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EC number: 294-268-8 | CAS number: 91697-07-3
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: INVITTOX (UK) protocol no. 98
- Version / remarks:
- 1994
- GLP compliance:
- yes
Test material
- Reference substance name:
- Butanedioic acid, sulfo-, C-C16-18-alkyl esters, disodium salt
- EC Number:
- 294-268-8
- EC Name:
- Butanedioic acid, sulfo-, C-C16-18-alkyl esters, disodium salt
- Cas Number:
- 91697-07-3
- Molecular formula:
- C20H38O7S.2Na – C22H40O7S.2Na
- IUPAC Name:
- octasodium 4-(hexadecyloxy)-4-oxo-2-sulfonatobutanoate 4-(hexadecyloxy)-4-oxo-3-sulfonatobutanoate 4-(octadecyloxy)-4-oxo-2-sulfonatobutanoate 4-(octadecyloxy)-4-oxo-3-sulfonatobutanoate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: CS82130005
- Storage: Room temperature
- Expiry Date: 2009-07-30
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- - Test system: Freshly isolated bovine cornea
- Source: Odenwaldschlachthof Brensbach, D-64395, Brensbach
Test system
- Vehicle:
- Hank's balanced salt solution
- Controls:
- yes
- Amount / concentration applied:
- The test item was tested as a 5% suspension.
- Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 2 h
- Number of animals or in vitro replicates:
- 3 corneas per group
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
All eyes were carefully examined macroscopically for defects. Those presenting defects such as vascularization, pigmentation, opacity and scratches were discarded.
The cornea was carefully removed from the eye using scalpel and rounded scissors. A rim of about 2mm of tissue (sclera) was left for stability and handling of the isolated cornea. All corneas used in the experiment were collected in Hank's BSS supplemented with streptomycin / penicillin and checked finally with a view box for defects listed above.
Each cornea was mounted in a cornea holder with the endothelial side against the sealing ring (o-ring) of the posterior part of the holder. The cornea was gently flattened over the O-ring but stretching was avoided. After the anterior part of the holder was positioned on top of the cornea and fixed in place with srews, both compartments of the holder were filled with complete medium. The posterior compartment was filled first to return the cornea to its natural convex position. Care was taken to assure no air bubbles were present within the compartments.
NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED
0.9 % saline
POSITIVE CONTROL USED
2-Ethoxyethanol
APPLICATION DOSE AND EXPOSURE TIME
5% suspension, 10 min incubation
POST-INCUBATION PERIOD: yes
2h
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: minimum 3 times
- POST-EXPOSURE INCUBATION: 2h
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: yes
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV/VIS spectrophotometry
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 1st
- Value:
- -0.33
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 2nd
- Value:
- 0.67
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 3rd
- Value:
- 0.67
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: In vitro Score
- Run / experiment:
- Mean
- Value:
- 0.86
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- In conclusion, it can be stated that under the conditions of this study, the test item is not considered to be an eye irritant.
- Executive summary:
The test substance (5% suspension) was tested in the in-vitro BCOP assay for its eye irritation properties. The test item was applied to corneas and incubated for 10 minutes at 32 °C. After incubation the corneas were washed and incubated for another 120 minutes. Opacity was measured before and after treatment and after postincubation time. After the opacity measurements permeability was determined with a fluorescein solution. With the negative control neither an increase of opacity nor permeability of the corneas could be observed. The positive control showed clear opacity and distinctive permeability of the corneas.
The test item did not cause any opacity or permeability of the corneas. In conclusion, it can be stated that under the conditions of this study, the test item is not considered to be an eye irritant.
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