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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Skin Irritation
REACH_not irritating | Human skin model | OECD Draft Guideline | #key study#
Eye Irritation
REACH_not irritating | OECD 492 EpiOcular | #key study#
REACH_not irritating | HET-CAM | #key study#
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:
- June 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to: OECD Guideline for the Testing of Chemicals, Draft Proposal for a New Guideline, In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method, 11 December 2009, Vers. 4
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for the Testing of Chemicals, Draft Proposal for a New Guideline, In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method, 11 December 2009, Vers. 4
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Remarks:
- EpiSkin
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- skin obtained from plastic surgery from multiple donors
- Source strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 10 µL
- Duration of treatment / exposure:
- 15 min
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- other: Mean rel. MTT absorbance
- Run / experiment:
- 15 min treatment
- Value:
- 104.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100.0
- Positive controls validity:
- valid
- Remarks:
- 9.5
- Other effects / acceptance of results:
- After treatment with the test item Sa 57 the mean relative absorbance value did not decrease (104.3%) compared to the negative control. Therefore, the test item is not considered to possess an irritant potential.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Sa 57 is not irritant to skin.
- Executive summary:
This in vitro study was performed to assess the irritation potential of Sa 57 by means of the Human Skin Model Test.
Three tissues of the human skin modelEpiSkin™ were treated with the test item, the negative or the positive control for 15 minutes.
Approximately 10 µL of the neat test item were applied to each tissue and spread to match the tissue size.
10 µL of either the negative control (deionised water) or the positive control (5% Sodium lauryl sulfate) were applied to each tissue.
After treatment with the negative control the absorbance values were well within the required acceptability criterion of mean OD 0.6 and ≤ 1.5 for the15 minutes treatment interval thus showing the quality of the tissues and the specific batch of the tissue model.
Treatment with the positive control induced a decrease in the relative absorbance as compared to the negative control to 9.5% thus ensuring the validity of the test system.
The standard deviations between the % variabilities of the test item, the positive and negative controls were below 18% thus ensuring the validity of the study.
The control values are well in the range of our historical data.
After treatment with the test item Sa 57 the mean relative absorbance value did not decrease (104.3%) compared to the negative control. Therefore, the test item is not considered to possess an irritant potential.
According to the current prediction model no classification and labeling of Sa 57 is necessary with respect to skin irritation under EU and UN classification.
Reference
Optical evaluation of the MTT-reducing capacity of the test item after 1 hour incubation with MTT-reagent did not show blue colour.
Table 1: Results after treatment with Sa 57
Dose group |
Treat-ment Interval |
Absorbance 570 nm |
Absorbance 570 nm |
Absorbance 570 nm |
Mean Absorbance of 3 Tissues |
Standard Deviation of 3 Tissues |
Rel. Absorbance [% of Negative Control]** |
Standard Deviation [%] |
Negative Control |
15 min |
0.857 |
0.936 |
0.896 |
0.896 |
0.039 |
100.0 |
4.4 |
Positive Control |
15 min |
0.061 |
0.087 |
0.107 |
0.085 |
0.023 |
9.5 |
2.6 |
Sa 57 |
15 min |
0.988 |
0.902 |
0.916 |
0.935 |
0.046 |
104.3 |
5.1 |
* Mean
of two replicate wells after blank correction
** relative
absorbance [rounded values]:
After treatment with the test item Sa 57 the mean relative absorbance value did not decreas (104.3%) compared to the negative control. This value is well above the threshold for irritancy of ≤50%. Therefore, the test item is not considered to possess an irritant potential.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to: INVITTOX Protocol No. 47: HET-CAM Test.
- Qualifier:
- according to guideline
- Guideline:
- other: INVITTOX Protocol No. 47: HET-CAM Test. http://ecvam-sis.jrc.it
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: HET-CAM
- Strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Approx. 100 mg of the neat test item were applied onto the CAM
- Duration of treatment / exposure:
- 5 min
- Details on study design:
- Approx. 100 mg of the neat test item were applied onto the CAM in order to cover at least 50% of the CAM. The CAM was exposed to the test item for 5 minutes. During this 5 minutes reactions on the blood vessels in and under the CAM in close proximity to the test item were monitored. The CAMs of three eggs were treated with the test item. In addition to the test item a negative control (0.9% NaCl w/v)), two positive controls (1% SDS solution in deionised water and 0.1 N NaOH), and a reference item (5% (w/v) Texapon) were tested.
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean (5 min. exposure)
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Remarks:
- other: INVITTOX Protocol No. 47: HET-CAM Test. http://ecvam-sis.jrc.it
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Sa 57 does not possess any irritating potential.
- Executive summary:
This in vitro study was performed to assess the irritating potential of Sa 57 by detection of damages in blood vessels under the chorioallantoic membrane of 9 day incubated chicken eggs.
Each 300 µL of the test item, the positive and the negative controls, and the reference item were applied to three eggs each such that at least 50 % of the membrane was covered. During the observation period for 300 seconds any lesions in close proximity to the covered membrane were monitored and recorded. The observation time was 5 minutes at room temperature.
Physiological sodium chloride solution (0.9 % (w/v) in deionised water) was used as negative control.
The negative control showed no irritating effect on the blood vessels under the membrane. The irritancy mean index is 0.00.
A 1 % solution of SDS and 0.1 NaOH were used as positive controls.
The positive controls induced a severe irritation on the blood vessels. The calculated mean irritancy indices are 11.11 for 1 % SDS and 19.26 for 0.1 N NaOH. The reference itemTexapon ASV Spezial (5 % AS) was chosen because of its known eye irritating properties and induced a severe irritation on the blood vessels. The calculated mean irritancy index is 10.78.
The mean irritancy indices of the controls are well comparable with the historical control values and are within the acceptance criteria. The result of the reference item demonstrated a correct interpretation. Therefore, it was concluded that the test was valid.
No irritating effects were observed during 5 min incubation with Sa 57. The calculated irritancy mean index is 0.00.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-12-20 to 2018-01-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guidline study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for the Testing of Chemicals No. 492: (OECD Guideline for the Testing of Chemicals No. 492: Reconstructed human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification for eye irritation.
- Version / remarks:
- 28 July 2018
- Qualifier:
- according to guideline
- Guideline:
- other: EURL ECVAM DB-ALM Method Summary No. 164: EpiOcular™ Eye Irritation Test - Summary
- Version / remarks:
- 22 July 2018
- Qualifier:
- according to guideline
- Guideline:
- other: EpiOcular™ Eye Irritation Test (OCL-200-EIT) For the prediction of acute ocular irritation of chemicals For use with MatTek Corporation’s Reconstructed Human EpiOcular™ Model, r irritation of chemicals with MatTek
- Version / remarks:
- 29 June 2015
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Germany)
- Species:
- other: Reconstructed human cornea-like epithelium (RhCE) EpiOcular
- Details on test animals or tissues and environmental conditions:
- The test was carried out with the EpiOcular™ reconstructed human cornea-line epithelium (RhCE) model (MatTek). The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a stratified, highly differentiated squamous epithelium morphologically similar to that found in a human cornea. The EpiOcular™ RhCE tissue construct consists of at least 3 viable layers of cells and a non-keratinised surface, showing a cornea-like structure analogous to that found in vivo.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 1. Negative Control 50 μL Aqua dest.
2. Positive Control 50 μL methyl acetate
3. Test Item 50 μL (undiluted) - Duration of treatment / exposure:
- incubation: 30 +/-2 min.
- Duration of post- treatment incubation (in vitro):
- post soak: 12 +/- 2 min.
post treatment: 120 +/- 15 min. - Number of animals or in vitro replicates:
- The test was performed on a total of 2 tissues per dose group.
- Details on study design:
- The test was performed on EpiOcular, a reconstituted three-dimensional human corneal epithelium model. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 30 min exposure period and 120 min post-treatment period and compared to those of the concurrent negative controls.
- Irritation parameter:
- other: Mean relative tissue viability (% negative control) %
- Run / experiment:
- 1
- Value:
- 104.9
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Value Cut off pass/fail
Mean Absolute OD570 nm NK 1.814 0.8 < NK < 2.5 pass
Mean Relative Viability PC [%] 20.5 < 50% pass
Max. Difference of % Viability [%] 1.4 < 20% pass - Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no irritant effects. The test item is classified as “non-irritant“ in accordance with UN GHS “No Category”
- Executive summary:
In the present study the eye irritating potential of Sa 57 was analysed. Since irritant substances are cytotoxic to the corneal epithelium after a short time exposure the cytotoxic effects of the test item on EpiOcular™, a reconstituted three-dimensional human corneal epithelium model, were determined. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 30 min exposure period and 120 min post-treatment period and compared to those of the concurrent negative controls.
The test item showed no irritant effects. The mean relative tissue viability (% negative control) was > 60% (104.9%).The controls confirmed the validity of the study. The mean absolute OD570 of the two negative control tissues was > 0.8 and < 2.5 (1.814, 2.098). The mean relative tissue viability (% negative control) of the positive control was < 50% (20.5%). The maximum inter tissue difference of replicate tissues of all dose groups was < 20% (0.9%).
Referenceopen allclose all
Table 1: Results with Sa 57, as well as negative and positive controls, and the reference item
Test Group |
Time until Haemorrhage [s] |
Time until Lysis [s] |
Time until Coagulation [s] |
Irritancy Index |
Mean Irritancy Index |
Negative Control |
301 |
301 |
301 |
0.00 |
0.00 |
301 |
301 |
301 |
0.00 |
||
301 |
301 |
301 |
0.00 |
||
Positive Control 0.1 N NaOH |
10 |
45 |
17 |
19.34 |
19.26 |
9 |
41 |
16 |
19.48 |
||
11 |
57 |
20 |
18.96 |
||
Positive Control 1% SDS |
13 |
30 |
301 |
11.12 |
11.11 |
14 |
28 |
301 |
11.15 |
||
14 |
32 |
301 |
11.06 |
||
Reference Item 5% AS Texpon |
17 |
35 |
301 |
10.94 |
10.78 |
22 |
47 |
301 |
10.58 |
||
20 |
38 |
301 |
10.82 |
||
Test Item |
301 |
301 |
301 |
0.00 |
0.00 |
301 |
301 |
301 |
0.00 |
||
301 |
301 |
301 |
0.00 |
Mean irritancy index of 3 eggs: Test Item = 0.00
Mean irritancy index of 3 eggs: Positive Control (Sodium dodecyl sulphate) = 11.11
Positive Control (Sodium hydroxide solution) = 19.26
Reference Item (Texapon) = 10.78
The mixture of 50 µl test item per 1 mL MTT medium showed reduction of MTT as compared to the solvent. The mixture turned red. Sincethe mean relative tissue viability of the test item treated tissues (TM) was above the 60% threshold value killed tissue controls were performed for quantitative correction of results.
NSMTT [%] = [(ODKT- ODKU)/ODNK] * 100 = 0.23%
Difference of NSMTT of the two duplicate tissues must be < 20%, otherwise not accepted.
NSMTT1 [%] = [meanODKT1 - ODKU)/ODNK] * 100 = 0.25%
NSMTT2 [%] = [meanODKT2 - ODKU)/ODNK] * 100 = 0.20%
NSMTT1 - NSMTT2 = ± 0.05%
NSMTT was ≤ 60% (0.23%) relative to the negative control of living epidermis and could therefore be used for determination of the killed control corrected viability (KCCV) according to the following formula:
KCCV [%] = viabilityTM- NSMTT = 104.9%
The mixture of 50 µL test item per 1 mL A. dest. and per 2 mL isopropanol showed no colouring as compared to the solvent.Therefore, NSCliving equalled 0%.
Result of the Test Item Sa 57
Name |
Negative Control |
Positive Control |
Test item |
|||
Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
OD570values |
1.798 |
1.775 |
0.400 |
0.405 |
1.914 |
1.917 |
1.847 |
1.837 |
0.401 |
0.424 |
1.898 |
1.893 |
|
OD570values |
1.754 |
1.731 |
0.356 |
0.361 |
1.870 |
1.873 |
1.803 |
1.794 |
0.357 |
0.380 |
1.854 |
1.849 |
|
mean of the duplicates |
1.778 |
1.762 |
0.356 |
0.371 |
1.862 |
1.861 |
mean OD |
1.770* |
0.364 |
1.861 |
|||
TODTT |
- |
- |
1.857 |
|||
mean sd OD |
0.034 |
0.011 |
0.012 |
|||
tissue viability [%] |
100.5 |
99.5 |
20.1 |
20.9 |
105.2 |
105.1 |
relative tissue viability difference [%]*** |
0.9 |
0.8 |
0.1 |
|||
mean tissue viability [%] |
100.0 |
20.5** |
105.1 |
|||
mean tissue viability [%] |
- |
- |
104.9 |
* Corrected mean OD570of the negative control corresponds to 100% absolute tissue viability
** Mean relative tissue viability of the positive control is < 50%
*** Relative tissue viability difference of replicate tissues is < 20%
Result of the NSMTT control
NSMTT |
KU |
KT |
Negative Control |
||||
Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
|
absolute OD570 -values |
0.076 |
0.076 |
0.082 |
0.081 |
2.098 |
2.048 |
|
0.076 |
0.078 |
0.081 |
0.081 |
2.111 |
2.021 |
||
OD570(Blank Corrected) |
0.033 |
0.032 |
0.038 |
0.037 |
2.054 |
2.004 |
|
0.033 |
0.034 |
0.037 |
0.037 |
2.067 |
1.977 |
||
mean OD570 |
0.033 |
0.033 |
0.038 |
0.037 |
2.061 |
1.990 |
|
total mean OD570 |
0.033 |
0.037 |
2.026 |
||||
SD OD570(of the replicate tissues) |
0.000 |
0.000 |
0.050 |
||||
NSMTT [%] |
0.23 |
- |
|||||
Relative Tissue Viability [%] |
- |
101.7 |
98.3 |
||||
Mean Relative Tissue Viability [%] |
- |
100.0 |
|||||
SD Tissue Viability [%] |
- |
2.5 |
|||||
CV [% Viabilities] |
- |
2.5 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
The test substance did not produce skin irritation and eye irritation. The substance does not need to be classified for irritation according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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