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EC number: 230-908-4 | CAS number: 7365-82-4
- 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
In a reliable in vitro skin corrosion study human skin tissue (eipdermis keratinocytes) was exposed to the undiluted substance for 3 and 60 minutes. There was 85.5% and 100.8 % tissue viability following the 3 and 60 minute exposure, respectively. Resultantly, the substance is considered to be a non-corrosive to human skin.
In a reliable in vitro skin irritation study conducted on the substance the mean value of relative tissue viability was increased to 107.2% after the treatment. This value is above the threshold for skin irritation (50%). Therefore, the substance is considered to be a non-irritant to skin.
In a reliable in vitro eye irritation study employing bovine cornea were exposed to the undiluted substance for 4 hours. Opacity and permeability values were measured. The mean IVIS was -1.78 following the 4 hour exposure point. Resultantly, the substance is considered to be a non-irritant to the eye.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 September 2018 - 13 September 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 29. Jul. 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Version / remarks:
- 30. May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch no. GL865320171205
Appearance White crystalline powder
Composition 2-((2-Amino-2-oxoethyl)amino)ethanesulfonic acid
Purity ≥99% Assay (Titration)
Homogeneity homogeneous
Expiry date 5. Dec. 2019
Storage Room Temperature (20 ± 5 °C) - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- As per the OECD Guidelines.
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Tissue 1 ( 3 min exposure): 26.7 mg
Tissue 2 ( 3 min exposure): 25.4 mg
Tissue 1 ( 1 h exposure): 25.9 mg
Tissue 2 ( 1 h exposure): 26.6 mg - Duration of treatment / exposure:
- 3 minutes and 1 hour
- Duration of post-treatment incubation (if applicable):
- 3 hours at 37 ± 1°C and 5.0 ± 0.5% CO2
- Number of replicates:
- Triplicate wells for two sets of tissues.
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of two tissues (3 min)
- Value:
- 85.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean ot two tissues (1 h)
- Value:
- 100.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The criterion for optical density of the negative control (≥ 0.8 and ≤ 2.8) was fulfilled: optical density was 1.6 (3 minutes) and 1.5 (1 hour). The positive control showed clear corrosive effects. The criterion for the viability of the 1 hour experiment, expressed as % of the negative control (< 15%), was fulfilled, too. The mean value of relative tissue viability was 9.3%. Values for negative control and for positive control were within the range of historical data of the test facility. Therefore the experiment is considered valid.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is considered to be non-corrosive to skin based on a reliable in vitro skin corrosion study conducted according to OECD TG 431.
- Executive summary:
In an in vitro skin corrosion study conducted according to OECD TG 431, human skin tissue (epidermis keratinocytes) was exposed to undiluted substance for 3-minutes and 1-hour. The mean value of relative tissue viability of the substance was 85.5% after 3 minutes treatment. This value is above the threshold for corrosivity (50%). After 1-hour treatment, the mean value of relative tissue viability of the substance was 100.8%, which is above the threshold for corrosivity (15%). Therefore, the substance is considered as non-corrosive to skin.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 September 2018 - 14 September 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted 28. July 2015
- Deviations:
- yes
- Remarks:
- The pre-incubation time was 1 hour, instead of 18 ± 3 hours overnight. This can be seen as uncritical, because the pre-incubation time must be at least 1 hour (in consultation with the tissue supplier; MatTek In Vitro Life Science Laboratories).
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- adopted 06. Jul. 2012
- Deviations:
- yes
- Remarks:
- The pre-incubation time was 1 hour, instead of 18 ± 3 hours overnight. This can be seen as uncritical, because the pre-incubation time must be at least 1 hour (in consultation with the tissue supplier; MatTek In Vitro Life Science Laboratories).
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch no. :GL865320171205
Appearance :White crystalline powder
Composition :2-((2-Amino-2-oxoethyl)amino)ethanesulfonic acid
Purity :>=99% Assay (Titration)
Homogeneity :homogeneous
Expiry date :5. Dec. 2019
Storage :Room Temperature (20 ± 5 °C) - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- As per the OECD Guidelines.
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Substance is a powder.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Tissue 1: 25.8 mg
Tissue 2: 24.2 mg
Tissue 3: 25.5 mg - Duration of treatment / exposure:
- 1 hour.
- Duration of post-treatment incubation (if applicable):
- 23 hours at 37 ± 1°C and 5.0 ± 0.5% CO2.
- Number of replicates:
- Three
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of three tissues
- Value:
- 107.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is considered to be a non-irritant to skin based on an in vitro study conducted according to OECD TG 439.
- Executive summary:
In an in vitro skin irritation study conducted according to OECD TG 439 human skin tissue (epidermis keratinocytes) was exposed to the undiluted substance for 60-minutes. There was 107.2% tissue viability following the 60-minute exposure point. This value is above the threshold for skin irritation (50%). Resultantly, the substance is considered to be a non-irritant to human skin.
Referenceopen allclose all
Mean Absorbance Values of the 3 Minutes Experiment
Designation | Negative Control | Substance | Positive Control |
Mean – blank (tissue 1) | 1.668 | 1.478 | 0.559 |
Mean – blank (tissue 2) | 1.630 | 1.343 | 0.492 |
Mean of the two tissues | 1.649 | 1.411 | 0.526 |
Relative standard deviation | 1.6% | 6.8% | 9.0% |
Mean Absorbance Values of the 1 h Experiment
Designation | Negative Control | Substance | Positive Control |
Mean – blank(tissue 1) | 1.576 | 1.563 | 0.134 |
Mean – blank (tissue 2) | 1.500 | 1.536 | 0.151 |
Mean of the two tissues | 1.538 | 1.550 | 0.143 |
Relative standard deviation | 3.5% | 1.2% | 8.6% |
% Tissue Viability
Designation | N-(2-Acetamido)-2-aminoethanesulfonic acid; N-(Carbamoylmethyl)taurine (ACES) | Positive Control |
% Tissue viability (tissue 1) | 105.5% | 4.1% |
% Tissue viability (tissue 2) | 106.4% | 3.7% |
% Tissue viability (tissue 3) | 109.8% | 3.3% |
% Tissue viability (mean) | 107.2% | 3.7% |
± SD of mean tissue viability (%) | 2.3% | 0.4% |
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:
- 05 September 2018 - 13 September 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- Adopted
09. Oct. 2017 - Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for the Testing of Chemicals, Series on Testing and Assessment No. 160
- Version / remarks:
- “GUIDANCE DOCUMENT ON “THE BOVINE CORNEAL OPACITY AND PERMEABILITY (BCOP) AND ISOLATED CHICKEN EYE (ICE) TEST METHODS: COLLECTION OF TISSUES FOR HISTOLOGICAL EVALUATION AND COLLECTION OF DATA ON NON-SEVERE IRRITANTS”, 25. Oct. 2011
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Version / remarks:
- For Identifying (i) Chemicals Inducing Serious Eye Damage and (ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage, adopted 14. Feb. 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch no. GL865320171205
Appearance: White crystalline powder
Composition: 2-((2-Amino-2-oxoethyl)amino)ethanesulfonic acid
Purity: ≥ 99% Assay (Titration)
Homogeneity: homogeneous
Expiry date: 05. Dec. 2019
Storage: Room temperature (20 ± 5 °C) - Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Fresh bovine eyes were obtained, on the day of the test. The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hanks’ Balanced Salt Solution with 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 µg/mL) in a suitable cooled container within 1 hour.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Replicate 1: 551.4 mg
Replicate 2: 550.3 mg
Replicate 3: 550.3 mg - Duration of treatment / exposure:
- 4 hours at 32 ± 1 °C
- Duration of post- treatment incubation (in vitro):
- 90 minutes at 32 ± 1 °C in a horizontal position
- Number of animals or in vitro replicates:
- Three
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- replica 1
- Value:
- 0.72
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- replica 2
- Value:
- -2.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- replica 3
- Value:
- -2.03
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance showed no effects on the cornea of the in vitro bovine eye and the calculated mean IVIS was -1.78. Therefore the substance is considered to be a non-irritant to the eyes.
- Executive summary:
In an in vitro opacity and permeability study employing bovine cornea, which were exposed to undiluted substance for 4 hours, opacity and permeability values were measured. There was a mean IVIS of -1.78 following the 4-hour exposure point. Resultantly, the substance is considered to be non-irritant to the eye and not expected to cause serious eye damage.
Reference
The calculated IVIS for each replicate and the corresponding means are presented in the following table:
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control |
1.91 |
2.18 |
30.52% |
1.69 |
|||
2.93 |
|||
Substance |
0.72 |
- 1.78 |
54.18% |
- 2.60 |
|||
- 2.03 |
|||
Positive Control |
115.33 |
125.44 |
11.82% |
142.46 |
|||
118.53 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the findings of reliable in vitro skin irritation, skin corrosion and eye irritation studies conducted on the substance, classification of the substance is not justified.
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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