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EC number: 220-266-3 | CAS number: 2695-37-6
- 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
- Study period:
- 16 to 22 March 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Sodium 4-vinylbenzenesulphonate
- EC Number:
- 220-266-3
- EC Name:
- Sodium 4-vinylbenzenesulphonate
- Cas Number:
- 2695-37-6
- Molecular formula:
- C8H8O3S.Na
- IUPAC Name:
- .
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd mice
- Sex:
- female
- Details on test animals and environmental conditions:
- Species and strain: CBA/CaOlaHsd mice
Source: Envigo (formerly Harlan Laboratories S.r.l.) San Pietro al Natisone (UD)
Zona Industriale Azzida, 57, 33049 Italy
Hygienic level: SPF at arrival; standard housing conditions during the study
Justification of strain: On the basis of OECD Guideline, mice of CBA/Ca or
CBA/J strain can be used. Females are used because the existing database is predominantly based on females.
Number of animals: 4 animals / group
Sex: Female, nulliparous, non pregnant
Age of animals at starting: 8 weeks old (age-matched, within one week)
Body weight range at starting: 17.0 – 18.8 grams (The weight variation in animals in the study did not exceed 20 % of the mean weight.)
Acclimatization time: 7 days
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 50, 25 and 10 % w/v
- No. of animals per dose:
- 4 per dose
- Details on study design:
- Preliminary Irritation/Toxicity Test: Conducted on CBA/CaOlaHsd mice using two doses (2 animals/dose) at test item concentrations of 50 and 25 % (w/v) in 1% Pluronic.
The maximum concentration of test item in an acceptable solvent was established according to OECD guideline 429. Based on the observation of the solubility test, the maximum available concentration was 50 % (w/v).
In the Preliminary Irritation / Toxicity Test, all mice were observed daily for any clinical signs of systemic toxicity or local irritation at the application site. Both ears of each mouse were observed for erythema and scored. Ear thickness was also measured using a thickness gauge on Day 1 (pre-dose), Day 3 (approximately 48 hours after the first dose) and Day 6. Additional quantification of the ear thickness was performed by ear punch weight determination after the euthanasia of the experimental animals.
During the study, animals were topically dosed with 25 µL of the appropriate formulation using a pipette on the dorsal surface of each ear. Each animal was dosed once a day for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. - Positive control substance(s):
- other: 25 % HCA in AOO
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Remarks on result:
- other: The stimulation index values were 0.9, 1.5 and 1.1 at concentrations of 50, 25 and 10 % (w/v), respectively. The stimulation index value of the positive control 25 % (w/v) HCA in AOO was 18.4
- Key result
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: The DPM values were 288.4, 473.6 and 352.7 at concentrations of 50, 25 and 10 % (w/v), respectively. The DPM value of the positive control 25 % (w/v) HCA in AOO was 7236.4
Any other information on results incl. tables
No mortality or signs of systemic toxicity were observed during the study. There were no indications of any irritancy at the site of application. Test item precipitate or minimal amount of test item precipitate was observed on the ears of the animals in the 50 and 25 % (w/v) dose groups on Days 1-3.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance was shown to have no sensitisation potential (non-sensitizer) in the Local Lymph Node Assay
- Executive summary:
The skin sensitisation potential of the substance NaSS was assessed by means of the OECD 429 test Guideline in compliance with GLP. The highest achievable concentration based on the regulatory requirements of the OECD guideline and the physical characteristics of the test item was 50 %(w/v).
The Preliminary Irritation/Toxicity Test was performed in CBA/CaOlaHsd mice using two doses (2 animals/dose): 50 and 25 % (w/v) in 1% Pluronic. Based on the observations recorded in the preliminary test, the 50 % (w/v) was selected as top dose for the main test.
In the main assay, twenty female CBA/CaOlaHsd mice were allocated to five groups of four animals each:
-three groups received test sample (formulated in 1% Pluronic) at 50, 25 and 10 % (w/v)concentrations,
-the negative control group received the vehicle (1% Pluronic),
-the positive control group received 25 % (w/v) HCA (dissolved in AOO (acetone:olive oil 4:1 (v:v)mixture)).
The test item solutions were applied on the dorsal surface of ears of experimental animals (25 µL/ear) for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. The cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were used to calculate stimulation indices(SI).
No mortality or signs of systemic toxicity were observed during the study. There were no indications of any irritancy at the site of application. Test item precipitate or minimal amount of test item precipitate was observed on the ears of the animals in the 50 and 25 % (w/v) dose groups on Days 1-3. No treatment related effects were observed on the body weight changes of the experimental animals.
The stimulation index values were 0.9, 1.5 and 1.1 at concentrations of 50, 25 and 10 % (w/v),respectively.
The result of the positive control substance α-Hexylcinnamaldehyde (HCA) dissolved in AOO was used to demonstrate the appropriate performance of the assay. A lympho proliferative response in line with historic positive control data was noted for the positive control chemical, this result confirmed the validity of the assay.
In conclusion, under the conditions of the present assay, NaSS tested in a suitable vehicle, was shown to have no sensitisation potential (non-sensitizer) in the Local Lymph Node Assay.
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