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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
Endpoint summary
Administrative data
Description of key information
The substance is not skin sensitising.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Please consult the Read-Across Justification Document in section 13 of IUCLID.
- Reason / purpose for cross-reference:
- read-across source
- 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
- 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
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Read across was done from nonyl acetate. Nonyl acetate was not skin sensitising.
- Executive summary:
Read-across is done from nonyl acetate. An open epicutaneous test (OET) was conducted on guinea pigs to determine the capacity of nonyl acetate to induce allergenic sensitization. Four test groups of 6 animals and a control group were included in the study. During the induction phase 100, 30, 10, and 3% of nonyl acetate in ethanol was applied to the clipped flank of each animal and left uncovered. The applications were repeated daily for 21 consecutive days. Skin irritation was evaluated at 7, 14 and 21 days. Challenge application was performed on days 21 and 35 on the contralateral flank. The minimal irritation concentration (10%) and 3% 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, nonyl acetate is considered not skin sensitizing in guinea pigs.
Based on this result, and on the structural, chemical and toxicological similarities between nonyl and decyl acetate, it can be concluded that decyl acetate is not skin sensitizing.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
For this endpoint there are 3 studies available. Two studies investigate the sensitising potential of the read-across substance nonyl acetate (1980 a and b) in guinea pigs and the third study (1974) assessed the skin sensitising potential of decyl acetate in humans.
In the first study (1980 a) an open epicutaneous test was conducted on guinea pigs with nonyl acetate using 100, 30, 10, and 3% in ethanol. The test item was left uncovered. The applications were repeated for 21 days and challenge was done on days 21 and 35 with 10% and lower concentrations and left uncovered. Reactions were read after 24, 48 and 72 hours later. No positive reactions were observed at any concentration, therefore, the test material is considered not skin sensitizing in guinea pigs.
In the second study (1980 b) an intradermal test with Freund's Complete Adjuvant (FCA) was conducted with guinea pigs. Induction was done with 5 intradermal injections of nonyl acetate mixed with FCA into the neck on days 0, 2, 4, 7 and 9. The challenge was on days 21 and 35, and reactions were read after 24, 48 and 72 hours. No effects were observed, and therefore it can be stated that the nonyl acetate has no sensitizing potential.
In the third study (1974) a maximization study was done with 25 human volunteers with 8% of decyl acetate in petrolatum. (See section 7.10.4 in IUCLID.) The occlusive patch tests were placed on forearm of the subjects 5 alternate days for 48 hours with a 24 hour rest period between removal and re-application of the patch. After a 2 week rest period challenge was done by a 48-hour occluded patch with the maximum non-irritating concentration. The challenge site was scored 24 and 48 hours after patch removal and the sensitisation index is noted. No reactions were observed.
Taking together all available information on the source substance nonyl acetate and the target substance decyl acetate, it can be concluded that decyl acetate is not skin sensitizing.
Justification for classification or non-classification
Skin sensitisation
The substance did not provoke any skin sensitisation effects in 3 different studies. According to the Tables 3.4.3 and 3.4.4 of the CLP Regualtion No 1272/2008 the substance is not to be classified as skin sensitiser.
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