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EC number: 695-243-8 | CAS number: 500731-87-3
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30th July 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete or methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Gaitonde Committee Guidelines
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-hydroxy-3-({3-[(2E)-3-(4-methoxyphenyl)prop-2-enamido]propyl}dimethylazaniumyl)propane-1-sulfonate
- EC Number:
- 695-243-8
- Cas Number:
- 500731-87-3
- Molecular formula:
- C18H28N2O6S
- IUPAC Name:
- 2-hydroxy-3-({3-[(2E)-3-(4-methoxyphenyl)prop-2-enamido]propyl}dimethylazaniumyl)propane-1-sulfonate
- Test material form:
- other: liqiud
- Details on test material:
- Test material: Galaxy Sunbetaine
Characteristics of the test material:
Physical state: Liquid
Quantity Recd: 100 ml x 01 bottle
Colour: Clear
Batch no. BP-07-24 laboratory batch
Date of Manufacture: July 2001
Date of expiry: NIL
Date of reciept of sample: 28th July 2001
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Test Animal:
Species: Albino rabbits
Strain: New Zealand White
Source: National Toxicology Centre
Weight range: 1.7 to 2.1 kg
Age: 6 to 9 weeks
Sex: male and female
Number: 3 per sex
Housing: The animals were housed singly
Diet: Pelleted feed supplied by Nav Maharasthra Chakan Oil Mills Ltd., Pune
Water: Community tap water ad libitum
Room temperature: 19 to 22 degrees Celsius
Relative humidity: 35 to 75%
Lighty cycle: 12 hours day 12 hours dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- The test material in the amount of 0.10 ml was placed directly into animals eye. The other eye was untreated as a control.
- Duration of treatment / exposure:
- Once the test material was applied the eyelid was held down for two seconds to prevent loss of test substance.
- Observation period (in vivo):
- Each eye was carefully examined, observed at 24, 48 and 72 hours and the observations extended to determine the reversibility or irreversibility.
- Number of animals or in vitro replicates:
- Six rabbits, three per sex were used for this study.
- Details on study design:
- Six rabbits, three per sex, were used for this study. The test material in the amount of 0.10 ml was placed in the conjuctival sac of one eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for approximately two seconds in order to prevent the loss of the test material. The other eye remained untreated and served as a control. The animals were housed singly.
Clinical Observations:
Each eye was carefully examined, observed at 24, 48 and 72 hours and the observations extended to deterimine the reversibility or irreversibility. Any redness, chemosis and discharge was recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks:
- Not applicable as overall irritation score = 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- Irritaion score = 0
- Other effects:
- None observed
Any other information on results incl. tables
A summary of the individiual irritant response following application of "Galaxy Sunbetaine"
Rabbit No. |
Sex |
Cornea |
Iris |
Conjuctivae |
||
|
|
|
|
Redness |
Chemosis |
Discharge |
1 |
M |
0 |
0 |
0 |
0 |
0 |
2 |
M |
0 |
0 |
0 |
0 |
0 |
3 |
M |
0 |
0 |
0 |
0 |
0 |
4 |
F |
0 |
0 |
0 |
0 |
0 |
5 |
F |
0 |
0 |
0 |
0 |
0 |
6 |
F |
0 |
0 |
0 |
0 |
0 |
Hours 24 48 72
SCORE 0 0 0
Grand Total: 0.00
Where 0 = no reaction
Irritation Score: 0.00
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material "Galaxy Sunbetaine" caused no irritation to the eye in rabbits.
The test material is termed as non-irritant. - Executive summary:
The objective of the study was reported here was to determine the mucous membrane irritation potential of "Galaxy Sunbetaine" in rabbits following the Gaitonde Committee Protocol.
The test material in the amount of 0.10 ml was instilled in the conjuctival sac of one eye of each animal. Each eye was carefully observed and the reaction evaluated at 24, 48 and 72 hours post instillation.
The test material caused no irritation to the eye in rabbits.
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