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EC number: 939-651-9 | CAS number: 1474044-70-6
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1983-06-01 To 1983-07-01
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Conducted at a GLP accredited laboratory to GLP
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- : Post-study body weights of animals are not mentioned.
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hacking and Churchill Ltd.
- Age at study initiation: Young females
- Weight at study initiation: 599-853 gm
- Housing: Caged in groups of two by dose group in grid floor propylene cages.
- Diet (e.g. ad libitum): Guinea Pig diet, standard with vitamin C, Special diets Srvices Ltd., Witham, ad libitum
- Water (e.g. ad libitum): ad libitum (A certificate for quality of drinking water was issued by the Yorkshire Water Authority)
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26 deg C
- Humidity (%): 40-64%
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): 12/12 (artificial light, 06.00 to 18.00)
IN-LIFE DATES: From: 1983-06-01 To: 1983-07-01 - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- One group of 20 test animals was treated with 0.4 ml of undiluted test material for an exposure period of 6 hours weekly for 3 induction exposures.
Both test (20) and control (10) animals were challenged with 0.4 ml of undiluted test material. - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- One group of 20 test animals was treated with 0.4 ml of undiluted test material for an exposure period of 6 hours weekly for 3 induction exposures.
Both test (20) and control (10) animals were challenged with 0.4 ml of undiluted test material. - No. of animals per dose:
- Induction: group of 20 test animal treated with 0.4 ml of undiluted sodium cumene sulphonate.
Range Finding test: 2 test animals were taken, for each of the following concentration- undiluted test material, 50%, 25% and 10% (v/v).
Primary challenge: 10 control animals previously untreated were treated with undiluted test material. - Details on study design:
- RANGE FINDING TESTS: 2 test animals were taken, for each of the following concentration- undiluted test material, 50%, 25% and 10% (v/v).
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 0.4 ml of undiluted sodium cumene sulphonate.
- Control group: None
- Site: Shaved left flank of each animal.
- Frequency of applications: once a week for 3 weeks
- Duration: 6 hours, test substance was applied to the lint pads and were held in place with an overlapping impermeable occlusive tape and secured by elastic adhesive bandage.
- Concentrations: undiluted sodium cumene sulphonate.
B. CHALLENGE EXPOSURE
- No. of exposures: One 6 hour exposure
- Day(s) of challenge: 2 weeks after the last induction exposure
- Exposure period: 6 hours under occlusion
- Test groups: 0.4 ml of undiluted sodium cumene sulphonate.
- Control group: 0.4 ml of undiluted sodium cumene sulphonate.
- Site: freshly clipped Right flank that has not been treated before.
- Concentrations: undiluted sodium cumene sulphonate.
- Evaluation (hr after challenge): 21 and 45 hours after challenge exposure
OTHER: None - Challenge controls:
- 10 control animals (previously unexposed) treated with 0.4 ml of undiluted sodium cumene sulphonate.
- Positive control substance(s):
- no
- Statistics:
- Not applicable
- Reading:
- 1st reading
- Hours after challenge:
- 21
- Group:
- test chemical
- Dose level:
- 0.4 ml of undiluted sodium cumene sulphonate
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No response
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 21.0. Group: test group. Dose level: 0.4 ml of undiluted sodium cumene sulphonate. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No response.
- Reading:
- 1st reading
- Hours after challenge:
- 21
- Group:
- negative control
- Dose level:
- 0.4 ml of undiluted sodium cumene sulphonate.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No response
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 21.0. Group: negative control. Dose level: 0.4 ml of undiluted sodium cumene sulphonate.. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No response.
- Reading:
- 2nd reading
- Hours after challenge:
- 45
- Group:
- test chemical
- Dose level:
- 0.4 ml of undiluted sodium cumene sulphonate.
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No response
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 45.0. Group: test group. Dose level: 0.4 ml of undiluted sodium cumene sulphonate.. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No response.
- Reading:
- 2nd reading
- Hours after challenge:
- 45
- Group:
- negative control
- Dose level:
- 0.4 ml of undiluted sodium cumene sulphonate.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No response
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 45.0. Group: negative control. Dose level: 0.4 ml of undiluted sodium cumene sulphonate.. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No response.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Thus, undiluted sodium cumene sulphonate is not a skin sensitizer in guinea pigs.
- Executive summary:
The sensitization potential of sodium cumene sulfonate was assessed in a study where one group of 20 test animals was treated with 0.4 ml of undiluted sodium cumene sulphonate for an exposure period of once weekly to 6 hours induction exposures for 3 weeks. After a 2 week rest period, both test (20) and control (10) animals were challenged with 0.4 ml of undiluted sodium cumene sulphonate.
On challenge with 0.4 ml of undiluted sodium cumene sulphonate, no reaction was observed in any of the test animals and conrtrol animals at both the 21 -hour and 45 -hour reading. No evidence for sensitization was observed in this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Since no skin sensitisation study is available for SDIBP, a read-across is performed from sodium cumene sulphonate (CAS No. 28348-53-0). The sensitization potential of sodium cumene sulfonate was assessed in GLP compliant, OECD 406 - Buehler skin sensitisation study (Jones, 1983). 20 female guinea pigs had occlusive epicutaneous exposures to 0.5 mL of a 50% solution of the test material in test 1 and to 0.4 mL of an undiluted test material in test 2. There were three 6-hour per week inductions followed by a challenge on day 28. Readings at 21 and 45 hours indicated there were no sensitization responses in either study.
Category Justification
According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances.
Applying the category approach read-across concept to SDIBP, data will be used from a representative member of the hydrotropes category to avoid unnecessary (animal) testing. The endpoints for which the read-across approach to SDIBP is applied, are: toxicokinetics, short-term toxicity to fish, toxicity to microorganism, acute toxicity (inhalation and dermal), skin irritation/corrosivity, skin sensitisation, genetic toxicity (in vitro, in vivo), repeated-dose toxicity (oral and dermal), screening for carcinogenicity, and screening for reproductive / developmental toxicity.
Hazard assessment related key information for SDIBP:
SDIPB and the hydrotrope members exhibit similar levels of low toxicity. Acute toxicity values are above the classification limits, they are not sensitizing and show no genotoxic effects. Both exhibit neglible irritation to the skin, but are moderately irritating to the eyes (Cat 2B). Together with the chemical structure similarity and their similar chemical properties, it is deemed correct to fill the existing data gaps on mammalian toxicity of SDIPB with the data of the hydrotrope category.
Migrated from Short description of key information:
There is no skin sensitisation study available for SDIBP. Hence read-across from sodium cumene sulphonate (CAS No. 28348-53-0) for skin sensitisation was performed, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5. The GLP compliant study indicated these substances are "not sensitising".
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
- Migrated from Short description of key information:
No study available
Justification for classification or non-classification
The available read-across study from the member of the hydrotrope category demonstrate that SDIBP is not a skin sensitizer. Therefore a classification is not justified.
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.
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