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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 271-843-1 | CAS number: 68609-93-8
- 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 May 13, 2014 to July 25, 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Food and Agricultural Materials Inspection Centre (FAMIC), 12 Nohsan, Notification No. 8147, April 2011; including the most recent partial revisions.
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA study was not conducted as the substance is a surfactant. Surfactants have been shown to often give false-positive results in LLNA studies. Therefore GPMT studies are more adapted to this type of chemistry.
Test material
- Reference substance name:
- 9-Octadecenoic acid (Z)-, sulfonated, potassium salts
- EC Number:
- 271-843-1
- EC Name:
- 9-Octadecenoic acid (Z)-, sulfonated, potassium salts
- Cas Number:
- 68609-93-8
- Molecular formula:
- A generic formula cannot be provided for this UVCB substance. The alkyl chain length of the sulfonated fatty acids range from C12-C22, however the major alkyl chain is C18.
- IUPAC Name:
- 9-Octadecenoic acid (Z)-, sulfonated, potassium salts
- Test material form:
- other: powder/flakes with lumps
- Details on test material:
- - Name of test material (as cited in study report): 9-Octadecenoic acid (Z)-, sulfonated, potassium salts
- Physical state: Beige-yellow powder/flakes with lumps (i.e., determined at WIL Research Europe B.V.)
- Analytical purity: 100%
- Water content: 0.5%
- pH: 6 at concentration of 1g/L
- Lot/batch No.: 7495382
- Expiration date of the lot/batch: December 31, 2015
- Storage condition of test material: At room temperature in the dark
- Stability in vehicle: Water: Yes
- Solubility in vehicle: Water: Completely miscible
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Dunkin Hartley strain (SPF-quality)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L’arbresle Cedex, France
- Age: Young adult animals (approximately 4 weeks old) were selected. Females were nulliparous and non-pregnant.
- Housing: Group housing of maximally 5 animals per labeled Noryl cage (i.e., Tecniplast; 74 cm x 54 cm x 25 cm height) containing sterilized sawdust as bedding material (i.e., Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) and shelters (i.e., CS3B02A Play tunnels (90 mm x 5 mm x 125 mm), Datesand, Manchester, UK) as cage enrichment
- Diet: Complete maintenance diet for guinea pigs (SSNIFF® Spezialdiäten GmbH, Soest, Germany). In addition, hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least twice a week
- Water: Free access to tap water
- Acclimation period: At least 5 d
- Animal identification: Ear tattoo
- Health inspection: At least prior to dosing. It was ensured that the animals were healthy and that the skin to be treated was intact and free from any abnormality
ENVIRONMENTAL CONDITIONS
- Temperature: 18 to 24°C
- Humidity: 40 to 70%
- Air changes: 10 air changes/h
- Photoperiod: 12 h light/12 h dark cycle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: water and Freunds' Complete Adjuvant were used for the intradermal applications and water for the dermal applications
- Concentration / amount:
- Induction:
Concentration for intradermal injection: 0.5%
Concentration for dermal application: 5%
Challenge:
Concentration for dermal application: 5%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: water and Freunds' Complete Adjuvant were used for the intradermal applications and water for the dermal applications
- Concentration / amount:
- Induction:
Concentration for intradermal injection: 0.5%
Concentration for dermal application: 5%
Challenge:
Concentration for dermal application: 5%
- No. of animals per dose:
- Number of animals in experimental group: 10 females
Number of animals in control group: 5 females - Details on study design:
- Main study
The concentrations and induction method were selected based on the results of the preliminary irritation study.
INDUCTION - Experimental animals
Day 1: The scapular region was clipped and three pairs of intradermal injections (i.e., 0.1 mL/site) were made in this area as follows:
A) A 1:1 w/w mixture of Freunds' Complete Adjuvant (Difco, Detroit, U.S.A.) with water for injection (B.Braun Melsungen AG, Melsungen. Germany).
B) The test substance at a 0.5% concentration.
C) A 1:1 w/w mixture of the test substance, at twice the concentration used in (B) and Freunds' Complete Adjuvant.
Note: One of each pair was on each side of the midline and from cranial A) to caudal C).
Day 3: The dermal reactions caused by the intradermal injections were assessed for irritation.
Day 8: The scapular area between the injection sites was clipped and subsequently treated with 0.5 mL of a 5% test substance concentration using a Metalline patch (i.e., 2x3 cm) mounted on Medical tape, which was held in place with Micropore tape and subsequently Coban elastic bandage.
The dressing was removed after 48 h exposure, the skin cleaned of residual test substance using water and the dermal reactions caused by the epidermal exposure were assessed for irritation.
INDUCTION - Control animals
The control animals were treated as described for the experimental animals except that, instead of the test substance, vehicle alone was administered.
CHALLENGE - All animals
Day 22: One flank of all animals was clipped and treated by epidermal application of a 5% test substance concentration and the vehicle (i.e., 0.1 mL each), using Patch Test Plasters (Curatest, Lohmann, Almere, The Netherlands). The patches were held in place with Micropore tape and subsequently Coban elastic bandage.
The dressing was removed after 24 h exposure and the skin cleaned of residual test substance and vehicle using water. The treated sites were assessed for challenge reactions 24 and 48 h after removal of the dressing.
After termination, animals were sacrificed using isoflurane (Abbott B.V., Hoofddorp, The Netherlands) and an intra-peritoneal injection of Euthasol® 20% (AST Farma BV, Oudewater, The Netherlands).
Observations
-Mortality/Viability: Twice daily
-Toxicity: At least once daily.
-Body weights: Prior to start and at termination of the study.
-Irritation: Skin reactions were graded according to the numerical scoring systems. Furthermore, a description of all other (local) effects was recorded for the epidermal treated skin sites.
To facilitate scoring, the epidermally treated skin-areas were clipped at least 3 h before the 48 h reading of these areas in the challenge phase. - Positive control substance(s):
- yes
- Remarks:
- (alpha-hexylcinnamaldehyde, technical grade tested in another study)
Results and discussion
- Positive control results:
- After the challenge treatment with 20% concentration positive response was observed in 50% of the treated animals.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% dermal application
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% dermal application
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5% dermal application
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5% dermal application
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 20% dermal application
- No. with + reactions:
- 5
- Total no. in group:
- 5
Any other information on results incl. tables
PRELIMINARY IRRITATION STUDY
The results of the intradermal injections and epidermal exposures for the selection of suitable test substance concentrations for the main study are described in following tables.
SKIN REACTIONS AFTER INTRADERMAL INJECTION
|
|
|
|
||
Animal |
Conc % |
24 h after injection |
48 h after injection |
||
number |
|
Erythema |
Necrosis |
Erythema |
Necrosis |
|
|
(grade) |
(mm) |
(grade) |
(mm) |
|
|
|
|
|
|
28 |
50 |
|
8 |
|
8 |
|
20 |
|
8 |
|
8 |
29 |
10 |
|
8 |
|
8 |
|
5 |
|
7 |
|
7 |
25 |
1 |
|
2 |
|
2 |
|
0.5 |
2 |
|
1 |
|
30 |
0.2 |
1 |
|
1 |
|
|
0.1 |
1 |
|
1 |
|
|
|
|
|
|
|
SKIN REACTIONS AFTER EPIDERMAL EXPOSURE
|
|
|
|
||
Animal |
Conc. % |
24 h after exposure |
48 h after exposure |
||
number |
|
Erythema |
Oedema |
Erythema |
Oedema |
|
|
(grade) |
(grade) |
(grade) |
(grade) |
|
|
|
|
|
|
26 |
50 |
np |
1 |
n |
1 |
|
20 |
np |
0 |
np |
0 |
27 |
50 |
np |
1 |
n |
1 |
|
20 |
np |
0 |
np |
0 |
28 |
10 |
np |
0 |
np |
0 |
|
5 |
0s |
0 |
0s |
0 |
29 |
10 |
np |
0 |
np |
0 |
|
5 |
0s |
0 |
0s |
0 |
|
|
|
|
|
|
s. Scaliness
np. Signs of superficial necrosis
n. Signs of necrosis
Based on the results, the test substance concentrations selected for the main study were a 0.5% concentration for the intradermal induction and a 5% concentration for the epidermal induction exposure. A 5% test substance concentration was selected for the challenge phase.
MAIN STUDY
Induction phase
The skin effects caused by the intradermal injections and epidermal exposure during the induction phase are given in following table:
|
|
|
|
|
||||||||||||
Animal |
|
Intradermal injection (i.e., Day 3) |
|
Epidermal exposure (i.e., Day 10) |
||||||||||||
Number |
|
A |
|
B |
|
C |
|
|
D |
|||||||
|
|
|
|
|
|
|
|
|||||||||
Control |
|
E |
N |
|
E |
N |
|
E |
N |
|
|
Erythema |
Oedema |
|||
31 |
|
3 |
|
|
0 |
|
|
3 |
|
|
|
|
0 |
|
0 |
|
32 |
|
3 |
|
|
0 |
|
|
3 |
|
|
|
|
0 |
|
0 |
|
33 |
|
3 |
|
|
0 |
|
|
2 |
|
|
|
|
0 |
|
0 |
|
34 |
|
3 |
|
|
0 |
|
|
3 |
|
|
|
|
0 |
|
0 |
|
35 |
|
3 |
|
|
0 |
|
|
3 |
|
|
|
|
0 |
|
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Experimental |
E |
N |
|
E |
N |
|
E |
N |
|
|
|
|
|
|
||
36 |
|
3 |
|
|
1 |
|
|
3 |
|
|
|
|
0 |
|
0 |
|
37 |
|
3 |
|
|
1 |
|
|
|
4 |
|
|
|
0 |
|
0 |
|
38 |
|
3 |
|
|
1 |
|
|
|
4 |
|
|
|
0 |
|
0 |
|
39 |
|
3 |
|
|
0 |
|
|
|
4 |
|
|
|
0 |
|
0 |
|
40 |
|
2 |
|
|
1 |
|
|
3 |
|
|
|
|
0 |
|
0 |
|
41 |
|
3 |
|
|
1 |
|
|
|
3 |
|
|
|
0 |
|
0 |
|
42 |
|
3 |
|
|
1 |
|
|
|
3 |
|
|
|
0 |
|
0 |
|
43 |
|
3 |
|
|
1 |
|
|
|
5 |
|
|
|
0 |
|
0 |
|
44 |
|
3 |
|
|
1 |
|
|
|
4 |
|
|
|
0 |
|
0 |
|
45 |
|
3 |
|
|
0 |
|
|
|
4 |
|
|
|
0 |
|
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
A. 1:1 Mixture of Freunds' Complete Adjuvant and water for injection.
B. A 0.5% test substance concentration (Experimental); vehicle (Control).
C. 1:1 Mixture of Freunds' Complete Adjuvant and a 10% concentration (Experimental) or vehicle (Control).
D. A 5% test substance concentration (Experimental); vehicle (Control).
Skin effects intradermal injections:
E. Erythema (grade)
N. Signs of necrosis (mm in diameter)
Challenge phase
No positive skin reactions were evident after the challenge exposure in the experimental and control animals. Scaliness was noted for one experimental animal which was not considered a positive sign indicating sensitization.
Toxicity / Mortality
No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.
Body weights
Body weights and body weight gain of experimental animals remained in the same range as controls over the study period .
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- Under the study conditions, the test substance showed no evidence of sensitising properties.
- Executive summary:
A study was conducted to determine the skin sensitization potential of the test substance according to OECD Guideline 406 (guinea pig maximization test), in compliance with GLP. Based on the results of the preliminary study, 0.5 and 5% of test substance in water were selected as intradermal and dermal induction doses. The concentration used for challenge application was 5% test substance in water. None of the animals in the treatment group showed skin reactions 24 and 48 hours after removal of the dressings. Under the study conditions, the test substance showed no evidence of sensitising properties (Van Huygevoort, 2014).
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.