Registration Dossier
Registration Dossier
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EC number: 248-655-3 | CAS number: 27776-21-2
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:
- 2 014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,2'-[azobis(1-methylethylidene)]bis[4,5-dihydro-1H-imidazole dihydrochloride
- EC Number:
- 248-655-3
- EC Name:
- 2,2'-[azobis(1-methylethylidene)]bis[4,5-dihydro-1H-imidazole dihydrochloride
- Cas Number:
- 27776-21-2
- Molecular formula:
- C12H22N6.2ClH
- IUPAC Name:
- 2,2'-[azobis(1-methylethylidene)]bis[4,5-dihydro-1H-imidazole dihydrochloride
- Test material form:
- solid: flakes
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Isolated bovine cornea: The test system (target tissue) is the isolated bovine cornea. Bovine eyes are obtained as a by-product of freshly slaughtered cattle (age of the animals: minimum 12 months, maximum 60 months).
Test system
- Vehicle:
- other: De-ionized water
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 20% (w/v) solution in de-ionized water
- Duration of treatment / exposure:
- The corneas were incubated in a horizontal position at about 32 °C for approximately 4 hours (non-surfactant solids).
- Number of animals or in vitro replicates:
- Each treatment group (test substance, NC and PC) consisted of 3 corneas
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 2.6
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- The IVIS score of the test substance of 2.6 would classify it as a substance that does not cause eye irritation or serious eye damage
- Conclusions:
- Applying the criteria of the OECD 437 for the assessment of the BCOP test results, the IVIS score of the test substance of 2.6 would classify it as a substance that does not cause eye irritation or serious eye damage. However, the Guideline also states, that due to limited accuracy of the BCOP test to correctly identify substances that do not require classification for eye irritation or serious eye damage, this test method should not be the first choice to initiate a bottom-up approach. Based on this statement test substances leading to IVIS <3 are generally examined in the EpiOcular test as well.
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