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EC number: 616-248-3 | CAS number: 75627-31-5
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to: OECD Guideline for the testing of Chemicals 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method (Original Guideline adopted July 22, 2010)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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 (incl. QA statement)
Test material
- Reference substance name:
- disodium 2-({2-hydroxy-3-[2-(4-nonylphenoxy)ethoxy]propyl}(methyl)amino)acetate 2-{[3-({1-chloro-3-[2-(4-nonylphenoxy)ethoxy]propan-2-yl}oxy)-2-hydroxypropyl](methyl)amino}acetate
- EC Number:
- 616-248-3
- Cas Number:
- 75627-31-5
- Molecular formula:
- UVCB not applicable
- IUPAC Name:
- disodium 2-({2-hydroxy-3-[2-(4-nonylphenoxy)ethoxy]propyl}(methyl)amino)acetate 2-{[3-({1-chloro-3-[2-(4-nonylphenoxy)ethoxy]propan-2-yl}oxy)-2-hydroxypropyl](methyl)amino}acetate
- Details on test material:
- Identity: Nonylphenol ethoxylate, sarcosine derivative
CAS No.: 75627-31-5
Batch-No.: 120229AAH
Appearance: Light yellow liquid
Purity: 81.7% weight % (dose calculation was adjusted to purity, see 9.4)
Stability in Solvent: Not relevant
Storage: At room temperature
Expiration Date: February 28, 2017
Constituent 1
Test system
- Amount / concentration applied:
- Each 35.5 µL of the undiluted test item were applied to three EpiDerm (MatTek) tissues. Due to the purity of 81.7% of the test item, the applied volume was adjusted from 30 µL to 35.5 µL.
- Duration of treatment / exposure:
- The skin equivalents were exposed to the test item for 60 minutes. After completion of the treatment the test item was rinsed off and the skin equivalents were incubated for further 42 hours.
- Details on study design:
- Each 35.5 µL of the undiluted test item were applied to three EpiDerm (MatTek) tissues. Due to the purity of 81.7% of the test item, the applied volume was adjusted from 30 µL to 35.5 µL. From the negative control (DPBS) and the positive control (5% SLS) each 30 µL were applied to three tissues. The test item as well as the controls were rinsed off the tissues after 60 minutes treatment. After further 42 hours incubation the tissues were treated with the MTT solution for 3 hours following approximately 72 hours extraction of the colorant from the cells. The amount of extracted colorant was determined photometrically at a wavelength of 570 nm.
Results and discussion
In vivo
- Irritant / corrosive response data:
- After treatment with the of the test item Nonylphenol ethoxylate, sarcosine derivative the mean relative absorbance value was reduced to 5.3% (threshold for irritancy of ≤ 50%). Therefore, the test item is considered to possess an irritant potential.
Any other information on results incl. tables
Results after treatment with Nonylphenol ethoxylate, sarcosine derivative and the controls
Dose Group |
Treatment Interval |
Absorbance 570 nm |
Absorbance 570 nm |
Absorbance 570 nm |
Mean Absorbance of 3 Tissues |
%Absorbance |
Stand. Deviation |
Mean Rel. Absorbance [% of Negative Control]** |
Nega-tive Control |
60 min |
1.938 |
1.905 |
1.899 |
1.914 |
101.3 99.5 |
1.1 |
100.0 |
Positive Control |
60min |
0.086 |
0.082 |
0.090 |
0.086 |
5.2 5.4 |
0.2 |
4.5 |
Test Item |
60 min |
0.099 |
0.104 |
0.103 |
0.102 |
4.5 4.3 |
0.1 |
5.3 |
* Mean
of three replicate wells after blank correction
** relative
absorbance [rounded values]:
Optical evaluation of the MTT-reducing capacity of the test item after 1 hour incubation with MTT-reagent did not show blue colour.
The mean relative absorbance value of the test item, corresponding to the cell viability, decreased to 5.3% (threshold for irritancy:≤50%), consequently the test item was irritant to skin.
Since the present result was not borderline, the performance of the IL-1α Immunoassay was not necessary.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Nonylphenol ethoxylate, sarcosine derivative is irritant to skin category 2 according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008.
- Executive summary:
This in vitro study was performed to assess the irritation potential of Nonylphenol ethoxylate, sarcosine derivative by means of the Human Skin Model Test.
Each three tissues of the human skin model EpiDerm™ were treated with the test item, the negative or the positive control for 60 minutes.
35.5 µL of the undiluted test item were applied to each of triplicate tissues. Due to the purity of 81.7% of the test item, the applied volume was adjusted from 30 µL to 35.5 µL.
30 µL of either the negative control (DPBS) or the positive control (5% Sodium lauryl sulfate) were applied to each tissue.
The test item and the positive and negative controls were washed off the skin tissues after 60 minutes treatment. After further incubation for about 42 hours the tissues were treated with the MTT solution for 3 hours following approximately 72 hours extraction of the colorant from the cells. The amount of extracted colorant was determined photometrically at 570 nm.
After treatment with the negative control the mean absorbance values were well above therequired acceptability criterion of mean OD greater or equal than 1.0 and less or equal than 2.5 for the 60 minutes treatment interval thus showing the quality of the tissues.
Treatment with the positive control induced a decrease in the mean relative absorbance as compared to the negative control to 4.5% 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 2% (threshold of the "OECD Guideline for the Testing of Chemicals 439: In vitro Skin Irritation: Reconstructed Human Epidermis Test Method”: 18%), thus ensuring the validity of the study.
After treatment with the test item Nonylphenol ethoxylate, sarcosine derivative the mean relative absorbance value was reduced to 5.3% (threshold for irritancy of ≤ 50%). Therefore, the test item is considered to possess an irritant potential.
Due to the unambiguous result of the test, the performance of the IL-1 α Immunoassay was not necessary.
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