Registration Dossier
Registration Dossier
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EC number: - | 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:
- 22/09/2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 2019
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N-(3-methacrylamidopropyl)-N,N-dimethyldodecan-1-aminium bromide
- Cas Number:
- 129684-50-0
- Molecular formula:
- C21H43N2O.Br
- IUPAC Name:
- N-(3-methacrylamidopropyl)-N,N-dimethyldodecan-1-aminium bromide
- Test material form:
- liquid: viscous
Constituent 1
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- The following EpiOcular™-EIT Model was used:
Lot. No. 34930; OCL-200-EIT, MatTek In Vitro Life Science Laboratories, s.r.o Mlynské Nivy 73, 821 05 Bratislava II, Slovak Republic.
Following criteria for the EpiOcular™ RhCE tissue construct was checked or assured by the supplier (MatTek). Each batch of the EpiOcularTM Tissues used met defined production release criteria, set by the supplier.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
Results and discussion
In vitro
Results
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Test substance
- Value:
- 1.9
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Dimethylaminopropylmethacrylamide, dodecyl bromide is predicted to cause eye irritation since, under the present test conditions using EpiOcular™ RhCE tissue constructs, the mean percent cell viability value obtained was below the cut-off percentage of cell viability (≤ 60 %) that distinguishes irritant from non-irritant test items. As the test does not allow discrimination between irritancy (UN GHS Category 2) and serious eye damage (UN GHS Category 1), no conclusion regarding the classification of the test item could be made.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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