Registration Dossier
Registration Dossier
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: 204-658-1 | CAS number: 123-86-4
- 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

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- year of publication: 1986
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- sufficiently documented literature data with some shortcomings (results were not presented for each animal) (reliable with restrictions), but as MEST is suitable as a screening test only and cannot be used to cover the endpoint as a stand-alone test, RL3 is assigned to this study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
- Principles of method if other than guideline:
- Mouse Ear Swelling Test (MEST) (mentioned as method in OECD TG 406 (adopted 17.07.1992) on skin sensitisation, but according to this testing guideline negative results obtained in MEST, have to be verified with guinea pig assays)
- GLP compliance:
- not specified
- Type of study:
- mouse ear swelling test
- Justification for non-LLNA method:
- The study was performed before 11th october 2016 when LLNA test was not requested as default. When used in a weight of evidence approach the data are considered to fulfill data requirements for skin sensitisation. Further details are given in the endpoint summary.
Test material
- Reference substance name:
- N-butyl acetate
- EC Number:
- 204-658-1
- EC Name:
- N-butyl acetate
- Cas Number:
- 123-86-4
- Molecular formula:
- C6H12O2
- IUPAC Name:
- butyl acetate
- Details on test material:
- - Name of test material (as cited in study report): butyl acetate
- purity: at least 98%
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CF-1
- Sex:
- female
- Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Age at study initiation: 6-8 weeks
- Housing: five per cage in wire-bottom stainless-steel cages
- Diet: Purina Rodent Laboratory Chow 5001 ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: 70% ethanol
- Concentration / amount:
- 100% induction
50% challenge
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: 70% ethanol
- Concentration / amount:
- 100% induction
50% challenge
- No. of animals per dose:
- 10 or 15 animals per test group, 5 or 10 animals in the control group (not clearly specified)
- Details on study design:
- RANGE FINDING TESTS:
- four groups with 2 mice each
- four induction applications over a 4-day period and mock "challanged" once on the ears (each group at a different concentration)
- concentrations used in the main study were the highest which were minimally or nonirritating to the stomach region (for induction) and nonirritating to the ear (for challenge)
MAIN STUDY:
- animals were shaved and tape stripped at the start of the study (stomach region)
- two intradermal injections of FCA (Freund's Complete Adjuvans) were performed into the stomach induction site prior to the first induction application
- induction was performed with 100 µl of test item
- tape stripping and topical application were repeated for three additional consecutive days
CHALLENGE
- challenge was performed 7 days after the last application for induction: 20 µl of a 50% dilution of the test item in 70% ethanol were applied to the left ear and 20 µl of the vehicle (when necessary) to the right ear
- 24 and 48 hours after this challenge thicknesses of both ears were measured under light ether anesthesia
- ears were measured using a spring-loaded "Oditest" D1000 gauge
EVALUATION
- positive response (based on an animal-by-animal basis): test ear showed at least a 20% greater thickness than the control ear
- percentage responsiveness was calculated
- Positive control substance(s):
- yes
- Remarks:
- e.g. N,N-dimethyl-p-nitrosoaniline and 1-chloro-2,4-dinitrobenzene (DNCB), for further information see below
Results and discussion
- Positive control results:
- N,N-dimethyl-p-nitrosoaniline: 100% of tested animals were sensitised (0.3% induction concentration; 0.3% challenge concentration in 70% ethanol)
DNCB: 80% of tested animals were sensitised (0.5% induction concentration; 1% challenge concentration in 70% ethanol)
In vivo (non-LLNA)
Results
- Reading:
- other: 1st and 2nd reading
- Group:
- test chemical
- Dose level:
- 20 µl of 50% solution
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: other: 1st and 2nd reading. Group: test group. Dose level: 20 µl of 50% solution. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no data.
Any other information on results incl. tables
0% of the test animals (10 or 15, not clearly stated) were sensitized by butyl acetate
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- n-Butyl acetate was not sensitising in the mouse ear swelling test.
- Executive summary:
A mouse ear swelling test (MEST) was performed with n-butyl acetate in female CF-1 mice (at least 10 animals in the test group and 5 animals in the control group). Induction was performed with the pure test substance and challenge with a 50% dilution in 70% ethanol. The test item was not sensitising in this test (Gad et al., 1986).
The study was judged to be not reliable (RL3), as the MEST is a screening study only and cannot be used as a stand-alone study to cover this endpoint. Negative results obtained with the MEST should be confirmed by a guinea pig test. So, a MEST alone does not fulfil the information requirement. The study is used in a "weight of evidence" approach.
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.
