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EC number: 258-556-7 | CAS number: 53445-37-7
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-12-02 to 1985-12-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- (1981)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2,2,4(or 2,4,4)-trimethyladipic acid
- EC Number:
- 258-556-7
- EC Name:
- 2,2,4(or 2,4,4)-trimethyladipic acid
- Cas Number:
- 53445-37-7
- Molecular formula:
- C9H16O4
- IUPAC Name:
- 2,2,4-trimethylhexanedioic acid; 2,4,4-trimethylhexanedioic acid
- Details on test material:
- 2,2,4(or 2,4,4)-Trimethylhexanedioic acid of Hüls AG, purity 87 %, impurities methylpentanedoic acid and methylbutanedioic acid not quantified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Strain: Bor: WISW (SPF TNO)
- Source: F. Winkelmann, Borchen (Germany)
- Weight at study initiation: 5 males mean 117 g, 5 females mean 108 g
- Controls: no
- Fasting period before study: 16 hours
- Diet: ad libitum, R10 special diet for rats, SSniff R
- Water: ad libitum, tap water
- Acclimation period: 4 - 8 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 1 °C
- Humidity: 60 +/- 5 %
- Photoperiod: 12 hours artificial light, 12 hours dark
- Air changes: 15 per hour
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- ADMINISTRATION:
- Preparation of test substance: heating to 60 °C in water bath
- Doses per time period: single dose (gavage) at 30-40 °C
- Volume administered or concentration: 3.70-5.87 ml/kg bw of undiluted test substance
- Post dose observation period: 14 days - Doses:
- 3980; 5010; 6310 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- EXAMINATIONS:
- Body weights: before, and 1, 7, 14 days post dosing
- Clinical signs and mortality: within 6 hours after dosing, thereafter daily
- Necropsy: all animals (macroscopic) - Statistics:
- LD50 is generally determined according to Litchfield and Wilcoxon, reported with 95 % confidence limits.
Means of body weights were calcultated
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 4 900 mg/kg bw
- 95% CL:
- >= 4 414 - <= 5 439
- Mortality:
- MORTALITY:
- Number of deaths at each dose:
3980 mg/kg bw: no deaths
5010 mg/kg bw: 2 males, 4 females dead within 26 hours
6310 mg/kg bw: 5 males, 5 females dead within 24 hours - Clinical signs:
- CLINICAL SIGNS:
- 30-60 minutes after application: Rough skin, hunched posture, low temperature, slowness, slight sedation and ataxia, and prone position.
- Later: Tremor, moderate to severe sedation and ataxia, staggering, convulsions, bloody noses and dark eyes. Surviving animals showed no
symptoms 24 (low dose) - 48 hours (mid dose) after application. - Body weight:
- Body weight gain was not affected.
- Gross pathology:
- NECROPSY FINDINGS:
- Animals that died during the study: Strong hyperemia of the mucosa of the stomach and necrosis of the intestine mucosa; some necrosis on
kidney, spleen and lungs.
- Surviving animals: Hyperemia of the gastric mucosa in some animals - Other findings:
- no other findings
Any other information on results incl. tables
Applicant's summary and conclusion
- Interpretation of results:
- relatively harmless
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU Directive 67/548/EEC
- Conclusions:
- According to this study the LD50 value (oral) was determined to be 4900 mg/kg bw in rats for the test item 2,2,4(or 2,4,4)-trimethylhexanedioic acid.
- Executive summary:
In a study according to OECD TG 401 (1981) the test item 2,2,4(or 2,4,4)-trimethylhexanedioic acid was applied once to 3 dose groups of rats (5 male and 5 female Wistar rats per dose group) in doses of 3980, 5010 and 6310 mg/kg bw undiluted at a temperature of 30 - 40 °C. The observation period was 14 days.
Some mid- and high-dose animals died within 26 hours after oral application of the test item.
Clinical signs 30 -60 minutes after application were rough fur, hunched posture, low temperature, slowness, slight sedation and ataxia, and prone position.
Later the rats showed tremor, moderate to severe sedation and ataxia, staggering, convulsions, bloody noses and dark eyes.
Animals that died during the study showed strong hyperemia of the mucosa of the stomach and necrosis of the intestine mucosa; some necrosis on kidney, spleen and lung.
Some surviving animals revealed hyperemia of the gastric mucosa.
The LD50 value (oral) was determined to be 4900 (4414 - 5539) mg/kg bw in rats for the test item 2,2,4(or 2,4,4)-trimethylhexanedioic acid.
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