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EC number: 266-841-2 | CAS number: 67662-96-8
- 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:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Non-GLP study meets generally accepted scientific principles, acceptable for assessment with restrictions: only 8 animals in each test group; 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:
- 1 973
- Report date:
- 1973
Materials and methods
- Principles of method if other than guideline:
- Method: Open epicutaneous test
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Type of study:
- open epicutaneous test
Test material
- Reference substance name:
- Phenethyl pivalate
- EC Number:
- 266-841-2
- EC Name:
- Phenethyl pivalate
- Cas Number:
- 67662-96-8
- Molecular formula:
- C13H18O2
- IUPAC Name:
- 2-phenylethyl 2,2-dimethylpropanoate
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): LRA 303 “Centifolyl”
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:
- epicutaneous, open
- Vehicle:
- other: acetone
- Concentration / amount:
- Preliminary test: 100, 30, 10 and 3 % or lower in acetone
Main test:
- Topical induction exposure: 100, 30, 10 and 3 %
- Topical challenge exposures 1 and 2: Minimal irritating (10 %) and lower concentrations
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: acetone
- Concentration / amount:
- Preliminary test: 100, 30, 10 and 3 % or lower in acetone
Main test:
- Topical induction exposure: 100, 30, 10 and 3 %
- Topical challenge exposures 1 and 2: Minimal irritating (10 %) and lower concentrations
- No. of animals per dose:
- Eight
- Details on study design:
- PRELIMINARY TEST:
- Estimation of threshold-toxic concentration: One day before starting the induction procedure, 0.025 mL of each test concentration (100, 30, 10 and 3 % or lower in acetone) was applied directly to the clipped flank skin (2 cm2) of the guinea pigs and the skin reactions were observed after 24 h. The minimal irritant and the maximal non-irritant concentrations were determined by an all-or-none criterion.
MAIN STUDY
A. INDUCTION EXPOSURE: EPICUTANEOUS
- No. of exposures: 21
- Test groups: 0.1 mL of each test concentration was applied directly to the skin of animals and the application sites were left uncovered.
- Site: Clipped flank skin (8 cm2)
- Frequency of applications: Once daily for 3 weeks
- Evaluation of skin reactions: 24 h after application or at the end of each week
- Duration: Days 0-20
B. CHALLENGE EXPOSURE: EPICUTANEOUS
- No. of exposures: Two
- Day of challenge: Days 21 and 35
- Test groups: 0.025 mL of each test concentration was applied directly to the skin and the application sites were left uncovered.
- Site: Contralateral flank skin (2 cm2)
- Evaluation (h after application): 24, 48 and/or 72 h - Challenge controls:
- On Days 21 and 35, 0.025 mL of each test concentration was applied directly to the skin of vehicle treated or untreated control animals. The application sites were left uncovered and observed for skin reactions after 24, 48 and/or 72 h.
- 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/or 72 h)
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Induction: 3-100 %; challenge: 10 % or lower
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Clinical observations:
- no data
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: challenge 1 on Day 21 (readings at 24, 48 and/or 72 h). . Hours after challenge: 72.0. Group: test group. Dose level: Induction: 3-100 %; challenge: 10 % or lower. No with. + reactions: 0.0. Total no. in groups: 8.0. Clinical observations: no data.
- Reading:
- other: challenge 2 on Day 35 (readings at 24, 48 and/or 72 h)
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Induction: 3-100 %; challenge: 10 % or lower
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Clinical observations:
- no data
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: challenge 2 on Day 35 (readings at 24, 48 and/or 72 h). . Hours after challenge: 72.0. Group: test group. Dose level: Induction: 3-100 %; challenge: 10 % or lower. No with. + reactions: 0.0. Total no. in groups: 8.0. Clinical observations: no data.
Any other information on results incl. tables
Preliminary test:
- Lowest irritant concentration: 10 %
- Highest non-irritant concentration: 3 %
Table 7.4.1/1: Main test: skin irritation after repeated applications over 21 successive days
Concentration in % |
Skin irritation after days |
||
7 |
14 |
21 |
|
100 |
very slight |
very slight |
very slight |
30 |
very slight |
very slight |
very slight |
10 |
very slight |
very slight |
very slight |
3 |
none |
none |
none |
Table 7.4.1/2: Main test: capacity to induce allergic sensitisation
Concentration in % (after daily applications over 3 weeks) |
Sensitisation rate |
|
Day 21 |
Day 35 |
|
100 |
0/8 |
0/8 |
30 |
0/8 |
0/8 |
10 |
0/8 |
0/8 |
3 |
0/8 |
0/8 |
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, LRA 303 “CENTIFOLYL” was considered not to be a skin sensitiser to guinea pig.
- Executive summary:
In an open epicutaneous test (OET), groups of guinea pigs (8/group) were epicutaneously induced with 0.1 mL of the test item, LRA 303 “CENTIFOLYL”, at concentrations of 100, 30, 10 and 3 % in acetone. Each test concentration was applied directly to the clipped flank skin (8 cm2) of guinea pigs, once daily for 21 successive days (Days 0-20) and the application sites were left uncovered. On Days 21 and 35, 0.025 mL of the test item at the minimal irritating (10 %) and some lower concentrations were applied to the contralateral skin of previously treated and untreated or vehicle treated animals.
No skin reactions were noted at the challenge sites of the test group animals on Days 21 and 35. LRA 303 “CENTIFOLYL” produced a 0% (0/8) sensitisation rate and was considered not to be a skin sensitiser to guinea pig.
Under these test conditions, LRA 303 “CENTIFOLYL” was considered not to be a skin sensitiser to guinea pig.
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