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EC number: 700-087-1 | CAS number: 201872-72-2
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-06-05 - 2004-07-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- (adopted December 17; 2001)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- (Dir. 96/54 EEC)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- EPA 712-C-02-189; December 2002
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 1,6-dimethyl (2R)-2,4,4-trimethylhexanedioate; 1,6-dimethyl (2S)-2,4,4-trimethylhexanedioate; 1,6-dimethyl (4R)-2,2,4-trimethylhexanedioate; 1,6-dimethyl (4S)-2,2,4-trimethylhexanedioate
- EC Number:
- 700-087-1
- Cas Number:
- 201872-72-2
- Molecular formula:
- C11H20O4
- IUPAC Name:
- 1,6-dimethyl (2R)-2,4,4-trimethylhexanedioate; 1,6-dimethyl (2S)-2,4,4-trimethylhexanedioate; 1,6-dimethyl (4R)-2,2,4-trimethylhexanedioate; 1,6-dimethyl (4S)-2,2,4-trimethylhexanedioate
- Details on test material:
- Test substance: 2,2,4-(2,4,4)-trimethylhexanedioic acid dimethyl ester of Degussa AG.
Batch No.: Campaign 5 of 25 May 2004.
Approximately 40 % 2,2,4-isomer and 60 % 2,4,4-isomer
Stability: stable
Storage: at room temperature
Colour: light yellowish, clear
Physical state at room temperature: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Test Animals:
- Strain: HsdBrlHan : WIST (SPF)
- Source: Harlan-Winkelmann GmbH, D-33178 Borchen (Germany)
- Weight at study initiation: 3 females 153-164 g (step 1); 3 females 152-153 g (step 2)
- Controls: no
Animal Husbandry:
- the animals were barrier maintained in an air conditioned room (22 +/- 3 °C; 55 +/- 10% rel. humidity; photoperiod: 12h ligh / 12h dark; air change 10 x / hour)
- Feeding ad libitum, Altromin 1324 maintenance diet for rats and mice, totally-pathogen-free (TPF)
- Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
- animals were kept in Macrolon cages on Altromin saw fiber bedding
- Adequate acclimatisation period
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Cottonseed oil
- Details on oral exposure:
- The animals were clinically observed prior to the administration. Prior to administration of the test item animals were fasted by withholding food overnight. Following the period of fasting the animals were weighted and the test item was administered. Then the food was withheld for a further 3-4 hours.
The test item was administered in a single dose by gavage using an intubation cannula according to body weight at a volume of 10 mL/kg bw. - Doses:
- Starting dose (step 1 and 2): 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- Clinical examination:
Animals were observed for 14 days after dosing and were weighed prior to the administration and once a week thereafter. A clinical examination was made several times on the day of dosing. Part of this were at least three observations within the first four hours post-dose. Animals were observed once a day thereafter. Observations included changes in the skin and fur, eyes and mucous membranes.
Further observations: respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern . Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma
Pathology:
At the end of the observation period the animals were euthanised by an overdosage of pentobarbital and were subject to gross necropsy. All gross pathological changes were recorded.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- The dosage of 2000 mg/kg bw caused no compound-related mortality in any animals of step1 and 2 within the 14 days post-dose period.
- Clinical signs:
- other: No clinical signs of toxicity were observed during the study
- Gross pathology:
- No findings
- Other findings:
- No other treatment related effects were observed within this study
Any other information on results incl. tables
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2 / female |
158 |
188 |
213 |
3 / female |
153 |
178 |
205 |
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2 / female |
152 |
159 |
194 |
3 / female |
153 |
177 |
190 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU GHS (EC Regulation 1272/2008) and EC Directive 67/548/EEC
- Conclusions:
- No treatment related mortality or any other sublethal symptoms were observed within the 14 day post-dosing period at step 1 and 2. According to the acute toxic class method regime, no further testing was required. Under the conditions of this acute oral toxicity test the test item showed no acute oral toxic characteristics.
- Executive summary:
The acute oral toxicity to rats was evaluated by acute toxic class method. The test item was administerd to six female rats in a single dose by gavage at a dose fo 2000 mg/kg body weight. The animals were observed for mortality and any sub-lethal effects for 14 days after dosing.
No treatment related mortality or any other sublethal symptoms were observed within the 14 day post-dosing period at step 1 and 2. According to the acute toxic class method regime, no further testing was required. Under the conditions of this acute oral toxicity test the test item showed no acute oral toxic characteristics.
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