Registration Dossier
Registration Dossier
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EC number: 695-243-8 | CAS number: 500731-87-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 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: Gaitonde Committee Annexure III
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal 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: liquid
- Details on test material:
- Test substance: Galaxy Sunbetaine
Characteristics:
Physical state: Liquid
Quantity Recd. 100 ml x 01 bottle
Colour: Clear
Date of Manufacture: July 2001
Batch No. BP-07-24 (Laboratory Batch)
Date of expiry: NIL
Date of reciept of sample: 28th July 2001
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Species: Albino rabbits
Source: National Toxicology Centre
Weight range: 1.8 to 2.0 kg
Age: 6 to 9 weeks
Sex: male and female
Number: 3 per sex
Housing: The animals were housed singly.
Diet: Pelleted feed
Water: Community tap water ad libitum
Room temperature: 19 - 22°C
Relative humidity: 35% - 75%
Light cycle: 12 hours light, 12 hours dark.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- Test substance used directly in 0.5 ml quantity.
- Duration of treatment / exposure:
- Once the test material was applied the animals were housed singly with a plastic collar around their neck to avoid ingestion of test material. After 24 hours any unabsorbed test material was removed.
- Observation period:
- Each site of application was carefully examined, observed and the reaction evaluated according to Draize's method at 24, 48 and 72 hours post application.
- Number of animals:
- Six rabbits, three per sex were used for this study.
- Details on study design:
- The hair of the back on both sides of the vertebral column was removed with the help of electric clippers, one day before the treatment. The test material in the amount of 0.50 ml was applied to the intact and abraded skin sites of each test animal. Care was taken to note that the abrasions penetrate the Stratum correum but not the dermis. A gauze patch was secured over each treated area by means of an adhesive tape.
The animals were house singly with a plastic collar around their neck for 24 hours to avoid the ingestion of the test material. The patch and the unabsorbed test material were removed after 24 hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: test substance was non-irritant
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No eryhema or odema observed in an animal at any timepoint.
Primary skin irritation score: 0.00
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance caused no irritation to thh skin in rabbits.
- Executive summary:
The test material was applied in the amount of 0.5 ml to the shaven back skin, both intact and abraded skin sites, of six rabbits (three per sex). Each site of application was carefully observed and the reaction evaluated according to Draize's method at 24, 48 and 72 hours post application.
The test material caused no irritation to the skin in rabbits till the end of the observation period.
The primary skin irritation index was 0.00.
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