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EC number: 203-942-2 | CAS number: 112-17-4
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Guinea pigs were induced with 5 intradermal injections of the compound mixed with Freund's Complete Adjuvant (FCA) into the neck on days 0, 2, 4, 7 and 9. The test group and the control animals are challenged on days 21 and 35 and reactions are read after 24, 48 and 72 hours.
- GLP compliance:
- not specified
- Type of study:
- Freund's complete adjuvant test
- Justification for non-LLNA method:
- The method allows to determine sensitizing reactions in guinea pigs.
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Route:
- intradermal
- Vehicle:
- other: Freund's Complete Adjuvant
- Concentration / amount:
- 0.1 mL of a 5% emulsion
- Day(s)/duration:
- 20
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- not specified
- Concentration / amount:
- 0.025 mL
- Day(s)/duration:
- at day 21 and 35
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5
- Exposure period: 20 days
- Test groups: yes
- Control group: yes
- Frequency of applications: days 0, 2, 4, 7 and 9
- Concentrations: 5% emulsion in Freund's Complete Adjuvant
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 21 and 35
- Test groups: yes
- Control group: no
- Site: 2 cm2
- Concentrations and vehicle not clearly specified, but the "primary non-irritant solution" was used (which is stated to be 10% after single and after repeated application).
- Evaluation (hr after challenge): 24, 48 and 72 - Challenge controls:
- no
- Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- non-irritant dose
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- non-irritant dose
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance should not be classified as a skin sensitizer.
- Executive summary:
In the current study the capacity for allergic sensitization by the test item was determined by the intradermal test with Freund's Complete Adjuvant (FCAT). Ten guinea pigs were used and a control group was included in the study. Induction consisted of 5 intradermal injections of the compound mixed with Freund's Complete Adjuvant (FCA). Injections occured into the neck on days 0, 2, 4, 7 and 9.
The test group and the control animals were challenged epicutaneously on days 21 and 35 and reactions were read after 24, 48 and 72 hours.
No effects were observed. Under the conditions of the study, the test material exhibited no sensitizing potentialities.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Open Epicutaneous Test (OET)
- Principles of method if other than guideline:
- During the induction phase 100, 30, 10 or 3 of the test item in ethanol is applied to the animals and left uncovered. Applications are repeated daily for 21 consecutive days. Skin irritation is evaluated at 7, 14 and 21 days. Challenge is done on days 21 and 35 on the contralateral flank (with 10% (minimal irritation concentration) and 3%) and left uncovered. Reactions were read at 24, 48 and 72 hours after application.
- GLP compliance:
- not specified
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- The method allows to determine the minimal sensitizing concentration necessary for inducing allergic contact hypersensitivity and the minimal eliciting concentration necessary to cause a positive reaction.
Test material
- Reference substance name:
- Nonyl acetate
- EC Number:
- 205-585-8
- EC Name:
- Nonyl acetate
- Cas Number:
- 143-13-5
- Molecular formula:
- C11H22O2
- IUPAC Name:
- nonyl acetate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- 3, 10, 30 and 100%
- Day(s)/duration:
- 21
- Adequacy of induction:
- not specified
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- 10 and 3 %
- Day(s)/duration:
- at day 21
- No.:
- #2
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- 10 and 3%
- Day(s)/duration:
- at day 35
- No. of animals per dose:
- 6
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 21
- Exposure period: 20 days
- Test groups: 4
- Control group: 1
- Site: 8 cm2
- Frequency of applications: daily
- Concentrations: 3, 10, 30 and 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: day 21 and 35
- Exposure period: week 3 and 5
- Test groups: 4 + control group of induction exposure
- Control group: no
- Site: contralateral flank - 2 cm2
- Concentrations: minimal irritating concentration: 10 and 3%
- Evaluation (hr after challenge): 24, 48 and 72 - Challenge controls:
- no
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100, 30, 10 and 3%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100, 30, 10 and 3%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not skin sensitising.
- Executive summary:
In an open epicutaneous test (OET) on guinea pigs the capacity of the test material to induce allergenic sensitization was assessed in 4 test groups of 6 animals and a control group. During the induction phase 100, 30, 10, and 3% of the test item in ethanol was applied to the clipped flank and left uncovered. The applications were repeated daily for 21 consecutive days. Skin irritation was evaluated at 7, 14 and 21 days. A challenge application was performed on days 21 and 35 on the contralateral flank. The minimal irritation concentration (10%) and some lower concentrations were used and left uncovered. Reactions were read after 24, 48 and 72 hours after application. The test material is considered allergenic at a concentration when at least 1 out of 6 animals of the concentration group shows positive reactions with non-irritant concentrations used for challenge.
No positive reactions were observed at any concentration, not after induction and not after the first or the second challenge. Therefore, the test material is considered not skin sensitizing in guinea pigs.
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