Registration Dossier
Registration Dossier
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EC number: 224-536-1 | CAS number: 4402-30-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- other: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,1'-(methylimino)dipropan-2-ol
- EC Number:
- 224-536-1
- EC Name:
- 1,1'-(methylimino)dipropan-2-ol
- Cas Number:
- 4402-30-6
- Molecular formula:
- C7 H17 N O2
- IUPAC Name:
- 1-[(2-hydroxypropyl)(methyl)amino]propan-2-ol
- Details on test material:
- Name of test substance: N-Methyldiisopropanolamin
Test-substance No.: 11/0383-1
Batch identification: B 5614 vom 21.12.2010
CAS No.: 4402-30-6
Purity: 99.7 corr. area-% (for details see project No.: 11L00331)
Homogeneity: The test substance was homogeneous by visual inspection.
Storage stability: The stability under storage conditions over the study period
was guaranteed by the sponsor, and the sponsor holds this
responsibility.
Constituent 1
Test animals
- Species:
- other: human-derived epidermal keratinocytes
Test system
- Controls:
- other: positive and negative controls
- Duration of treatment / exposure:
- 3 and 60 min
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: corrosion
- Basis:
- other: mean OD50
- Time point:
- other: 3 min
- Score:
- 74
- Remarks on result:
- other: viability [% of NC]
- Irritation parameter:
- other: corrosion
- Basis:
- other: mean OD50
- Time point:
- other: 1 hour
- Score:
- 11
- Remarks on result:
- other: viability [% of NC]
- Irritation parameter:
- other: irritation
- Basis:
- other: mean OD50
- Time point:
- other: 1 hour
- Score:
- 6
- Remarks on result:
- other: viability [% of NC]
Any other information on results incl. tables
Corrosive potential of the test materials is predicted from the mean relative tissue viabilities obtained after 3 min treatment compared to the negative control tissues concurrently treated with highly de-ionized water. A chemical is considered as "corrosive", if the mean relative tissue viability after 3 min treatment with a test material is decreased below 50%. In addition, those materials with a viability of ≥ 50% after 3 min treatment are considered as "corrosive" if the mean relative tissue viability after 1 hour treatment with a test material is decreased below 15%.
Although the method is not finally validated for categorizing the severity of corrosivity according to certain classification and labeling systems, it is suggested to use the most stringent category for test substances leading to viabilities below 50% after 3 min treatment. Irritant potential of the test materials is predicted from the mean relative tissue viabilities compared to the negative control tissues concurrently treated with sterile PBS. A chemical is considered as "irritant", if the mean relative tissue viability with a test material is less than or equal to 50%.
Applicant's summary and conclusion
- Conclusions:
- Based on the observed results and applying the evaluation criteria it was concluded, that N-Methyldiisopropanolamin shows a corrosive potential in the EpiDerm™ skin corrosion/irritation test under the test conditions chosen.
- Executive summary:
Corrosion test:
The mean viability of the test-substance treated tissues determined after an exposure period of 3 minutes was 74%, and it was 11% after an exposure period of 1 hour.
Irritation test:
The mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 6%.
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