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EC number: 308-783-3 | CAS number: 98510-75-9
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study. GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- July 17th, 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Undecylenamidopropyl Betaine
- IUPAC Name:
- Undecylenamidopropyl Betaine
- Details on test material:
- - Name of test material (as cited in study report): Undecylenamidopropyl Betaine
- Physical state: solid
- Analytical purity: 84%
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
- Weight at study initiation: 360.2 ± 20.5 g (test group) and 340.3 ± 18.6 g (control group)
- Housing: 2 or 3 animals in Makrolon-cages No. IV
- Diet (e.g. ad libitum): type "3023" from Altromin International, Lage, Germany as pelleted diet, ad libitum
- Water (e.g. ad libitum): tap water from municipal source, ad libitum
- Acclimation period: 13 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: tap water, filter sterilized
- Concentration / amount:
- Intradermal induction: 0.5 % (w/w) in vehicle
Dermal induction: 35 % (w/w) in vehicle
Challenge: 5 % (w/w) in vehicle
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: tap water, filter sterilized
- Concentration / amount:
- Intradermal induction: 0.5 % (w/w) in vehicle
Dermal induction: 35 % (w/w) in vehicle
Challenge: 5 % (w/w) in vehicle
- No. of animals per dose:
- Number of animals in the test group: 10
Number of animals in the negative control group: 5
Number of animals in the dose range finding study: 3 - Details on study design:
- RANGE FINDING TESTS:
Intradermal: 0.1 mL of 5 %, 3.5 %, 2 % and 0.5 % (w/w) solution in vehicle.
Dermal: soaked patch with 50 %, 35 %, 20 % and 5 % (w/w) solution in vehicle.
Challenge: soaked patch with Duhring chamber with 20 % and 5 % (w/w) solution in vehicle.
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal application (day 0)
- No. of exposures: 1
- Test groups:
(1) 0.1 mL FCA (1 + 1).
(2) 0.1 mL per side of the solution 0.5% test substance
(3) 0.1 mL per side of the solution 0.5% test substance experiment in FCA (1 + 1).
- Control group:
(1) 0.1 mL FCA (1 + 1).
(2) 0.1 mL per side of the solution of the vehicle
(3) 0.1 mL per side of the solution of the vehicle in FCA (1 + 1)
- Site: Ieft and right shoulder
Topical application (day 7)
- No. of exposures: 1
- Exposure period: 48 h
- Test groups: 35 % (w/w) in vehicle
- Control group: vehicle
- Site: same as for intradermal induction
As the applied test substance concentration was slightly irritating, no pretreatment to generate local irritation was required.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21
- Exposure period: 24 h
- Test groups: left flank: 5 % (w/w) in vehicle in Duhring chamber; right flank: vehicle in Duhring chamber
- Control group: left flank: 5 % (w/w) in vehicle in Duhring chamber; right flank: vehicle in Duhring chamber
- Evaluation (hr after challenge): 24 + 48 h - Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole
Results and discussion
- Positive control results:
- Sensitisation rate of 90 % (9 of 10 animals positive) (experiment: 2008-02-25 to 2008-03-28)
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- 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: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- 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: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- 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: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- 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: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Skin reactions after induction
|
|
Intradermal Induction |
Epicutanous Induction |
||
Group |
Animal |
Erythema |
Edema |
Erythema |
Edema |
Test group |
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
|
3 |
1 |
0 |
0 |
0 |
|
4 |
0 |
0 |
0 |
0 |
|
5 |
1 |
0 |
1 |
0 |
|
6 |
1 |
1 |
1 |
0 |
|
7 |
0 |
0 |
0 |
0 |
|
8 |
0 |
0 |
0 |
0 |
|
9 |
1 |
0 |
0 |
0 |
|
10 |
1 |
0 |
1 |
0 |
|
Control group |
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
|
4 |
0 |
0 |
0 |
0 |
|
5 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- In this study, Undecylenamidopropyl Betaine is not a dermal sensitiser.
- Executive summary:
In a dermal sensitisation study according to OECD TG 406, 1992 with Undecylenamidopropyl Betaine (84% a.i.) in filter-sterilised tap water, female Dunkin-Hartley guinea pigs were tested using the Maximization test method. Positive control substance was 2-Mercaptobenzothiazole with a sensitisation rate of 90%.
In the main experiment ten animals were treated intradermally with a 0.5% (w/w) solution of the test substance in vehicle; for the dermal induction a 35% (w/w) concentration of the test substance in vehicle was used (= test group). Further five female animals were treated similarly - with the exception that they received only the vehicle instead of the test substance (= control group).
On day 21 of the application period the challenge application was performed on all control and test group animals. Duhring chambers with a 5% (w/w) solution of the test substance in vehicle were used.
Besides slight crust formation at the injection sides after intradermal application with FCA no symptoms of systemic toxicity or other toxic reactions were observed at any time during the study. Body weight development of the animals was positive and within normal ranges.
In the challenge no visible changes (no erythema and no edema) were observed at any time point; i.e, there was no positive challenge result in the test and the control group animals. Thus, the sensitisation rate was 0%.
In this study, Undecylenamidopropyl Betaine is not a dermal sensitiser.
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