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EC number: 271-517-9 | CAS number: 68583-52-8
- 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
In an acute oral toxicity study in male and female Wistar rats with the test substance, no deaths or adverse clinical signs were noted. There were no adverse necropsy findings. The acute oral LD 50 value was found to be greater than 5000 mg/kg bw.
In an acute dermal toxicity study in male and female New Zealand White rabbits with a surrogate material, no deaths were noted during the observation period. There were no necrospsy findings. The acute dermal LD 50 value was found to be greater than 20 g/kg.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 19, 1995 to October 13, 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1175 (Acute Oral Toxicity)
- Version / remarks:
- July 1, 1991
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- The test substance was received from the C.P. Hall Company on July 5, 1995. The BIN number was 024910
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Wistar-strain, albino rats were used for this test. Animals were obtained from Ace Animals, Inc., in Boyertown, PA., in equal numbers of each sex, between 200 and 300 grams bodyweight, and approximately six to nine (6 to 9) weeks of age.
Upon receipt, animals were carefully checked for respiratory difficulty, ocular or nasal lacrimation, dehydration, diarrhea, and general condition.
Animals were acclimated for eight (8) days prior to test initiation. They were housed in stainless steel cages with indirect bedding, in a room with a 12 hour light/dark cycle. The room temperature was controlled, to provide for the health and comfort of the animals with an approximate range of 65° to 75° F. The humidity was also monitored. Diet consisted of Lab Diet Certified Rodent Diet #5002, as well as water, ad libitum. - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Rats received a single bolus dose by oral gavage at a calculated dose of 5,000 mg/kg bw.
- Doses:
- A single 5,000 mg/kg bw dose was administered.
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Prior to test initiation, the test article's mass to volume relationship (specific gravity) was determined to facilitate volumetric dosing.
Twenty-four (24) hours prior to test initiation, the rats were reexamined for general condition as described above. A group of five (5) male and five (5) female rats, of sufficient weight to assure a fasted bodyweight between 200 and 300 grams, was labelled and set aside.
The following day, after approximately 18 hours of fasting, each rat was weighed and marked with an ear clip. The weight variation of animals used did not exceed +20% of the mean weight for each sex. Individual doses, calculated on the basis of bodyweight, were administered using a stainless steel intragastric feeding needle, of sufficient bore to allow even passage of the test article. Rats were then returned to their cages, where food and water were available ad libitum. Each cage was labelled uniquely with respect to job number, test article, dose level, sex, animal number(s), and date of dosing.
Animals were observed for signs of pharmacologic activity and drug toxicity at 1, 3, 6, and 24 hours post-dosage. Observations were made at least once daily thereafter for a total of 14 days. Interim bodyweights were recorded on day seven (7).
Animals sacrificed at the end of the 14 day observation period were subjected to complete gross necropsy, with all findings noted. Sacrificing was accomplished via carbon dioxide asphyxiation. - Statistics:
- Not stated
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None recorded
- Clinical signs:
- other: No adverse clinical signs were reported. All rats reported as normal at all observation points.
- Gross pathology:
- No gross changes observed.
- Conclusions:
- The acute oral LD50 in male and female rats is > 5,000 mg/kg bw.
Reference
Acute Oral Toxicity in Rats - Bodyweights
Dose Level: 5,000 mg/kg bw
Animal Number and Sex |
Bodyweight (grams) |
Day 7 |
Termanal |
Change (+/-) |
1 M |
230 |
309 |
344 |
+114 |
2 M |
218 |
305 |
338 |
+120 |
3 M |
237 |
307 |
340 |
+103 |
4 M |
228 |
300 |
332 |
+104 |
5 M |
233 |
342 |
384 |
+151 |
6 F |
220 |
262 |
282 |
+62 |
7 F |
218 |
251 |
264 |
+46 |
8 F |
224 |
262 |
284 |
+60 |
9 F |
246 |
264 |
270 |
+24 |
10 F |
236 |
243 |
260 |
+24 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The key result is based on a guideline study conducted in rats. Supporting data from stucturally similar ester materials further supports the low acute oral toxicity of the test substance.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Read across to members of the US HPV Glycol Esters category. See attached file.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- other: A limit dose was administered
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 20 000 mg/kg bw
- Quality of whole database:
- The key result is based on a guideline study conducted in rabbits.
Additional information
The test substance is a member of a category of aliphatic esters submitted by The American Chemistry Council's (ACC) Aliphatic Esters Panel (Panel) under the High Production Volume (HPV) Chemical Challenge Program (ACC, 2003). Information from a Screening Information Data Set (SIDS) developed in that program serves as supplementary or weight-of-evidence information in the current dossier. The glycol esters chosen to supply additional information are very closely related in molecular structure They exhibit similar behavior with respect to physicochemical , environmental fate. Category ester compounds with similar structures and functionalities were of low acute oral toxicity in rats. In the first of three studies conducted in rats, heptanoic acid, oxybis(2,1 -ethanediyloxy-2,1 -ethanediyl)ester (CAS 70729 -68 -9) displayed little or no toxicity in male or female Wistar rats up to a limit gavage dose of 2000 mg/kg bw. No mortality was reported in this study. Limited clinical signs included slight piloerection and sporadic findings. Similarly, CAS 70729 -68 -9 displayed little or no acute toxicity when administered by gavage to male rats at a limit dose of 25 g/kg bw. There was only one mortality. Clinical signs included hyperemia, lethargy and prostration. In a third study with CAS 70729 -68 -9, the acute oral LD50 of the test substance in females rats after gavage administration was > 24 g/kg bw and < 25 g/kg bw. All deaths occurred within 2 days of dosing. At this elevated dose level, clinical observations included flat body posture, moribundness, labored breathing, stained/wet perineal area, lacrimation, stained face, weakness, ataxia, lethargy, prostration, salivation and chromodacryorrhea. Information from a secondary source reports LD50 values in rats of 12.5 g/kg bw and 31.4 g/kg bw for the test material 2,2'-ethylenedioxydiethyl bis(2 -ethylhexanoate) (CAS 94 -28 -0). Heptanoic acid, ester with 2,2,4 -trimethyl-1,3 -pentanediol (CAS 71839 -38 -8) displayed an acute oral LD50 of > 2000 mg/kg in male and female rats. 2 -Ethylhexanoic acid, diester with tetraethyleneglycol (CAS 18268 -70 -7), when tested in male and female Sprague-Dawley rats, caused no deaths and only minimal clinical changes that resolved by 3 to 5 days of observation. The acute oral LD50 was found to be >5000 mg/kg bw.
Justification for classification or non-classification
Based on the results of acute oral and dermal toxicity testing in rats with the test substance or a surrogate, the test substance would not be classified for acute toxicity according to the European Regulation (EC) No. 1272/2008 on classification and labelling of chemicals.
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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