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Registration Dossier
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EC number: 204-839-5 | CAS number: 127-39-9
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1969
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was performed with a +-45% active ingredient formulation, and not under GLP compliance. However, the study was conducted according to standards of that time, therefore the study is considered to be adequate, reliable and relevant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 969
- Report date:
- 1969
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FHSA, 16cfr1500.41 CPSC
- Principles of method if other than guideline:
- FHSA: Federal Hazardous Substances Act
CPSC: Consumer Product Safety Commission - GLP compliance:
- no
Test material
- Reference substance name:
- Sodium 1,2-diisobutoxycarbonylethanesulphonate
- EC Number:
- 204-839-5
- EC Name:
- Sodium 1,2-diisobutoxycarbonylethanesulphonate
- Cas Number:
- 127-39-9
- Molecular formula:
- C12H22O7S.Na
- IUPAC Name:
- sodium 1,4-diisobutoxy-1,4-dioxobutane-2-sulfonate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): AEROSOL® IB, Sodium di-iso-butyl sulfosuccinate
- Physical state: Not provided
- Analytical purity: 44-46 %
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Purity test date: Not provided
- Lot/batch No.: Not provided
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Not provided
- Storage condition of test material: Not provided
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- Not provided
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5g of the product, prepared as an aqueous paste
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- Both intact and abraded skin were tested.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- other: for intact areas
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Remarks on result:
- other: not specified
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Remarks on result:
- other: not specified
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Remarks on result:
- other: not specified
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 48 h
- Remarks on result:
- other: not specified
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 48 h
- Remarks on result:
- other: not specified
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 48 h
- Remarks on result:
- other: not specified
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Remarks on result:
- other: not specified
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Remarks on result:
- other: not specified
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Remarks on result:
- other: not specified
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 48 h
- Remarks on result:
- other: not specified
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 48 h
- Remarks on result:
- other: not specified
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 48 h
- Remarks on result:
- other: not specified
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
Any other information on results incl. tables
Table1. Observations
Time, Hours |
Reaction |
Rabbit number, Value |
Mean Value |
|||||
1 |
2 |
3 |
4 |
5 |
6 |
|||
|
Erythema |
|
|
|
|
|
|
|
24 |
Intact |
1 |
2 |
0 |
1 |
1 |
1 |
1.0 |
72 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
24 |
Abraded |
2 |
2 |
1 |
1 |
2 |
2 |
1.7 |
72 |
Abraded |
0 |
1 |
0 |
1 |
1 |
0 |
0.5 |
|
Edema |
|
|
|
|
|
|
|
24 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
72 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
24 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
72 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
No structure of the tissue at the site of contact was destroyed or changed irreversible in 24 hours or less.
The scoring system used herein for skin irritation reactions is that of Draize, J.H.,Woodward, G., and Calvery, H.O.: J. Pharmacol. Exptl. Therap., B2; 377,1944. The maximum possible value for a skin reaction (excluding necrosis) is 4. The “primary irritation score” is the sum of the mean values divided by 4.
Primary irritation score 0.8
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Primary irritation score of the test item containing 44-46% active ingredient in a Rabbit Skin Irritation Test with 0.5g in occlusive contact for 24 hours with shaved Skin was 0.8.This test item was only slightly irritating to rabbit skin. Therefore, it is not expected to produce significant skin irritation under conditions of ordinary industrial handling.
- Executive summary:
6 Male albino rabbits underwent a covered application to the clipped intact and abraded skin of 0.5 g test item containing 44 -46% active ingredient as an aqueous paste. Scoring according to Draize et al. (1944) demonstrated a primary irritation score of 0.8, based on erythema which was reversible within 72 hours. It was concluded that the test item has no irritating potential under conditions of ordinary industrial handling.
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.

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