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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
Endpoint summary
Administrative data
Description of key information
SKIN IRRITATION: A single 4-hour, semi-occluded application of SAS to the intact skin of three rabbits according to OECD Guideline 404 (Acute Dermal Irritation/Corrosion) and conducted under GLP concluded that SAS did not meet the criteria for classification as irritant according to EU labeling regulations Commission Directive 2001/59/EC or CLP.
EYE IRRITATION: A single application of SAS to the non-irrigated eye of three rabbits according to OECD Guidelines 404 (Acute Eye Irritation/Corrosion) and conducted under GLP, concluded that SAS did not meet the criteria for classification as irritant according to EU labeling regulations Commission Directive 2001/59/EC or CLP.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- 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
- 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 - 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. - 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
- 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
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Limited methodology was reported
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD Guideline 430 [In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER) ]
- Deviations:
- yes
- Remarks:
- Limited methodology was reported.
- 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
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: N/A
- Age at study initiation: N/A
- Weight at study initiation: N/A
- Housing: N/A
- Diet (e.g. ad libitum): N/A
- Water (e.g. ad libitum): N/A
- Acclimation period: N/A
ENVIRONMENTAL CONDITIONS
- Temperature (deg. C): N/A
- Humidity (%): N/A
- Air changes (per hr): N/A
- Photoperiod (hrs dark / hrs light): N/A
IN-LIFE DATES: From: N/A To: N/A
OTHER: Skin discs were obtained from a humanely euthanized young Wistar strain rat. - Type of coverage:
- other: not applicable
- Preparation of test site:
- other: Skin discs were prepared from a humanely euthanized young Wistar rat.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): N/A
- 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:
- - The test substance was applied to the epidermal surface of skin discs for a contact period of 24 hours.
- Observation period:
- none
- Number of animals:
- three skin discs
- Details on study design:
- TEST SITE
- Area of exposure: N/A
- % coverage: N/A
- Type of wrap if used: N/A
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the contact period the test substance was removed using a jet of warm tap water and analysis was performed.
- Time after start of exposure: 24 hours
SCORING SYSTEM: Corrosive substances produce an irreversible loss of normal stratum corneum integrity and function, this is measured as a reduction in the inherent transcutaneous electrical resistance (TER) assay. Test substances that give a mean electrical resistance of 5K-omega or less are considered likely to be corrosive in vivo. The TER was measured using a low voltage alternating current electronic databridge. - Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Value:
- 14
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Interpretation of results:
- other: unlikely to be corrosive in vivo
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- - The results of this Transcutaneous Electrical Resistance test indicated that the test substance is unlikely to have the potential to cause corrosion in vivo.
- Executive summary:
N/A
Referenceopen allclose all
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.
N/A
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- 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”
- 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 - 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. - 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. - 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
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Test substance purity information was lacking
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The ocular irritancy potential of the test substance was assessed using the Rabbit Enucleated Eye Test (REET). This method involves the application of the test substance onto the cornea of the enucleated eye. The REET is used as the first stage in the assessment of ocular irritancy potential. A negative ocular irritancy potential may require further investigation using an in vivo ocular irritation test. The test has undergone validation and has been shown to reliably detect substances that are negligible, or moderate to severe ocular irritants.
- GLP compliance:
- not specified
- Species:
- other: enucleated rabbit eyes
- Strain:
- other: Enucleated eyes were obtained from the New Zealand White Rabbit and maintained at a temperature of 32+/-1.5 deg C within the superfusion apparatus.
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: N/A
- Age at study initiation: N/A
- Weight at study initiation: N/A
- Housing: N/A
- Diet (e.g. ad libitum): N/A
- Water (e.g. ad libitum): N/A
- Acclimation period: N/A
ENVIRONMENTAL CONDITIONS
- Temperature (deg. C): N/A
- Humidity (%): N/A
- Air changes (per hr): N/A
- Photoperiod (hrs dark / hrs light):N/A
IN-LIFE DATES: From: N/A To: N/A - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: A further two enucleated eyes were treated, for control purposes, with saline solution (0.9% sodium chloride)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test substance, which was found to weigh approximately 91 mg, was applied onto the cornea of each eye.
- 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:
- 240 minutes
- Observation period (in vivo):
- - Corneal opacity and corneal epithelium condition were observed at 60, 120, 180 and 240 minutes post-dosing.
- Fluorescein uptake was determined 240 minutes post-dosing.
- Corneal swelling was measured at 60, 120 and 240 minutes post-dosing. - Number of animals or in vitro replicates:
- - three enucleated rabbit eyes
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): N/A
- Time after start of exposure: N/A
SCORING SYSTEM: The direct effect of the test substance on the cornea was assessed by evaluation of corneal thickness, corneal opacity, alteration of corneal epithelium and fluorescein uptake. Scoring was performed using the Method for Evaluation of Ocular Irritation by Split-Lamp Biomicroscopic Examination-McDonald-Shadduck Score System. See below for more details.
TOOL USED TO ASSESS SCORE: Slit-lamp biomicroscopic examination - Irritation parameter:
- cornea opacity score
- Run / experiment:
- 60, 120, 180 and 240 minutes
- Value:
- 0
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- 240 minutes
- Value:
- 0
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Test Eyes 60 minutes
- Value:
- 8.1
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Test Eyes 120 minutes
- Value:
- 6.3
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Test Eyes 240 minutes
- Value:
- 5.3
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Control Eyes 60 minutes
- Value:
- 0.6
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Control Eyes 120 minutes
- Value:
- 0.6
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- Control Eyes 240 minutes
- Value:
- 0.8
- Irritant / corrosive response data:
- - No corneal cloudiness was observed.
- Corneal epithelium condition was normal at all time points.
- No fluorescein uptake was observed.
- Corneal Swelling-see below - Other effects:
- N/A
- Interpretation of results:
- other: unlikely to have the potential to cause severe ocular irritancy in vivo
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- The REET results indicated that the test substance was considered unlikely to have the potential to cause severe ocular irritancy in vivo.
- Executive summary:
N/A
Referenceopen allclose all
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 |
|
aMean of three eyes; bMean of two-eyes
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
1) Eye irritation: Studies were performed to assess the irritation potential of SAS to the eye of New Zealand White Rabbit. The method met the requirements of OECD Guidelines 405 (Acute Eye Irritation/Corrosion). A single application of SAS to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. Two treated eyes appeared normal at the 48-hr observation and the remaining treated eye appeared normal at the 7-day observation. In addition, the in-vitro study, the Rabbit Enucleated Eye test was performed to assess ocular irritation potential of SAS. A volume of 0.1 mL (91 mg) SAS was applied onto the cornea of each of three enucleated eyes from New Zealand White Rabbits for 60 seconds. Corneal opacity and corneal epithelium condition were observed at 60, 120, 180, and 240 minutes, fluorescein uptake was measured at 240 minutes post-dosing, and corneal swelling was measured at 60, 120 and 240 minutes post-dosing. After 240 minutes, no corneal cloudiness or fluorescein uptake was observed and corneal epithelium condition was normal, indicating that SAS was considered unlikely to have the potential to cause severe ocular irritancy in vivo.
2) Skin Irritation: Studies were performed to assess the irritation potential of SAS to the skin of New Zealand White Rabbit. The method met the requirements of OECD Guideline 404 (Acute Dermal Irritation/Corrosion). A single 4-hr, semi-occluded application of SAS to the intact skin of three rabbits produced very slight to well-defined erythema and very slight oedema. Light brown discoloration of the epidermis, loss of skin elasticity and slight desquamation were also note. In addition, the in-vitro Transcutaneous Electrical Resistance Test (TER) study was also used to assess the skin corrosivity potential of SAS when applied to the epidermal surface of skin discs obtained from young Wistar rats for a contact period of 24 hours, followed by removal using a jet of warm tap water. Based on the results of the TER assay, SAS was considered unlikely to have the potential to cause corrosion in vivo.
Justification for classification or non-classification
Eye irritation: conclusive but not sufficient for classification.
Skin Irritation: conclusive but not sufficient for classification.
Respiratory irritation: Data lacking.
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