Registration Dossier
Registration Dossier
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EC number: 922-363-2 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 58 days
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 491 (Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (2Z)-but-2-enedioic acid; N-[2-(dimethylamino)ethyl]-5-(1,2-dithiolan-3-yl)pentanamide
- EC Number:
- 922-363-2
- Cas Number:
- 865661-00-3
- Molecular formula:
- C16H28N2O5S2
- IUPAC Name:
- (2Z)-but-2-enedioic acid; N-[2-(dimethylamino)ethyl]-5-(1,2-dithiolan-3-yl)pentanamide
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- Positive control, Vehicle Control & Medium Control are used for STE test
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- other: Saline
- Controls:
- other: Positive control, Vehicle Control & Medium Control are used for STE test
- Amount / concentration applied:
- Both 5% and 0.05% concentration of samples were tested for Eye irritation.
- Number of animals or in vitro replicates:
- 3 In Vitro replicates
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Cell Viability
- Value:
- > 70 - <= 70
- Vehicle controls validity:
- valid
- Negative controls validity:
- not valid
- Positive controls validity:
- valid
- Remarks on result:
- other: The test material falls under " No prediction can be made" Category of UN GHS Classification.
Applicant's summary and conclusion
- Interpretation of results:
- other: The test material falls under " No prediction can be made" Category of UN GHS Classification.
- Conclusions:
- The study "In-vitro Eye Irritation by Short time Exposure (STE) Test Method" confirms that Thioctamidoethyl Dimethylamine Maleate is considered as " No prediction can be made" as per the UN GHS for classification of Chemicals following OECD guidelines No. 491 using SIRC cell line.
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