest. water) with and without a metabolic activation system (Aroclor 1254-induced rat liver S9-mix). No increase in the number of revertant colonies was noted in any strain of bacteria tested, with and without a metabolic activation system. No cytotoxicity was observed up to the highest dose tested. The included positive and negative controls showed the expected results and were therefore considered as valid. Under the conditions of this study, the test substance did not induce mutations in the bacterial mutation tests in the absence and presence of a metabolic activation system in any of the strains tested (Banduhn, 1991a). A further experiment in the tester strains Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA 100 confirmed the above described results (Ebert, 1995). In concentrations from 50 to 5000 µg/plate with and without a metabolic activation system, no cytotoxicity was apparent and no increase in the number of revertant colonies was observed in any of the strains tested.
Thus, the test substance did not induce mutations in the bacterial mutation assay in the absence and presence of a metabolic activation system in any of the strains tested.
CAS 84988-75-0
A study investigating the genetic toxicity in vitro of Fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol is available. The study was conducted according to OECD guideline 471 under GLP conditions (Banduhn, 1991b). In two independent experiments, the tester strains Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537 and TA 1538 were tested according to the plate incorporation procedure. Concentrations from 8 to 5000 µg/plate were investigated with and without a metabolic activation system (Aroclor 1254-induced rat liver S9-mix). No increase in the number of revertant colonies was noted in any of the bacterial strains, with and without metabolic activation system. No cytotoxicity was observed up to the highest dose tested. The included positive and negative controls showed the expected results and were therefore considered as valid. Thus, under the conditions of this study, the test substance did not induce mutations in the bacterial mutation tests in the absence and presence of a metabolic activation system in any of the strains tested.
CAS 91031-31-1
The gene mutation properties of the category member Fatty acids, C16-18, esters with ethylene glycol were determined according to OECD guideline 471 under GLP conditions (Banduhn, 1991c). The tester strains, Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537 and TA 1538 were used. The main study was performed in triplicates each in two independent experiments according to the plate incorporation procedure at concentrations from 8 to 5000 µg/plate (vehicle: Tween 80; 1:1 (w/w) dilution with water) with and without a metabolic activation system (Aroclor 1254-induced rat liver S9-mix). No increase in the number of revertant colonies was noted in any of the bacterial strains, with and without metabolic activation system. No cytotoxicity was observed up to the highest dose tested. Precipitation was noted at the highest test concentration of 5000 µg/plate. The positive and negative controls showed the expected results and were therefore considered as valid. Under the conditions of this study, the test substance did not induce mutations in the bacterial mutation tests in the absence and presence of a metabolic activation system in any of the strains tested.
Genetic toxicity (cytogenicity) in mammalian cells in-vitro
CAS 853947-59-8
An in vitro mammalian chromosome aberration test was conducted with C8-10, 1,3-Butandiolester in accordance with OECD guideline 473 under GLP conditions (Dechert, 1997). The induction of structural chromosome aberrations was evaluated in vitro in Chinese hamster lung fibroblasts (V79) cells, incubated for 18 and 28 h with and without a metabolic activation system (S9-mix from rats treated with Aroclor 1245). Concentrations of 10-100 µg/mL (18 h incubation) and 80 and 100 µg/mL (28 h incubation) of the test substance in the vehicle ethanol were applied. The solubility limit of the test substance in the vehicle ethanol in the culture medium was determined to be 100 µg/mL. In the first experiment without metabolic activation, the negative controls exhibited a mitotic index of 2.0% only and the experiment was therefore repeated. Thereafter, the negative as well as the positive controls showed the expected results and were within the range of historical control data. The frequency of polyploidy cells with and without metabolic activation was within the expected range (< 10%). In the experiments both with and without metabolic activation, a systematic influence of the test substance was observed, which led to a reduction in the mitotic index. No statistically or biologically significant increase in the incidence of chromosome aberrations was observed.
Therefore, under the conditions of the study, the test substance did not show clastogenic activity in this chromosomal aberration test with and without metabolic activation performed in Chinese hamster lung fibroblasts in vitro.
Genetic toxicity (mutagenicity) in mammalian cells in-vitro
CAS 91031-31-1
The in vitro mammalian cell gene mutation study of Fatty acids, C16-18, esters with ethylene glycol was carried out according to OECD guideline 476 under GLP conditions (Verspeek-Rip, 2010). Gene mutations in the thymidine kinase locus were investigated in L5178Y mouse lymphoma cells in the presence and absence of a metabolic activation system (Phenobarbital/β-naphtoflavone-induced rat liver S9). In the first experiment, cells were exposed for 3 h to test substance at concentrations of 0.1-333 µg/mL (in DMSO) with and without metabolic activation. Concentrations of the second experiment without metabolic activation for an exposure time of 24 h ranged from 3-175 µg/mL and with metabolic activation (3 h; 12% S9-mix) from 0.1-333 µg/mL. The vehicle and positive controls in the study showed the expected results and were within the range of historical control data. No cytotoxicity was observed up to the precipitating concentration of 100 µg/mL and up to 333 µg/mL, respectively. There was no significant increase in the number of forward mutations at the thymidine kinase locus of L5178Y mouse lymphoma cells treated with the test material, neither in the presence nor in the absence of a metabolic activation system. Under the conditions of the study, Fatty acids, C16-18, esters with ethylene glycol did not show gene mutation activity in this test performed in L5178Y mouse lymphoma cells in vitro.
Genetic toxicity in vivo
CAS 151661-88-0
The in vivo micronucleus assay of Fatty acids, C18 and C18 unsatd., epoxidized, ester with ethylene glycol was carried out according to OECD guideline 474 under GLP conditions (Banduhn, 1990). Based on the results of a preliminary dose range finding study, the test substance diluted in arachis oil was administered at 3000, 4000 and 5000 mg/kg bw as single oral doses to groups of 6 male and female CFW1 mice, observed for 24, 48 and 72 h post-dose. A concurrent negative control with the vehicle alone and a positive control group given cyclophosphamide was included in the study. No mortality and no signs at clinical examinations were reported. The test substance did not induce a statistically significant increase in the number of micronucleated polychromatic erythrocytes in the bone marrow of the animals. The negative and positive controls showed the expected results. Therefore, under the conditions of the study, Fatty acids, C18 and C18 unsatd., epoxidized, ester with ethylene glycol did not induce chromosomal mutations in the bone marrow of mice.
Conclusion for genetic toxicity
In summary, several studies investigating the genetic mutation in bacteria in-vitro are available within the Glycol Ester category for Ethylene distearate (CAS No. 627-83-8), Decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS No. 68583-51-7), Fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol Fatty acids (CAS No. 84988-75-0) and C16-18, esters with ethylene glycol (CAS No. 91031-31-1), all providing negative results. Furthermore, no cytogenicity in mammalian cells in-vitro (CAS No. 853947-59-8), no mutagenicity in mammalian cells in-vitro (CAS No. 151661-88-0) and no genetic toxicity in-vivo (CAS No. 91031-31-1) was observed with members of the Glycol Ester category.
Therefore, no properties for genetic toxicity were observed within the Glycol Ester group for any member.
For a detailed reference list please refer to the CSR or IUCLID section 13.
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 group concept is applied to the members of the Glycol Ester Category, data will be generated from representative reference substance(s) within the category to avoid unnecessary animal testing. Additionally, once the group concept is applied, substances will be classified and labeled on this basis.
Therefore, based on the group concept, all available data on genetic toxicity 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.
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.
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