Registration Dossier
Registration Dossier
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EC number: 608-174-5 | CAS number: 28183-82-6
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
- Justification for type of information:
- 2018 study following guidelines and performed to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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-Propenenitrile, polymer with 1,2-ethanediamine
- EC Number:
- 608-174-5
- Cas Number:
- 28183-82-6
- IUPAC Name:
- 2-Propenenitrile, polymer with 1,2-ethanediamine
- Test material form:
- liquid: viscous
- Details on test material:
- Named in some reports as 2-propenenitrile, polymer with 1,2-ethanediamine
Dried material, described as viscous liquid, is used for some tests.
Constituent 1
- Specific details on test material used for the study:
- Water-free material
Purity: 92.5%
Physical state/Appearance: Greenish-yellow viscous liquid
Test animals / tissue source
- Species:
- cattle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 0.75 ml undiluted added to the chamber with the cornea
- Duration of treatment / exposure:
- Incubated at 32 ± 1 ºC for 10 minutes
- Duration of post- treatment incubation (in vitro):
- 120 minutes
- Number of animals or in vitro replicates:
- Three replicates for test material and controls
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- ca. 2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
The positive control In Vitro Irritancy Score was within the range of 31.6 to 58.7.
The negative control gave opacity of ≤3.0 and permeability ≤0.077.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Although the study design is more suitable for the Eye Dam 1 and Eye Irrit 2 boundary, the method is validated to accept very low scores as being non-classified for CLP.
The method was chosen as the substance was considered likely to be Eye Irrit 2 based on free amine and reported pH.
The irritation scroe of 2.0 is sufficiently low to conclude non-classification for CLP
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