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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-01-18 to 2008-02-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Purity of the test substance was not provided.
- 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues 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: Animals were housed individually in suspended cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (deg. C): The temperature was set to achieve limits of 17-23 deg C. Any occasional deviation from this was considered not to have affected the purpose or integrity of the study.
- Humidity (%): The relative humidity was set to achieve limits of 30-70 %. Any occasional deviation from this was 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye of each animal served as the control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A volume of 0.1 mL of the test substance, which was found to weigh approximately 97 mg (as measured by gently compacting the required volume into an adapted syringe) was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test substance, and then released.
- Concentration (if solution): N/A
VEHICLE
- Amount(s) applied (volume or weight with unit): N/A
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A - Duration of treatment / exposure:
- approximately one hour
- Observation period (in vivo):
- Immediately after the administration of the test substance, an assessment of the initial pain reaction was made. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. An additional observation was made, in one treated eye, on Day 7 to assess the reversibility of the ocular effects.
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance after treatment was flushed from the test eye using 20 mL of distilled water, with the control eye treated in a similar manner.
- Time after start of exposure: ~1 hour
SCORING SYSTEM: Assessment of ocular damage/irritation was done according to the Draize Test. (Draize JH (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington, DC pp. 48 to 49). Using the numerical data obtained a modified version of the system described by Kay JH and Calandra JC (1962), J. Soc. Cosmet. Chem. 13, 281-289 was used to classify the ocular irritancy potential of the test substance. This was achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The group means of the total scores for each observation were calculated. The highest of these group means (the maximum group mean score) together with the persistence of the reactions enabled classification of the eye irritancy potential of the test substance. If evidence of irreversible ocular damage was noted, the test substance was classifed as corrosive to the eye.
TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: Total score of 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: Total score of 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: Total score of 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: Total score of 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: Total score of 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: Total score of 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 6
- Max. score:
- 20
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 20
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 6
- Max. score:
- 20
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 20
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 6
- Max. score:
- 20
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 72 h
- Score:
- 2
- Max. score:
- 20
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Score:
- 6
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis 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:
- - No corneal or iridial effects were noted.
- Minimal conjunctival irritation was noted in all treated eyes one hour after treatment, at the 24 h observation, and persisted in one treated eye at the 48 and 72 h observations.
- Two treated eyes appeared normal at the 48 h observation and the remaining treated eye appeared normal at the 7 day observation. - Other effects:
- - Black residual test substance was noted in all treated eyes at the 1 hour observation.
- Light brown-colored staining of the fur was noted around two treated eyes during the study.
Any other information on results incl. tables
The test substance produced minimal conjunctival irritation. Two treated eyes appeared normal at the 48 hour observation and the remaining treated eye appeared normal at the 7 day observation. The test substance produced a maximum group mean score of 6.0 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) according to a modified Kay and Calandra classification system. The test substance did not meet the criteria for classification as irritant according to GHS and CLP classification.
Individual Scores and Individual Total Scores for Ocular Irritation |
|||||||||||||
Rabbit Number and Sex |
67066 Male |
67101 Male |
67102 Male |
||||||||||
IPR = 2 |
IPR = 2 |
IPR = 2 |
|||||||||||
Time After Treatment |
1 Hour |
24 Hours |
48 Hours |
72 Hours |
1 Hour |
24 Hours |
48 Hours |
72 Hours |
1 Hour |
24 Hours |
48 Hours |
72 Hours |
7 Day |
CORNEA |
|||||||||||||
E = Degree of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F = Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (E x F) x 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IRIS |
|||||||||||||
D |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (D x 5) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
CONJUNCTIVAE |
|||||||||||||
A = redness |
1 |
1 |
0 |
0 |
1Sf |
1Sf |
0Sf |
0 |
1Sf |
1 |
1 |
1 |
0 |
B = chemosis |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
C = discharge |
1Re |
0 |
0 |
0 |
1Re |
0 |
0 |
0 |
1Re |
1 |
0 |
0 |
0 |
Score (A x B x C) x 2 |
6 |
2 |
0 |
0 |
6 |
2 |
0 |
0 |
6 |
6 |
2 |
2 |
0 |
Total Score |
6 |
2 |
0 |
0 |
6 |
2 |
0 |
0 |
6 |
6 |
2 |
2 |
0 |
IPR = Initial pain reaction |
|||||||||||||
Re = Black residual test material in the treated eye |
|||||||||||||
Sf = Light brown-coloured staining of the fur around the treated eye |
.
Individual Total Scores and Group Mean Scored for Ocular Irritation |
|||||
Rabbit Number and Sex |
Individual Total Scores At: |
||||
1 Hour |
24 Hours |
48 Hours |
72 Hours |
7 Days |
|
67066 Male |
6 |
2 |
0 |
0 |
- |
67101 Male |
6 |
2 |
0 |
0 |
- |
67102 Male |
6 |
6 |
2 |
2 |
0 |
Group Total |
18 |
10 |
2 |
2 |
0 |
Group Mean Score |
6.0 |
3.3 |
0.7 |
0.7 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was classified as a mild irritant (class 4 on a 1-8 scale) to the rabbit eye (according to the modified Kay and Chandra Classification System) based on a maximum group mean score of 6.0. However, SAS did not meet the criteria for classification as irritant according to EU labeling regulations Commission Directive 2001/59/EC.
The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC. - Executive summary:
N/A
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.