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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 247-873-6 | CAS number: 26650-05-5
- 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:
- supporting study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Tested in human subjects
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
- Principles of method if other than guideline:
- A primary skin irritation was carried out on human subjects.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 26550-05-5
- IUPAC Name:
- 26550-05-5
- Details on test material:
- - Name of test material (as cited in study report): SBU 185, VARSULF SBU-185
- Substance type: Sulfosuccinate (tensio-active)
- Physical state: Pale, yellow liquid
- Analytical purity: 50% (active ingredient VARSULF SBU-185)
- 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.: Sample A : SC-154-52A; Sample B: SC-154-52B
- 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:
- human
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- Not applicable
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- other: distilled water
- Controls:
- other: Sample B did not contain Varsulf SBU-185
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.3 mL
- Concentration (if solution): 10% v/v of Sample A and Sample B - Duration of treatment / exposure:
- 3 times 24 hours
- Observation period:
- 24 hours (after last application)
- Number of animals:
- 12
- Details on study design:
- TEST SITE
- Area of exposure: outer aspect of the right upper arm
- % coverage: no data
- Type of patch: Parke, Davis Readi Band patches
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the sites were cleansed with clear water and then the skin was dried with a soft paper towel
- Time after start of exposure: 24 hours
SCORING SYSTEM:
0 No evidence of irritation
1 Minimal erythema, barely perceptible
2 Definite erythema, readily visible; or minimal edema; or minimal popular response
3 Erythema and papules
4 Definite erythema
5 Erythema, edema and papules
6 Vesicular eruption
7 Strong reaction spreading beyond test site
A Slight glazed appearance
B Marked glazing
C Glazing with pealing and cracking
F Glazing with fissures
G Film of dried serous exudate covering all or portion of the patch site
H Small petechial erosions and/or scabs
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- Application 1 15 min.
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Sample A
- Irritation parameter:
- overall irritation score
- Remarks:
- Application 2 15 min.
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.18
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Sample A
- Irritation parameter:
- overall irritation score
- Remarks:
- Application 3 15 min.
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.25
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Sample A
- Irritation parameter:
- overall irritation score
- Remarks:
- Application 3 24h
- Basis:
- mean
- Time point:
- other: 96 h
- Score:
- 0.42
- Max. score:
- 7
- Reversibility:
- not specified
- Remarks on result:
- other: Sample A
Any other information on results incl. tables
Table1. Table of Results of Skin Irritation Scores
Sample A (SC-154-52A)
Panelist Number |
Application 1 15 Min.* |
Application 2 15 Min.* |
Application 3 15 Min.* 24 Hours* |
|
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
3 |
L |
L |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
6 |
0 |
0 |
0 |
0 |
7 |
0 |
0 |
0 |
1A |
8 |
0 |
0 |
0 |
0 |
9 |
0 |
1A |
1A |
1A |
10 |
0 |
0 |
0 |
0 |
11 |
0 |
1A |
1A |
1A |
12 |
0 |
0 |
1A |
2B |
Sample B (SC-154-52B) not containing Varsulf SBU-185
Panelist Number |
Application 1 15 Min.* |
Application 2 15 Min.* |
Application 3 15 Min.* 24 Hours* |
|
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
3 |
L |
L |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
6 |
0 |
0 |
0 |
0 |
7 |
0 |
1A |
1A |
1A |
8 |
0 |
0 |
0 |
0 |
9 |
0 |
1A |
1A |
1A |
10 |
0 |
0 |
0 |
0 |
11 |
0 |
1A |
1A |
1A |
12 |
0 |
0 |
1A |
2B |
*Time after removal of patches.
L= Lost Patch
A= Slight glazed appearance
B= Marked glazing
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- A 10% v/v aqueous solution of both samples was slightly irritating to the skin, under the conditions of this experiment.
- Executive summary:
A primary skin irritation was carried out on 12 female subjects with Sample A (SC-154-52A)(containing 10% VARSULF SBU-185; 50% active) and Sample B (SC-154-52B)(containing 0% VARSULF SBU-185). Both samples were diluted to 10% v/v with distilled water. Each subject received 3 consecutive exposures to the test materials. Each exposure was for 24 hours under semi-occlusive conditions.
Under the conditions of this study, occasional cases of slight skin irritation were observed with 10% v/v aqueous solutions of both samples. This irritation was in form of minimal erythema with slight glazing over the patch site. One subject displayed a response of definite erythema with marked glazing. This reaction was observed 24 hours after removal of the third application patch. For each sample, it appears that the incidence of irritation increases with each application. Both samples, under the conditions of this study, appear to be mildly 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.
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.