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EC number: 827-581-0 | CAS number: -
- 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
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Remarks:
- Read-across SCI
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- Refer to read-across justification document for SCMI in section 13
- Reason / purpose for cross-reference:
- read-across: supporting information
- Guideline:
- other: In house method
- Principles of method if other than guideline:
- Eight animals were exposed to each of the test materials applied under individual semi occlusive patches for 4 hours after which the area was wiped clean of any excess material. Treatments were sited in a randomised manner.
Irritation reactions were assessed immediately after removal of the patch and at 24, 48 and 72 hours. - GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-12 weeks - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- Test material was applied as supplied or diluted in distilled water to give concentrations of 10, 25, 40, 55 and 70% active substance.
0.2 g solid test substance (i.e. substance as supplied) was applied to moistened pad or 0.5 ml of test solution applied to dry pad. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 8 rabbits used in study. Six test groups investigated. Each rabbit received all six test groups.
- Details on study design:
- TEST SITE
- Area of exposure: A 2.5 cm square of 8 ply cotton gauze folded in was laid on the polythene such that the edges of the pad were attached to the zinc oxide plaster. The patches were firmly attached to ensure good contact between the skin and test substance.
- % coverage:
- Type of wrap if used: Thin flexible polythene (3 x 3 cm) was attached to a piece of zinc oxide plaster (9 x 2.5 cm).
REMOVAL OF TEST SUBSTANCE
When the test patches are removed the treatment sites are wiped clean of excess material.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
cracking using an 8 point scale, ranging from very slight (1) to severe (8).
-: no reaction
a : marginal/very slight
b : slight
c: fairly distinct
d: quite distinct
e: becoming well developed
f: well developed
g: becoming severe
h: severe
An overall irritation score was calculated as follows:
0: normal skin -
1: marginal slight erythema and oedema (grade a) at 24 hours but no effects at 72 hours
2: slight slight erythema and oedmema (grades up to bbbb) at 24 and 72 hours
3: slight/moderate slight/moderate erythema and oedema (grades ca /cc) at 24 hours. The reaction generally reduces to slight at 72 hours but sometimes the slight/moderate reaction may be maintained.
4: moderate moderate erythema and oedema (grades c and d) with slight cracking and scaling at 24 hours with the erythema and oedema being maintained at least at slight/moderate level with cracking and scaling developed at 72 hours
5: Strong As for 4 above or greater erythema and oedema with evidence of up to ¼ of the site affected by necrosis.
6: Severe Most of the site affected by suspected necrosis
7: Extreme Deep necrosis over the whole site identified by depressed, hard scab/ tissue and surrounding inflammatory reaction. - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Treatment Group A
- Time point:
- 24/48/72 h
- Score:
- 1.21
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Treatment Group B
- Time point:
- 24/48/72 h
- Score:
- 1.79
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Treatment Group C
- Time point:
- 24/48/72 h
- Score:
- 1.83
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Treatment Group D
- Time point:
- 24/48/72 h
- Score:
- 0.96
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Treatment Group E
- Time point:
- 24/48/72 h
- Score:
- 0.92
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Treatment Group F
- Time point:
- 24/48/72 h
- Score:
- 1.375
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Treatment Group A
- Time point:
- 24/48/72 h
- Score:
- 0.96
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Treatment Group B
- Time point:
- 24/48/72 h
- Score:
- 1.25
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Treatment Group C
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Treatment Group D
- Time point:
- 24/48/72 h
- Score:
- 0.79
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Treatment Group E
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Treatment Group F
- Time point:
- 24/48/72 h
- Score:
- 1
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information
- Conclusions:
- The results of the study indicate that the test substance produced some irritation to rabbit skin, which was reversible. However, the test was not extended past 72 hours, so it is not possible to demonstrate conclusively when the oedema, erythema, cracking and scaling was resolved. These effects were only scored as slight by the 72 hour time point and therefore it is likely that skin would have returned to normal should the test have been continued to 14 days.
- Endpoint:
- skin irritation / corrosion
- Remarks:
- other: Review report
- Type of information:
- other: Assessment of Eye Irritation Properties of SCI under the High Production Volume Chemical Challenge Program.
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Assessment of Eye Irritation Properties of SCI under the High Production Volume Chemical Challenge Program.
- Justification for type of information:
- Refer to read-across justification document for SCMI in section 13
- Reason / purpose for cross-reference:
- read-across: supporting information
- Principles of method if other than guideline:
- Review of available data on SCI
- GLP compliance:
- no
- Irritation / corrosion parameter:
- other: Primary irritation (PDII) score
- Value:
- 2.24
- Irritation / corrosion parameter:
- other: Primary irritation (PDII) score
- Value:
- 2.4
- Irritation / corrosion parameter:
- other: Primary irritation (PDII) score
- Value:
- > 0.4 - < 0.5
- Irritation / corrosion parameter:
- other: Primary irritation (PDII) score
- Value:
- 1.38
- Irritation / corrosion parameter:
- other: Primary irritation (PDII) score
- Value:
- 4.5
- Interpretation of results:
- other: mildly to moderating irritating
- Remarks:
- Criteria used for interpretation of results: US EPA pesticides
- Conclusions:
- The authors concluded that the sum total of these five studies demonstrate that SCI is only mildly to moderately irritating to the skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Remarks:
- read-across to SCI
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Justification for type of information:
- Refer to read-across justification document for SCMI in section 13
- Reason / purpose for cross-reference:
- assessment report
- Guideline:
- other: In house method
- Principles of method if other than guideline:
- 0.5 g of the test substance was applied to the intact and abraded skin of New Zealand white rabbits for a period of 24 hours. Skin was evaluated at 24 and 72 hours and scored for erythema/eschar and oedema.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- not specified
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- Up to 14 days
- Number of animals:
- 6
- Irritation parameter:
- overall irritation score
- Remarks:
- Abraded skin
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2.7
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- overall irritation score
- Remarks:
- Intact skin
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.8
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.15
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Interpretation of results:
- slightly irritating
- Remarks:
- Criteria used for interpretation of results: US EPA pesticides
- Conclusions:
- The report concludes that the test substance was moderately irritating (Primary Irritation Index 4.5) and that severe effects found in one animal were reversed by 14 days. However, two things are noted
1) the exposure period is 24 hours rather than the current OECD recommendation of 4 hours. Therefore, exposure was much more severe than the current OECD guideline recommendation of 4 hours.
2) total score for Primary Irritation Index is based on intact and abraded skin. The total score for Intact skin only was 1.8 and therefore slightly irritating. - Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Remarks:
- read-across to SLMI
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- Refer to read-across justification document for SCMI in section 13
- Reason / purpose for cross-reference:
- assessment report
- Principles of method if other than guideline:
- Approximately 0.1-0.15g of each test article was placed onto a Parke-Davis Readi-Bandage occlusive patch that measured 2cm by 2cm. The patch was then applied to the back of each subject between the scapulae and the waist, adjacent to the spinal mid line. Patching occurred for 14 consecutive days. Each day following application, the patches were removed, the sites were evaluated and identical patches were reapplied to the same test sites. Evaluations were made according to a 6 point scale.
- GLP compliance:
- no
- Species:
- human
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- water
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.15 g per day - Duration of treatment / exposure:
- 14 days . Fresh treatment applied each day.
- Number of animals:
- 22 volunteers
- Details on study design:
- A 14 day cummulative irritation study using 14 test articles on 22 subjects. 0.1-0.15 g per day of each test item was applied to the back of each test subject. The irritant reponses were quantified by visual clinical evaluation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 20
- Max. score:
- 56
- Remarks on result:
- probability of mild irritation
- Interpretation of results:
- other: mildly-moderately irritating
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- For SLMI the total cummulative irritancy score was 400 with a mean score of 20. The highest potential mean irritation score was 56. This indicates that SLMI is mildly-moderately irritating with pink/red erythema covering the contact site.
SLMI was ranked lower in irritancy than SCI, which is also not classified for skin irritancy - Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Remarks:
- Read-across to SCI
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- Refer to read-across justification document for SCMI in section 13
- Reason / purpose for cross-reference:
- assessment report
- Guideline:
- other: Study conducted according to MatTek EpiDerm in vitro toxicity system
- Principles of method if other than guideline:
- MatTek's EpiDerm Skin Model consists of normal, human-derived epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis.
- GLP compliance:
- yes
- Species:
- human
- Details on test animals or test system and environmental conditions:
- TEST Cells
- Source: Human-derived epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis. - Type of coverage:
- other: EpiDerm Skin Model consists of normal, human-derived epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 1-20 hours
The exposure period for the negative controls was 4.5 hours. - Details on study design:
- SCORING SYSTEM:
ET-50 hrs Expected in vivo irritancy Example
>0.5 Severe, Probably corrosive, Conc Nitric acid
0.5-4 Moderate 1% Sodium Dodecyl sulphate
4-12 Moderate - mild 1% Triton X-100
12-24 Very mild Baby shampoo
24 Non irritating 10% Tween 20 - Irritation / corrosion parameter:
- other: Expected in vivo irritancy response
- Run / experiment:
- ET-50 (estimated time for 50% cellular dysfunction) in hours
- Value:
- 2.6
- Remarks on result:
- other:
- Remarks:
- Remarks: Tauranol I-78 Flakes 5% solution is classified as a moderate irritant. (migrated information)
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Under the conditions of the study, Tauranol I-78 Flakes 5% solution elicited an in vitro response that corresponded to an in vivo dermal irritancy potential in the moderate range.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Remarks:
- read-across to SLMI
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted following the MatTek EpiDerm invitro toxicity system.
- Justification for type of information:
- Refer to read-across justification document for SCMI in section 13
- Reason / purpose for cross-reference:
- read-across: supporting information
- Principles of method if other than guideline:
- Study conducted according to MatTek EpiDerm in vitro toxicity system
- GLP compliance:
- yes
- Species:
- human
- Type of coverage:
- other: EpiDerm Skin Model consists of normal, human-derived epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis
- Controls:
- yes
- Duration of treatment / exposure:
- 1-20 hours
- Observation period:
- 1-20 hours
- Number of animals:
- Not applicable
- Irritation / corrosion parameter:
- other: Expected in vivo irritancy response
- Run / experiment:
- ET-50 (estimated time for 50% cellular dysfunction) in hours
- Value:
- 2.5
- Remarks on result:
- other:
- Remarks:
- Remarks: Pureact SLMI-85 5% is classified as a moderate irritant. (migrated information)
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the study, Pureact SLMI-85 5% Active Solution elicited an in vitro response that corresponded to an in vivo dermal irritancy potential in the moderate range.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Remarks:
- Read-across SLMI
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed using the MatTek EpiDerm in vitro toxicity system
- Justification for type of information:
- Refer to read-across justification document for SCMI in section 13
- Reason / purpose for cross-reference:
- read-across: supporting information
- Principles of method if other than guideline:
- Study conducted according to MatTek EpiDerm in vitro toxicity system
- GLP compliance:
- yes
- Species:
- human
- Type of coverage:
- other: EpiDerm Skin Model consists of normal, human-derived epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis
- Controls:
- yes
- Duration of treatment / exposure:
- 1-20 hours
- Observation period:
- 1-20 hours
- Number of animals:
- Not applicable
- Irritation / corrosion parameter:
- other: Expected in vivo irritancy response
- Run / experiment:
- ET-50 (estimated time for 50% cellular dysfunction) in hours
- Value:
- 2.9
- Remarks on result:
- other:
- Remarks:
- Remarks: Pureact SLMI-85 10% Active Solution is classified as a moderate irritant. (migrated information)
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the study, Pureact SLMI-85 10% Active Solution elicited an in vitro response that corresponded to an in vivo dermal irritancy potential in the moderate range.
- Endpoint:
- skin irritation / corrosion
- Remarks:
- other: Review report
- Type of information:
- other: Review report
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Refer to read-across justification document for SCMI in section 13
- Reason / purpose for cross-reference:
- assessment report
- Principles of method if other than guideline:
- The author provides a comprehensive review of the manufacture, properties and applications of the anionic surfactants known as taurates and isethionates (fatty acids sulphoalkyl amide and esters, respectively). This includes a review of the toxicological properties, with emphasis on the skin irritancy.
- GLP compliance:
- no
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Data reviewed by the author demonstrate that isethionates, including SCI have low irritancy to skin.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Remarks:
- reead-across to SCI
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- Refer to read-across justification document for SCMI in section 13
- Reason / purpose for cross-reference:
- read-across: supporting information
- Principles of method if other than guideline:
- MatTek's EpiDerm Skin Model consists of normal, human-derived epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis.
- GLP compliance:
- not specified
- Species:
- human
- Details on test animals or test system and environmental conditions:
- Human-derived epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis.
- Duration of treatment / exposure:
- 1-24 hours
- Details on study design:
- SCORING SYSTEM:
ET-50 hrs Expected in vivo irritancy Example
>0.5 Severe, Probably corrosive, Conc Nitric acid
0.5-4 Moderate 1% Sodium Dodecyl sulphate
4-12 Moderate - mild 1% Triton X-100
12-24 Very mild Baby shampoo
24 Non irritating 10% Tween 20 - Irritation / corrosion parameter:
- other: Expected in vivo irritancy response
- Run / experiment:
- ET-50 (estimated time for 50% cellular dysfunction) in hours
- Value:
- 9.79
- Remarks on result:
- other:
- Remarks:
- Remarks: Tauranol I-78 was classified as a mild irritant. (migrated information)
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Under the conditions of the study, Tauranol I-78 was classified as a mild irritant.
Referenceopen allclose all
Exposure to the test material as supplied, resulted in only marginal/very slight to slight erythema and oedema in the most animals and time points.
At the 24 hour time point, one animal (351) showed quite distinct erythema and one animal (404) fairly distinct erythema. At 48 hours this was reduced to slight erythema in both of these animals, with all other animals either showing marginal/slight effects or no reaction. At 72 hours all animals except 351 (which showed slight erythema) had either no reaction or marginal/very slight erythema or oedema. Marginal/ slight cracking and scaling was observed in three animals and was still evident in two of these at the 72 hour time point
When the test substance was diluted in water to give a 70% a.i. concentration, only marginal/very slight or slight erythema and oedema was observed in all animals at 4 hours and 24 hours (apart from animal 404 where fairly distinct erythema was observed at 24 hours). After 48 and 72 hours skin was normal in the majority of cases, with only two animals exhibiting marginal/slight erythema and oedema. In these animals marginal/slight cracking and scaling was observed at the 72 hours time point
The study was not extended past the 72 hour time point, and therefore it is not possible to determine how long the reactions still evident at 72 hours would have persisted
An interpolation of the recorded results to the Draize scale gives the following results. The totals presented are mean scores from the treatment groups.
Treatment Group |
24 hours |
48 hours |
72 hours |
Mean 24 -72 hours |
||||
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
|
A= 10% ai |
1.75 |
1.125 |
1.125 |
1 |
0.75 |
0.75 |
1.21 |
0.96 |
B= 25% ai |
1.875 |
1.375 |
1.75 |
1.125 |
1.75 |
1.25 |
1.79 |
1.25 |
C= 40% ai |
1.75 |
1.625 |
2 |
1.375 |
1.75 |
1.5 |
1.83 |
1.5 |
D= 55% ai |
1.375 |
1 |
0.875 |
0.875 |
0.625 |
0.5 |
0.96 |
0.79 |
E= 70% ai |
1.375 |
1.125 |
0.625 |
0.375 |
0.75 |
0.5 |
0.92 |
0.66 |
F= as supplied |
1.75 |
1.25 |
1.25 |
1 |
1.125 |
0.75 |
1.375 |
1 |
These scores indicate that the solutions of SCI are mildly irritating.
In a study by Wo and Shapiro (1984), the resultant primary irritation (PDII) score was 2.24 (moderately irritating).
The studies by van Baaren, Baszcak and Nitka and Palanker, resulted in moderate, mild, and mild irritation and PDII scores of 2.4, 0.4-0.5, and 1.38 for the three studies, respectively.
The study by Lodestedt had a PDII score of 4.5 (see full summary provided separately).
Exposure time (hours) |
Average value |
|
Erythema and Eschar Formation |
||
Intact Skin |
24 |
2.3 |
72 |
2.0 |
|
Abraded Skin |
24 |
3.0 |
72 |
3.0 |
|
Edema Formation |
||
Intact Skin |
24 |
1.7 |
72 |
1.3 |
|
Abraded Skin |
24 |
2.3 |
72 |
2.3 |
|
Total Score ¿ Intact Skin |
1.8 |
|
Total Score ¿ Abraded Skin |
2.7 |
|
Combined Score |
4.5 |
For SLMI the total cummulative irritancy score was 400 with a mean score of 20. The highest potential mean irritation score was 56. This indicates that SLMI is mildly-moderately irritating with pink/red erythema covering the contact site.
SLMI was ranked lower in irritancy than SCI, which is also not classified for skin irritancy
Test substance |
Conc |
Exposure |
Average% viability |
ET50 (hr) |
Classification |
Tauranol 1-78-E |
5% |
20 hr |
7 |
2.6 |
moderate |
4.5 hr |
27 |
||||
1 hr |
86 |
||||
Triton X-100 |
1% |
20 hr |
8 |
7 |
mild/moderate |
4.5 hr |
67 |
||||
1 hr |
94 |
||||
Water |
100% |
4.5 hr |
100 |
NA |
NA |
Under the conditions of the study, Tauranol I-78 Flakes 5% solution, elicited in vitro results which indicate an ET-50 of approximately 2.6 hours. This corresponds to an estimated dermal irritancy potential in the moderate range.
The following results were obtained:
Test substance |
Conc |
Exposure |
Average% viability |
ET50(hr) |
Classification |
Pureact SLMI-85 5% Active Solution |
5% |
20 hr |
12 |
2.5 |
moderate |
4.5 hr |
15 |
||||
1 hr |
106 |
||||
Triton X-100 |
1% |
20 hr |
10 |
8.2 |
mild/moderate |
4.5 hr |
77 |
||||
1 hr |
96 |
||||
Water |
100% |
NA |
NA |
NA |
NA |
Under the conditions of the study, Pureact SLMI-85 5% Active Solution, elicited in vitro results which indicate an ET-50 of approximately 2.5 hours. This corresponds to an estimated dermal irritancy potential in the moderate range.
The following results were obtained:
Test substance |
Conc |
Exposure |
Average% viability |
ET50(hr) |
Classification |
Pureact SLMI-85 10% Active Solution |
5% |
20 hr |
10 |
2.9 |
moderate |
4.5 hr |
25 |
||||
1 hr |
100 |
||||
Triton X-100 |
1% |
20 hr |
10 |
8.2 |
mild/moderate |
4.5 hr |
77 |
||||
1 hr |
96 |
||||
Water |
100% |
NA |
NA |
NA |
NA |
Under the conditions of the study, Pureact SLMI-85 10% Active Solution, elicited in vitro results which indicate an ET-50 of approximately 2.9 hours. This corresponds to an estimated dermal irritancy potential in the moderate range.
In the paper, the lack of skin irritation is documented as the most noteworthy (toxicological) feature of the isethionates. Petter refers to reviews by other authors (Frosch, 1982; Fremaux, 1982) to substantiate this. A review by Frosch found that isethionate based bars were milder than any other product.
Data published by Fremaux demonstrates the mildness of SCI to skin compared to other commonly used anionic and amphoteric surfactants. In Fremaux's study the following surfactants were tested for irritancy on intact rabbit skin (various concentrations, ranging from 1.8 to 28%, kept in contact with shaved skin for 24 hours), to give an irritation rating versus concentration:
Sodium lauryl sulphate,
TEA-lauryl sulphate,
Cocounut acid cycloimidinium derivative,
ammonium laureth-3-sulphate
sodium cocoyl isethionate
Fremaux found that irritancy decreased in the order given above, with alkyl sulphates (e.g. sodium lauryl sulphate) being the most irritant and isethionate showing only negligible irritation As reported by Petter, the reduced differences in irritancy have been related to the effects of surfactants in reducing water binding capacity of the stratum corneum. The author refers to a study by Middleton (1969), which demonstrates that sodium lauryl sulphate can extract lipid from the corneum cell walls, resulting in increasing permeability and allowing the escape of intracellular water soluble substances, responsible for much of the water binding ability. SLI was found to extract less material from the cell wall and had little effect on water binding. The study by Fremaux also found water binding data consistent with this for these two types of surfactants.
Test substance |
Conc |
Exposure |
Average% viability |
ET50 (hr) |
Classification |
Tauranol 1-78-E |
5% |
1 hr |
89.2 |
9.79 |
mild |
4 hr |
53.3 |
||||
24 hr |
8.7 |
||||
Triton X-100 |
1% |
1 hr |
84.7 |
12.47 |
very mild |
4 hr |
88.0 |
||||
24 hr |
8.1 |
||||
Water |
neat |
1 hr |
na |
na |
na |
4 hr |
na |
||||
24 hr |
na |
Under the conditions of the study, Tauranol I-78 elicited in vitro results which indicate an ET-50 of approximately 9.79 hours. This corresponds to an in vivo dermal irritancy potential in the mild range.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Remarks:
- read-across to SCI
- 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 fuly reversibel within that time period 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 study may be used for C&L.
- Justification for type of information:
- Refer to read-across justification document for SCMI in section 13
- Reason / purpose for cross-reference:
- assessment report
- 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 testmaterial was placed into the conjunctival sac of the left eye while the right eye served as I 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 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.
- 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:
- 24/48/72 h
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks:
- The study was terminated after 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Irritant / corrosive response data:
- After treatment none of the animals showed any effects on the cornea. 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 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 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:
- highly irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- An eye irritation study was carried out according to OECD 405 and in-house quality assurance was in place.
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 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 substance is classified in category 2 (causes serious eye irritation). - Executive summary:
An eye irritation study was carried out according 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 category 2, causes serious eye irritation.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Remarks:
- read-across to SCI
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Not performed according to GLP or OECD guideline but conducted in a manner similar to OECD 405.
- Justification for type of information:
- Refer to read-across justification document for SCMI in section 13
- Reason / purpose for cross-reference:
- reference to other study
- Reason / purpose for cross-reference:
- assessment report
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Recover period was only 7 days after treatment
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazelton-Dutchland, Inc. Denver, Pennsylvania
- Age at study initiation: young adults
- Weight at study initiation: 2.2 to 2.7 kg
- Housing: individually housed; suspended, stainless steel cages
- Diet (e.g. ad libitum): purina lab rabbit chow HF (#5326) ad libitum
- Water (e.g. ad libitum):automatic watering system, ad libitum; municipal water supply
- Acclimation period:21 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 60-70 degrees F; monitored and recorded twice daily
- Humidity (%): 30-70% monitored and recorded once daily
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
IN-LIFE DATES: From: 1985-02-18 To: 1985-02-25 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1mL
- Concentration (if solution): 15% active ingredient
VEHICLE
not applicable - Duration of treatment / exposure:
- 7 days (eyes were not washed)
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 (4 females, 2 males)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: not applicable
SCORING SYSTEM: Draize*
TOOL USED TO ASSESS SCORE: fluorescein
*Total Draize score is the sum of the three scores obtained (cornea, iris, cunjuctivae) - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- <= 23.3
- Max. score:
- 23.3
- Reversibility:
- not specified
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- <= 14.3
- Max. score:
- 14.3
- Reversibility:
- not specified
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- <= 7
- Max. score:
- 7
- Reversibility:
- not specified
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- <= 1.7
- Max. score:
- 1.7
- Reversibility:
- not specified
- Other effects:
- No apparent discomfort, as demonstrated by squealing, was noted at the time of instillation of the test material.
No mortality was observed during the course of the study. - Interpretation of results:
- irritating
- Remarks:
- Criteria used for interpretation of results: other: US 16 CFR 1500.3(c) [Consumer Product Safety Commission, Federal Hazardous Substances Act Regulations]
- Conclusions:
- According to the study report, the test material, 648-01 is considered to be an eye irritant as defined in 16 CFR 1500.3(c) [CONSUMER PRODUCT SAFETY COMMISSION, Federal Hazardous Substances Act Regulations (USA). Definitions].
- Executive summary:
In an in vivo eye irritation study using New Zealand White rabbits conducted by Bio/dynamics Inc., the maximum average score, which occurred on Day 1, was 23.3. Test item produced moderate and transient ocular irritation. Most animals exhibited moderate conjunctival irritation (redness, chemosis, discharge), iridial changes and corneal opacities, ulceration and stippling. One animal was free of any ocular irritation within 7 days after instillation of the test material. The five remaining animals exhibited slight conjunctival irritation but were free of any corneal irritation at study termination (Day 7).
The test material. 648-01 is considered to be an eye irritant as defined in 16 CFR 1500.3(c) [CONSUMER PRODUCT SAFETY COMMISSION, Federal Hazardous Substances Act Regulations. Definitions].
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Remarks:
- read-across to SCI
- Adequacy of study:
- supporting study
- Study period:
- 1986-09-11 to 1986-09-25
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study not conducted according to GLP; however the study was conducted in a manner equivalent to relevant OECD guideline (405). The study contains a quality assurance statement and was conducted in accordance to the methodology proposed under the United States Federal Hazardous Substances Labelling Act (Federal Register, 1964, 29 13009).
- Justification for type of information:
- Refer to read-across justification document for SCMI in section 13
- Reason / purpose for cross-reference:
- assessment report
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Post-treatment observations were not performed at 14 and 21 days.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazelton Research Products, Inc.
- Age at study initiation: no data
- Weight at study initiation: >1.5kg
- Housing: Elevated wire mesh cages
- Diet (e.g. ad libitum): measured amount of Purina High Fiber Rabbit Chow (6oz/day) was offered to all rabbits rather than ad libitum feed.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >/= 7 days
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
- Temperature: 22-27 Degrees C
- Humidity: 56-79%
IN-LIFE DATES: From: 1986-09-11 To: 1986-09-25 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100mg
- Concentration (if solution): not applicable
VEHICLE
Not applicable - Duration of treatment / exposure:
- Eyes were not flushed of test material, therefore the duration of exposure was 7 days
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
not applicable - test substance was not flushed out of eyes
SCORING SYSTEM:
Draize technique
TOOL USED TO ASSESS SCORE: sodium fluorescein - Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- 24 h
- Score:
- <= 34.2
- Max. score:
- 34.2
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- 48 h
- Score:
- <= 31
- Max. score:
- 31
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- 72 h
- Score:
- <= 28.8
- Max. score:
- 28.8
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 4 days
- Score:
- <= 28
- Max. score:
- 28
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- <= 20.3
- Max. score:
- 20.3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2.5
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 2.7
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2.8
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 96 hours
- Score:
- 2.3
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 1.7
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.2
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 96 hours
- Score:
- 1.3
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0.8
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.8
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.8
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.8
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 96 hours
- Score:
- 0.7
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0.7
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2.2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 2.5
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2.2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 96 hours
- Score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 1.5
- Irritant / corrosive response data:
- See table 1 below
- Other effects:
- None
- Interpretation of results:
- irritating
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- In a study performed to OECD 405, based on the average scores for redness and chemosis, the substance (SCI) showed irritating properties under the conditions of this study.
- Executive summary:
In this study, where 6 rabbits received a single application of 100 mg of the substance (47.5% pure), iris lesions and redness and chemosis of the conjunctivae were seen. Blanching of the conjunctivae was seen in all animals at Day 1, in two animals at Day 2, in three animals at Day 3, and one animal at Days 4 and 7. Corneal epithelial peeling was observed in all animals on Days 1 and 2, in five animals at Days 3 and 4, and in four animals at Day 7. Other signs observed in some animals included necrosis, pannus, and corneal neovascularisation. The average Draize score is determined to be 2.0, however for redness and chemosis of the conjunctivae the scores are higher. There was no pain response in any of the animals, no clinical signs were observed and all animals had healthy body weight gain.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: Literature review
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Assessment of Eye Irritation Properties of SCI under the High Production Volume Chemical Challenge Program.
- Justification for type of information:
- Refer to read-across justification document for SCMI in section 13
- Reason / purpose for cross-reference:
- assessment report
- Principles of method if other than guideline:
- Review of available data on SCI
- GLP compliance:
- no
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 72 h
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 72 h
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Interpretation of results:
- moderately irritating
- Remarks:
- Criteria used for interpretation of results: US EPA pesticides
- Conclusions:
- Under the conditions of the studies, SCI was found to be mildly to moderately irritating to eyes.
Referenceopen allclose all
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 |
The maximum average score, which occurred on Day 1, was 23.3. The test item produced moderate and transient ocular irritation. Most animals exhibited moderate conjunctival irritation (redness, chemosis, discharge), iridial changes and corneal opacities. ulceration and stippling. One animal was free of any ocular irritation within 7 days after instillation of the test material. The five remaining animals exhibited slight conjunctival irritation but were free of any corneal irritation at study termination (Day 7).
Table 1: Average Eye Irritation Scores
Observation Period |
Cornea |
Iris |
Conjunctivae |
|||
|
Opacity |
Area |
Redness |
Chemosis |
Discharge |
|
Day 1 |
1.0 |
3.3 |
0.8 |
2.2 |
2.5 |
2.0 |
Day 2 |
1.0 |
2.8 |
0.8 |
2.5 |
2.7 |
1.2 |
Day 3 |
1.2 |
2.2 |
0.8 |
2.2 |
2.8 |
1.5 |
Day 4 |
1.3 |
1.8 |
0.7 |
2.0 |
2.3 |
1.3 |
Day 7 |
0.8 |
1.2 |
0.7 |
1.5 |
1.7 |
1.2 |
Table 2: Animal Body Weights
Animal Number |
Sex |
Vocalisation following dosing |
Animal body weights (g) |
||
Initiation |
Day 7 |
Day 14 |
|||
4736 |
M |
N |
2626 |
2860 |
2932 |
4737 |
M |
N |
2736 |
2862 |
2839 |
4738 |
M |
N |
2676 |
2636 |
2806 |
4776 |
F |
N |
2164 |
2432 |
2565 |
4740 |
F |
N |
2705 |
2886 |
3018 |
4741 |
F |
N |
2473 |
2668 |
2813 |
In the van Baaren study, corneal opacity and transient iritis was observed in one animal during the first 72 hours after treatment, and was still present at day 7 but healed completely by day 14. The other two animals exhibited only slight iridal and conjunctival irritation, which completely healed by day 7. Based on the effects seen in the one animal, the test substance was classified as an irritant.
In the first Blaszcak study, most animals experienced moderate conjunctival irritation and other effects and SCI was classified as moderately irritating. The second Blaszcak study resulted in a "mildly irritating" classification.
The studies by Glaza, Nitka and Palanker and Shapiro found SCI to be moderately irritating, mildly irritating, and mildly (unwashed) or minimally (washed) irritating.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin irritation: Nine studies provide a Weight Of Evidence approach for the skin irritancy endpoint of SLMI
York (1983) concluded that the read across material SCI was slightly irritating to the skin of rabbits
Long (2007) found that SLMI was mildly(slightly)-moderately irritating to human skin. SLMI was ranked lower in irritancy than SCI, which is also not classified for skin irritancy
A keller and heckman review of 5 studies found that SCI is mildly (slightly )-moderately irritating for the skin
Lodestadt (1986), found that for the intact skin of rabbits SCI was slightly irritating
In a surfactant review paper of several studies, Petter (1984) concluded that isethionates have low irritancy for the skin
In 4 in vitro studies SCI and SLMI produced similar testing results of moderately irritating. This confirms the read-across applicability. Animal and human testing proves these in vitro results to be exaggerated.
Eyeirritation: Nine read-across studies provide the data the eye irritancy endpoint of SCMI
An eye irritation study was carried out on the read across material SCI according to OECD 405 and in-house quality assurance was in place. 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 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 substance is classified in category 2 (causes serious eye irritation).
In a study performed to OECD 405, (Blascak, 1985) found the read across material, SCI to be severely irritating to the eye (max average score 23.3)
In a study performed to OECD 405, (Glaza, 1986) found the material to be irritating to the eye
In a review of the data on SCI, (Keller and heckman, 2006) found SCI to be mildly to moderately irritating to the eyes
3 further studies provide supporting evidence of the eye irritancy of SLMI and SCI to the eye,, (Nikta, 1982, Rachai, 1997, Nikta, 1999)
2 further in vitro studies on SLMI have been disregarded as the studies were flawed
Justification for selection of skin irritation / corrosion
endpoint:
good kliminsch score 2 study according to OECD 404
Justification for selection of eye irritation endpoint:
Good kliminsch score 2 study according to OECD 405
Effects on skin irritation/corrosion: slightly irritating
Effects on eye irritation: highly irritating
Justification for classification or non-classification
Animal and human studies showed some slight irritation of SLMI to skin. However A WOE approach concludes that the material is only slightly-moderately irritating to the skin and should not be labelled according to DPD and CLP as such.
Several studies on the read across substance, SCI showed eye irritation following exposure.
Therefore SCMI has been classified as a category 2 eye irritant according to CLP criteria or classified as R36 - Irritating to eyes, according to the criteria of Directive 67/548/EEC.
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