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EC number: 457-810-6 | CAS number: -
- 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:
- Between 13 December 2004 and 20 January 2005.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted according to OECD Guideline 406 with deviations: age at study initiation, housing and feeding conditions not reported. These deviations do not affect the quality of the study and are not considered to be relevant. The substance is adequately identified. Therefore full validation applies.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
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 not reported
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Directive 96/54/E.C.
- Deviations:
- yes
- Remarks:
- age at study initiation, housing and feeding conditions not reported.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 2004-07-01 / Signed on 2004-07-11.
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- According to REACH regulation, in vivo skin sensitisation studies that were warried out or initiated before 10 May 2017 shall be considered appropriate to address this standard information requirement.
Test material
- Reference substance name:
- -
- EC Number:
- 457-810-6
- EC Name:
- -
- Cas Number:
- 854737-08-9
- Molecular formula:
- C11 H18 O2
- IUPAC Name:
- 5-hept-6-enyloxolan-2-one
- Test material form:
- liquid
- Details on test material:
- - Physical state: colourless liquid
- Storage condition of test material: Room temperature
Constituent 1
- Specific details on test material used for the study:
- Date received: 09 December 2004
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: 267-361 g
- Housing: No data
- Diet: guinea-pig diet (certified 114)
- Water: No data
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20-23 °C
- Humidity: 28-56 %
IN-LIFE DATES: 13 December 2004 to 20 January 2005
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- olive oil
- Concentration / amount:
- intradermic injection at 12.5%
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- topical application at 100%
- Day(s)/duration:
- Day 7 / 24 hours
- Adequacy of induction:
- highest technically applicable concentration used
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 50%
- Day(s)/duration:
- Day 21 / 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 25%
- Day(s)/duration:
- Day 21 / 24 hours
- Adequacy of challenge:
- other: 1/2 MNIC
- No. of animals per dose:
- Preliminary study: 7 males.
Main study: 10 (5 males and 5 females) for treated group (Group 2) and 5 (2 males and 3 females) for negative control (Group 1) - Details on study design:
- PRELIMINARY TESTS:
Maximum Non Necrotizing Concentration (M.N.N.C.) determination: 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, at the concentration of 12.5%, 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: 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, it was only recorded a slight erythema in one animal on the treated area at 100%. In view of these results, the concentrations selected were pure (100%) for the 2nd induction of the main study and the MNIC began at the concentration of 50%
Maximum Non Irritant Concentration (M.N.I.C.) determination: 3 male guinea pigs were used. After induction by intradermal injection with olive oil and by topical application with paraffin oil and a 18-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: diluted at 50%, 25%, 12.5% and 6.25% in paraffin oil. 24 hours after removal of the occlusive dressings, no macroscopic reaction was recorded.In view of this result, the concentrations selected were 50% (MNIC) and 25% (1/2 MNIC) for the challenge phase.
MAIN STUDY
A. INDUCTION EXPOSURE (INTRADERMAL - 1st induction: Day 0)
- No. of exposures: One
- 2 intradermal injections of the test item diluted at 12.5% in olive oil.- 2 intradermal injections of Freund’s Complete Adjuvant diluted at 50% in in a physiological saline solution.- 2 intradermal injections of a mixture with equal volumes - Freund’s Complete Adjuvant at 50% and the product diluted at 25% in olive oil.
- Duration: 7 days
- Concentrations: 12.5% in olive oil
B. INDUCTION EXPOSURE (TOPICAL - 2nd induction: Day 7)
- No. of exposures: One
- Topical application, on the same zone, with the test item at 100%
- Concentrations: 100%
C. REST PHASE: 18 days
D. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: Day 27
- Exposure period: 24 h
- Challenge phase (Groups 1 & 2): topical application under occlusive dressing at the following concentrations: 50% and 25%.
- Evaluation: 24 and 48 h after challenge - Challenge controls:
- No. of animals for negative control group: 5 animals/tested concentrations: 25% and 50% (24h and 48h).
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole [49-30-4] Test 8; Neomycin sulfate [1405-10-3]Tests 6 & 7.
Results and discussion
- Positive control results:
- Historical data:
- NEOMYCIN SULFATE at 37.5% or 75% induced skin sensitisation in more than 30% of the treated animals indicating the validity of the study.
- 2-Mercaptobenzothiazole at 25% or 50% induced skin sensitisation in more than 30% of the treated animals 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:
- 25% and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- 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:
- 25% and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- 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:
- 25% and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- 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:
- 25%
- No. with + reactions:
- 4
- Total no. in group:
- 9
- Clinical observations:
- None
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Historical data
Any other information on results incl. tables
Sensitising potential assessment:
No macroscopic cutaneous reactions attributable to allergy was recorded during the examination following the removal of the occlusive dressing (challenge phase) from the animals of the treated group with the test product.No cutaneous intolerance reaction was recorded in animals from the negative control group
Mortality:
No death occurred during this study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, test substance is not classified as sensitiser according to the criteria of the Regulation EC No. 1272/2008 (CLP) and of the GHS.
- Executive summary:
In a Magnusson & Kligman maximisation study (GPMT) performed according to OECD Guideline 406 and in compliance with GLP, Guinea pigs were treated as follows:
After induction (intradermic injection at 12.5% and topical application at 100%) of 10 Guinea Pigs of treated group with the test substance and a 18 -day rest phase, the challenge phase, under occlusive dressing for 24 hours, consisted to a single topical application of the test item diluted at 25% and 50 % in paraffin oil. The test concentrations for the main study were determined from a preliminary study.
No macroscopic cutaneous reactions attributable to allergy was recorded during the examination following the removal of the occlusive dressing (challenge phase) from the animals of the treated group with the test item. No cutaneous intolerance reaction was recorded in animals from the negative control group.
The sensitivity of the guinea-pig was checked with known sensitiser i.e.,Neomycin sulfate and 2-Mercaptobenzothiazole indicating the validity of the study.
Under the test conditions, the test substance is not classified as sensitiser according to the criteria of the Regulation EC No. 1272 /2008 (CLP) and of the GHS.
This study is considered as acceptable and satisfies the requirement for skin sensitisation endpoint.
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