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EC number: 943-447-5 | 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:
- 07 Oct - 07 Nov 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministry of Environment, Nature Protection and Regional Planning, Potsdam, Germany
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Reaction mass of [(1R,2S)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1S,2R)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1S,2S)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1R,2R)-2-cyclopentylcyclopentyl] (E)-but-2-enoate
- Molecular formula:
- C14H22O2
- IUPAC Name:
- Reaction mass of [(1R,2S)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1S,2R)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1S,2S)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1R,2R)-2-cyclopentylcyclopentyl] (E)-but-2-enoate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Tierzucht Schönwald GmbH, Schönwalde, Germany
- Weight at study initiation: 356 - 406 g
- Housing: 2-3 animals per cage in polycarbonate macrolone cages (type IV) on softwood sawdust
- Diet: Altromin 3122 (Altromin, Lage, Germany), ad libitum
- Water: with vitamin C enriched domestic quality water acidified to pH 2.5, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: intradermal induction: peanut oil; dermal induction and challenge: ethanol/diethylphthalate (1:1)
- Concentration / amount:
- Induction: intradermal 2.5%, epicutaneous 100%
Challenge: epicutaneous 100%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: intradermal induction: peanut oil; dermal induction and challenge: ethanol/diethylphthalate (1:1)
- Concentration / amount:
- Induction: intradermal 2.5%, epicutaneous 100%
Challenge: epicutaneous 100%
- No. of animals per dose:
- 10 (controls), 20 (test group)
- Details on study design:
- RANGE FINDING TESTS:
A range finding study was performed to determine the appropriate dose level of the test substance following intradermal and epicutaneous administrations. The intradermal irritancy of the test substance was investigated in order to find the minimal irritant test substance concentration for the intradermal induction. The epicutaneous irritancy of the test substance was investigated in order to find the minimal irritant test substance concentration for the dermal induction, and the maximum non-irritating test substance concentration for challenge application. For the intradermal administration test item concentrations of 0.6, 1.25, 2.5 or 5% were injected intradermally in two animals each. Slight skin reactions were observed at all test concentrations in all animals after 24 h and 48 h after application.
For the epicutaneous administration test item concentrations of 12.5, 25, 50 and 100% were applied to the clipped skin of two animals. No skin reactions were observed up to the highest concentration tested 24 and 48 h after removal of the patch.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture FCA/sterile distilled water
Injection 2: test substance in peanut oil
Injection 3: equal amounts of 5% test substance and FCA/sterile water in a 1:1 mixture (v/v)
Epicutaneous: undiluted test substance
- Control group:
Injection 1: a 1:1 mixture FCA/sterile distilled water
Injection 2: peanut oil
Injection 3: equal amounts of peanut oil and FCA in a 1:1 mixture (v/v)
Epicutaneous: ethanol/diethylphthalate (1:1)
- Site: shoulder region (intradermal + epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 0-7
- Concentrations: intradermal 2.5%, epicutaneous 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 21
- Exposure period: 24 h
- Test groups: undiluted test substance and ethanol/diethylphthalate (1:1)
- Control group: undiluted test substance and ethanol/diethylphthalate (1:1)
- Site: right anterior flank (test substance) and left anterior flank (ethanol/diethylphthalate (1:1))
- Concentrations: 100%
- Evaluation: 24 and 48 h after patch removal - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- hexylcinnamaldehyde, induction: intradermal 10%, epicutaneous 100%, challenge: 100%
Results and discussion
- Positive control results:
- The positive control substance induced positive reactions (score 2 and 3) in 6/10 animals (60% second reading), thus meeting the reliability criteria for the Guinea Pig Maximisation Test (≥ 30% positive response). The positive control group was not carried out concurrently with this study but is a historical background data group from a study performed during June 1997.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction: 0%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Induction: 0%; challenge: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction: 2.5%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Induction: 2.5%; challenge: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Induction: 10%; challenge: 100%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: Induction: 10%; challenge: 100%. No with. + reactions: 8.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction: 0%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Induction: 0%; challenge: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 2.5%; challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Induction: 2.5%; challenge: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Induction: 10%; challenge: 100%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: Induction: 10%; challenge: 100%. No with. + reactions: 6.0. Total no. in groups: 10.0.
Any other information on results incl. tables
The challenge with undiluted test item revealed slight erythema (score 1) in 11 of 20 animals after 24 h. After 48 h one animal showed slight erythema (score 1).
The challenge with ethanol/diethylphthalate (1:1) revealed slight erythema (score 1) in 3 of 20 animals after 24 h. After 48 h no skin reactions were observed.
A slight or discrete erythema scored with „1" is not considered as a allergic reaction. The slight skin reactions were only seen in the test group. Some of the animals with this erythema showed a similar reaction on the patch area treated with the vehicle. After 48 h all skin reactions, except in one animal, disappeared. Therefore it is assurned, that the observed skin reactions were not caused by the treatment with the test article.
The animals showed normal body weight gain during the study period.
The animals showed no signs of ill health.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test the test substance revealed no sensitising properties.
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