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EC number: 948-034-3 | CAS number: -
- 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:
- 1986-04-02 to 1986-05-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- This test was performed before the LLNA was adopted as standard method for sensitisation testing.
Test material
- Reference substance name:
- Sodium octane-1-sulphonate monohydrate
- EC Number:
- 226-195-4
- EC Name:
- Sodium octane-1-sulphonate monohydrate
- Cas Number:
- 5324-84-5
- Molecular formula:
- C8H18O3S.Na
- IUPAC Name:
- sodium octane-1-sulfonate hydrate
- Test material form:
- liquid
- Details on test material:
- name of test material in study: BIO TERGE PAS-8S
appearance: clear liquid with cloudy precipitate at the bottom
The test material was received from Stepan Company on March 24, 1986, for use in this test. The sponsor has assumed responsibility for test substance derivation, characterization, and stability testing.
Constituent 1
- Specific details on test material used for the study:
- The material was stored at room temperature in a clear glass bottle throughout the study. The test material was disposed of at the conclusion of testing.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Remarks:
- Albino
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Murphy Breeding Laboratories, Inc.
- Weight at study initiation: 225 to 325 g.
- Housing: Animals were housed singly in wire mesh suspension cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Upon receipt in the laboratory the animals were maintained in quarantine for at least seven days.
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25 % w/v
- Day(s)/duration:
- 3 weekly applications of 6 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5 % w/v
- Day(s)/duration:
- 6 h, two weeks after last induction
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
Primary Irritation
Prior to induction and primary challenge, the test material was applied to guinea pigs to determine the concentrations appropriate for use during these study phases. For this purpose, BIO TERGE PAS-8S was tested undiluted and as 50 %, 25 %, 10 %, 5 %, 2.5 %, and 1.0 % w/v formulations in distilled water.
On the day before the applications were made, the backs of the animals were clipped with electric clippers to provide enough area to test four concentrations on each guinea pig. On the following day, the animals were placed in stainless steel restrainers and patches were applied to each animal. The patches, incorporating a 25 mm Hill Top Chamber, were moistened with 0.3 ml of one of the test formulations. The patches were occluded with dental dam placed over the back of each animal and secured with metal clips. The animals were restrained for six hours and then returned to their cages.
On the day following applications, the clipped areas were depilated with NEET CREAM HAIR REMOVER (Whitehall Laboratories, Inc.). The depilatory was allowed to remain on the sites for seven to nine minutes and then washed off with warm tap water. The patch sites were scored for severity of response at 24-hours and 48-hours without additional depilation. A concentration of 25 % w/v in distilled water was chosen for use at induction while a concentration of 5 % w/v in distilled water was chosen for use at primary challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 3 weeks
- Test groups: 1 group of 20 animals
- Control group: none
- Site: upper left quadrant of the back
- Frequency of applications: once per week
- Duration: 6 h
- Concentrations: 25 %w/v
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 1 week
- Exposure period: 6 h
- Test groups: 1 group of 20 animals
- Control group: yes, 10 animals
- Site: lower left quadrant of the back
- Concentrations: 5 % w/v
- Evaluation (hr after challenge): 24 h and 48 h
- Challenge controls:
- yes
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- no positive control
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 % w/v
- No. with + reactions:
- 5
- Total no. in group:
- 19
- Clinical observations:
- not specified
- Remarks on result:
- other: contradictory information on challenge concentration in report (reported as 5 %w/v and 10 % w/v)
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 % w/v
- No. with + reactions:
- 5
- Total no. in group:
- 19
- Clinical observations:
- not specified
- Remarks on result:
- other: contradictory information on challenge concentration in report (reported as 5 %w/v and 10 % w/v)
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5 % w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- not specified
- Remarks on result:
- other: contradictory information on challenge concentration in report (reported as 5 %w/v and 10 % w/v)
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5 % w/v
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- not specified
- Remarks on result:
- other: contradictory information on challenge concentration in report (reported as 5 %w/v and 10 % w/v)
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Table 1: Skin grades following primary challenge of the test item in guinea pigs
Animal No. |
Sex |
Numerical Score |
|
24-hour |
48-hour |
||
Test Material (10 % w/v in distilled water) in Induced Animals |
|||
T-1 YL327 |
M |
0 |
0 |
T-2 YL327 |
M |
0 |
0 |
T-3 YL327 |
M |
0 |
0 |
T-4 YL327 |
M |
0 |
0 |
T-5 YL327 |
M |
0 |
0 |
T-6YL327 |
M |
0 |
0 |
T-7 YL327 |
M |
0 |
± |
T-8 YL327 |
M |
0 |
0 |
T-9YL327 |
M |
0 |
0 |
T-10YL327 |
M |
0 |
± |
T-11YL327 |
F |
0 |
0 |
T-12YL327 |
F |
0 |
0 |
T-13YL327 |
F |
0 |
0 |
T-14YL327 |
F |
0 |
± |
T-15YL327 |
F |
± |
± |
T-16YL327 |
F |
0 |
0 |
T-17 YL327 |
F |
0 |
0 |
T-18 YL327 |
F |
0 |
0 |
T-19YL327 |
F |
FD |
FD |
T-20 YL327 |
F |
0 |
± |
|
|
Mean 0.03 |
Mean 0.1 |
Test Material (10 % w/v in distilled water) in Naive Animals |
|||
C-21YL327 |
M |
0 |
0 |
C-22 YL327 |
M |
0 |
0 |
C-23 YL327 |
M |
0 |
0 |
C-24YL327 |
M |
0 |
± |
C-25 YL327 |
M |
0 |
0 |
C-26YL327 |
F |
0 |
± |
C-27 YL327 |
F |
0 |
0 |
C-28 YL327 |
F |
0 |
0 |
C-29YL327 |
F |
0 |
± |
C-30YL327 |
F |
0 |
0 |
|
|
Mean 0.0 |
Mean 0.2 |
±=slight patchy erythema (Grades of + are equal to 0.5 for calculating the mean)
FD = Animal found dead following third induction. Necropsy showed lungs pale, liver pale, abdominal cavity filled with a red blood-like material, and slight post-mortem autolysis.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The potential of sodium octane-1-sulphonate monohydrate (EC 226-195-4; CAS 5324-84-5) as a 25 % w/v formulation in distilled water to produce a delayed contact hypersensitivity response in guinea pigs was evaluated in a modification of the Buehler test.
The incidence of grade + responses in the test group (5 of 19) was compared to that of the naive control group, (3 of 10) at primary challenge. The incidence and severity of the responses in the test group was essentially comparable to that produced by the naive control group indicating that sensitisation had not been induced. - Executive summary:
The potential of sodium octane-1-sulphonate monohydrate (EC 226-195-4; CAS 5324-84-5) to produce delayed contact hypersensitivity in guinea pigs was evaluated by a modification of the Buehler test. The test material, as a 25 % w/v formulation in distilled water, was applied to the backs of male and female Hartley guinea pigs for three six-hour periods at weekly intervals. Group sizes were 20 animals for the test group and 10 animals for the naive control group. Approximately two weeks after the last induction session, the test material prepared as a 5 % w/v formulation in distilled water was reapplied to the test animals for six hours. The test material was also applied to ten naive control animals. The next day the sites were depilated and scored for severity of response 24-hours and 48-hours after removal of the patches. The incidence of grade + responses in the test group (5 of 19) was compared to that of the naive control group, (3 of 10) at primary challenge. The incidence and severity of the responses in the test group was essentially comparable to that produced by the naive control group indicating that sensitisation had not been induced.
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