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EC number: 205-585-8 | CAS number: 143-13-5
- 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:
- key study
- Study period:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study meets generally accepted scientific principles, acceptable for assessment with restrictions: non-GLP study; no data about the purity and no certificate of analysis of the test substance; no information on the strain, age, sex, body weight, source and housing conditions of the animals; individual animal data was not reported.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Freund's complete adjuvant test
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Type of study:
- Freund's complete adjuvant test
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
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): ACETATE DE NONYLE (n-nonyl acetate)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- None
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- no data
- Concentration / amount:
- Induction: 5 % emulsion in Freund’s Complete Adjuvant (FCA)
Challenge: Non-irritant solutions (10 % or lower)
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- no data
- Concentration / amount:
- Induction: 5 % emulsion in Freund’s Complete Adjuvant (FCA)
Challenge: Non-irritant solutions (10 % or lower)
- No. of animals per dose:
- 10
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE: INTRADERMAL
- No. of exposures: 5
- Test groups: 0.1 mL of a 5 % emulsion of the test item in FCA was intradermally injected into the neck of guinea pigs. The emulsion was prepared by mixing 0.05 mL of the test item with 0.05 mL of FCA.
- Control groups: Animals in the control group were treated with 0.05 mL of FCA only.
- Site: Neck
- Frequency of applications: On Days 0, 2, 4, 7 and 9
B. CHALLENGE EXPOSURE: EPICUTANEOUS
- No. of exposures: Two
- Day of challenge: Days 21 and 35
- Test groups: 0.025 mL of the non-irritant solutions of the test item was applied to the skin of the animals.
- Site: Skin (2 cm2)
- Evaluation (h after application): 24, 48 and 72 h - Challenge controls:
- Animals in the control group were induced with 0.05 mL of FCA only. During challenge phase, 0.025 mL of the non-irritant solutions of the test item was applied to the skin of these animals.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- Not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: challenge 1 on Day 21 (readings at 24, 48 and 72 h)
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Induction: 5 % emulsion in FCA; challenge: non-irritant solutions
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no data
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: challenge 1 on Day 21 (readings at 24, 48 and 72 h). . Hours after challenge: 72.0. Group: test group. Dose level: Induction: 5 % emulsion in FCA; challenge: non-irritant solutions. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no data.
- Reading:
- other: challenge 2 on Day 35 (readings at 24, 48 and 72 h)
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Induction: 5 % emulsion in FCA; challenge: non-irritant solutions
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no data
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: challenge 2 on Day 35 (readings at 24, 48 and 72 h). . Hours after challenge: 72.0. Group: test group. Dose level: Induction: 5 % emulsion in FCA; challenge: non-irritant solutions. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no data.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under these test conditions, ACETATE DE NONYLE was considered not to be a skin sensitiser to guinea pig.
- Executive summary:
In a Freund's complete adjuvant test, 0.1 mL of a 5 % emulsion of the test item, ACETATE DE NONYLE, in Freund’s Complete Adjuvant (FCA) was intradermally injected into the neck of 10 guinea pigs on Days 0, 2, 4, 7 and 9. Animals in the control group were treated with 0.05 mL of FCA only. On Days 21 and 35, 0.025 mL of the non-irritant solutions of the test item (concentrations: 10 % or lower) were applied to the skin (2 cm2) of treated and control animals.
No skin reactions were noted at the challenge sites of the test group animals on Days 21 and 35. ACETATE DE NONYLE produced a 0 % (0/10) sensitisation rate and was considered not to be a skin sensitiser to guinea pig.
Under these test conditions, ACETATE DE NONYLE was considered not to be a skin sensitiser to guinea pig.
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