Registration Dossier
Registration Dossier
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EC number: 226-045-8 | CAS number: 5244-34-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2'-ethylenedithiodiethanol
- EC Number:
- 226-045-8
- EC Name:
- 2,2'-ethylenedithiodiethanol
- Cas Number:
- 5244-34-8
- Molecular formula:
- C6H14O2S2
- IUPAC Name:
- 2,2'-Ethylenedithiodiethanol
Constituent 1
Test animals / tissue source
- Species:
- other: in vitro - Bovine
- Strain:
- not specified
Test system
- Vehicle:
- other: 20% w/v solution in 0.9% sodium chloride solution
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 1
- Value:
- 27.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: Corneal Permeability
- Run / experiment:
- 1
- Value:
- 1.491
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- 49.71
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- It was concluded that 2,2'-ethylenedithiodiethanol, produced an IVIS score of 49.71
and no prediction can be made in respect of its potential to cause eye irritation. It is
noted that the IVIS is at the higher end of the no prediction (>3 - ≤55) range.,
based on the value of ivis and precautionary principle the substance is classified as Eye irritation cat. 2b
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