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EC number: 268-159-0 | CAS number: 68015-93-0
- 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:
- 04 November 2015 - 11 December 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The LLNA is the study of choice for skin sensitisation. As detailed in the OECD 429 guideline, despite the advantages of the LLNA, it should be recognised that there are certain limitations that may necessitate the use of TG 406. Chemical groups such as metal salts, organometal, unsaturated compounds and surfactants have been known to be linked to false positive. The Substance is considered to be amphiphilic and therefore would likely have surfactant characteristics, and an unsaturated compound which are known to be falsely positive in the LLNA. Therefore a Guinea Pig Study, OECD 406, was conducted.
Test material
- Reference substance name:
- Octadec-2-enylsuccinic acid
- EC Number:
- 268-159-0
- EC Name:
- Octadec-2-enylsuccinic acid
- Cas Number:
- 68015-93-0
- Molecular formula:
- C22H40O4
- IUPAC Name:
- 2-octadec-2-en-1-ylsuccinic acid
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Physical Description: Pale amber waxy solid
Purity: 100%
Storage Conditions: Kept in a controlled room temperature area
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Temperatures of 68°F to 72°F (20°C to 22°C) with a relative humidity of 45% to 55% were maintained. A 12 hour light/12 hour dark cycle was maintained, except when interrupted for designated procedures. Ten or greater air changes per hour with 100% fresh air (no air recirculation) were maintained in the animal rooms.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Moistened with corn oil
- Concentration / amount:
- 100% (0.3 mL)
- Day(s)/duration:
- 3 inductions (Day 0, 7, 14) over 3 weeks / 6 hour exposure per induction
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 75%/ 0.3 mL
- Day(s)/duration:
- 1 Challlenge (Day 28)/ 6 hour exposure
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 animals for the main test
10 animals for control - Details on study design:
- The dermal sensitization potential of the Substance was evaluated in Hartley-derived albino guinea pigs. Ten male and 10 female guinea pigs were topically treated with the Substance, as received, once per week, for 3 consecutive weeks. Following a 2-week rest period, a challenge was performed whereby the 20 test and 10 previously untreated (naïve) challenge control guinea pigs were topically treated with 75% the Substance in PEG 400.
- Challenge controls:
- On the day prior to challenge dose administration, the test, HCA test, challenge control, and HCA challenge control animals were weighed and the hair was removed from the right side of the animals. On the day following clipping (Day 28), Hilltop chambers were applied.
- Positive control substance(s):
- yes
- Remarks:
- a-Hexylcinnamaldehyde (HCA)
Results and discussion
- Positive control results:
- The results of the HCA positive control study demonstrated that a valid test was performed and indicated that the test design would detect potential contact sensitizers.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Clinical observations:
- No related clinical signs were noted during the study
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- scores of 1 or 2
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- No related clinical signs were noted during the study
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- score of 1 or 2
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- No related clinical signs were noted during the study
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No related clinical signs were noted during the study
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 2.5%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 2.5%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
See attached background documents
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Based on the results of this study,the Substance s considered to be a contact sensitizer in guinea pigs as >15% of the test animals responded at challenge.
- Executive summary:
The dermal sensitization potential ofthe Substance was evaluated in Hartley-derived albino guinea pigs. Ten male and 10 female guinea pigs were topically treated withthe Substance, as received,once per week, for 3 consecutive weeks. Following a 2-week rest period, a challenge was performed whereby the 20 test and 10 previously untreated (naïve) challenge control guinea pigs were topically treated with 75%the Substancein PEG 400.
Following challenge with 75%the Substancein PEG 400, dermal scores of 1 or 2 were noted in 19/20 test animalsand1/10 challenge control animals at the 24-hour scoring interval. At the
48-hour scoring interval, dermal scores of 1 or 2 were noted in 20/20 test animals. Dermal reactions in the remaining test and challenge control animals were scores of 0 or ±. Group mean dermal scores were higher in the test animals (1.6) as compared to challenge control animals (0.3 to 0.2).Based on the results of this study,the substanceis considered to be a contact sensitizer in guinea pigsas >15% of the test animals responded at challenge. The results of the HCA positive control study demonstrated that a valid test was performed and indicated that the test design would detect potential contact sensitizers.
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