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Diss Factsheets
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EC number: 287-024-7 | CAS number: 85408-62-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 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).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- 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
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Test report states that sample 758.05 is 47.5% sodium cocoyl isethionate in a soap bar. The substance was described as a waxy, white solid.
Test animals / tissue source
- 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
Test system
- 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
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- <= 34.2
- Max. score:
- 34.2
- Reversibility:
- not specified
- Remarks on result:
- other: See table 1 below
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- <= 31
- Max. score:
- 31
- Reversibility:
- not specified
- Remarks on result:
- other: See table 1 below
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- <= 28.8
- Max. score:
- 28.8
- Reversibility:
- not specified
- Remarks on result:
- other: See table 1 below
- 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:
- other: See table 1 below
- 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:
- other: See table 1 below
- Irritant / corrosive response data:
- See table 1 below
- Other effects:
- None
Any other information on results incl. tables
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 |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Based on the average scores for redness and chemosis, the substance 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.
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