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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26th August 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: Guidelines of Gaitonde Committee Annexure III (following the method of Litchfield & Wilcoxon (1949))
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
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: liquid
- Details on test material:
- Identifier: Galaxy Sunbeataine
Physical State: Liquid
Colour: Colourless
Quantity recd. 250 ml
Date of receipt of sample: 24th August 2001
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test Animal:
Species: Albino rabbits
Strain: New Zealand white
Source: National Toxicology Centre
Weight Range: 1.8 to 2.1 kg
Age: 6 to 9 weeks
Sex: male and female
Number: 2 per sex
Housing: The animals were housed singly
Diet: Pelleted feed supplied by Nav Maharashtra, Chakan Oil Mills Ltd., Pune.
Water: community tap water ad libitum
Room temperature: 19-22 degrees celsius
Relative humidity: 35-75%
Light cycle: 12 hours light and 12 hours dark
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Four rabbits, two per sex were used for this study. Approximately 24 hours before the test, the hair of the trunk was removed with the help of electric clippers, to expose 10% of the body surface. The test material in the amount of 5 g/kg or 5.0 ml/kg was applied on the skin site.
The test material was held in contact with the skin with a porous gauze and a non-irritating adhesive tape throughout the 24 hour exposure period. The animals were housed singly and were restrained with a plastic collar around their neck for 24 hours, in order to avoid the ingestion of the test material and to ensure that the test subsance does not get removed for at least 24 hours. At the end of the exposure period, residual test materia.l was removed using water. - Duration of exposure:
- Test substance was applied once and left for 24 hours, followed by removal with water.
- Doses:
- Single dose of 5 g/kg or 5.0 ml/kg was applied to the testing area.
- No. of animals per sex per dose:
- Two males and two females at 5 g/kg or 5.0 ml/kg.
- Control animals:
- no
- Details on study design:
- Clinical Observations :
Any toxic symptoms and mortality were recorded at 1/2, 1, 2, 3, 4 and 24 hours and later twice a day thereafter upto 14 days to determine their general health, behaviour and moribund condition.
Any abnormality observed during this period was recorded and the subsequent progress monitored.
Body weight change:
Animals were weighed individually on the day the test material was applied, weekly thereafter and prior to sacrifice.
Necopsy:
A gross necropsy was performed on all tne animals that died during the course of the test and sacrificed at the termination of the study. - Statistics:
- None stated
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animals died.
- Clinical signs:
- other: Clinical signs of intoxication Group I - 5.00 ml/kg : All the animals appeared normal and showed no clinical signs of intoxication after the application of the test material, till the end of the study.
- Gross pathology:
- Necropsy findings:
Group Dose Animals found dead Killed at termination
1 5.0 ml/kg NIL NAD
Any other information on results incl. tables
Results
A summary of the individual scores on the skin following application of Galaxy Sunbetaine-MM-30 to the rabbits.
Rabbit No. |
Sex |
Days Post Application |
|
|
1 2 3 7 14 |
1 |
M |
0 0 0 0 0 |
2 |
M |
0 0 0 0 0 |
3 |
F |
0 0 0 0 0 |
4 |
F |
0 0 0 0 0 |
Grand Total: 0.00
0 = no reaction
LD50 in rabbits:
Group |
Dose ml/kg |
No. Of animals died/No. of animals treated |
% Mortality |
1 |
5.00 |
0/4 |
NIL |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 value of the test material GALAXY-SUNBETAINE-MM-30 was found to be greater than 5.00 ml/kg (5000 mg/kg bw).
- Executive summary:
Summary:
The objective of the study now reported was to determine the acute dermal toxicity of Galaxy Sunbeat MM-30 in rabbits, following the Gaitonde Committee Protocol.
The test material was applied to the 10% surface area in four rabbits, two per sex, at the limit dose (5 ml/kg or 5 g/kg). All the animals were observed for clinical signs upto 14 days after treatment.
The test material did not cause any clinical signs of intoxication in the treated animals. There was no erythema or oedema to the skin in all the rabbits during and till the end of the study.
The LD50 value of Galaxy Sunbetaine-MM-30 in rabbits by the dermal route was found to be greater than 5.00 ml/kg.
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