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Diss Factsheets
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EC number: 203-007-9 | CAS number: 102-13-6
- 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:
- 1973
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Older human volunteer study, reporting is very brief. The study was conducted prior to development of GLP and current test guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The study was a patch test conducted in human volunteers, and was conducted prior to development of current guidelines. A preliminary irritation screen was performed, followed by a maximisation test.
- GLP compliance:
- no
- Remarks:
- Conducted prior to development of GLP
- Type of study:
- patch test
- Justification for non-LLNA method:
- Other study data available which together justify a WOE approach.
Test material
- Reference substance name:
- Isobutyl phenylacetate
- EC Number:
- 203-007-9
- EC Name:
- Isobutyl phenylacetate
- Cas Number:
- 102-13-6
- Molecular formula:
- C12H16O2
- IUPAC Name:
- isobutyl phenylacetate
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): RIFM 72-4-168 Isobutyl phenylacetate
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Strain:
- other: N/a
- Sex:
- male
- Details on test animals and environmental conditions:
- Twenty five healthy adult males, aged between 22 and 62 years.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- no data
- Concentration / amount:
- No further information provided (it is assumed the test substance was applied undiluted).
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- no data
- Concentration / amount:
- No further information provided (it is assumed the test substance was applied undiluted).
- No. of animals per dose:
- 25 (total)
- Details on study design:
- Pre-testing:
A preliminary irritation screen was conducted on five subjects in order to determine whether sodium lauryl sulfate pre-treatment was required. A patch of the test substance was applied to normal sites on the back for 48 hours under occlusion. The sites were assessed for any reactions.
Maximisation test:
The test substance was applied under occlusion to the same sites on the volar forearms on all subjects for five alternate-day, 48-hour exposure periods. Each test application was preceded by 24 hour occlusive pre-treatment of the patch site with 5% aqueous sodium lauryl sulfate. Following a ten day rest period, challenge patches were preceded by one hour pretreatment with 10% aqueous sodium lauryl sulfate. The challenge sites were evaluated for signs of reactions on removal of patches and 24 hours thereafter. - Challenge controls:
- No controls.
- Positive control substance(s):
- not required
Results and discussion
- Positive control results:
- Not applicable - no positive control
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 25.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 25.0.
Any other information on results incl. tables
Results:
Subject no. |
Age |
Race |
Challenge |
|
48 Hours |
72 Hours |
|||
1. |
24 |
B |
0 |
0 |
2. |
27 |
B |
0 |
0 |
3. |
40 |
B |
0 |
0 |
4. |
22 |
B |
0 |
0 |
5. |
23 |
B |
0 |
0 |
6. |
32 |
B |
0 |
0 |
7. |
22 |
B |
0 |
0 |
8. |
36 |
B |
0 |
0 |
9. |
28 |
B |
0 |
0 |
10. |
28 |
B |
0 |
0 |
11. |
39 |
B |
0 |
0 |
12. |
22 |
B |
0 |
0 |
13. |
31 |
B |
0 |
0 |
14. |
46 |
B |
0 |
0 |
15. |
49 |
B |
0 |
0 |
16. |
25 |
B |
0 |
0 |
17. |
62 |
B |
0 |
0 |
18. |
39 |
B |
0 |
0 |
19. |
23 |
B |
0 |
0 |
20. |
23 |
B |
0 |
0 |
21. |
25 |
B |
0 |
0 |
22. |
25 |
B |
0 |
0 |
23. |
30 |
B |
0 |
0 |
24. |
24 |
B |
0 |
0 |
25. |
24 |
B |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No skin reactions were observed following the challenge application.
- Executive summary:
The sensitising potential of isobutyl phenylacetate was evaluated in a human volunteer study. Initially, a preliminary irritation screen was conducted in 5 male subjects: the test substance was applied to the back skin under an occlusive patch for 48 hours. No reactions were observed, therefore a maximisation test was conducted in 25 healthy adult males. The test substance was applied to the same test site on the volar forearm on all subjects under an occlusive patch for five alternate-day, 48-hour periods. Each test application was preceded by a 24 hour occlusive pre-treatment of the test site with 5% aqueous sodium lauryl sulfate. Following a ten-day rest period, challenge applications were made (under an occlusive patch) to a fresh test site for 48 hours. Challenge applications were preceded by a 1-hour pre-treatment with 10% aqueous sodium lauryl sulfate. The challenge sites were evaluated for signs of reactions at patch removal, and again 24 hours later. There were no reactions to challenge in any of the test subjects. It can be concluded that under the conditions of the human volunteer study, the test substance was not sensitising.
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