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EC number: 946-448-9 | 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:
- 08 October to 08 November 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The in vivo study data were obtained in studies performed before any in vitro sensitization tests had been validated and accepted for regulatory purposes
Test material
- Reference substance name:
- Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 1-aminopropane-2-ol
- EC Number:
- 939-479-4
- Molecular formula:
- not applicable, UVCB
- IUPAC Name:
- Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 1-aminopropane-2-ol
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1)
- Name of product (as cited on Certificate of Analysis): MARLON AMI 80
- Substance type: technical product
- Physical state: colourless to light yellow liquid
- Analytical purity: 78% benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1) in 22% 1,2-propylene glycol (communication with sponsor)
- Batch No.: 126
- Storage condition of test material: room temperature in the dark
- Other: data not verified by the laboratory; identity details were supplied by the Sponsor
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River (F-69592 L'ABRESLE)
- Age at study initiation: 4 weeks
- Weight at study initiation: 240 to 276 g
- Housing: in polycarbonate containers, florring covered with dust-free cuttings, stainless steel lid
- Diet: ad libitum
- Water: d libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30-70
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 50% v/v isotonic sodium chloride for the induction phase, 50% v/v distilled water
- Concentration / amount:
- Induction phase: intredermal injection of 0.2%, epicutaneous application at 20%
challenge: 1% and 0.5% test material
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 50% v/v isotonic sodium chloride for the induction phase, 50% v/v distilled water
- Concentration / amount:
- Induction phase: intredermal injection of 0.2%, epicutaneous application at 20%
challenge: 1% and 0.5% test material
- No. of animals per dose:
- 10 (5 control)
- Details on study design:
- RANGE FINDING TESTS:
intradermal injection ( determination of Maximal Non Necrotizing Concentration: MNNC)-5, 10, 25 and 50% test item in isotonic sodium chloride. Necrosis was seen in all dose levels, and hence, lower concentrations were tested: 0.2, 0.5, 1 and 2%
topical application-
1.determination of the Pre-Maximal Non Irritant Concentration (Pre-MNIC): 10, 20, 50, 100% in distilled water, 24 h occlusive dressing
2. determination of the Maximal Non Irritant Concentration: 1, 2, 5 and 10% in distilled water
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 pairs of intradermal injections and one epicutaneous application
- Test groups: intradermal- 1. FCA in vehicle, 2. TM (Test Material) at 0.2% in vehicle, 3. FCA 50% v/v, 50% TM (0.4% v/v) in vehicle
epicutaneous- 0.5 mL TM (20%) in distilled water, occlusive dressing for 48 hours
- Control group: intradermal- 1. 50% FCA in vehicle, 2. vehicle, 3. FCA at 50% in vehicle (equal volumes)
epicutaneous- 0.5 mL distilled water
- Site: scapular zone
- Frequency of applications: day 0 (intradermal) and day 7 (epicutaneous)
- Duration: 0-9 days
B. CHALLENGE EXPOSURE
- Exposure period: 24 h
- Test groups: 1% and 0.5% test material
- Site: dorso-lumbar area - Positive control substance(s):
- yes
- Remarks:
- α-Hexylcinnamaldehyde
Results and discussion
- Positive control results:
- α-Hexylcinnamaldehyde showed positive results, i.e. it exerted allergenic reactions on the guinea pigs tested.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 and 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 and 1%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 and 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 and 1%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 and 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.5 and 1%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 and 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5 and 1%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 6.25 and 12.5%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 6.25%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 12.5%
- No. with + reactions:
- 10
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In view of this results, MARLON AMI 80 and hence,benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1) are not a dermal sensitizers.
- Executive summary:
In a dermal sensitization study with MARLON AMI 80 (78% benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1) in 22% 1,2-propylene glycol).Ten young adult Dunkin-Hartley guinea pigswere tested using the method of Magnusson and Kligmann according to OECD 406.α-Hexylcinnamaldehyde was used as apositive control material. No cutaneous reaction attributable to allergy was recorded in animals from the treated group after the challenge phase, with the test item at 1% and 0.5%. No cutaneous intolerance reaction was recorded in animals from the negative control group after thechallenge phase, on the treated area with the test item at 1% and 0.5%.
In this study, MARLON AMI 80 and hence,benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1) is not a dermal sensitizer.
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