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Diss Factsheets
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EC number: 205-393-4 | CAS number: 140-04-5
- 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
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary source.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Straight Chain Lepidopteran Pheromones (SCLPs) Group - DAR - Vol. 3 - Annex B.6 - Part 2
- Author:
- European Food Safety Authority (EFSA)
- Year:
- 2 008
- Bibliographic source:
- EFSA ,Draft Assessment Report (DAR), STRAIGHT CHAIN LEPIDOPTERAN PHEROMONES (SCLP) of the fourth stage of the review programme referred to in Article 8(2) of Council Directive 91/414/EEC Volume 3, Annex B, part 2/B, B.6, September 2008
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- The skin sensitization study (7E, 9Z)-dodecadienyl acetate was performed in guinea pig by Guinea pig maximization test
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Not specified.
Test material
- Reference substance name:
- (7E,9Z)-dodecadienyl acetate
- EC Number:
- 259-127-7
- EC Name:
- (7E,9Z)-dodecadienyl acetate
- Cas Number:
- 54364-62-4
- Molecular formula:
- C14H24O2
- IUPAC Name:
- dodeca-1,3-dien-1-yl acetate
- Test material form:
- not specified
Constituent 1
- Specific details on test material used for the study:
- Details on test material
- Name of test material (as cited in study report): (7E, 9Z)-Dodecadien-l-yl Acetate BAS288…..I
- Molecular formula:C14H24O2
- Molecular weight: 224.341g/mole
- Substance type: organic
- Physical state: No data available
- Purity: 81.3%
- Lot/batch No.:24623/45
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white , DunkinHartley HOE DHPK (SPF-LAC)BO
- Sex:
- not specified
- Details on test animals and environmental conditions:
- Details on test animal
TEST ANIMALS
- Source: Lippische Versuchstierzucht. Hagemann GmbH & Co. KG. W4923 Exertal 1. FAG, Germany.
- Age at study initiation: Young adult
- Weight at study initiation:270-348g
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Olive oil DAB 9
- Concentration / amount:
- For intradermal injection :0.1ml FCA , 5% test substance in olive oil DAB9 and test substance formulation in FCA
For epicutaneous application : 0.3 g of test substance 75% test substance in olive oil DAB 9 - Day(s)/duration:
- For intradermal injection:24hr For epicutaneous application:48hr
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Olive oil DAB 9
- Concentration / amount:
- 0.15 g test substance formulation (50%test substance in vehicle)
- Day(s)/duration:
- 24hr
- No. of animals per dose:
- Total:50
Test group:20
Control group:10
Positive control group:20 - Details on study design:
- Details on study design
RANGE FINDING TESTS:Pretests were conducted to determine the dose levels used in induction and challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: For intradermal injection:24hr
For epicutaneous application:48hr
- Test groups:20
- Control group: 10
- Site: No data available
- Frequency of applications: one week after intra dermal injection
- Duration: For intradermal injection:24hr
For epicutaneous application:48hr
- Concentrations: For intradermal injection :0.1ml FCA , 5% test substance in olive oil DAB9 and test substance formulation in FCA
For epicutaneous application : 0.3 g of test substance 75% test substance in olive oil DAB 9
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: 21 days after intradermal injection
- Exposure period: 24hr
- Test groups:20
- Control group: 10
- Site: two different site
- Concentrations: 0.15 g test substance formulation (50%test substance in vehicle)
- Evaluation (hr after challenge): 24hr and 48hr - Challenge controls:
- Yes
- Positive control substance(s):
- yes
- Remarks:
- 1-chlor-2,4-dinitro-benzol (1% test substance preparation
Study design: in vivo (LLNA)
- Statistics:
- No data available
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.15 g test substance formulation (50%test substance in vehicle)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- There were no dermal effects noted in treated animals after Induction Phases or at challenge
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Executive summary:
The skin sensitization study of Dodeca-1,3-dien-1-yl acetatewas performed by Guinea pig maximization test usingPirbright white , DunkinHartley HOE DHPK (SPF-LAC)BO guinea pig .10 animals in control group and 20 animals in test group were used also 20 animals used as positive control group.
In a pre-test, 0.15 g of testsubstance formulationwas applied to the skin of 4 guinea pigs under occlusive conditions for 24hr within period of 96hr observation done after 24 and 48hr after application.
In induction phase ,For intradermal injection :0.1ml FCA , 5% test substance in olive oil DAB9 and test substance formulation in FCA were used ,after 24hr reading was noted .after one week epicutaneous application of 0.3 g of test substance ( 75% test substance in olive oil DAB 9)was applied for 48 hr as occlusive patch. Reading noted after 48 hr.
In challenge phase, 21 days after intradermal injection0.15 g test substance formulation(50%test substance in vehicle) was applied at two different site for a period of 24hr .reading were performed after 24 and 48hr after removal of patch .In addition, a positive control group of 20 animals was treated with 1-chlor-2,4-dinitro-benzol (1% test substance preparation) using the same procedures described for the test group.
After intradermal injection of FCA, test substance formulation or test substance formulation in FCA gave rise to well-defined erythema (grade 2) and slight oedema (grade 2) in all animals. In challenge phase no skin sensitization observed in any animal .In positive control group,2/20 animals exhibited moderate to severe erythema (grade 3), 14/20 animals showed well-defined erythema (grade 2) and very slight erythema (grade 1) were found in 4/20 animals. In addition, 13/20 animals showed very slight oedema. From above finding it is considered that Dodeca-1,3-dien-1-yl acetatewas considered to benot skin sensitizing in guinea pig.
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