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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, conventional breeding
- Age at study initiation: Ca. 3-5 months
- Weight at study initiation: 2.1-2.5 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
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- Not provided
- Observation period:
- 72 hours and after this period additional observations till 21 days for the positive findings
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: In the dorsal region of the trunk
- % coverage: Not provided
- Type of wrap if used: An adhesive patch (2.5 x 2.5 cm) with cellulose coating (Custom-made by Fa. Beiersdorf AG, Hamburg) was fixed to the prepared skin site. Under these patches 0.5 mL of the undiluted test substance was applied. Subsequently, the area was covered with a semi-occlusive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: Erythema and eschar formation as well as edema formation were evaluated numerically. All other skin changes were recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Irritant / corrosive response data:
- One to 48 hours after removal of the patch, the animals showed barely perceptible to clearly defined erythema and partially very slight to slight edema .
72 hours after application partially clearly defined to moderate erythema and very slight edema were observed. In one animal the reddening was not assessable due to discoloration.
7 days after application no irritation was observed. 14 to 21 days after application, one animal showed barely perceptible to moderate erythema. The irritations 24 hours to 14 days after patch removal partially were dry, brittle, fine or large flaking and parchment-like skin surface, fissured skin, induration, eschar formation and large-area yellow or light-brown skin discoloration.
Any other information on results incl. tables
Table 2. Individual findings
Time after patch removal |
1h |
24h |
48h |
72h |
7d |
14d |
21d |
||||||||||||||
Animal No. |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
|
|||||||||||||||||||||
Erythema and eschar formation |
2 |
1 |
1 |
2 |
2 |
1 |
2 |
2 |
2 |
3 |
* |
2 |
0 |
0+ |
0+ |
0 |
3 |
0 |
0 |
1 |
0 |
Edema |
2 |
1 |
1 |
0 |
2 |
2 |
0 |
2 |
2 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|||||||||||||||||||||
Skin surface: -dry, brittle - scaly -large scaly -indurated -parchment-like |
|
||||||||||||||||||||
|
|
|
|
|
|
x |
|
|
x |
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
|
|
x |
x |
x |
|
x |
x |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x |
x |
|
x |
x |
|
|
|
|
Deeply fissured skin |
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
Eschar formation |
|
|
|
|
|
|
|
|
|
x |
|
|
|
|
|
|
|
|
|
|
|
Skin discoloration -large area yellow -large area light-brown |
|
||||||||||||||||||||
|
|
|
|
x |
|
|
x |
x |
|
x |
x |
|
x |
x |
|
|
|
|
|
|
* due to discoloration not assessable + judged for the discoloration
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 skin 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 38- irritating to the skin.
- Executive summary:
Three New Zealand White rabbits were shaved in an area of ca. 25 cm2,dorsal of the trunk , approximately 24 hours before the start of the study. An adhesive patch (2.5 x 2.5 cm) with cellulose coating (Custom-made by Fa. Beiersdorf AG, Hamburg) was fixed to the prepared skin site. Under these patches 0.5 mL of the undiluted test item was applied. Subsequently, the area was covered with a semi-occlusive bandage.
Observations were performed 30-60 minutes and 24, 48 and 72 hours after removal of the patch. At 72 hours there were still findings , thus additional observations were done at 7, 14 and 21 days after patch removal.
Erythema , eschar formation and edema were numerically scored. Mean 24-72h scores were 2/4 for erythema and 1.1/4 for edema. All other skin changes were recorded.One to 48 hours after removal of the patch, the animals showed barely perceptible to clearly defined erythema and partially very slight to slight edema . 72 hours after application partially clearly defined to moderate erythema and very slight edema were observed. In one animal the reddening was not assessable due to discoloration. 7 days after application no irritation was observed. 14 to 21 days after application, one animal showed barely perceptible to moderate erythema. The irritations 24 hours to 14 days after patch removal partially were dry, brittle, fine or large flaking and parchment-like skin surface, fissured skin, induration, eschar formation and large-area yellow or light-brown skin discoloration.
Based on this study and taking into account any other skin 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 38- irritating to the skin.
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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