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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 261-245-9 | CAS number: 58430-94-7
- 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
Endpoint summary
Administrative data
Description of key information
There was no indication for skin sensitizing properties of the substance in a vaild guinea pig maximation test according to OECD 406.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 1982-03-17 to 1982-04-21
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted in 1982, when the GPMT was an internationally accepted and recommended method in order to investigate skin sensitization potential.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Environmental Safety Division, Unilever Research Laboratory, Colworth House, Sharnbrook, Bedfordshire, England
- Weight at study initiation: ca. 320 g
- Diet: ad libitum
- Water: ad libitum - Route:
- intradermal
- Vehicle:
- other: dobs/saline
- Concentration / amount:
- 2 %
- Day(s)/duration:
- day 0
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: acetone/PEG
- Concentration / amount:
- 25 %
- Day(s)/duration:
- day 8
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: acetone/PEG
- Concentration / amount:
- 5 %
- Day(s)/duration:
- day 21 - 22 / 24 h
- No.:
- #2
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: acetone/PEG
- Concentration / amount:
- 5 %
- Day(s)/duration:
- day 28 - 29 / 24 h
- No. of animals per dose:
- 4 males and 6 females (one female was died before the end of the observation period, therefore conclusion is based on 9 animals)
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 pairs of intradermal injections:
two 0.1 mL injections of 50 % Freund's complete adjuvant (FCA),
two 0.1 mL injections of test substance at 2 % (in 0.01 % dobs/saline)
two 0.1 mL injections of test substance in solvent mixed 50/50 with FCA such that the final concentration of test substance injected is 2 % (in 0.01 % dobs/saline)
One week after the injections the same area was exposed as topical application:
A 2x4 cm filter paper patch attached by double-sided adhesive tape to a 4x6 cm piece of thin polyethene, is saturated with the test substance at 25 %(in acetone/PEG) concentration and placed over the shaved site.
- Test groups: one
- Control group:
treated control group: mock induction treatment
untreated control group: no induction
- Site: dorsal shoulder
- Frequency of applications: one week between intradermal injection and topical application
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 13-14 days after application of the induction patch and one week after the first challenge
- Exposure period: 24 hours
- Test groups: one
- Control group:
treated controls: at first challenge they are treated in exactly the same way as the test animals
untreated controls: at every challenge in the test 4 previously untreated animals of the same sex at challenge are treated in exactly the same way as the test animals
- Site: flank
- Concentrations: 5 % (in acetone/PEG)
- Evaluation (hr after challenge): 24 and 48 - Challenge controls:
- yes
- Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- no reaction
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- no reaction
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- no reaction
- Remarks on result:
- other: treated control
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- no reaction
- Remarks on result:
- other: treated control
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- no reaction
- Remarks on result:
- other: untreated control
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- no reaction
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- no reaction
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- no reaction
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- no reaction
- Remarks on result:
- other: treated control
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- no reaction
- Remarks on result:
- other: treated control
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- no reaction
- Remarks on result:
- other: untreated control
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- no reaction
- Remarks on result:
- other: untreated control
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 3,5,5-trimethylhexyl acetate is not a skin sensitizer when tested in accordance to the method of Magnusson and Kligman in a guinea pig maximisation test.
- Executive summary:
The skin sensitisation potential of the substance 3,5,5-trimethylhexyl acetate (Inonyl acetate) was studied under non-GLP conditions in guinea pigs with a Magnusson-Kligman maximisation test following principles widely similar to those of OECD TG 406. A preliminary irritation test showed that suitably irritant concentration for intradermal induction was 2% of the test item and suitably irritant concentration for induction application was 25% of the test item. The highest non irritant concentration for challenge application was 5% of the test item. Ten albino Dunkin/Hartley strain guinea pigs (4 males and 6 females) were induced for sensitisation via intradermal injection (2%) and one week later by topical application (25%) of the test item. One female guinea pig was killed prior to challenge 1 as it suffered a broken leg. 13 to 14 days after application of the induction patch the animals were challenged (using a dilution containing 5% of test substance) on the clipped and shaved flank by occluded patch. The patch was held in place for 24 hours. The treatment sites were examined for evidence of sensitisation 24 and 48 hours after removal of the patches. One week after the first challenge a second challenge was made on the opposite flank exactly as for the first challenge. Treated and untreated controls were used. Treated controls obtained a mock induction treatment and were challenged exactly the same way as the test animals (5%). Untreated controls were not induced, but challenged in exactly the same way as the test animals. No reaction of sensitisation was observed during both challenges in the examined animals. According to the maximisation test, 3,5,5-trimethylhexyl acetate is not a sensitizer.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The substance was not sensitising to the skin in a valid guinea pig maximisation test following the principles of OECD TG 406. No skin sensitisation potential of the substance was found in two additional in vivo studies with guinea pigs. Hence there is convincing evidence that the substance 3,5,5-trimethylhexyl acetate should be considered as non-sensitising to the skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Based on
available data on skin sensitizing properites the
test item is not classified as skin sensitizer according
to Regulation (EC) No 1272/2008 (CLP), as amended for the eighth time in
Regulation (EU) No 2016/918.
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.