Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 249-894-6 | CAS number: 29857-13-4
- 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:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to GLP and valid testing guidelines, therefore it is considered relevant, adequate and reliable for classification.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium 1,4-diisodecyl sulphonatosuccinate
- EC Number:
- 249-894-6
- EC Name:
- Sodium 1,4-diisodecyl sulphonatosuccinate
- Cas Number:
- 29857-13-4
- IUPAC Name:
- sodium 1,4-diisodecyl sulphonatosuccinate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Netzer SB 10, sulfobernsteinsäureester-Natriumsalz, Di-isodecylsulfobernsteinsäureester-mono-natriumsalz
- Physical state: Almost colorless, clear liquid
- Analytical purity: 63.0-67.0%
- 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.: E06 124 505 (produced 1985-07-03)
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Not provided
- Storage condition of test material: In the dark, at 22°C
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, conventional breeding
- Age at study initiation: Ca. 3-5 months
- Weight at study initiation: 2.3-3.0 kg
- Fasting period before study: Not provided
- Housing: Individual cages
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät- Kaninchen, Altromin GmbH, Lage/Lippe, ad libitum as well as hay (ca. 15 g täglich)
- Water (e.g. ad libitum): Deionized, chlorinated water from automatic drinkers, ad libitum
- Acclimation period: Not provided
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 72 hours (1, 24, 48 and 72h after application) and 14 days (7 and 14 days after application) in addition for the positive findings
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline solution
- Time after start of exposure: 24 h after application and at all observation points
SCORING SYSTEM: See under “Any other information on material and methods incl. tables”
TOOL USED TO ASSESS SCORE: fluorescein (at 24 and 72 hours and for positive findings at 7 and 14 days))
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- One to 72 hours after application, the conjunctivae showed a diffuse bright red color and a very clear swelling to a swelling with more than half-closed lids. The iris was red, the cornea showed diffuse opacity areas to easily discernible translucent areas. 7 Days after application significant hyperemia of some blood vessels to diffuse crimson-red colored conjunctivae and very slightly to significantly swollen conjunctivae were observed. One animal showed scattered areas of opacity of the cornea. 14 Days after application all signs of irritation were reversible. One hour to 7 days after application, the irritation was accompanied with a clear, colorless or white mucous discharge. One animal showed 24 hours to 7 days after application partially white discolorations, bleeding and detachments of parts of the conjunctivae and nictitating membrane.
Any other information on results incl. tables
Table 2. Individual findings
Time after application |
1h |
24h |
48h |
72h |
7d |
14d |
||||||||||||
Animal No. |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
|
||||||||||||||||||
Conjunctivae chemosis |
3 |
3 |
2 |
3 |
2 |
2 |
4 |
2 |
3 |
4 |
2 |
1 |
2 |
1 |
1 |
0 |
0 |
0 |
Conjunctivae redness |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
2 |
1 |
1 |
0 |
0 |
0 |
Iris |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea opacity |
1 |
0 |
1 |
1 |
1 |
2 |
2 |
1 |
2 |
2 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
Fluorescein Test* |
|
|
|
4 |
4 |
3 |
|
|
|
3 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
|
||||||||||||||||||
Eye discharge |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- clear, colorless |
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-white, mucous |
|
|
|
x |
x |
x |
x |
x |
x |
x |
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conjunctivae |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- white discoloration |
|
|
|
x |
|
|
x |
|
|
x |
|
|
x |
|
|
|
|
|
- detachment of part |
|
|
|
|
|
|
x |
|
|
x |
|
|
x |
|
|
|
|
|
- with bleeding |
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Iris |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-reddened |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
x |
|
|
|
|
|
|
*Indicated is the area of whitening of the corneal surface under UV light after instillation of a drop of fluorescein sodium (0.01%)
0= no whitening
1= punctiform to 1/4
2= more than 1/4 to 1/2
3= more than 1/2 to 3/4
4= more than 3/4 to 4/4
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on this study and taking into account any other eye changes the test item is classified as irritant according to the classification criteria of Directive 83/467/EEC and the Hazardous Substances Regulation and is labeled R 36- irritating to the eyes.
- Executive summary:
Three New Zealand White rabbits underwent a single application in the conjunctival sac of the left eye of 0.1 mL of the test item. The untreated eye served as a control. 24 Hours after administration of the test item as well as to all other assessment time points at which, the treated eyes still showed discharges or in which a corneal examination with fluorescein sodium solution was done, the treated eyes were thoroughly washed with physiological saline solution (ca. 37°C).
The assessments of the eyes were made 1, 24, 48 and 72 hours after instillation. In addition the cornea was also examined under UV light, after instillation of a drop of fluorescein sodium solution, at the assessment time points 24 and 72 hours. Damage to the cornea, iris and conjunctivae were scored numerically. Mean 24 -72h scores were 1.4/4 for cornea, 1/2 for iris, 3/3 for conjuctiva and 2.6/4 for chemosis. All other changes were recorded. Because eye effects were still present at 72 hours, an additional assessment was carried out after 7 and 14 days.
One to 72 hours after application, the conjunctivae showed a diffuse bright red color and a very clear swelling to a swelling with more than half-closed lids. The iris was red, the cornea showed diffuse opacity areas to easily discernible translucent areas. 7 Days after application significant hyperemia of some blood vessels to diffuse crimson-red colored conjunctivae and very slightly to significantly swollen conjunctivae were observed. One animal showed scattered areas of opacity of the cornea. 14 Days after application all signs of irritation were reversible. One hour to 7 days after application, the irritation was accompanied with a clear, colorless or white mucous discharge. One animal showed 24 hours to 7 days after application partially white discolorations, bleeding and detachments of parts of the conjunctivae and nictitating membrane.
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.