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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Remarks:
- Acute toxicity of TegMeR 804 in rabbits
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 18, 1992, to December 15, 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 Ro denticide 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, male and female New Zealand White rabbits weighing between 2064 grams to 2467 grams at the start of the study were used. The test material was administered as received at a limit dose of 20 g/kg bw.
- 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:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Young adult male and female New Zealand White rabbits were used. Animals weighed between 2064 and 2467 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 singly in wire mesh suspension cages and were supplied PURINA LABORATORY RABBIT 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
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Shortly prior to dosing, the hair of each rabbit was closely clipped from the ventral surface of the trunk using an electric clipper so as to expose approximately 10% of the body surface area.
Animals were weighed shortly before test material exposure in order to calculate doses. The test material was applied to sleeves of rubber dental dam. Each sleeve was wrapped around the trunk of the respective animal and secured with staples. An outer layer of gauze was then wrapped around the trunk of each aniaml and secured with tape. Each rabbit was then fitted with a colar to prohibit removal of the wrapping.
At the end of a 24-hour exposure period, the wrapping was removed and any unabsorbed test material remaining on the skin was removed by gently sponging using a moistened towel. The presence or absence of any residual test material was documented. - Duration of exposure:
- 24 hours
- Doses:
- All animals received a single dermal application of 20 gm/kg bwt.
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- All animals were observed for signs of toxicity and behavioral changes once, or more frequently if clinical signs were present, on the day of treatment. All surviving rabbits were then maintained for 14 days following completion of the exposure period. An examination for gross signs of toxicity were carried out once daily with additioinal checks for viability during the day. Skin reactions and other evidence of injury including erythema, edema, atonia, desquamaation, necrosis, coriaceousness and fissuring were noted if present.
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:
- other: A limit dose was administered
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- There was no mortality in the study.
- Clinical signs:
- other: Mild to marked erythema and edema were observed in all animals and generally decreasing in severity at the end of the 14-day observation period. Mild to marked desqamation was observed in all animals generally in the last 4 or 5 days of the 14-day observa
- Gross pathology:
- There was no gross pathology noted.
Any other information on results incl. tables
Table 1: Body Weight Data in Male and Female Rabbits Treated Dermally with Undiluted Test Material at a Dose Level of 20 g/kg
Animal Number | Sex | Day 0 | Day 7 | Day 14 | Body Weight Change (grams) Day 0 -14 |
1 | M | 2084 | 2206 (1) | 2331 | 267 |
2 | M | 2335 | 2363 (1) | 2471 | 136 |
3 | M | 2301 | 2260 (1) | 2343 | 42 |
4 | M | 2326 | 1621 | 2454 | 128 |
5 | M | 2258 | 1548 | 2364 | 106 |
Mean | 2257 | 2000 | 2393 | 136 | |
Standard Deviation | 112 | 384 | 65 | 82 | |
6 | F | 2346 | 2437 (1) | 2457 | 111 |
7 | F | 2336 | 2555 (1) | 2524 | 188 |
8 | F | 2408 | 2609 (1) | 2806 | 398 |
9 | F | 2233 | 2236 (1) | 2259 | 26 |
10 | F | 2238 | 2230 (1) | 2361 | 113 |
Mean | 2312 | 2413 | 2479 | 167 | |
Standard Deviation | 75 | 176 | 209 | 141 | |
(1) Day 7 body weights taken with collars on.
Applicant's summary and conclusion
- Interpretation of results:
- other: Category IV - Greater than 20,000 mg/kg Hazard potential as specified in 40 CFR 156.10
- Conclusions:
- The test material is relatively non-toxic to rabbits.
- Executive summary:
The acute dermal 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.
There were no necrospsy findings.
The acute dermal LD 50 value was found to be greater than 20 g/kg in male and female New Zealand White rabbits.
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