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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
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Remarks:
- Cytotoxicity Assay in vitro with BALB/c 3T3 Cells: Neutral Red Test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental start date: 23 November 2016 Experimental completion date: 16 December 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: • OECD Guideline for Testing of Chemicals: Guideline: 432; In vitro 3T3 NRU phototoxicity test (Revised and approved by the National Co-ordinators in May 2002, approved by Council April 2004).
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No. 440/2008 B 41", dated May 30, 2008.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Committee for Proprietary Medicinal Products (CPMP) Note for Guidance on Photosafety testing, EMEA, CPMP/SWP/398/01, adopted 27 June 2002, into operation in Dec 2002.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- liquid
- Details on test material:
- Chemical Name: N-[2-(2-Hydroxyethoxy)ethyl]acetamide
CAS No.: 118974-46-2
Batch: 27191705
Purity: 82% (dose calculation was adjusted to puriy)
Appearance: Pale to yellow liquid
Expiry Date: 16 June 2017
Storage Conditions: At room temperature
Stability in Solvent: Stable in water (not quantified)
Purpose of Use: Industrial chemical
Constituent 1
Test animals
- Species:
- other: BALB/c 3T3 cell line
- Details on test animals or test system and environmental conditions:
- Details on mammalian cell line
The BALB/c 3T3 cell line was isolated from the muscle tissue of the mouse embryo. This fibroblast cell line has a high proliferation rate (doubling time 16 - 20 hours in stock cultures) and a high plating efficiency of untreated cells (as a rule more than 70%) both necessary for the appropriate performance of the study. The cell line BALB/c 3T3 was isolated first by Aaronson and Todaro.
Administration / exposure
- Route of administration:
- other: In vitro exposure of cells
- Vehicle:
- other: EBSS
- Details on exposure:
- Test concentrations with justification for top dose
The following concentrations were tested (each concentration of the test item was tested in six replicates: with and without irradiation in both experiments 7.81 15.6 31.3 62.5 125 250 500 1000 µg/mL of the test item - Doses:
- The following concentrations were tested (each concentration of the test item was tested in six replicates: with and without irradiation in both experiments 7.81 15.6 31.3 62.5 125 250 500 1000 µg/mL of the test item
- Control animals:
- not specified
- Details on study design:
- The neutral red (NR) test was developed by Borenfreund & Puerner and is used for the investigation of the cytotoxic potential of a test item. In this study the toxicity of the test item after irradiation with artificial sunlight is determined. The test protocol was developed in 1991 at Beiersdorf AG, Hamburg and validated in an ECVAM, COLIPA, and ZEBET coordinated ring trial. The study was initiated involving 11 laboratories.
The NR assay is based on the uptake of neutral red, a vital dye, and its accumulation in the lysosomes of viable uninjured cells. After storing the neutral red in the lysosomes of the viable uninjured cells, they are lysed with a mixture of deionised water (49% (v/v)), ethanol (50% (v/v)) and glacial acetic acid (1% (v/v)). The extracted neutral red is quantified photometrically at 540 nm.
For the determination of a phototoxic potential the cells were treated with various concentrations of the test item with and without irradiation with artificial sunlight (wave length > 320 nm). The cytotoxic response curves of the test groups were compared. The IC50-values were determined and compared to measure a possible phototoxicity
Results and discussion
Effect levels
- Dose descriptor:
- other: No cytotoxicity observed
- Effect level:
- > 1 000 other: µg/mL
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Any other information on results incl. tables
Results AND DISCUSSION
Table2 RFE: Treatment of BALB/c 3T3 withElfaMoist AC
With artificial sunlight |
Without artificial sunlight |
||||||
Conc. [µg/mL] |
O.D.540 nmMean Value |
Standard Deviation |
% of Solv. Control |
Conc. [µg/mL] |
O.D.540 nmMean Value |
Standard Deviation |
% of Solv. Control |
Solvent Control |
0.7028* |
0.0311 |
100.00 |
Solvent Control |
0.7372* |
0.0459 |
100.00 |
7.81 |
0.7067 |
0.0121 |
100.56 |
7.81 |
0.7258 |
0.0161 |
98.45 |
15.6 |
0.7078 |
0.0198 |
100.71 |
15.6 |
0.7017 |
0.0304 |
95.17 |
31.3 |
0.7011 |
0.0174 |
99.75 |
31.3 |
0.7132 |
0.0428 |
96.73 |
62.5 |
0.7221 |
0.0181 |
102.75 |
62.5 |
0.7201 |
0.0231 |
97.67 |
125 |
0.7058 |
0.0139 |
100.43 |
125 |
0.7119 |
0.0439 |
96.56 |
250 |
0.6832 |
0.0098 |
97.21 |
250 |
0.6820 |
0.0370 |
92.51 |
500 |
0.7209 |
0.0274 |
102.57 |
500 |
0.7053 |
0.0381 |
95.66 |
1000 |
0.6912 |
0.0191 |
98.34 |
1000 |
0.7015 |
0.0281 |
95.15 |
* mean O.D.540 nmout of 12 wells
IC50values = could not be determined, since the viability of the cells was not reduced with and without irradiation
PIF = could not be determined, since no IC50values could be calculated
MPE = -0.044
Mean OD540 nmsolvent control value (≙viability) irradiated versus non-irradiated group: 95.3%
Table3 RFE:Treatmentof BALB/c 3T3with the Positive Control (chlorpromazine)
With artificial sunlight |
Without artificial sunlight |
||||||
Conc.[µg/mL] |
O.D.540 nmMean Value |
Standard Deviation |
% of Solv.Control |
Conc. [µg/mL] |
O.D.540 nmMean Value |
Standard Deviation |
% of Solv. Control |
Solvent Control |
0.6892* |
0.0590 |
100.00 |
Solvent Control |
0.7584* |
0.0768 |
100.00 |
0.125 |
0.6597 |
0.0627 |
95.72 |
6.25 |
0.7020 |
0.0177 |
92.56 |
0.250 |
0.4959 |
0.0534 |
71.95 |
12.5 |
0.3755 |
0.0226 |
49.51 |
0.500 |
0.3743 |
0.0403 |
54.31 |
25.0 |
0.0628 |
0.0050 |
8.28 |
0.750 |
0.3494 |
0.0429 |
50.69 |
37.5 |
0.0585 |
0.0029 |
7.72 |
1.000 |
0.2653 |
0.0669 |
38.49 |
50.0 |
0.0561 |
0.0011 |
7.39 |
1.500 |
0.0667 |
0.0106 |
9.68 |
75.0 |
0.0578 |
0.0025 |
7.62 |
2.000 |
0.0602 |
0.0032 |
8.73 |
100 |
0.0594 |
0.0021 |
7.83 |
4.000 |
0.0623 |
0.0037 |
9.04 |
200 |
0.0601 |
0.0037 |
7.93 |
* mean O.D.540 nmout of 12 wells
IC50value (with artificial sunlight) = 0.60 µg/mL
IC50value (without artificial sunlight) = 11.88 µg/mL
PIF = 20.04
MPE = 0.540
Mean OD540nm solvent control value (≙viability) irradiated versus non-irradiated group: 90.9%
Table4 ME: Treatment of BALB/c 3T3 withElfaMoist AC
With artificial sunlight |
Without artificial sunlight |
||||||
Conc. [µg/mL] |
O.D.540 nmMean Value |
Standard Deviation |
% of Solv. Control |
Conc. [µg/mL] |
O.D.540 nmMean Value |
Standard Deviation |
% of Solv. Control |
Solvent Control |
0.8461* |
0.0291 |
100.00 |
Solvent Control |
0.8195* |
0.0356 |
100.00 |
7.81 |
0.8595 |
0.0234 |
101.58 |
7.81 |
0.8027 |
0.0173 |
97.95 |
15.6 |
0.8571 |
0.0348 |
101.30 |
15.6 |
0.7830 |
0.0264 |
95.55 |
31.3 |
0.8404 |
0.0282 |
99.33 |
31.3 |
0.7726 |
0.0179 |
94.28 |
62.5 |
0.8437 |
0.0138 |
99.72 |
62.5 |
0.7847 |
0.0227 |
95.75 |
125 |
0.8310 |
0.0365 |
98.22 |
125 |
0.8018 |
0.0214 |
97.84 |
250 |
0.8239 |
0.0252 |
97.38 |
250 |
0.7753 |
0.0201 |
94.60 |
500 |
0.8073 |
0.0223 |
95.41 |
500 |
0.7865 |
0.0266 |
95.97 |
1000 |
0.8264 |
0.0186 |
97.68 |
1000 |
0.7695 |
0.0288 |
93.89 |
* mean O.D.540 nmout of 12 wells
IC50values = could not be determined, since the viability of the cells was not reduced with and without irradiation
PIF = could not be determined, since no IC50values could be calculated
MPE = -0.029
Mean OD540 nmsolvent control value (≙viability) irradiated versus non-irradiated group: 103.2%
Table 5 ME:Treatmentof BALB/c 3T3with the Positive Control (chlorpromazine)
With artificial sunlight |
Without artificial sunlight |
||||||
Conc.[µg/mL] |
O.D.540 nmMean Value |
Standard Deviation |
% of Solv.Control |
Conc. [µg/mL] |
O.D.540 nmMean Value |
Standard Deviation |
% of Solv. Control |
Solvent Control |
0.7766* |
0.0172 |
100.00 |
Solvent Control |
0.8160* |
0.0193 |
100.00 |
0.125 |
0.7573 |
0.0271 |
97.50 |
6.25 |
0.8228 |
0.0171 |
100.84 |
0.250 |
0.7221 |
0.0339 |
92.98 |
12.5 |
0.1285 |
0.0103 |
15.75 |
0.500 |
0.5974 |
0.0373 |
76.92 |
25.0 |
0.0675 |
0.0056 |
8.27 |
0.750 |
0.4479 |
0.0609 |
57.67 |
37.5 |
0.0677 |
0.0096 |
8.29 |
1.000 |
0.1292 |
0.0133 |
16.63 |
50.0 |
0.0666 |
0.0069 |
8.16 |
1.500 |
0.0882 |
0.0070 |
11.36 |
75.0 |
0.0689 |
0.0107 |
8.44 |
2.000 |
0.0839 |
0.0083 |
10.80 |
100 |
0.0679 |
0.0075 |
8.33 |
4.000 |
0.0919 |
0.0088 |
11.83 |
200 |
0.0720 |
0.0161 |
8.83 |
* mean O.D.540 nmout of 12 wells
IC50value (with artificial sunlight) = 0.77 µg/mL
IC50value (without artificial sunlight) = 10.72 µg/mL
PIF = 13.89
MPE = 0.548
Mean OD540nm solvent control value (≙viability) irradiated versus non-irradiated group: 95.2%
Applicant's summary and conclusion
- Conclusions:
- Reaction mass of N-[2-(2-hydroxyethoxy)ethyl]acetamide and glycerol did not have any phototoxic effects on BALB/c 3T3 cells, and showed no cytotoxicity up to the highest tested concentration of 1000 µg/mL.
- Executive summary:
The study was performed to assess the phototoxic potential of reaction mass of N-[2-(2-hydroxyethoxy)ethyl]acetamide and glycerol. The test was performed using BALB/c 3T3 cells clone 31.
1000 µg/mL of the test item, dissolved in EBSS were applied as the highest concentration.
The experiment was performed twice. The first experiment served as a range finding experiment (RFE), the second experiment was the main experiment (ME).
The following concentrations of the test item were tested with and without irradiation in both experiments:
7.81, 15.63, 31.25, 62.5, 125, 250, 500, 1000 µg/mL
As solvent control EBSS was used.
Chlorpromazine was used as positive control. The following concentrations were applied:
without irradiation
6.25, 12.5, 25.0, 37.5, 50, 75, 100, 200 µg/mL
with irradiation
0.125, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0 µg/mL
In both experiments one test group of cells treated with the test item was irradiated withartificial sunlight for 50 minutes with 1.65 mW/cm2UVA, resulting in an irradiation dose of~ 5 J/cm2UVA. Another test group of test item treated cells were kept in the dark for 50 minutes.
Table1 Summary of Results
Test Item
IC50(+UV) [µg/mL]
IC50(-UV) [µg/mL]
PIF
MPE
% viability of solvent control of irradiated versus non irradiated plate
RFE
ElfaMoist AC
-
-
-
-0.044
95.3
Positive control
0.60
11.88
20.04
0.540
90.9
ME
ElfaMoist AC
-
-
-
-0.029
103.2
Positive control
0.77
10.72
13.89
0.548
95.2
In both experiments no cytotoxic effects were observed after treatment of cells with reaction mass of N-[2-(2-hydroxyethoxy)ethyl]acetamide and glycerol, neither in the presence nor in the absence of irradiation with artificial sunlight. Therefore, IC50-values or PIFs could not be calculated. The resulting MPE was -0.044 or -0.029, respectively,and therefore, the test item is classified as not phototoxic.
The positive control chlorpromazine induced phototoxicity in the expected range after irradiation with artificial sunlight.
In conclusion, it can be stated that in the study described and under the experimental conditions reported Reaction mass of N-[2-(2-hydroxyethoxy)ethyl]acetamide and glycerol did not have any phototoxic effects on BALB/c 3T3 cells.
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