Registration Dossier
Registration Dossier
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EC number: 268-610-1 | CAS number: 68131-13-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 7-8, 2010
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline No. 431
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Naphthenic acids, reaction products with diethylenetriamine
- EC Number:
- 268-610-1
- EC Name:
- Naphthenic acids, reaction products with diethylenetriamine
- Cas Number:
- 68131-13-5
- Molecular formula:
- C16H21N3O2 (minimal)
- IUPAC Name:
- Naphthenic acids, reaction products with diethylenetriamine
- Details on test material:
- product name: MK195KSF
Sample description: orange/brown hazy solid
Volatile: no
Density: 0.83
pH: 9.07
Storage conditions: at room temperature
Constituent 1
Test animals
- Details on test animals or test system and environmental conditions:
- Assessment of effect on EpiDerm TM, a reconstitued three-dimensional human epidermis model.
Test system
- Controls:
- no
- Amount / concentration applied:
- 25 mg test item + 25 uL H2O
- Duration of treatment / exposure:
- 3 and 60 minutes
- Number of animals:
- none
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: relative tissue viability (OD550)
- Basis:
- mean
- Time point:
- other: 3 min
- Score:
- 1.639
- Remarks on result:
- other: 89%
- Irritation parameter:
- other: relative tissue viability (OD550)
- Basis:
- mean
- Time point:
- other: 60 min
- Score:
- 1.408
- Remarks on result:
- other: 85%
Any other information on results incl. tables
3 min. |
Negative Control |
Test item |
Positive Control |
|||
tissue 1 |
tissue 2 |
tissue 1 |
tissue 2 |
tissue 1 |
tissue 2 |
|
absolute OD550- value |
1.808 |
1.853 |
1.630 |
1.619 |
0.402 |
0.426 |
1.764 |
1.894 |
1.651 |
1.662 |
0.396 |
0.417 |
|
1.808 |
1.907 |
1.646 |
1.624 |
0.410 |
0.421 |
|
OD550(mean of 3 aliquots) |
1.793 |
1.885 |
1.642 |
1.635 |
0.403 |
0.421 |
OD550(mean of 2 replicate tissue) |
1.839* |
1.639 |
0.412 |
|||
Mean relative tissue viability [%] |
100 |
89 |
22** |
|||
Inter tissue viability difference [%]*** |
5.0 |
0.4 |
4.5 |
|||
* mean OD550≥ 0.8
** mean relative tissue viability of the 3min. positive control ≤30%
*** inter tissue viability difference ≤30%
60 min. |
Negative Control |
Test item |
Positive Control |
|||
tissue 1 |
tissue 2 |
tissue 1 |
tissue 2 |
tissue 1 |
tissue 2 |
|
absolute OD550- value |
1.667 |
1.678 |
1.524 |
1.267 |
0.183 |
0.183 |
1.681 |
1.679 |
1.536 |
1.290 |
0.185 |
0.186 |
|
1.651 |
1.641 |
1.551 |
1.280 |
0.185 |
0.182 |
|
OD550(mean of 3 aliquots) |
1.666 |
1.666 |
1.537 |
1.279 |
0.184 |
0.184 |
OD550(mean of 2 replicate tissue) |
1.666* |
1.408 |
0.184 |
|||
Mean relative tissue viability [%] |
100 |
85 |
11 |
|||
Inter tissue viability difference [%]*** |
0.0 |
18.3 |
0.3 |
|||
* mean OD550≥ 0.8
*** inter tissue viability difference ≤30%
Applicant's summary and conclusion
- Interpretation of results:
- other: no corrosive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test item showed no corrosive effects. The test item is classified as "non corrosive".
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