Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 226-603-0 | CAS number: 5435-64-3
- 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:
- July 1996 until May 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 3,5,5-trimethylhexanal
- EC Number:
- 226-603-0
- EC Name:
- 3,5,5-trimethylhexanal
- Cas Number:
- 5435-64-3
- Molecular formula:
- C9H18O
- IUPAC Name:
- 3,5,5-trimethylhexanal
- Details on test material:
- Date of production: February/March 1996
Properties: clear, colourless, visually homogeneous liquid
Stability: > 1 year
Expiry date: March 1997
Purity: 91,2 mass-% (gaschromatographic analysis)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- healthy, young adult animals/weight variation did not exceed +/- 20 % of the mean body weight
rat, Wistar (HsdCpb:WU/SPF)
Housing:
Animals were housed in Markolon type III cages, group caged by sex, each cage containing max. five rats
Acclimatization:
Animals were acclimatized for at least five days.
Room temperature: 22 +/- 3 ° C
Relative humidity: 30 - 70 %
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- A single oral application of the test substance was given.
The undiluted litquid test substance was administered by gavage using a stomach tube with an application volume at 2.44 cm³/kg bodyweight. - Doses:
- 2000 mg/kg bodyweight (2.44 cm³/kg bodyweight)
- No. of animals per sex per dose:
- ten rats ( five males and five females)
- Control animals:
- no
- Details on study design:
- Approximately 16 hours before treatment the animals were starved.
In the first instance two male and two female rats were given a single oral application of the test substance at a dose level of 2000 mg/kg/bodyweight.Since no mortalities occured within 24 hours p.a., three male and three female rats were treated in the same way.
The dosing formulation was applied to the rats by gavage using a stomach tube (2.44 cm³/kg/bodyweight).
The day of dosing was deginated day 0.
No control animyls were included in this study.
Results and discussion
- Preliminary study:
- No preliminary study, 2000 mg/kg was used as the fixed dose.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000
- Remarks on result:
- other: Fixed dose test
- Mortality:
- One female rat died following a singe oral application at 2000 mg/kg bodyweight.
- Clinical signs:
- other: All animals showed severe clinical symptoms within the first six hours after treatment with the test substance. Symptoms like sedation, padding movements, gait abnormality, piloerection, tremor, impaired coordination, loss of weight, squatting and abdomin
- Gross pathology:
- The macroscopic examination of the female animal found dead 72 hours after application of the test substance showed emaciation, autolytic
changes, lesions caused by cannibalism, hyperaemia of the gastric mucosa and the lung and lung emphysema.
The animals killed on day 14 showed thickening and induration of the mucosa of the forestormach.
No other abnormalities were observed in these
animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- no classification according to CLP Regulation (EC) No. 1272/2008
- Executive summary:
A study(limit test) was performed to assess the acute oral toxicity of 3,5,5 -Triomethylhexanal to the rat. A group of ten rats (five males and five females) was given a single oral application of the test substance at a dose level of 2000 mg/kg bodyweight (bw). The undiluted liquid test substance was administered by gavage using a stomach tube with an application volume at 2.44 cm³/kg bodyweight.
All animals showed severe clinical symptoms within the first six hours after treatment with the test substance. Symptoms like sedation, paddling movements, gait abnomality, piloerection, tremor, impaired coordination, loss of weight, squatting and abdominal position were protocolled. 24 and 48 hours after treatment most of the animals still showed the described serve clinical signs. 72 hours after treatment only one male still showed these severe clinical symptoms and one female was found dead. The other animals showed milder clinical signs. Piloerection and loss of weight were protocolled. Individual animals showed mild clinical signs until day 5. After day 5 until the end of the observation period there were no more signs of systemic reaction to treatment.
In the frist 4 days after application of the test substance, bodyweight loss was noticed in male and female animals. After day 5 until the end of the study, all animals achieved satisfactory bodyweight gains.
The macroscopic examination of the feals animal found dead 72 hours after application of the test substance showed emaciation, autolytic changes, lesions caused by cannibalism, hyperaemia of the gastric mucosa and the lung and lung emphysema.
The animals killed on day 14 showed thickening and induration of the mucosa of the forestomach. No other abnormalities were observed in these animals.
The dosis letalis media (LD50oral) to male and female rats of TRIMETHYLHEXANAL was found to be: > 2000 mg/kg
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.