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EC number: 242-149-6 | CAS number: 18268-70-7
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Remarks:
- Acute toxicity of TegMeR 804 in rats - limit test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 18, 1992, to December 3, 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- A study conducted under Good Laboratory Practice Standards (40 CFR) and conforming with internationally recognized protocols and in particular satisfying criteria of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), the Toxic Substances Control Act (40 CFR), and OECD Guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: The protocol satisfies the criteria established by the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), the Toxic Substances Control Act (40 CFR), and the OECD Guidelines.
- Deviations:
- no
- Principles of method if other than guideline:
- Young adult, Sprague Dawley derived rats (male and femald) weighing between 232 and 342 grams at the start of the study were used. The undiluted test material was administered to five male and five female rats at a dose level of 5.0 g/kg.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- All aspects of this study, as defined in the Protocol and the Project Instruction Sheet, were conducted in accordance with Good Laboratory Practice Standards (40 CFR).
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 3,6,9-trioxaundecamethylene bis(2-ethylhexanoate)
- EC Number:
- 242-149-6
- EC Name:
- 3,6,9-trioxaundecamethylene bis(2-ethylhexanoate)
- Cas Number:
- 18268-70-7
- Molecular formula:
- C24H46O7
- IUPAC Name:
- 3,6,9-trioxaundecamethylene bis(2-ethylhexanoate)
Constituent 1
- Specific details on test material used for the study:
- The test material was a clear, golden-yellow liquid and was stored at room temperature throughout the study in two clear, glass jars.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Young, adult male and female Sprague-Dawley derived albino rats were used. Animals weighed between 232 and 342 grams at the start of the study. The animals were purchased from a U.S.D.A. approved supplier.
All animals were acclimated to the laboratory for at least four days before use. Animals were housed in groups of five (5) in wire mesh suspension cages and were supplied PURINA LABORATORY RODENT CHOW (or other comparable diet) and tap water ad libitum except for the withholding of food overnight prior to dosing. The animals were maintained in 12-hour light/12-hour dark cycles.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Each animal received the test material by gavage at a dose level of 5.0 g/kg bwt. The material was administered undiluted. Individual doses were calculated using post-fast body weights.
- Doses:
- All animals received a single dose of 5.0 gm/kg bwt
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- All animals were observed for gross signs of systemic toxicity and mortality several times during the day of dosing, and at least twice daily thereafter for a total of 14 days.
Body weights were measured for each animal on the day of dosing, on day 7 of the observation period, and at the time of necropsy either at the end of 14 days or following the death of any animal.
At the end of the 14-day observation period, each surviving rat was sacrificed and a gross necropsy performed. - Statistics:
- Individual and mean body weights with standard deviations were determined.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There was no mortality in the study.
- Clinical signs:
- Normal behavior was observed in all animals. Fecal staining was seen in 1 or 2 animals during the first 3 to 5 days of the observation period. Oily hair coat was observed in some or all of the animals during this same time period.
- Body weight:
- Body weights were not affected by the dosing.
- Gross pathology:
- There was no gross pathology noted.
Any other information on results incl. tables
Table 1: Body Weight Data in Male and Female Rats Treated Orally with Undiluted Test Material
Animal Number | Sex | Day 0 | Day 7 | Day 14 | Body Weight Change (grams) Day 0 -14 |
1 | M | 340 | 410 | 441 | 101 |
2 | M | 294 | 330 | 361 | 67 |
3 | M | 320 | 362 | 380 | 60 |
4 | M | 342 | 395 | 419 | 77 |
5 | M | 305 | 361 | 383 | 78 |
Mean | 320 | 372 | 397 | 77 | |
Standard Deviation | 21 | 31 | 32 | 18 | |
6 | F | 256 | 294 | 304 | 48 |
7 | F | 232 | 258 | 269 | 37 |
8 | F | 237 | 269 | 277 | 40 |
9 | F | 263 | 291 | 305 | 42 |
10 | F | 271 | 311 | 314 | 42 |
Mean | 252 | 285 | 294 | 42 | |
Standard Deviation | 17 | 21 | 20 | 4 | |
Applicant's summary and conclusion
- Interpretation of results:
- other: Category IV - Greater than 5,000 mg/kg
- Remarks:
- Hazard potential as specified in 40 CFR 156.10
- Conclusions:
- The test material is relatively non-toxic to rats.
- Executive summary:
The acute oral toxicity of the test material was evaluated in compliance with the conditions specified in the regulation for the enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), the Toxic Substances Control Act (40 CFR), and the OECD Guidelines
No deaths were noted during the observation period.
Minimal clinical changes were noted involving fecal staining and oily hair coat. These generally resolved by 3 to 5 days of observation.
There were no necropsy findings
The acute oral LD 50 value was found to be greater than 5.0 g/kg in male and female Sprague Dawley rats.
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