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EC number: 613-240-1 | CAS number: 63503-98-0
- 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
- Study period:
- 17 September 2014 until 22 September 2014.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed study according to OECD 439 with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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
Test material
- Reference substance name:
- sodium 4-(3-oxobutanamido)benzene-1-sulfonate
- EC Number:
- 613-240-1
- Cas Number:
- 63503-98-0
- Molecular formula:
- C10H11NO5S.Na
- IUPAC Name:
- sodium 4-(3-oxobutanamido)benzene-1-sulfonate
- Details on test material:
- Identification: Acetessigsulphanilsäure-Natriumsalz, trocken
CAS-No.: 63503-98-0
EC-No.: 613-240-1
Purity: 95.9% (w/w)
Expiry Date: 23 June 2016
Constituent 1
Test animals
- Species:
- other: reconstituted human epidermis model
- Strain:
- other: reconstituted human epidermis model
Test system
- Type of coverage:
- other: Topical
- Preparation of test site:
- other: Not applicable
- Vehicle:
- other: No vehicle used
- Amount / concentration applied:
- Each approximately 25 mg of the test item were applied to the tissues, wetted with 25 µL DPBS, and spread to match the surface of the tissue.
VEHICLE: No vehicle used - Duration of treatment / exposure:
- 60 minutes
- Observation period:
- Not applicable
- Number of animals:
- Not applicable
- Details on study design:
- Each three tissues of the human skin model EpiDerm™ were treated with the test item, the negative or the positive control for 60 minutes.
Approximately 25 mg of the test item were applied to each tissue, wetted with 25 µL of DPBS, and spread to match the surface of triplicate tissue.
30 µL of either the negative control (DPBS) or the positive control (5% SLS) were applied to triplicate tissue each.
The test item and the positive and negative controls were washed off the skin tissues after 60 minutes treatment. After further incubation for about 43 hours the tissues were treated with the MTT solution for 3 hours following 69.75 hours extraction of the colorant from the cells. The amount of extracted colorant was determined photometrically at 570 nm.
Results and discussion
In vivo
- Irritant / corrosive response data:
- Compared to the relative absorbance value of the negative control the mean relative absorbance value was reduced to 81.1% after exposure of the skin tissues to the test item. This value is above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential.
- Other effects:
- No
Any other information on results incl. tables
Results after treatment with Acetessigsulphanilsäure-Natriumsalz, trocken and the controls
Dose Group |
Treat-ment Interval |
Absor-bance 570 nm |
Absor-bance 570 nm |
Absor-bance 570 nm |
Mean Absor-bance of 3 Tissues |
Rel. Absor-bance [%] Tissue 1, 2, and 3** |
Relative Standard Deviation [%] |
Mean Rel. Absorbance [% of Negative Control]*** |
Negative Control |
60 min |
1.742 |
1.808 |
1.904 |
1.818 |
95.8 |
4.5 |
100.0 |
Positive Control |
60 min |
0.126 |
0.117 |
0.103 |
0.115 |
6.9 |
9.7 |
6.3 |
Test Item |
60 min |
1.481 |
1.322 |
1.617 |
1.474 |
81.5 |
10.0 |
81.1 |
* Mean of three replicate wells after blank correction
** relative absorbance per tissue [rounded values]:
*** relative absorbance per treatment group [rounded values]:
Since the test item was not coloured, there was no need to perform the test for colour interference.
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 81.1% (threshold for irritancy:≤50%), consequently the test item was not irritant to skin.
Applicant's summary and conclusion
- Interpretation of results:
- not 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, Acetessigsulphanilsäure-Natriumsalz, trocken is not irritant to skin according to UN GHS and EU CLP regulation.
- Executive summary:
- This
in vitro study was performed to assess the irritation potential of
Acetessigsulphanilsäure-Natriumsalz, trocken 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.
Approximately 25 mg of the test item were applied to each tissue, wetted with 25 µL of DPBS, and spread to match the surface of triplicate tissue.
30 µL of either the negative control (DPBS) or the positive control (5% SLS) were applied to triplicate tissue each.
The test item and the positive and negative controls were washed off the skin tissues after 60 minutes treatment. After further incubation for about 43 hours the tissues were treated with the MTT solution for 3 hours following 69.75 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 absorbance values were well within the required acceptability criterion of mean OD³0.8 and ≤ 2.8 for the 60 minutes treatment interval thus showing the quality of the tissues.
Treatment with the positive control induced a decrease in the relative absorbance as compared to the negative control to 6.3% thus ensuring the validity of the test system.
The rel. standard deviations between the % variabilities of the test item, the positive and negative controls were below/at 10% (threshold of the "OECD Guideline for the Testing of Chemicals 439:In vitroSkin Irritation: Reconstructed Human Epidermis Test Method”: 18%), thus ensuring the validity of the study.
Compared to the relative absorbance value of the negative controlthe mean relative absorbance value was reduced to 81.1% after exposure of the skin tissues to the test item. This value is above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential.
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