Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 236-164-7 | CAS number: 13197-76-7
- 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:
- From 16th March 2010 to 16th April 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- OECD 406 method but non GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- The original study is reported in Japanese; an English translation is available but is not considered to be GLP
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test conducted much before the choice of LLNA is the first choice.
Test material
- Reference substance name:
- Dodecyl(2-hydroxy-3-sulphonatopropyl)dimethylammonium
- EC Number:
- 236-164-7
- EC Name:
- Dodecyl(2-hydroxy-3-sulphonatopropyl)dimethylammonium
- Cas Number:
- 13197-76-7
- Molecular formula:
- C17H37NO4S
- IUPAC Name:
- dodecyl(2-hydroxy-3-sulphonatopropyl)dimethylammonium
Constituent 1
- Specific details on test material used for the study:
- -Lot No. : PAPS1x
-Purity: 31.4%
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- -Test system
1) Species, strain and microbiological control level
Guinea pigs, Hartley strain (Std: Hartley), clean
2) Supplier
Japan SLC, Inc. (3371-8, Koto-cho, Nishi-ku, Hamamatsu, Shizuoka)
3) Age in weeks and body weights
Animals were obtained at 4 weeks of age, acclimatized to laboratory conditions and quarantined for 7 days. Only well-grown animals in good physical condition were subjected to the study. The mean body weight was 337 g at the time of sensitization and 457 g at the time of challenge.
-Animal-rearing management
1) Rearing environment
Animals were kept under the following conditions: room temperature, 23±3ºC; relative humidity, 50±20%; ventilation frequency, 17 times/hour; lighting time, 12 hours (6:00 to 18:00)/day.
2) Rearing equipment and housing
Upon receipt, animals were housed 5 per cage in stainless-steel cages (W350XD400×H230 mm: Natsume Seisakusyo Co., Ltd.) placed on an automatic flush rack (Natsume Seisakusyo Co., Ltd.).
3) Feed and Drinking water
Animals were given free access to solid feed (RC4: Oriental Yeast Co., Ltd.) and municipal tap water filtered through a 5-μm cartridge filter.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Saline for intradermaland and water for epicutaneous
- Concentration / amount:
- For intradermal: 0.1 and 0.2 w/w%
For epicutaneous: 1 w/w% - Day(s)/duration:
- For epicutaneous: 48h
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%
- Day(s)/duration:
- 24h
- No. of animals per dose:
- A total of 23 animals (8 of the preliminary test group, 10 of the sensitization group and 5 of the control group) were subjected to the study.
- Details on study design:
- -Materials
1) Freund’s complete adjuvant (FCA:DIFCO LABORATORIES, Lot No.8353847)
2) Physiological saline (Japanese pharmacopoeia (JP), Otsuka Pharmaceutical Factory Inc., Lot No. K9K74)
3) Distilled water for injection (Distilled water: JP, Otsuka Pharmaceutical Factory Inc., Lot No. K9K76)
-Test solutions and Preparation methods
The samples were prepared at the following concentrations (w/w%) (as an active ingredient concentration).
1) Preliminary test
(1) Test solutions used for intradermal administration
Concentration (%): 0.1, 0.5, 0.3, 0.2, 0.1, 0.05 with vehicle as Physiological saline
(2)Test solutions used for occlusive-patch application
Concentration (%): 0.05, 0.1, 0.3, 0.5,1, 3 with vehicle as Distilled water
2) Test solutions used for intradermal sensitization
a: 1:1(v/v) emulsion of FCA and physiological saline
b: 0.1% solution (vehicle: physiological saline, state: solution)
c: 0.2% solution (vehicle: physiological saline, state: solution), 1:1(v/v) emulsion with FCA
d: Physiological saline
3) Test solutions used for epicutaneous sensitization
Sensitization group: 1% solution (vehicle: distilled water, state: solution)
Control group: Distilled water
4) Test solutions used for challenge
Concentration (%): 0.005, 0.01, 0.03, 0.05,0.1, 0.3 with vehicle as Distilled water
-Study methods
1) Preliminary test
(1) Intradermal administration
Primary skin irritation was tested to establish the concentrations for intradermal sensitization.
The injection site was the left flank of animals, and 0.1 mL each of the test solutions for intradermal administration was injected.
(2) Occlusive-patch application
Primary skin irritation was tested to establish the concentrations for contact sensitization and challenge.
Animals of the FCA emulsion treatment group (0.1 mL each of FCA emulsion was intradermally injected symmetrically into 4 sites of the left and right dorsal back region of animals one week before occlusive patch application) were subjected to the study. The application site was the left and right flanks of animals. The fabric of a tape for a patch test was impregnated with 0.05 mL each of test solutions for occlusive patch application, and a 24-hour occlusive-patch test was performed. The application sites were varied among the animals so that the reaction might be averaged among the application sites.
2)Sensitization method
(1) Intradermal sensitization
The injection site was the dorsal neck region. On Day 0, 0.1 mL each of the test solutions for intradermal sensitization was injected into the left and right dorsal neck regions (two sites) of animals of the sensitization group in the following order from the front: a, b and c, and of animals of the control group in the following order from the front: a, d and a (the injection space between the test solutions for intradermal sensitization, a and b and between a and d was narrowed).
(2) epicutaneous sensitization
Seven days after the start of sensitization, the intradermal injection site of animals in the sensitization group was covered with a 2×4 cm lint fabric (Nishio Eisei Zairyo KK) that was impregnated with 0.2 mL of the test solution for contact sensitization using the impermeable tape (Blenderm: 3M company) and elastic, adhesive bandage (Silkytex: Alcare co.) by the 48-hour occlusive patch test method. In the control group, animals were treated in the similar manner using distilled water.
3) Challenge method
Twenty-one days after the start of sensitization, an occlusive challenge patch was applied for 24 hours. The application site was the left and right flanks of animals, and a tape for a patch test (small size: Torii Pharmaceutical Co., Ltd.), the fabric of which was impregnated with 0.05 mL each of the test solutions for challenge, was applied. In addition, for securing dressings, the tape for a patch test was secured with adhesive sponge tape (Microfoam: 3M company) and elastic adhesive bandage. The application sites were varied among the animals so that the reaction might be averaged among the application sites.
4) Judgment criteria
In the preliminary test, skin reactions after intradermal administration were read 24, 48 and 72 hours after administration based on the following criteria (1). In addition, skin reactions after occlusive-patch application and challenge application were read 3, 24 and 48 hours after removal of the patch according to Draize scoring criteria described in (2) in the preliminary test.
(1) Judgment criteria for skin reactions after intradermal administration
- : 0: No reaction
± : 1: Very slight erythema
+ : 2: Well-defined erythema
+ + : 3: Well-defined erythema with edema
+ + + : 4: Eschar formation, necrosis
(2) Judgment criteria for skin reactions after occlusive-patch application and challenge application (occlusive-patch application) (Draize’s method)
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well-defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet redness) to slight eschar formation (injuries in depth)
0: No edema
1: Very slight edema (barely perceptible)
2: Slight edema (edges of area well defined by definite raising)
3: Moderate edema (raised approximately 1 mm)
4: Severe edema (raised more than 1 mm and extending beyond the area of exposure)
5) Average reaction strength
Scores for erythema, eschar formation and edema formation were divided by the number of animals and added.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 27
- Group:
- test chemical
- Dose level:
- 0.3 w/w%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- No abnormalities in clinical signs were observed, and normal body weight gain was noted during the sensitization and challenge phases of the study.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.3 w/w%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- No abnormalities in clinical signs were observed, and normal body weight gain was noted during the sensitization and challenge phases of the study.
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.3 w/w%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- No abnormalities in clinical signs were observed, and normal body weight gain was noted during the sensitization and challenge phases of the study.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 27
- Group:
- test chemical
- Dose level:
- 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No abnormalities in clinical signs were observed, and normal body weight gain was noted during the sensitization and challenge phases of the study.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No abnormalities in clinical signs were observed, and normal body weight gain was noted during the sensitization and challenge phases of the study.
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No abnormalities in clinical signs were observed, and normal body weight gain was noted during the sensitization and challenge phases of the study.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 27
- Group:
- negative control
- Dose level:
- 0.3 w/w%
- No. with + reactions:
- 2
- Total no. in group:
- 5
- Clinical observations:
- No abnormalities in clinical signs were observed, and normal body weight gain was noted during the sensitization and challenge phases of the study.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.3 w/w%
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Clinical observations:
- No abnormalities in clinical signs were observed, and normal body weight gain was noted during the sensitization and challenge phases of the study.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 27
- Group:
- negative control
- Dose level:
- 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No abnormalities in clinical signs were observed, and normal body weight gain was noted during the sensitization and challenge phases of the study.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No abnormalities in clinical signs were observed, and normal body weight gain was noted during the sensitization and challenge phases of the study.
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No abnormalities in clinical signs were observed, and normal body weight gain was noted during the sensitization and challenge phases of the study.
- Reading:
- other: Not tested
- Hours after challenge:
- 0
- Group:
- positive control
- Dose level:
- Not tested
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
The challenge results (24 hours after removing the patches) are shown below.
Sample |
Concentration (%) |
Solvent |
Mean reaction intensity |
||
Sensitization group |
Control groups |
||||
(1) |
10-S-020 |
Act.0.3 |
Distilled water |
0.2 |
0.2 |
(2) |
10-S-020 |
Act.0.1 |
Distilled water |
0 |
0 |
(3) |
10-S-020 |
Act.0.05 |
Distilled water |
0 |
0 |
(4) |
10-S-020 |
Act.0.03 |
Distilled water |
0 |
0 |
(5) |
10-S-020 |
Act.0.01 |
Distilled water |
0 |
0 |
(6) |
10-S-020 |
Act.0.005 |
Distilled water |
0 |
0 |
The above results indicate that the test article has no sensitization potential.
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitising
- Conclusions:
- The study results indicate that the test substance has no sensitization potential.
- Executive summary:
The skin sensitization potential of 10-S-020 was examined in guinea pigs according to the Guinea Pig Maximization Test method.
A total of 23 animals including 8 for the preliminary test, 10 for the sensitization group, and 5 for the control group were used.
The concentration of the active ingredient in the test article was 31.4%. All samples were prepared based on the concentration of the active ingredient.
For sensitization induction, the following 3 preparations were intracutaneously administered to the back of each guinea pig: (a) an emulsion as prepared by mixing an equal volume of the Freund’s complete adjuvant (FCA) and physiological saline; (b) 0.1% solution of the test article (solvent: physiological saline); and (c) emulsion as prepared by mixing an equal volume of a 0.2% solution of the test article (solvent: physiological saline) and FCA. On Day 7 after starting sensitization, a patch infiltrated with a 1% solution of the test article (solvent: distilled water) was applied to each intracutaneous administration site and covered for 48 hours. The animals in the control group were treated in the same mannerexceptthe use of the solvent at each sensitization induction point.
For challenge, a patch infiltrated with the challenge solution was applied to the left and right flanks on Day 21 and covered for 24 hours.
The challenge results (24 hours after removing the patches) are shown below.
Sample
Concentration (%)
Solvent
Mean reaction intensity
Sensitization group
Control groups
(1)
10-S-020
Act.0.3
Distilled water
0.2
0.2
(2)
10-S-020
Act.0.1
Distilled water
0
0
(3)
10-S-020
Act.0.05
Distilled water
0
0
(4)
10-S-020
Act.0.03
Distilled water
0
0
(5)
10-S-020
Act.0.01
Distilled water
0
0
(6)
10-S-020
Act.0.005
Distilled water
0
0
The above results indicate that the test article has no sensitization potential.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.