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EC number: 236-124-9 | CAS number: 13177-41-8
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Dimethyloctadecyl(3-sulphopropyl)ammonium hydroxide
- EC Number:
- 236-124-9
- EC Name:
- Dimethyloctadecyl(3-sulphopropyl)ammonium hydroxide
- Cas Number:
- 13177-41-8
- Molecular formula:
- C23H49NO3S
- IUPAC Name:
- dimethyl(octadecyl)(3-sulfopropyl)azanium hydroxide
- Test material form:
- solid
1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- Mice CBA/CaOlaHsd
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- Pre-screen test: 25, 10 & 5 %w/v
Main test: 10, 5 & 2.5 %w/v - No. of animals per dose:
- 5
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Valid, SI 13.53
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 4.1
- Test group / Remarks:
- 2.5%
- Parameter:
- SI
- Value:
- 2.43
- Test group / Remarks:
- 5%
- Parameter:
- SI
- Value:
- 5.94
- Test group / Remarks:
- 10%
- Parameter:
- EC3
- Value:
- 4.1
- Test group / Remarks:
- 5%
- Parameter:
- EC3
- Value:
- 5.81
- Test group / Remarks:
- 10%
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
2.5 %: 11622
5 %: 6882
10%: 16839
EC3 CALCULATION
Estimated concentration of a test substance needed to produce a stimulation index of three. EC3 value is determined by linear interpolation of points on dose-response curve, immediately above and below of SI value, according to the equation:
EC3=c+[(3-d)/(b-d)]x(a-c)
a – higher concentration, b – SI of higher concentration, c – lower concentration, d – SI of lower concentration
If all points are below the stimulation index of three, no EC3 value can be stated.
CLINICAL OBSERVATIONS:
Daily clinical observation of animals did not show visible clinical signs of systemic toxicity in all treated mice
BODY WEIGHTS
No effects on body weights in all treated mice
SIGNS OF TOXICITY (including dermal irritation at the site of administration, if any, e.g. increased ear thickness).
No signs of significant local irritation were observed in test item treated groups. Slight vascular drawing was visible on ears of in high dosed group of mice (high dose group 10 %) on days 2-3. At the application site, white precipitates were observed at the ends of the ears.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Based on the EC3 value of 5% the test item is considered a skin sensitizer. According to the ECETOC classification, test item is classified as moderate allergen.
- Executive summary:
The sensitization potential of the test item was evaluated using Local Lymph Node Assay (LLNA) accoridng to OECD 429. Based on the observation in the Pre-screen test, the concentrations of 10 %, 5 % and 2.5 % (w/v) were selected for the Main study. Five female mice (CBA/CaOlaHsd) per group were topically exposed (dorsum of both ears) to the test item at concentrations. Lymphocyte proliferation was measured using incorporation of radioactive 3H-methyl-thymidine in the draining lymph nodes. The radioactive incorporation was measured as disintegrations per minute (DPM). Results were expressed as Stimulation Index (SI) calculated as DPM/pooled treatment group divided by DPM/vehicle control group.
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