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EC number: 297-664-9 | CAS number: 93686-15-8
- 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
Endpoint summary
Administrative data
Description of key information
No experimental data are available for the target substance C16 IOS-Na.
A negative in-vivo skin sensitisation study according to OECD TG 406 (GPMT) is available for the closely related source substance 1(C16-18 IOS-Na C16-rich).
The skin sensitization potential of C16-18 IOS-Na C16-rich was examined in guinea pigs according to the maximization test method. A total of 15 animals were used in the following groups: 10 animals in the test-substance sensitization group and 5 animals in the control group. Observation of skin reaction was performed 24 and 48 hours after patch removal.
As a result, no skin reaction was noted at any test concentration in either of the test-substance sensitization group or control group. During the observation period, no abnormalities were found in the general condition of the animals, and weight gain was satisfactory. In conclusion, the test substance has no skin-sensitization potential based on the above results.
According to the criteria of the CLP criteria the test substance does not have to be classified as skin sensitising.
Absence of critical impurities sultones (unsaturated 1,3-sultons and chloro sultones) was analytically proven for the target and source substance.
Sultones are below the limit of detection of 1 mg/kg (ppm).
Target (C16 IOS): <1 mg/kg
Source-1 (C16/18 IOS C16-rich): < 1 mg/kg
The result for source substance 1 can be also applied for the target substance because the minor structural differences between the target substance and source substance 1 are not expected to have an impact on the skin sensitising potential.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar (eco)toxicological properties because
Source and target substances share structural similarities (predominantly linear aliphatic hydrocarbon chain) with a common functional group: (polar sulfonate group). The molecular structure is almost identical.
They are manufactured from similar resp. identical precursors under similar conditions. Therefore, common breakdown products via physical and biological processes, which result in structurally similar chemicals are evident. Target and source substances are both a mixture of linear long chain Sulfonic acids, alkene, sodium salts and Sulfonic acids, alkane hydroxy, sodium salts and share an identical counter ion. A constant pattern in the changing of the potency of the properties across the target and source substances by chain-length and is not observed, because the distribution is too narrow.
Therefore, read-across from the existing toxicity studies on the source substance, is considered as an appropriate adaptation to the standard information requirements of Annex VII, 8.1, 8.2, 8.3, 8.4, 8.5 as well as 9.1 and 9.2 of the REACH Regulation for the target substance, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
see cross reference to assessment report: Justification for read-across document attached to section 13
3. ANALOGUE APPROACH JUSTIFICATION
see cross reference to assessment report: Justification for read-across document attached to section 13
4. DATA MATRIX
see cross reference to assessment report: Justification for read-across document attached to section 13 - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Type of study:
- guinea pig maximisation test
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- 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:
- 10
- Clinical observations:
- No abnormalities were found in the general condition of the animals, and weight gain was satisfactory.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- 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 were found in the general condition of the animals, and weight gain was satisfactory.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- 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:
- 10
- Clinical observations:
- No abnormalities were found in the general condition of the animals, and weight gain was satisfactory.
- Key result
- Reading:
- 2nd 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 were found in the general condition of the animals, and weight gain was satisfactory.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, Sulfonic acids, C16-alkane hydroxy and C16-alkene, sodium salts has no skin-sensitization potential based on the results with a structurally similar substance.
- Executive summary:
This read-across is based on the hypothesis that source and target substances have similar (eco)toxicological properties because
Source and target substances share structural similarities (predominantly linear aliphatic hydrocarbon chain) with a common functional group: (polar sulfonate group). The molecular structure is almost identical.
They are manufactured from similar resp. identical precursors under similar conditions. Therefore, common breakdown products via physical and biological processes, which result in structurally similar chemicals are evident. Target and source substances are both a mixture of linear long chain Sulfonic acids, alkene, sodium salts and Sulfonic acids, alkane hydroxy, sodium salts and share an identical counter ion. A constant pattern in the changing of the potency of the properties across the target and source substances by chain-length and is not observed, because the distribution is too narrow.
Therefore, read-across from the existing guinea pig maximisation test on the source substance, is considered as an appropriate adaptation to the standard information requirements of Annex VII, 8.3.2 of the REACH Regulation for the target substance, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 28th September 2012 to 6th December 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA was considered not to be suitable for the test substance.
- Specific details on test material used for the study:
- Expiry/retest date: 31 December 2012
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Slc: Hartley, closed colony, SPF
- Age at study initiation: 5 Weeks old
- Weight at study initiation: 301–328 g
- Housing: The animals were housed 5 or 6 per cage during the quarantine and acclimatization period, and 5 per cage during the experimental period.
- Diet: Pellet diet RC4 was offered ad libitum.
- Water: Municipal tap water filtered through a 5 -μm cartridge filter was offered ad libitum through an automatic water-supply system.
- Acclimation period: For 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.9–24.6
- Humidity (%): 45.8%–64.1
- Air changes (per hr): 12 Times /hour
- Photoperiod (hrs dark / hrs light): 12 Hours/day (on at 6:00 AM, off at 6:00 PM) - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- For intradermal sensitization: 0.05 w/w%
For contact sensitization: 0.5 w/w% - Day(s)/duration:
- For contact sensitization: 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- For challenge: 0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 animals in the test-substance sensitization group
5 animals in the control group - Details on study design:
- RANGE FINDING TESTS: In the preliminary study conducted under non-GLP conditions (study No. 1217-[1]), the test-substance solutions at 10, 5, 3, 1, 0.5, 0.3, 0.1, 0.05, 0.03, 0.01, 0.005, and 0.003 w/w% were intradermally administered. As a result, the solutions at 10, 5, 3, 1, 0.5, and 0.3 w/w% induced necrosis; the solution at 0.1w/w% induced subtle erythema to erythema with edema; and the solution at 0.05 w/w% induced subtle erythema. After occlusive application of the test-substance solutions at 5, 3, 1, 0.5, 0.3, and 0.1 w/w%, the solutions at 5 and 3 w/w% induced erythema of Score 4 (Score 4 means eschar) with edema of Scores 2 or 3; the solution at 1 w/w% induced erythema of Scores 1 through 4 (Score 4 means eschar) with edema of Score 1; and the solution at 0.5w/w% solution induced erythema of Score 1. Based on the above results, 0.05 w/w% was selected for intradermal sensitization; 0.5 w/w%, for contact sensitization; and 6 concentrations of 0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%, for challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
For intradermal sensitization of the test-substance group, 0.1 mL each of the following 3 test materials were intradermally injected into 2 sites of the cervical region of the guinea pigs:
A, an emulsion of equal volumes of Freund’s complete adjuvant (FCA) and physiological saline;
B, the test-substance solution at 0.05w/w% (vehicle: physiological saline);
C, an emulsion of equal volumes of the test-substance solution at 0.1 w/w% (vehicle: physiological saline) and FCA.
For contact sensitization, 0.2 mL of the test-substance solution at 0.5 w/w% (vehicle: water for injection) was impregnated into a 2×4-cm piece of lint cloth on the day 7, followed by occlusive application to the sites for intradermal injection for 48 hours.
The control animals were treated in the same manner with the vehicles for each sensitization.
B. CHALLENGE EXPOSURE
For challenge, 0.1 mL each of the test-substance solutions at 0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w% (vehicle: water for injection) was impregnated into 1.5×1.5-cm pieces of lint cloth on the day 21 of the sensitization, and 24-hour occlusive application was made on the right and left lateral region.
Observation of skin reaction was performed 24 and 48 hours after patch removal. - Positive control substance(s):
- not required
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- 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:
- 10
- Clinical observations:
- No abnormalities were found in the general condition of the animals, and weight gain was satisfactory.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- 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 were found in the general condition of the animals, and weight gain was satisfactory.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- 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:
- 10
- Clinical observations:
- No abnormalities were found in the general condition of the animals, and weight gain was satisfactory.
- Key result
- Reading:
- 2nd 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 were found in the general condition of the animals, and weight gain was satisfactory.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, the test substance has no skin-sensitization potential based on the above results.
- Executive summary:
The skin sensitization potential of Internal Olefin Sulfonate was examined in guinea pigs according to the maximization test method. A total of 15 animals were used in the following groups: 10 animals in the test-substance sensitization group and 5 animals in the control group.
For intradermal sensitization of the test-substance group, 0.1 mL each of the following 3 test materials were intradermally injected into 2 sites of the cervical region of the guinea pigs: A, an emulsion of equal volumes of Freund's complete adjuvant (FCA) and physiological saline; B, the test-substance solution at 0.05w/w% (vehicle: physiological saline); C, an emulsion of equal volumes of the test-substance solution at 0.1 w/w% (vehicle: physiological saline) and FCA. For contact sensitization, 0.2 mL of the test-substance solution at 0.5 w/w% (vehicle: water for injection) was impregnated into a 2×4-cm piece of lint cloth on the day 7, followed by occlusive application to the sites for intradermal injection for 48 hours. The control animals were treated in the same manner with the vehicles for each sensitization. For challenge, 0.1 mL each of the test-substance solutions at 0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w% (vehicle: water for injection) was impregnated into 1.5×1.5-cm pieces of lint cloth on the day 21 of the sensitization, and 24-hour occlusive application was made on the right and left lateral region. Observation of skin reaction was performed 24 and 48 hours after patch removal.
As a result, no skin reaction was noted at any test concentration in either of thetest-substance sensitization group or control group. During the observation period, no abnormalities were found in the general condition of the animals, and weight gain was satisfactory. In conclusion, the test substance has no skin-sensitization potential based on the above results.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No skin reaction was noted at any test concentration in either of the test-substance sensitization group or control group. During the observation period, no abnormalities were found in the general condition of the animals, and weight gain was satisfactory. In conclusion, the test substance has no skin-sensitization potential based on the above results.
According to the criteria of the CLP criteria the substance does not have to be classified as skin sensitising and labelling is not necessary.
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.