Registration Dossier
Registration Dossier
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EC number: 813-142-0 | CAS number: 1417782-28-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- batch No.of test material: L85-76 - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™
PREDICTION MODEL / DECISION CRITERIA: 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 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%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 50 µL - Duration of treatment / exposure:
- 3 minutes and 1 hour
- Number of replicates:
- 2
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 118.3
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- For the test substance the final mean viability is given after KC correction.
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour
- Value:
- 104
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- For the test substance the final mean viability is given after KC correction.
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: No
- Direct-MTT reduction: Yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes - Interpretation of results:
- GHS criteria not met
Table 2: 3 min exposure
|
Test substance |
Tissue 1 |
Tissue 2 |
Mean |
SD |
CV [%] |
|
NC |
viable tissues |
mean OD570 |
2.039 |
2.035 |
2.037 |
0.003 |
|
viability [% of NC] |
100.1 |
99.9 |
100.0 |
0.1 |
0.1 |
||
KC tissues |
mean OD570 |
0.102 |
0.121 |
0.112 |
0.013 |
|
|
viability [% of NC] |
5.0 |
5.9 |
5.5 |
0.6 |
11.7 |
||
Test substance |
viable tissues |
mean OD570 |
2.230 |
2.619 |
2.425 |
0.275 |
|
viability [% of NC] |
109.4 |
128.6 |
119.0 |
13.5 |
11.4 |
||
KC* tissues |
mean OD570 KC NC corrected |
0.000 |
0.030 |
0.015 |
0.021 |
|
|
viability [% of NC] |
0.0 |
1.5 |
0.7 |
1.0 |
141.4 |
||
Final mean viability after KC correction [% of NC] |
118.3 |
|
|
||||
PC |
viable tissues |
mean OD570 |
0.287 |
0.441 |
0.364 |
0.109 |
|
viability [% of NC] |
14.1 |
21.7 |
17.9 |
5.3 |
29.9 |
||
Table 3: 1 hour exposure
|
Test substance |
Tissue 1 |
Tissue 2 |
Mean |
SD |
CV [%] |
|
NC |
viable tissues |
mean OD570 |
2.038 |
2.166 |
2.102 |
0.090 |
|
viability [% of NC] |
97.0 |
103.0 |
100.0 |
4.3 |
4.3 |
||
KC tissues |
mean OD570 |
0.111 |
0.108 |
0.110 |
0.002 |
|
|
viability [% of NC] |
5.3 |
5.1 |
5.2 |
0.1 |
1.6 |
||
Test substance |
viable tissues |
mean OD570 |
2.146 |
2.293 |
2.219 |
0.104 |
|
viability [% of NC] |
102.1 |
109.1 |
105.6 |
4.9 |
4.7 |
||
KC tissues |
mean OD570 KC NC corrected |
0.027 |
0.039 |
0.033 |
0.008 |
|
|
Viability [% of NC] |
1.3 |
1.8 |
1.6 |
0.4 |
25.9 |
||
Final mean viability after KC correction [% of NC] |
104.0 |
|
|
||||
PC |
viable tissues |
mean OD570 |
0.121 |
0.143 |
0.132 |
0.016 |
|
viability [% of NC] |
5.8 |
6.8 |
6.3 |
0.7 |
11.8 |
||
* Negative values are set to zero for further calculation
NC = Negative Control
PC = Positive Control
OD570 = Optical Density [wavelength 570 nm]
SD = Standard Deviation
CV = Coefficient of Variation
KC = Killed Control for MTT-reduction control
Due to the ability of the test substance to reduce MTT directly, KC tissues were applied in parallel. The results of the tissues indicate an increased MTT reduction (mean viability 0.7% of NC). Thus for the test substance the final mean viability is given after KC correction.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]ethanone
- EC Number:
- 813-142-0
- Cas Number:
- 1417782-28-5
- Molecular formula:
- C15 H10 Cl F3 O2
- IUPAC Name:
- 1-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]ethanone
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- batch No.of test material: L85-76
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™
PREDICTION MODEL / DECISION CRITERIA:
lrritant 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%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 30 µL - Duration of treatment / exposure:
- 1 hour
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 76.9
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: No
- Direct-MTT reduction: Yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
Any other information on results incl. tables
Table 2: Individual and mean OD570 values, individual and mean viability values, standard deviations and coefficient of variation
Test substance |
|
|
Tissue 1 |
Tissue 2 |
Tissue 3 |
mean |
SD |
CV [%] |
NC |
viable tissues |
mean OD570 |
2.809 |
2.714 |
2.843 |
2.789 |
0.067 |
|
viability [% of NC] |
100.7 |
97.3 |
101.9 |
100.0 |
2.4 |
2.4 |
||
KC tissues |
mean OD570 |
0.066 |
0.064 |
0.064 |
0.065 |
0.001 |
|
|
viability [% of NC] |
2.4 |
2.3 |
2.3 |
2.3 |
0.0 |
1.6 |
||
Test substance |
viable tissues |
mean OD570 |
1.787 |
2.257 |
2.426 |
2.157 |
0.331 |
|
viability [% of NC] |
64.1 |
80.9 |
87.0 |
77.3 |
11.9 |
15.4 |
||
KC tissues |
mean OD570 |
0.013 |
0.020 |
0.004 |
0.012 |
0.008 |
|
|
viability [% of NC] |
0.5 |
0.7 |
0.1 |
0.4 |
0.3 |
66.8 |
||
Mean viability of tissues after KC correction [% of NC] |
76.9 |
|
|
|||||
PC |
viable tissues |
mean OD570 |
0.101 |
0.089 |
0.115 |
0.101 |
0.013 |
|
viability [% of NC] |
3.6 |
3.2 |
4.1 |
3.6 |
0.5 |
12.8 |
||
NC = negative Control
PC = Positive Control
OD570 = Optical Density [wavelength 570 nm]
SD = Standard Deviation
CV = Coefficient of Variation
KC = Killed Control for MTT-reduction control
Due to the ability of the test substance to reduce MTT directly, KC tissues were applied in parallel. The results of the KC tissues indicate an increased MTT reduction (mean viability 0.4% of NC). Thus for the test substance the final mean viability is given after KC correction.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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