Registration Dossier
Registration Dossier
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EC number: 308-020-4 | CAS number: 97808-97-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2nd July 2019 - 21st August 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 29 July 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Version / remarks:
- Commission Regulation (EC) No 440/2008, of 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Water
- Reference substance name:
- C12-C14 alcohol
- IUPAC Name:
- C12-C14 alcohol
- Reference substance name:
- Mono (C12-C14 alkyl) phosphate ester
- IUPAC Name:
- Mono (C12-C14 alkyl) phosphate ester
- Reference substance name:
- Di (C12-C14 alkyl) diphosphate ester
- IUPAC Name:
- Di (C12-C14 alkyl) diphosphate ester
- Reference substance name:
- Tri (C12-C14 alkyl) triphosphate ester
- IUPAC Name:
- Tri (C12-C14 alkyl) triphosphate ester
- Reference substance name:
- C12-C14 alkyl pyrophosphate esters
- IUPAC Name:
- C12-C14 alkyl pyrophosphate esters
- Reference substance name:
- Ortho-phosphoric acid
- IUPAC Name:
- Ortho-phosphoric acid
- Reference substance name:
- unknown
- Molecular formula:
- unknown
- IUPAC Name:
- unknown
- Test material form:
- solid: bulk
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
- Specific details on test material used for the study:
- CAS Number: 68412-59-9
Batch: 1023S17201
Purity: 100%
Physical state/Appearance: White solid
Expiry Date: 09 July 2020
Storage Conditions: Room temperature in the dark
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Not specified
- Source strain:
- other: not applicable
- Details on animal used as source of test system:
- EpiDerm™ Reconstructed Human Epidermis Model Kit.
Supplier: MatTek In Vitro Life Sciences Laboratories
Date received: 02 July 2019
EpiDermTM Tissues (0.63cm2) lot number: 30804
Assay Medium lot number: 062719MSC
Upon receipt of the EpidermTM tissues, the sealed 24-well plate was stored in a refrigerator until use. - Justification for test system used:
- Recommended test by OECD TG.
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- 0.1777 g.
- Duration of treatment / exposure:
- 3 minutes and 60 minutes
- Duration of post-treatment incubation (if applicable):
- Additionally for the 3 minute treatment time point, the media was aspirated and replaced with fresh medium and samples were incubated further to bring the total time to 60 min of incubation. At the end the samples were rinsed and incubated for further 3 h for the MTT-loading stage (for each treatment time point).
- Number of replicates:
- Duplicate
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3 minute exposure time point
- Run / experiment:
- 1
- Value:
- ca. 1.94
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: No indication of corrosion
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 60 minute exposure time point
- Run / experiment:
- 1
- Value:
- 0.965
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: No indication of corrosion
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3 minute exposure time point
- Run / experiment:
- 2
- Value:
- ca. 1.72
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: No indication of corrosion
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 60 minute exposure time point
- Run / experiment:
- 2
- Value:
- ca. 1.435
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: No indication of corrosion
Any other information on results incl. tables
Mean OD570 Values and Viabilities for the Negative Control, Positive Control and Substance.
|
3 -minute application viability (%) |
1 -hour application viability (%) |
||||||
A (OD570) |
B (OD570) |
Mean (OD570) |
SD (+/-) |
A (OD570) |
B (OD570) |
Mean (OD570) |
SD (+/-) |
|
Negative control |
2.073 |
2.066 |
2.070 |
0.005 |
2.234 |
2.320 |
2.277 |
0.061 |
Substance |
1.940 |
1.720 |
1.830 |
0.156 |
0.965 |
1.435 |
1.200 |
0.332 |
Positive control |
0.104 |
0.069 |
0.087 |
0.025 |
0.094 |
0.069 |
0.082 |
0.018 |
SD = Standard deviation
Duplicate exposures are indicated by A and B.
The relative mean viabilities for each treatment group were as follows:
| Exposure period (min) | Viability (%) | ||
| Negative control | Substance | Positive control | |
| 3 | 100* | 88.4 | 4.2 |
| 60 | 100* | 52.7 | 3.6 |
*The mean viability of the negative control tissues is set at 100%
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is considered to be non-corrosive to skin based on a reliable in vitro skin corrosion study.
- Executive summary:
In a reliable in vitro skin corrosion study, conducted according to the OECD Guideline 431, 'In Vitro Skin Corrosion: reconstructed human epidermis (RHE) test method', the undiluted substance (0.1777g) was applied onto reconstructed human skin tissue (epidermal model, EpiDermTM tissue (0.63cm2)) in duplicate for a period of 3 or 60 minutes.
Skin corrosion is expressed as the remaining cell viability after exposure to the substance. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with the substance compared to the negative control tissues was 88.2% and 52.7%, respectively. Because the mean relative tissue viability for the substance was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment the substance is considered to be not corrosive.
In conclusion, the substance is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this study.
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