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EC number: 248-983-7 | CAS number: 28348-53-0
- 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
-The acute eye irritation study indicates that Sodium cumenesulphonate as 60% solution
caused mild irritation.
Result: Slight eye irritating at 60% solution
Effects on eye irritation: slightly irritating
-The results indicate that Sodium cumenesulphonate is not irritating to the skin.
The test substance was not irritating to skin. No irritation was observed; all scores were “0”.
Result: not irritating to skin
Conclusion
Sodium cumenesulphonate is not irritating to the skin and slightly irritating to the eye.
Result: Slight eye irritating at 60% solution
Effects on eye irritation: slightly irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- CAS Number: 28348-53-0
Identity: Cumene sulfonic acid, sodium salt
Purity: 96.0%
Remarks: 60% aqueous solution - Species:
- rabbit
- Strain:
- other: Small White Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.2 - 2.4 kg
- Housing: single housing in stainless steel cages
- Diet (e.g. ad libitum): Ssniff K4 complete feed for rabbits, ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Aqua dist.
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm³
-Concentration: 60% in aqua dist. (paste) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours after patch removal
- Number of animals:
- 6 (3 male, 3 female)
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² of shaved skin of the dorsal and lateral parts of the trunk of the animals
- % coverage: not mentioned
- Type of wrap if used: on the application area a mull patch (2,5 x 2,5 cm) was placed, which was covered with a polyethylen film (6 x 6 cm). The application area was then immobilised with an elastic dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with distilled water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to OECD guideline 404 - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 0
- Edema: 0 - Interpretation of results:
- other: not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test substance was not irritating to skin. No irritation was observed; all scores were “0”.
- Executive summary:
The test substance was not irritating to skin. No irritation was observed; all scores were “0”.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
Table: Irritant/corrosive response data for each animal at each observation time of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: |
Max. score: |
|
60 min |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
24 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
48 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
72 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0 |
0 |
Reversibility*) |
- |
- |
Average time (unit) for reversion |
|
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Test Substance
CAS Number: 28348-53-0
Identity: Cumene sulfonic acid, sodium salt
Purity: 96.0% - Species:
- rabbit
- Strain:
- other: Small White Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.0 - 2.4 kg
- Housing: conventional, singly in stainless steel cages
- Diet (e.g. ad libitum): K4 complete feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GembH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye
- Amount / concentration applied:
- Application of 50 mg into the conjunctival sac of one eye.
- Duration of treatment / exposure:
- The test substance was not washed out of the eyes of the treated animals and remained until the test was terminated.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours, and 6, 8 and 14 days after application
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
Test substance was not washed out
SCORING SYSTEM: according to guideline
TOOL USED TO ASSESS SCORE: ophthalmic lamp, the disappearance of corneal findings was checked by adding Sodium-Fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.44
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.94
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Slight irritation at 60% solution.Eye irritation is slight .
- Interpretation of results:
- other: Slight irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Slight irritation at 60% solution.Eye irritation is slight .
Result: Slight irritating at 60% solution - Executive summary:
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
Table: Irritant/corrosive response data for each animal at each observation time of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
1/1/1/1/1/1 |
0/0/0/0/0/0 |
1/1/1/1/1/1 |
1/1/1/3/1/2 |
24 h |
1/1/1/1/1/1 |
1/1/1/1/1/1 |
2/1/1/1/2/1 |
1/1/0/2/1/0 |
48 h |
1/1/1/1/1/1 |
0/1/0/1/0/0 |
1/1/1/1/1/1 |
0/0/0/1/0/0 |
72 h |
1/1/1/1/1/1 |
0/0/0/0/0/0 |
0/1/0/1/1/0 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
1.00 |
0.44 |
0.94 |
0.33 |
Reversibility*) |
c. |
c. |
c. |
c. |
Average time (unit) for reversion |
14 days |
72 hours |
6 days |
72 hours |
*) Reversibility: c. = completely reversible;= not completely reversible; n. = not reversible
Animals #1 -3: male; #4 -6: femaEndpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Conclusion
Sodium cumenesulphonate is not irritating to the skin and slightly irritating to the eye.
Result: Slight eye irritating at 60% solution
Effects on eye irritation: slightly irritating
Justification for classification or non-classification
Based on the hazard assessment of Sodium cumenesulphonate in section 2.1 and 2.2. in IUCLID 6., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health” andaccording to the criteria described in Directive 67/548 and in the CLP Regulation:
Directive 67/548 |
Skin Corrosivity C R35 Causes severe burns R34 Causes burns Skin Irritation Xi R38 Irritating to skin R43 May cause sensitization by skin contact Eye Irritation (Ocular Lesions) Xi R36 Irritating to eyes R37 irritating to respiratory system R41 Risk of serious damage to eyes R36/37/38 Irritating to eyes, respiratory system and skin. R36/38 Irritating to eyes and skin. |
CLP |
Skin Corrosivity H314 Skin Corr 1A Causes severe skin burns and eye damage H314 Skin Corr 1B Causes severe skin burns and eye damage Skin Irritation H315 Skin Irrit. 2 Causes skin irritation H317 Skin Sens. 1 May cause an allergic skin reaction Eye Irritation (Ocular Lesions) Xi H319 Eye Irrit. 2 Causes serious eye irritation H318 Eye Dam. 1 Causes serious eye damage H335 STOT SE 3 May cause respiratory irritation |
It is concluded that the substance Sodium cumenesulphonate meet the criteria to be classified for human health hazards for Dermal-local effect :
H319 Eye Irrit. 2 Causes serious eye irritation,
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