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EC number: 230-949-8 | CAS number: 7381-01-3
- 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
Coco fatty acids 2-sulfoethyl ester, sodium salt CAS No 61789-32-0, is not classified as irritating to skin in rabbits, causing only slight skin irritation in the key study. There are three eye irritation studies, the key study and main supporting study indicate that Coco fatty acids 2-sulfoethyl ester, sodium salt CAS No 61789-32-0 is moderately irritating to eyes and requires classification under EU CLP.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1983-04-26 to 1983-06-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Not conducted according to GLP or OECD gudeline but equivalent to OECD guideline 404, with modified scoring scheme. Test substance (Fenopon AC798) idetfied in study report as Sodium Lauryl isethionate. Read-across is based upon a commonality of functional groups, constituents, breakdown products and metabolic pathways. A detailed justification is appended in Section 13.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Scoring system for skin irritation is based on a scale of 0-7 not 0-4 but is equivalent to Draize.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: 9-12 weeks
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum):no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: no data - 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): 0.2g test solid (83% active) applied to a moistened patch
- Concentration (if solution): not applicable
VEHICLE
not applicable, test material applied as a solid - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 4, 24, 48 & 72 hours after treatment
- Number of animals:
- 8 per group
- Details on study design:
- TEST SITE
- Area of exposure: dorsal surface
- % coverage: no data
- Type of wrap if used: cotton gauze under zinc oxide plaster under thin, flexible polythene wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none (treatment sites wiped clean of excess test material upon removal of patches)
- Time after start of exposure: 4 hours
SCORING SYSTEM: 8-point scale ranging from "a" (very slight) to "h" (severe)
Insert table of overall test scoring system (p. 13) - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- >= 1
- Max. score:
- 1
- Reversibility:
- no data
- Remarks on result:
- other: Mean score for 8 animals.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- >= 1
- Max. score:
- 1
- Reversibility:
- no data
- Remarks on result:
- other: Mean score for 8 animals.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- >= 1.3
- Max. score:
- 2
- Reversibility:
- no data
- Remarks on result:
- other: Mean score for 8 animals.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- >= 1
- Max. score:
- 1
- Reversibility:
- no data
- Remarks on result:
- other: Mean score for 8 animals
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- >= 0.9
- Max. score:
- 1
- Reversibility:
- no data
- Remarks on result:
- other: Mean score for 8 animals.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- >= 0.9
- Max. score:
- 1
- Reversibility:
- no data
- Remarks on result:
- other: Mean score for 8 animals.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- >= 0.6
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 out of 8 animals
- Remarks on result:
- other: Mean score for 8 animals.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- >= 0.4
- Max. score:
- 1
- Reversibility:
- fully reversible within: 5 out of 8 animals
- Remarks on result:
- other: Mean score for 8 animals.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: #7
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #7
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: #8
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #8
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Sodium Cocoyl Isethionate (83% ai) is slightly irritant to rabbit skin when tested as supplied.
- Executive summary:
The skin irritation potential of Sodium Cocoyl Isethionate (83%ai) was studied in an in vivo rabbit skin irritation study.
Fenopon AC78 (83% ai) is slightly irritant to rabbit skin when tested as supplied.
Reference
Table 1: Summary of Skin Irritation Results
Rabbit No. |
4 hours |
24 hours |
48 hours |
72 hours |
Animal Mean 24 -72 hrs | |||||
Er* |
Oe** |
Er |
Oe |
Er |
Oe |
Er |
Oe |
Er | Oe | |
351 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1.33 | 1 |
356 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0.66 | 0.66 |
359 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0.66 | 0.66 |
385 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
1 | 0.66 |
398 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
1 | 0.66 |
400 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0.33 | 0.33 |
401 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 | 1 |
404 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1.33 | 1 |
Mean |
1 |
1 |
1.3 |
1 |
0.9 |
0.9 |
0.6 |
0.4 |
*Erythema
**Oedema
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was only carried out for 7 days and the effects are not fully reversible within that time period but the a decrease in severity was seen over a period of 7 days. Therefore the assumption is made that the effects are likely to be fully reversible within 21-days and the study may be used for C&L. Read-across is based upon a commonality of functional groups, constituents, breakdown products and metabolic pathways. A detailed justification is appended in Section 13.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- audited inhouse
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm D -2740 Bremervorde, Neuendamm 88
- Age at study initiation: no data
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: Single caging in battery of cages size: 40 cm high, 45 cm wide, 50 cm long with paper roll disposal system.
- Diet (e.g. ad libitum): ad libitum
Producer: Ssniff Spezialfutter GmbH, 4770 Soest/ Westfalen, Name: Ssniff Mu Z (Alleindiat fur Zuchtkaninchen) Type: pellets, 1.0 - 1.5 cm large, 0.5 cm diameter
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2
- Humidity (%): 50-85
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no data - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 0.1 g of the test material was placed into the conjunctival sac of the left eye while the right eye served as the control. On animal 4- 6 the treated eye was carefully washed out 4 sec p.a. with lukewarm water.
- Observation period (in vivo):
- Prior to treatment, 24 hours p. a. and if necessary 7 days p. a., the eyes were examined for potential eye lesions by means of 1 % Fluorescin. The eyes were scored at 1, 2, 8 hours and 1, 2, 3, 4, 5, 6 and 7 days after treatment.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): On animal 4- 6 the treated eye was carefully washed out
- Time after start of exposure: 4 sec p.a. with lukewarm water
SCORING SYSTEM: DRAIZE
Scoring system eye irritation
Cornea: degree of density (area most dense taken for reading)
0 No ulceration or opacity
1 Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 Easily discernible translucent areas, details of iris slightly obscured
3 Nacrous areas, no details of iris visible, size of pupil barely discernible
4 Opaque cornea, iris not discernible through the opacity
Area of Cornea Involved
1 One quarter (or less) but not zero
2 Greater than one quarter but less than half
3 Greater than half but less than three quarters
4 Greater than three quarters, up to whole area
Iris
0 Normal
1 Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) Iris still reaction to light (sluggish reaction is positive)
a x 5, total maximum = 10 No reaction to light .Hemorrhage. Gross destruction (any or all of these) (2)
Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae cornea and iris)
0 Blood vessels normal
1 Some blood vessels definitely hyperaemic
(injected)
2 Diffuse, crimson colour, individual vessels not easily discernible
3 Diffuse, beefy red
Chemosis (lids and/or nictitating membranes)
0 No swelling 0
1 Any swelling above normal (includes nictitating membranes)
2 Obvious swelling with partial eversion of lids
3 Swelling with lids about half-closed
4 Swelling with lids more than half-closed
Discharge
0 No discharge
1 Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2 Discharge with moistening of the lids and hairs just adjacent to lids
3 Discharge with moistening of the lids and hairs a considerable area around the eye
Score (a + b + c ) x 2 Total maximum = 20
TOOL USED TO ASSESS SCORE: no data - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- animals 1-3
- Time point:
- other: 24-48-72 hours
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: The study was terminated after 7 days.
- Irritation parameter:
- cornea opacity score
- Remarks:
- Unwashed eyes
- 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
- Remarks:
- Unwashed eyes
- 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
- Remarks:
- Unwashed eyes
- 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
- Remarks:
- Unwashed eyes
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- Unwashed eyes
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- Unwashed eyes
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed eyes
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed eyes
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Unwashed eyes
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- Unwashed eyes
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- Unwashed eyes
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- Washed eyes
- 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
- Remarks:
- Washed eyes
- 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
- Remarks:
- Washed eyes
- 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
- Remarks:
- Washed eyes
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- Washed eyes
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- Washed eyes
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed eyes
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed eyes
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Washed eyes
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- Washed eyes
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- Washed eyes
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- Washed eyes
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- After treatment in none of the animals effects on the cornea were observed. One hour after treatment effects on the Iris were observed in all animals. One animal from the group where the eye was not washed out did not react to light up to 5 days after treatment. In two animals from this group effects on the Iris were not fully reversible, in one animal the effects disappeared after 5 days. In the group where the eyes were washed out after 4 seconds effects were not fully reversible in one animals and in the two other animals effects were gone on day 2 or 4. Conjunctivae were affected in all animals with 4 as the highest score in one animal for chemosis. In the first group on day 2 effects started to decrease but were only fully reversible within 7 days in one animal. In the second group the same effects were observed but only less severe with a highest score of 3. In two animals effects were fully reversible on day 4 or 5, in the third animals effects were not fully reversible after 7 days.
- Interpretation of results:
- irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test substance causes a score of ≥ 1 for iris and a ≥ 2 score for chemosis. The effects are not fully reversible within 7 days but the a decrease in severty was seen over a period of 7 days. Therefore the assumption is made that the effests are likely to be fully reversible within 21-days and the substance is classified in catergory 2 (irritating to eyes).
- Executive summary:
An eye irritation study was carried out acoording to OECD405 and inhouse quality assurance was in place.
0.1g of the test substance (white powder) was instilled in the eyes of 6 rabbits. In 3 rabbits the eyes were washed after 4 seconds. Prior to treatment, 24 hours post application and if necessary 7 days post application, the eyes were examined for potential eyelesions by means of 1 % Fluorescin.
The eyes were scored at 1, 2, 8 hours and 1, 2, 3, 4, 5, 6 and 7 days after treatment.
After treatment in none of the animals effects on the cornea were observed. One hour after treatment effects on the Iris were observed in all animals. One animal from the group with unwashed eyse did not react to light up to 5 days after treatment. In two animals from this group effects on the Iris were not fully reversible, in one animal the effests disappeared after 5 days.
In the group where the eyes were washed out after 4 seconds effects were not fully reversible in one animals and in the two other animals effects were gone on day 2 or 4. Conjunctivae were affected in all animals with 4 as the highest score in one animal for chemosis.
In the first group on day 2 effects started to decrease but were only fully reversible within 7 days in one animal.
In the second group the same effecst were observed but only less severe with a higest score of 3. In two animals effects were fully reversible on day 4 or 5, in the third animals effects were not fully reversible after 7 days.
The test substance causes a score of ≥ 1 for iris and a ≥ 2 score for chemosis. The effects are not fully reversible within 7 days but the a decrease in severty was seen over a period of 7 days. Therefore the assumption is made that the effests are likely to be fully reversible within 21-days and the substance is classified in catergory 2A (irritating to eyes).
Reference
Without removal of the test substance
Rabbit No and sex |
Region of the eye |
Hours after instillation |
Average 24-48-72hours |
||||
24 |
48 |
72 |
|||||
1 |
Cornea |
Degree of opacity |
0 |
0 |
0 |
0 |
|
Area of opacity |
0 |
0 |
0 |
0 |
|||
Iris |
2 |
2 |
2 |
2 |
|||
Conjunctivae |
Redness |
3 |
3 |
2 |
2.7 |
||
Chemosis |
3 |
3 |
2 |
2.7 |
|||
Discharge |
2 |
2 |
1 |
1.7 |
|||
2 |
Cornea |
Degree of opacity |
0 |
0 |
0 |
0 |
|
Area of opacity |
0 |
0 |
0 |
0 |
|||
Iris |
1 |
1 |
1 |
1 |
|||
Conjunctivae |
Redness |
3 |
1 |
1 |
1.7 |
||
Chemosis |
3 |
2 |
1 |
2 |
|||
Discharge |
2 |
1 |
1 |
1.7 |
|||
3 |
Cornea |
Degree of opacity |
0 |
0 |
0 |
0 |
|
Area of opacity |
0 |
0 |
0 |
0 |
|||
Iris |
1 |
1 |
1 |
1 |
|||
Conjunctivae |
Redness |
3 |
1 |
1 |
1.7 |
||
Chemosis |
4 |
2 |
2 |
2.7 |
|||
Discharge |
2 |
2 |
1 |
1.7 |
Removal of the test substance after 4 seconds
Rabbit No and sex |
Region of the eye |
Hours after instillation |
Average 24-48-72hours |
||||
24 |
48 |
72 |
|||||
4 |
Cornea |
Degree of opacity |
0 |
0 |
0 |
0 |
|
Area of opacity |
0 |
0 |
0 |
0 |
|||
Iris |
1 |
1 |
1 |
1 |
|||
Conjunctivae |
Redness |
3 |
3 |
3 |
3 |
||
Chemosis |
3 |
3 |
2 |
2.7 |
|||
Discharge |
2 |
2 |
2 |
2 |
|||
5 |
Cornea |
Degree of opacity |
0 |
0 |
0 |
0 |
|
Area of opacity |
0 |
0 |
0 |
0 |
|||
Iris |
1 |
1 |
1 |
1 |
|||
Conjunctivae |
Redness |
3 |
1 |
1 |
1.3 |
||
Chemosis |
3 |
2 |
1 |
2 |
|||
Discharge |
2 |
0 |
0 |
0.7 |
|||
6 |
Cornea |
Degree of opacity |
0 |
0 |
0 |
0 |
|
Area of opacity |
0 |
0 |
0 |
0 |
|||
Iris |
1 |
0 |
0 |
0.3 |
|||
Conjunctivae |
Redness |
3 |
2 |
2 |
2.3 |
||
Chemosis |
3 |
2 |
2 |
2.3 |
|||
Discharge |
2 |
0 |
0 |
0.7 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There are no eye or skin irritation studies available for lauric acid 2-sulfoethyl ester, sodium salt (sodium lauroyl isethionate) CAS No 7381-01-3.
There are however studies on the source chemical Coco fatty acids 2-sulfoethyl ester, sodium salt CAS No 61789 -32 -0: a skin irritation study which is rated Klimisch 2 and was carried out in a manner similar to OECD guideline 404, as mentioned in Unilever report CPS830017; and an eye irritation study, rated Klimisch 2 conducted according to OECD guideline 405 under GLP, as described in Sterner and Chibanguza, 1988.
Coco fatty acids 2-sulfoethyl ester, sodium salt CAS No 61789 -32 -0 is only slightly irritating to the skin of rabbits when tested undiluted. When tested in rabbit eyes it produced eye irritation; the effects seen were considered being reversible within 21 days even though the study was terminated on Day 7.
We have no test data for respiratory irritation. Inhalation is not an expected route of exposure but based on its eye irritation properties Coco fatty acids 2-sulfoethyl ester, sodium salt CAS No 61789 -32 -0 might cause some irritation in the respiratory tract if inhaled. However in the absence of any specific information it is not considered that a classification is required under EU CLP for respiratory irritation.
Read-across from the source chemical,Coco fatty acids 2 -sulfoethyl ester, sodium salt CAS no 61789 -32 -0
to the target chemical is considered to be justified based upon a commonality of functional groups, constituents, breakdown products and metabolic pathways.Therefore we consider these study endpoint results as sufficiently conservative to be taken account of in the risk assessment of lauric acid 2-sulfoethyl ester, sodium salt (sodium lauroyl isethionate) CAS No 7381-01-3.
Justification for selection of skin irritation / corrosion endpoint:
There is one skin irritation study in rabbits, a Unilever study which has Klimisch reliability 2, it was not conducted according to GLP or a specific OECD guideline, but it was equivalent to OECD 404 and conducted in a high quality testing facility. This study showed only slight skin irritation for the Coco fatty acids 2-sulfoethyl ester, sodium salt with a typical 83% active sample, this does not result in a classification using EU CLP criteria.
Justification for selection of eye irritation endpoint:
There are three eye irritation studies in rabbits; the key study is Sterner and Chibanguza, 1988. This is a Klimisch 2 as the study was terminated after 7 days when there was not complete recovery of the irritant effects seen in the eyes. However the effects were significantly reduced to the extent that it is concluded that they would have been full reversible in 21 days. The scores seen for eye irritation would result in an EU CLP classification of category 2. There are two supporting studies HPV Data Eye irritation which is also Klimisch 2 but only used a 47.5% solution of Coco fatty acids 2-sulfoethyl ester, sodium salt, this also showed eye irritation but a classification verdict was not recorded. The third weight of evidence study was also Klimisch 2, it was not GLP or to an OECD guideline but was similar to OECD 405. The main limitation as that the test substance was a 15% solution of Coco fatty acids 2-sulfoethyl ester, sodium salt in a gel cleaner formulation, the study concluded that the formulation was an eye irritant to US consumer product safety commission regulation 16 CFR 1500.3(c).
Effects on skin irritation/corrosion: slightly irritating
Effects on eye irritation: moderately irritating
Justification for classification or non-classification
The justification for classification of lauric acid 2-sulfoethyl ester, sodium salt (sodium lauroyl isethionate) CAS No 7381-01 -3 for irritation endpoints is
based upon read-across to studies available for Coco fatty acids 2-sulfoethyl ester, sodium salt CAS No 61789 -32 -0. Coco fatty acids 2-sulfoethyl ester, sodium salt CAS No 61789 -32 -0 when tested on rabbit skin was slightly irritant, however the scores did not meet the criteria for classification as a skin irritant according to EU CLP criteria. There are two acceptable quality studies on eye irritation in rabbits, the key study is on the undiluted product and resulted in eye irritation scores of >1 for the iris and >2 for chemosis which corresponds to a classification by EU CLP criteria of category 2 of eye irritation. In the absence of any specific information it is not considered that a classification is required under EU CLP for irritation of the respiratory tract.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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