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EC number: 688-159-8 | CAS number: 1024699-81-7
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Endpoint summary
Administrative data
Description of key information
In in vitro testing in reconstituted human epidermis model (OECD 439/EU B46) the viability following a treatment period of 15 minutes and a post-exposure incubation period of 42 hours resulted to 39.6%. As this is below 50% this indicates that the substance is irritating to skin.
A BCOP test with this substance resulted to an IVIS score of 36.3.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 26 July 2011 and 01 August 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
- Qualifier:
- according to guideline
- Guideline:
- other: EU Guideline Testing of Chemicals B46
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 439
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: reconstituted human epidermis model
- Strain:
- other: reconstituted human epidermis model
- Details on test animals or test system and environmental conditions:
- Not applicable
- Type of coverage:
- other: Topical
- Preparation of test site:
- other: Not applicable
- Vehicle:
- other: No vehicle used
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
The test material was applied neat.
Amount(s) applied (volume or weight with unit):
Approximately 10 µl of the test material was applied to the epidermis surface.
Concentration (if solution):
The test material was used as supplied.
VEHICLE
No vehicle used - Duration of treatment / exposure:
- 15 minutes & 42 hour post exposure incubation
- Observation period:
- Not applicable
- Number of animals:
- Not applicable
- Details on study design:
- TEST SITE
Area of exposure:
Approximately 10 µl of the test material was applied to the epidermis surface.
% coverage:
The test material was applied topically to the corresponding tissues ensuring uniform covering.
At the end of the exposure period, each tissue was removed from the well using forceps and rinsed using a wash bottle containing PBS with Ca++ and Mg++. Rinsing was achieved by filling and emptying each tissue insert for approximately 40 seconds using a constant soft stream of PBS to gently remove any residual test material.
Time after start of exposure:
15 Minutes post exposure
SCORING SYSTEM:
Quantitative MTT Assessment (percentage tissue viability):
For the test material the relative mean tissue viabilities obtained after the 15 minute treatment followed by the 42 hour post-exposure incubation period were compared to the mean of the negative control treated tissues (n=3). The relative mean viabilities were calculated in the following way:
mean OD540 of test material / mean OD540 of negative control x 100 = Relative mean tissue viability (percentage of negative control)
Classification of irritation potential is based upon relative tissue viability following the 15 minute exposure period followed by the 42 hour post-exposure incubation period according to the following:
Mean tissue viability is ≤50% : Irritant (Xi) R38
Mean tissue viability is >50% : Non-Irritant - Irritation / corrosion parameter:
- other: other: Viability of cells
- Remarks on result:
- other:
- Remarks:
- Basis: mean Viability of cells. Time point: Day 6. Reversibility: other: Not applicable. Remarks: See relative mean viability below.. (migrated information)
- Irritant / corrosive response data:
- The relative mean viability of the test material treated tissues was 39.6% after a 15 minute exposure.
- Other effects:
- No
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test item was considered to be Irritant (I) EU Risk Phrase R38.
- Executive summary:
- Introduction:
The
purpose of this test was to evaluate the skin irritation potential of the
test material using the EPISKINTM
reconstituted
human epidermis model after a treatment period of 15 minutes followed by a
post-exposure incubation period of 42 hours. The
principle of the assay was based on the measurement of cytotoxicity in
reconstituted human epidermal cultures following topical exposure to the
test material by means of the colourimetric MTT reduction assay. Cell
viability is measured by enzymatic reduction of the yellow MTT tetrazolium
salt (3 -[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to a
blue formazan salt (within the mitochondria of viable cells) in the test
material treated tissues relative to the negative controls. The
concentration of the inflammatory mediator IL-1α in the culture medium
retained following the 42 hour post-exposure incubation period is also
determined for test materials which are found to be borderline
non-irritant based upon the MTT reduction endpoint. This
complimentary end-point will be used to either confirm a non-irritant
result or will be used to override the non-irritant result.
Methods:
Triplicate tissues were treated with the test material for an exposure period of 15 minutes. At the end of the exposure period each tissue was rinsed before incubating for approximately 42 hours. At the end of the post-exposure incubation period each tissue was taken for MTT-loading. The maintenance medium from beneath each tissue was transferred to pre-labelled micro tubes and stored in a freezer for possible inflammatory mediator determination. After MTT loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT-loaded tissues.
At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 µl samples were transferred to the appropriate wells of a pre-labelled 96-well plate. The optical density was measured at 540 nm.
Data are presented in the form of percentage viability (MTT reduction in the test material treated tissues relative to negative control tissues).Results:
The relative mean viability of the test material treated tissues was 39.6% after a 15-minute exposure.
Quality criteria:
The quality criteria required for acceptance of results in the test were satisfied.
Reference
RESULTS
Direct MTT Reduction
The MTT solution containing the test material did not turn blue which indicated that the test material did not directly reduce MTT.
Test Material, Positive Control Material and Negative Control Material
The individual and mean OD540 values, standard deviations and tissue viabilities for the test material, negative control material and positive control material are given in Table 1(see below). The mean viabilities and standard deviations of the test material and positive control, relative to the negative control are also given in Table 1(see below).
The relative mean viability of the test material treated tissues was 39.6% after a 15-Minute exposure period.
Quality Criteria
The relative mean tissue viability for the positive control treated tissues was ≤40% relative to the negative control treated tissues and the standard deviation value of the percentage viability was ≤18%. The positive control acceptance criterion was therefore satisfied.
The mean OD540 for the negative control treated tissues was ≥0.6 and the SD value of the percentage viability was ≤18%. The negative control acceptance criterion was therefore satisfied. The standard deviation calculated from individual percentage tissue viabilities of the three identically treated tissues was ≤18%. The test item acceptance criterion was therefore satisfied.
Table1 : Mean OD540 Values and Percentage Viabilities for the Negative Control Material, Positive Control Material and Test Material
Item |
OD540of tissues |
Mean OD540of triplicate tissues |
±SDof OD540 |
Relative individual tissue viability (%) |
Relative mean viability (%) |
± SD of Relative mean viability (%) |
Negative Control Item |
0.654 |
0.660 |
0.040 |
99.1 |
100* |
6.1 |
0.623 |
94.4 |
|||||
0.703 |
106.5 |
|||||
Positive Control Item |
0.060 |
0.049 |
0.011 |
9.1 |
7.4 |
1.7 |
0.038 |
5.8 |
|||||
0.049 |
7.4 |
|||||
Test Item |
0.304 |
0.261 |
0.044 |
46.1 |
39.6 |
6.6 |
0.263 |
39.8 |
|||||
0.217 |
32.9 |
SD= Standard deviation
*= The mean viability of the negative control tissues is set at 100%
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation
- Remarks:
- other: ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed on 13 August 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 437
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: Excised Bovine Cornea
- Strain:
- other: Not Applicable
- Details on test animals or tissues and environmental conditions:
- Not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
-Amounts(s) applied (volume or weight with unit):
0.75 mL of the test material was applied to triplicate corneas.
-Concentration (if solution):
The test material was used as supplied.
VEHICLE
No vehicle used - Duration of treatment / exposure:
- The undiluted test material was applied for 10 minutes followed by an incubation period of 120 minutes.
- Observation period (in vivo):
- Not applicable
- Number of animals or in vitro replicates:
- Not applicable
- Details on study design:
- TEST SITE
-Area of exposure
0.75 mL of the test material was applied to triplicate corneas.
-% coverage:
The test material was topically applied to the cornea. The holders were gently tilted back and forth to ensure a uniform application of the material over the entire cornea.
-Type of wrap used:
None used
REMOVAL OF TEST SUBSTANCE
-Washing (if done):
At the end of the exposure period the test material was removed from the anterior chamber and each cornea was rinsed three times with fresh complete MEM containing phenol red before a final rinse with complete MEM.
-Time after start of exposure:
10 minutes post exposure
SCORING SYSTEM:
Results from the two test method endpoints, opacity and permeability, were combined in an empirically derived formula to generate an In Vitro Irritancy Score.
Opacity Measurement-
The change in opacity for each cornea (including the negative control) was calculated by subtracting the initial opacity reading from the final opacity reading. These values were then corrected by subtracting from each the average change in opacity observed for the negative control corneas. The mean opacity value of each treatment group was then calculated by averaging the corrected opacity values of each cornea for that treatment group.
Permeability Measurement
The corrected OD492 was calculated by subtracting the mean OD492 of the negative control corneas from the OD492 value of each treated cornea. The OD492 value of each treatment group was calculated by averaging the corrected OD492 values of the treated corneas for the treatment group.
The following formula was used to determine the in vitro score:
In Vitro Irritancy Score = mean opacity value + (15 x mean OD492 value)
DATA INTERPRETATION
A test material that induces an in vitro irritancy score > than or equal to 55.1 is defined as an ocular corrosive or severe irritant.
Additionally, the opacity and permeability values were evaluated independently to determine whether the test material induced a response through only one of the two endpoints.
Visual Observation
The condition of the cornea was visually assessed immediately after rinsing and at the final opacity measurement. - Irritation parameter:
- cornea opacity score
- Basis:
- other: Mean Score of Opacity & Permeability
- Time point:
- other: 120 Minutes Post Rinsing
- Max. score:
- 36.3
- Reversibility:
- other:
- Remarks on result:
- other: See Below
- Irritant / corrosive response data:
- The test material induced an in vitro irritancy score of 36.3.
- Other effects:
- The corneas treated with the test item were clear post treatment and cloudy post incubation.
- Interpretation of results:
- other: Non-Corrosive
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test item was considered not to be an ocular corrosive or severe irritant.
- Executive summary:
Introduction.
A study was performed to assess the ocular irritancy potential of the test material to the isolated bovine cornea. The method was designed to meet the requirements of the following:
OECD Guidelines for the Testing of Chemicals No. 437 (2009) “Bovine Corneal Opacity and Permeability Assay”
Method.
The undiluted test material was applied for 10 minutes followed by an incubation period of 120 minutes. Negative and positive control materials were tested concurrently. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate anIn VitroIrritancy Score (IVIS).
Results.
Thein vitroIrritancy scores are summarised as follows:
Treatment
In VitroIrritancy Score
Test Material
36.3
Negative Control
1.6
Positive Control
31.8
The corneas treated with the test item were clear post treatment and cloudy post incubation.
Conclusion.
The test item was considered not to be an ocular corrosive or severe irritant.
Reference
RESULTS
Corneal Opacity and Permeability Measurement
Individual and mean corneal opacity measurements and individual and mean corneal permeability measurements are given in Table 1.
Corneal Epithelium Condition
The condition of the cornea immediately after rinsing and at the final opacity measurement is given in Table 2.
The corneas treated with the test item were clear post treatment and cloudy post incubation. The corneas treated with the negative control item were clear post treatment and post incubation. The corneas treated with the positive control item were cloudy post treatment and post incubation.
In Vitro Irritancy Score
The results are summarised as follows:
Treatment |
In Vitro Irritancy Score |
Test Material |
36.3 |
Negative Control |
1.6 |
Positive Control |
31.8 |
Criteria for an Acceptable Test
The positive control In Vitro irritancy Score was within the range of 30.9 to 67.7. The positive control acceptance criterion was therefore satisfied.
Table 1 Individual and Mean Corneal Opacity and Permeability Measurements
Treatment |
Cornea Number |
Opacity |
Permeability (OD) |
In vitroIrritancy Score |
|||||
Pre-Treatment |
Post-Treatment |
Post-Incubation |
Post-Incubation-Pre‑Treatment |
Corrected Value |
|
Corrected Value |
|||
Negative Control |
1 |
2 |
3 |
4 |
2 |
|
0.020 |
|
|
2 |
3 |
3 |
4 |
1 |
|
0.014 |
|
|
|
3 |
3 |
3 |
4 |
1 |
|
0.013 |
|
|
|
|
|
|
|
1.3* |
|
0.016# |
|
1.6 |
|
Positive Control |
4 |
4 |
33 |
29 |
25 |
23.7 |
0.729 |
0.713 |
|
5 |
3 |
21 |
20 |
17 |
15.7 |
0.793 |
0.777 |
|
|
6 |
3 |
31 |
25 |
22 |
20.7 |
0.881 |
0.865 |
|
|
|
|
|
|
|
20.0· |
|
0.785· |
31.8 |
|
Test Item |
10 |
2 |
12 |
22 |
20 |
18.7 |
1.000 |
0.984 |
|
11 |
2 |
9 |
21 |
19 |
17.7 |
1.037 |
1.021 |
|
|
12 |
3 |
13 |
27 |
24 |
22.7 |
1.338 |
1.322 |
|
|
|
|
|
|
|
19.7· |
|
1.109· |
36.3 |
OD= Optical density * = Mean of the post treatment-pre‑treatment values # = Mean permeability · = Mean corrected value
Table 2 Corneal Epithelium Condition
Treatment |
Cornea Number |
Observation |
|
Post Treatment |
Post Incubation |
||
Negative Control |
1 |
clear |
clear |
2 |
clear |
clear |
|
3 |
clear |
clear |
|
Positive Control |
4 |
cloudy |
cloudy |
5 |
cloudy |
cloudy |
|
6 |
cloudy |
cloudy |
|
Test Item |
7 |
clear |
cloudy |
8 |
clear |
cloudy |
|
9 |
clear |
cloudy |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Irritation for(3-(methacryloylamino)propyl) trimethylammonium C10-13-alkylbenzene sulfonate salt (MAPTA-ABS salt) is expectedbased on available information on two parts of the salt ABS and 3-(methacrylamidopropyl) trimethylammonium (MAPTA), as ABS is (severely) irritating to skin and eyes and also for the methacrylamide part there is indication of possible skin irritation and severe eye irritation. (See document in support ofread-across attached to Chapter 13.)
Confirmation was obtained by testing the substance in in vitro test system for skin irritation EPISKIN reconstituted human epidermis model (OECD 439/EU B46). After a treatment period of 15 minutes followed by a post-exposure incubation period of 42 hours, viability was measured by MTT reduction, and resulted to 39.6%. As viability is below ≤ 50% this indicates that the substance is irritating.
A BCOP test (OECD 437) with this substance resulted to an IVIS score of 36.3. This score indicates that the substance is not corrosive to the eyes. On the other hand this score is indicative for possible irritation, which again is also expected on the bases of the information on the two separate ABS and methacrylamide parts of the salt. On the basis of this information it was decided that no furtherin vivotesting is needed as corrosion or non-irritation are both not conceivable results. Respiratory irritation:
There is no information on possible respiratory irritation. However, the likelihood for exposure via inhalation to cause irritation, is very low, inview of the high boiling point (> 300 °C) and very low vapour pressure (< 0.00000084 Pa at 20°C). Based on the available information on skin and eye irritation, there is theoretically some concern in this respect only in case of exposures to aerosols.
Justification for selection of skin irritation / corrosion endpoint:
Only study available.
Justification for selection of eye irritation endpoint:
Only study available.
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: irritating
Justification for classification or non-classification
Test results from in vitro testing in a reconstituted human epidermis model (OECD 439/EU B46) indicate that the substance should be classified as Cat.2 skin irritation under GHS.
Test results from BCOP study (OECD 437) also confirmed that the substance should be classification for eye irritation Cat.2.
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