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EC number: 474-190-2 | CAS number: 875471-31-1
- 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:
- Between 07 November 2005 and 10 February 2006.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted in compliance with OECD Guideline No. 406. However, age at study initiation, housing and feeding conditions not reported.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 17 July 1992
- Deviations:
- yes
- Remarks:
- age at study initiation, housing and feeding conditions are not reported.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 30 July 1996.
- Deviations:
- yes
- Remarks:
- age at study initiation, housing and feeding conditions are not reported.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 2005-10-03 / Signed on 2005-12-13.
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- According to REACH regulation, in vivo skin sensitisation studies that were carried out or initiated before May 2017 shall be considered appropriate to address this standard information requirement.
Test material
- Reference substance name:
- (5R)-5-pentyloxan-2-one
- Molecular formula:
- C10 H18 O2
- IUPAC Name:
- (5R)-5-pentyloxan-2-one
- Reference substance name:
- (5S)-5-pentyloxan-2-one
- Molecular formula:
- C10 H18 O2
- IUPAC Name:
- (5S)-5-pentyloxan-2-one
- Test material form:
- liquid
- Details on test material:
- - Physical state: Liquid
- Storage condition of test material: room temperature.
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Centre de production animale (F-45160 Olivet).
- Weight at study initiation: 329 - 484 g
- Housing: no data
- Diet: Guinea pigs breeding diets
- Water: no data
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17-25 °C. A temperature of 17°C was registered instead of 19°C. A relative humidity of 25% was registered instead of 30% (minimal limit). These deviations did not, in any case, influence the results of the study.
- Humidity: 25-50 %
- Air changes: no data
- Photoperiod: no data
IN-LIFE DATES: From 07 November 2005 to 10 February 2006.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- olive oil
- Concentration / amount:
- 6.25% for the 1st induction
- Day(s)/duration:
- Day 0 - 6.
- Adequacy of induction:
- other: 1st induction - intradermal injection at the maximal non necrosing concentration of 6.25%
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 100% for the 2nd induction
- Day(s)/duration:
- Day 7 - 10.
- Adequacy of induction:
- other: 2nd induction by maximal non-irritant concentration of 100%
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- topical application at 50% and 100%.
- Day(s)/duration:
- Day 20 - 21
- Adequacy of challenge:
- other: 100% (MNIC) and at 50% (1/2 MNIC).
- No. of animals per dose:
- MAIN STUDY:
Group 1 (negative control): 10 males and 2 females.
Group 2 (treated): 16 males and 6 females. - Details on study design:
- PRELIMINARY STUDIES:
- Maximum Non Necrotizing Concentration (M.N.N.C.) determination by intradermal injection: 2 male guinea pigs were used. The test item was injected by intradermal route at the following concentrations: 100%, diluted at 50%, 25%, 12.5%, 6.25% and 3.125% in olive oil. No necrosis has been observed, since the concentration of 6.25%, the first induction has been carried out by intradermal injection at the same concentration.
- Pre-Maximum Non Irritant Concentration (Pre-M.N.I.C.) determination by topical application: 2 male guinea pigs were used. The test item was applied under an occlusive dressing during 24 hours, at the following concentrations 100%, diluted at 50%, 25% and 12.5% in paraffin oil. 24 hours after the removal of the occlusive dressings, no cutaneous reaction was recorded whatever the tested concentration. In view of these results, the concentration selected was 100% for the 2nd induction of the main study and the MNIC determination began at this concentration of 100%
- Maximum Non Irritant Concentration (M.N.I.C.) determination by topical application: 3 female guinea pigs were used. After induction by intradermal injection with olive oil and by topical application with paraffin oil and a 17-day rest phase, the challenge phase under occlusive dressing for 24 hours consists in a single topical application of the test item at the following concentrations: 100% diluted at 50%, 25%, 12.5% in paraffin oil. 24 hours after removal of the occlusive dressings, no cutaneous reaction was recorded. In view of this result, the concentrations selected were 100% (MNIC) and 50% (1/2 MNIC) for the challenge phase.
MAIN STUDY
Induction phase: The induction phase was performed by intradermal injection at D0 with the test item at 6.25% and by topical application at D7 with the test item at 100% during 48 hours, 24 hours after brushing with a solution of sodium lauryl sulfate.
A. INDUCTION EXPOSURE (INTRADERMAL - 1st induction: Day 0)
- No. of exposures: One
- 2 intradermal injections of the test item diluted at 6.25%; 2 intradermal injections of Freund’s Complete Adjuvant diluted at 50% in isotonic sodium chloride; 2 intradermal injections of a mixture with equal volumes - Freund’s Complete Adjuvant at 50% and the test item at 12.5%.
- Site: Each side of the mid-line on scapular zone
- Exposure period: Day 0-6
- Duration: 6 days
Day 6: The scapular zone of all the animals in each group, shorn beforehand, was brushed with a solution of sodium lauryl sulfate at 10% in thick vaseline, in order to create a local irritation.
B. INDUCTION EXPOSURE (TOPICAL - 2nd induction: Day 7)
- No. of exposures: One
- Topical application, on the same zone, with the test item at 100%, 24 hours after brushing with 0.5 mL of a solution of Sodium lauryl sulfate at 10%.
- Test groups: 0.5 mL of the test item at 100%
- Control group: 0.5 mL of paraffin oil
- Site: Same intradermally injected area of scapular zone
- Frequency of applications: Single application
Day 10: Occlusive dressing removal
REST PHASE
- The animals of both groups were left for 10 days.
C. CHALLENGE EXPOSURE - FIRST CHALLENGE
- No. of exposures: One
- Day(s) of challenge: Day 20
- Exposure period: 24 h
- Day 21: Occlusive dressing removal
- The experimental procedure of this phase was identical for both negative control and treated groups submitted to this experimentation: on the previously shorn dorso-lumbar zone, an application on either side of the spine, under occlusive dressing, was performed during 24 hours:
- 1 sample cup containing the test item at 12.5% (MNIC) and at 6.25% (1/2 MNIC).
- Evaluation (h after removal of challenge patch): 24, 48 and 72 h - Positive control substance(s):
- yes
- Remarks:
- α-Hexylcinnamaldehyde
Results and discussion
- Positive control results:
- α-Hexylcinnamaldehyde induced skin sensitisation indicating the validity of the study.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 10
- Total no. in group:
- 22
- Clinical observations:
- None
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 6
- Total no. in group:
- 22
- Clinical observations:
- None
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 1
- Total no. in group:
- 22
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 7
- Total no. in group:
- 22
- Clinical observations:
- None
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 3
- Total no. in group:
- 22
- Clinical observations:
- None
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 22
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 12
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: 3rd
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 100 and 50%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Sensitising potential assessment:
It was recorded a slight erythema, respectively in 45% (10/22), 27% (6/22) and 5% (1/22) of the animals from the treated group, 24, 48 and 72 hours after the challenge phase, on the treated area at 100%. It was noted a slight to moderate erythema, respectively in 24%, 14% and 5% of the animals from the treated group, 24, 48 and 72 after the challenge phase, on the treated area at 50%.
No cutaneous intolerance reaction was recorded in animals from the negative control group. In effect, it was only noted a slight erythema, in only one animal (1/12) on the treated area at 50%, at the reading time 24 hours.
Weight evolution:
Not any abnormality was recorded in the weight growth of both groups, except for one treated animal for which a decrease of the body weight (-5%) was registered during the test.
Mortality: No mortality occurred during this study.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Under the test conditions, the test material is classified as skin sensitser in Category 1B according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In a Magnusson & Kligman maximisation study (GPMT) performed according to OECD Guideline 406 and in compliance with GLP, test item was assessed for skin sensitization in male and female Dunkin-Hartley Guinea pigs. After induction (intradermal injection at 6.25% and topical application at 100%) of 22 Guinea pigs of treated group with the test item and a 17-day rest phase, the challenge phase, under occlusive dressing for 24 hours, consisted of a single topical application of the test item at 100%, diluted at 50% in paraffin oil and of a negative control (liquid paraffin). Control group of 2 females and 10 males treated in similar manner. The test concentrations for the main study were determined from a preliminary study.
It was recorded a slight erythema, respectively in 45% (10/22), 27% (6/22) and 5% (1/22) of the animals from the treated group, 24, 48 and 72 hours after the challenge phase, on the treated area at 100%. It was noted a slight to moderate erythema, respectively in 24%, 14% and 5% of the animals from the treated group, 24, 48 and 72 after the challenge phase, on the treated area at 50%.
No cutaneous intolerance reaction was recorded in animals from the negative control group. In effect, it was only noted a slight erythema, in only one animal (1/12) on the treated area at 50%, at the reading time 24 hours.
The sensitivity of the guinea-pig was checked with known sensitiser i.e., α-Hexylcinnamaldehyde indicating the validity of the study.
Under these experimental conditions, the test material is classified as skin sensitiser in category 1B (H317: May cause an allergic skin reaction) according to the Regulation (EC) No. 1272 /2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for skin sensitisation endpoint.
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