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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

Eye irritation
Administrative data
- Endpoint:
- eye 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, 16cfr1500.42 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 / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Not provided
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- part 1 ( in part 2: 50% w/v aqueous dispersion of the product)
- Controls:
- no
- Amount / concentration applied:
- Part 1: 0.1g of the product as received
Part 2: 0.1g of a 50% w/v aqueous dispersion of the product - Duration of treatment / exposure:
- Not provided
- Observation period (in vivo):
- 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 6 (part 1)
3 (part 2)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 7.3
- Max. score:
- 80
- Reversibility:
- not reversible
- Remarks on result:
- other: product as received
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 10
- Reversibility:
- not reversible
- Remarks on result:
- other: product as received
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 7.3
- Max. score:
- 20
- Reversibility:
- not reversible
- Remarks on result:
- other: product as received
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 11
- Max. score:
- 80
- Reversibility:
- not reversible
- Remarks on result:
- other: 50% w/v aqueous dispersion of product
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24,48, 72 h
- Score:
- 0
- Max. score:
- 10
- Remarks on result:
- other: 50% w/v aqueous dispersion of product
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 10.7
- Max. score:
- 20
- Reversibility:
- not reversible
- Remarks on result:
- other: 50% w/v aqueous dispersion of product
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 6.67
- Max. score:
- 80
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: product as received
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 80
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: product as received
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 6.67
- Max. score:
- 80
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: product as received
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 10
- Max. score:
- 80
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: product as received
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 6.67
- Max. score:
- 80
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: product as received
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 11.67
- Max. score:
- 80
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: product as received
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: product as received
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: product as received
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: product as received
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: product as received
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: product as received
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 5
- Max. score:
- 10
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: product as received
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 6.67
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: product as received
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 5.33
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: product as received
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 7.33
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: product as received
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: product as received
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 9.33
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: product as received
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 14.67
- Max. score:
- 20
- Reversibility:
- not reversible
- Remarks on result:
- other: product as received
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: product as received
- Remarks:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- other: product as received
- Remarks:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- other: product as received
- Remarks:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Remarks on result:
- other: product as received
- Remarks:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Remarks on result:
- other: product as received
- Remarks:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Remarks on result:
- other: product as received
- Remarks:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 6.67
- Max. score:
- 80
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: 50% w/v aqueous dispersion of product
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 18.3
- Max. score:
- 80
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: 50% w/v aqueous dispersion of product
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 10
- Max. score:
- 80
- Remarks on result:
- other: 50% w/v aqueous dispersion of product
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: 50% w/v aqueous dispersion of product
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: 50% w/v aqueous dispersion of product
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: 50% w/v aqueous dispersion of product
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 10.67
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: 50% w/v aqueous dispersion of product
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 10.67
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: 50% w/v aqueous dispersion of product
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 11.33
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: 50% w/v aqueous dispersion of product
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: 50% w/v aqueous dispersion of product
- Remarks:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- other: 50% w/v aqueous dispersion of product
- Remarks:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- other: 50% w/v aqueous dispersion of product
- Remarks:
- not specified
Any other information on results incl. tables
Table1. Scores part 1 (test material as such)
Time, Hours |
Reaction |
Rabbit number, Value |
Mean Value |
|||||
1 |
2 |
3 |
4 |
5 |
6 |
|||
24 |
Cornea |
10 |
5 |
10 |
15 |
20 |
15 |
12 |
Iris |
0 |
0 |
0 |
0 |
0 |
5 |
1 |
|
Conjunctivae |
10 |
10 |
10 |
4 |
14 |
14 |
10 |
|
48 |
Cornea |
5 |
5 |
5 |
10 |
0 |
15 |
7 |
Iris |
0 |
0 |
0 |
0 |
0 |
5 |
1 |
|
Conjunctivae |
6 |
6 |
10 |
2 |
12 |
14 |
8 |
|
72 |
Cornea |
5 |
0 |
5 |
5 |
0 |
5 |
3 |
Iris |
0 |
0 |
0 |
0 |
0 |
5 |
1 |
|
Conjunctivae |
4 |
0 |
2 |
2 |
2 |
16 |
4 |
At the readings made at 24, 48 and 72 hours, there was:
- discernible opacity or ulceration of the cornea other than a slight dulling of the normal luster.
- no inflammation of the iris other than slight deepening of the folds, or slight circumcorneal injection.
- a diffuse, deep-crimson red appearance of the conjunctivae with individual vessels, not easily discernible.
- an obvious swelling of the conjunctivae, excluding cornea and iris, with partial eversion of the lid.
- no destruction or irreversible change of any tissue in 24 hours or less.
Table 2. Scores part 2 (50% w/v aqueous dispersion of the product)
Time, Hours |
Reaction |
Rabbit number, Value |
Mean Value |
|||||
1 |
2 |
3 |
4 |
5 |
6 |
|||
24 |
Cornea |
10 |
20 |
20 |
- |
- |
- |
17 |
Iris |
0 |
0 |
0 |
- |
- |
- |
0 |
|
Conjunctivae |
12 |
12 |
12 |
- |
- |
- |
12 |
|
48 |
Cornea |
5 |
20 |
5 |
- |
- |
- |
10 |
Iris |
0 |
0 |
0 |
- |
- |
- |
0 |
|
Conjunctivae |
12 |
10 |
12 |
- |
- |
- |
11 |
|
72 |
Cornea |
5 |
15 |
5 |
- |
- |
- |
8 |
Iris |
0 |
0 |
0 |
- |
- |
- |
0 |
|
Conjunctivae |
8 |
10 |
10 |
- |
- |
- |
9 |
At the readings made at 24, 48 and 72 hours, there was:
- discernible opacity or ulceration of the cornea other than a slight dulling of the normal luster.
- no Inflammation of the iris other than slight deepening of the folds, or slight circumcorneal injection.
- a diffuse, deep-crimson red appearance of the conjunctivae with individual vessels, not easily discernible.
- no obvious swelling of the conjunctivae, excluding cornea and iris, with partial eversion of the lids.
- no destruction or irreversible change of any tissue in 24 hours or less.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- This test item is sufficiently irritating to the rabbit eye so that precautions should be observed to avoid its introduction into or near the eyes.
- Executive summary:
An in vivo eye irritation study was conducted with a first phase where 6 rabbits received 0.1 g test item containing 44 -46% active ingredient in one eye as an aqueous paste. Scoring at 24, 48 and 72 hours demonstrated non-reversible scores for cornea and conjunctivae in all animals and iris changes in one animal, all not reversible within 72 hours. Mean 24 -72h scores for cornea, conjuctiva and iris were 7.3/80, 7.3/20 and 1/10, respectively. There was no destruction or irreversible change of any tissue in 24 hours,but discernible opacity or ulceration of the cornea, diffuse, deep-crimson red appearance of the conjunctivae and obvious swelling of the conjunctivae with partial eversion of the lid were observed. In a second part of the study, 3 rabbits received 0.1 g as a 50% dilution of the above test item (22 -23% active ingredient). Scoring at 24, 48 and 72 hours demonstrated non-reversible scores in all 3 animals for cornea and conjunctivae, not reversible within 72 hours. Mean 24 -72h scores for cornea, conjuctiva and iris were 11/80, 10.7/20 and 0/10, respectively.
There was no destruction or irreversible change of any tissue in 24 hours, but discernible opacity or ulceration of the cornea, and diffuse, deep-crimson red appearance of the conjunctivae were observed.
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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