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EC number: 269-212-0 | CAS number: 68201-32-1
- 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:
- 2007-12-19 to 2008-01-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- purity of the test substance was not supplied
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other 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:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Purity of the test substance was not supplied.
- Principles of method if other than guideline:
- N/A
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate from The Department of Health of the Government of the United Kingdom
Test material
- Reference substance name:
- Asphalt, sulfonated, sodium salt
- EC Number:
- 269-212-0
- EC Name:
- Asphalt, sulfonated, sodium salt
- Cas Number:
- 68201-32-1
- Molecular formula:
- UVCB
- IUPAC Name:
- Asphalt, sulfonated, sodium salt
- Details on test material:
- - Name of test material (as cited in study report): Sodium sulphonated asphalt
- Molecular formula (if other than submission substance): N/A
- Molecular weight (if other than submission substance): N/A
- Smiles notation (if other than submission substance): N/A
- InChl (if other than submission substance): N/A
- Structural formula attached as image file (if other than submission substance): N/A
- Substance type: active
- Physical state: black solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan, France
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (deg. C): 17-23; Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study.
- Humidity (%): 30-70; Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study.
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: N/A To: N/A
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped on the day before treatment
- Vehicle:
- other: distilled water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): N/A
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL was used to moisten the test substance.
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A
OTHER: On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5 g of the test substance, moistened with 0.5 mL of distilled water, was introduced. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal/flank area (Test substance was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position. The patch was secured in position with a strip of surgical adhesive tape (approximate size 2.5 cm x 4.0 cm).)
- % coverage: N/A
- Type of wrap if used: The trunk of each rabbit was wrapped in an elasticated corset.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test substance was removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
-Approx. one hour after the removal of the patches and 24, 48, and 72 h later, the test sites were examined for evidence of primary irritation and scored according to the Draize scale.
- The scores for erythema and oedema (24 and 72 hrs) were totaled for the three test rabbits (12 values) and this total was divided by six to give the primary irritation index of the test substance. See below for scales.
-An additional observation was made on Day 7 to assess the reversibility of skin reactions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: Calculated from 24 and 72 hour readings
- Score:
- 1.2
- Max. score:
- 8
- Reversibility:
- other: There was no irritation noted at 7 days.
- Remarks on result:
- other: Classification: Mild irritant
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Very slight erythema was noted at one treated skin site one hour after patch removal with very slight to well-defined erythema noted at all treated skin sites at the 24-hour observation, and very slight erythema was noted at two treated sites at the 48- and 72-hour observations. Very slight oedema was noted at one treated skin site at the 24- and 48-hour observations. Light brown discolouration of the epidermis was noted at one treated skin site at the 48- and 72-hour observations with loss of skin elasticity also noted at the 72-hour observation. Slight desquamation was noted at this treated skin site at the 7-day observation. One treated site appeared normal at the 48-hour observation, and one other treated site appeared normal at the 7-day observation.
- Other effects:
- N/A
Any other information on results incl. tables
Individual Skin Reactions |
|||||
Skin Reaction |
Observation Time (hrs72) |
Individual Scores – Rabbit Number and Sex |
Total |
||
66978 Male |
66979 Male |
66980 Male |
|||
Erythema / Eschar Formation |
1 |
1 |
0 |
0 |
(1) |
24 |
2 |
1 |
1 |
4 |
|
48 |
1 Br |
1 |
0 |
(2) |
|
72 |
1 BrLe |
1 |
0 |
2 |
|
7 days |
0 D |
0 |
0 |
(0) |
|
Oedema Formation |
1 |
0 |
0 |
0 |
(0) |
24 |
1 |
0 |
0 |
1 |
|
48 |
1 |
0 |
0 |
(1) |
|
72 |
0 |
0 |
0 |
0 |
|
7 days |
0 |
0 |
0 |
(0) |
|
( ) = Total values not used for calculation of primary irritation index; Br = light brown discolouration of the epidermis; D = slight desquamation; Le = loss of skin elasticity |
|||||
Sum of 24- and 72-hour readings (S) : 7 |
|||||
Primary Irritation Index (S/6) : 7/6 = 1.2 |
|||||
Classification : Mild Irritant according to Draize scale |
No corrosive effects were noted.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance produced a primary irritation index of 1.2 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. However, SAS did not meet the criteria for classification as irritant according to EU labeling regulations Commission Directive 2001/59/EC.
- Executive summary:
N/A
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