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Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 203-079-1 | CAS number: 103-09-3
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- The sensitization potential of some perfume ingredients tested using modified draize procedure
- Author:
- Sharp, DW
- Year:
- 1 978
- Bibliographic source:
- Toxicology, 9, 261-271
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- non-standard grading of skin effects, non-GLP
- Principles of method if other than guideline:
- The skin sensitisation potential of 3,5,5-trimethyl hexyl acetate was tested in guinea pigs in a modified Draize sensitisation test.
- GLP compliance:
- no
- Type of study:
- Draize test
- Justification for non-LLNA method:
- Study was performed before LLNA guideline implementation took place.
Test material
- Reference substance name:
- 3,5,5-trimethylhexyl acetate
- EC Number:
- 261-245-9
- EC Name:
- 3,5,5-trimethylhexyl acetate
- Cas Number:
- 58430-94-7
- Molecular formula:
- C11H22O2
- IUPAC Name:
- 3,5,5-trimethylhexyl acetate
- Details on test material:
- 3,5,5-Trimethylhexyl acetate, purity unknown
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Sensitization tests were carried out on inbred Hartley strain albino guinea pigs bred in our own colony. During testing they were housed in wire mesh
cages in pairs of the same sex and were fed pelleted guinea pig diet, cabbage, hay and water ad libitum. Ten animals weighing about 350 g at the start of testing were used in each test which comprised either 4 males and 6 females or visa versa. For demonstration of sensitivity by challenge with the test substance the hair was shaved from both flanks with Oster animal clippers, size 40 blades, and the test substance injected intradermally into one flank and applied topically without occlusion to the other flank.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- no data
- Concentration / amount:
- Intradermal induction concentration: 0.5%
Intradermal challenge concentration: 0.2%
Epicutaneous challenge concentration: 20%
Challengeopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- no data
- Concentration / amount:
- Intradermal induction concentration: 0.5%
Intradermal challenge concentration: 0.2%
Epicutaneous challenge concentration: 20%
- No. of animals per dose:
- 10 animals
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: one intradermal injection at 4 sites
- Exposure period: 14 days
- Test groups: single test group of 10 animals
- Control group: none
- Site: 4 sites overlying the 2 auxillary and 2 inguinal lymph nodes
- Frequency of applications: one
- Duration: 14 days
- Concentrations: 0.5% in 0.1 mL aliquots
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 14 days after induction
- Exposure period: One challenge as intradermal injection; for topical application not known, but test substance was probably not removed
- Test groups: single test group of 10 animals
- Control group: second challenge included control group
- Site: intradermal challenge in one flank and topical challenge in the other
- Concentrations: 0.2% in 0.1 mL aliquots intradermally; 20% in 0.1 mL aliquots topically
- Evaluation: first evaluation 24 hours after challenge; 7 days later second challenge with controls - Positive control substance(s):
- not required
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2% intradermally
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none were reported
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.2% intradermally. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none were reported.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20% topically
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none were reported
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20% topically . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none were reported.
- Reading:
- rechallenge
- Hours after challenge:
- 168
- Group:
- test chemical
- Dose level:
- 0.2% intradermally
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none were reported
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 168.0. Group: test group. Dose level: 0.2% intradermally . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none were reported.
- Reading:
- rechallenge
- Hours after challenge:
- 168
- Group:
- test chemical
- Dose level:
- 20 % topically
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none were reported
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 168.0. Group: test group. Dose level: 20 % topically. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none were reported.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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.
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