Registration Dossier
Registration Dossier
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EC number: 263-502-0 | CAS number: 62314-22-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate
- EC Number:
- 263-502-0
- EC Name:
- (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate
- Cas Number:
- 62314-22-1
- Molecular formula:
- C8H15O2.C6H16NO
- IUPAC Name:
- (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate
- Test material form:
- liquid: viscous
1
- Specific details on test material used for the study:
- Solvent-free Dabco TMR Batch# meyersl.20160601
Test animals / tissue source
- Species:
- cattle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Three bovine corneas per group were dosed with 0.75 ml of Solvent-free Dabco TMR
- Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- N/A
- Number of animals or in vitro replicates:
- Three bovine corneas per group
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- 34.12
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 1
- Value:
- 15.67
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: Corrected Mean Optical Density
- Run / experiment:
- 1
- Value:
- 1.23
- Vehicle controls validity:
- not applicable
- 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:
- Based on an In Vitro Irritatancy Score between 3 and 55, no prediction can be made for the UN GHS
categorization of the test article as defined in OECD Guideline #437.
According to EURL ECVAM DB-ALM Protocol No. 127, Solvent-free Dabco TMR Batch# meyersl.20160601 is considered to be a moderate eye irritant.
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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