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Diss Factsheets
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EC number: 201-739-3 | CAS number: 87-32-1
- 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:
- 2016-05-25 - 2016-05-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Skinethic skin irritation test -42bis Standard operating procedure (SOP) 2009
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz
Test material
- Reference substance name:
- Nα-acetyl-DL-tryptophan
- EC Number:
- 201-739-3
- EC Name:
- Nα-acetyl-DL-tryptophan
- Cas Number:
- 87-32-1
- Molecular formula:
- C13H14N2O3
- IUPAC Name:
- N-acetyltryptophan
- Test material form:
- solid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: SkinEthic™ RHE-model
- Source strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- No vehicle used; Test item was applied neat to the tissues
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: SkinEthic™ RHE-model (Episkin/Skin Ethic Laboratories, Lyon, France)
- Tissue batch number: 16-RHE-052
- Expiration Date: May 30, 2016
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 42 ± 1 min at room temperature; thereafter at 37 °C for 42 ± 1 h
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Tissues were gently rinsed with DPBS in order to remove any residual test material. Excess DPBS was removed by gently shaking the tissue inserts and blotting the bottom of the tissues inserts with blotting paper.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h ± 5 min
- Spectrophotometer: microplate reader (ELx800, BioTek Instruments GmbH, Bad Friedrichshall, Germany)
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: The quality of the RHE model was assessed by undertaking a MTT cell viability test.
- Barrier function: The barrier function was assessed by determination of the exposure time required to reduce tissue viability by 50% (ET-50) upon application of 100 μL of 1% Triton X-100. The ET-50 value was determined to be 6.9 h.
- Other: Absence of significant abnormalities after histological observations (HES stained vertical paraffin)
NUMBER OF REPLICATE TISSUES: The test item as well as the positive and negative control were tested in batch-triplicates. Therefore, a total number of nine tissues was used in this study.
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
The test substance did not directly reduce MTT.
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritant to skin if the viability is less than 50%
- The test substance is considered to be non-irritant to skin the viability is greater than or equal to 50%
ACCEPTABILITY CRITERA
The negative control OD values for the RHE-model have to be in the range of ≥ 0.8 and ≤ 3.0.
The negative control data meet the acceptance criteria if the mean OD value is higher or equal than a historically established boundary at 570 nm. The boundary is two standard deviations below the current historical mean (1.417). The standard deviation value is considered valid if ≤ 18% of the group mean value.
The positive control data meet the acceptance criteria if the mean viability value, expressed as % of the negative control, is lower than or equal to a historically established boundary. The boundary is three standard deviations above the current historical mean (3.26%).
The standard deviation between the three tissue replicates in each group shall be ≤ 18%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 16 mg per tissue
NEGATIVE CONTROL
- Amount applied: 16 µL per tissue (Dulbecco`s Phosphate-Buffered Saline)
POSITIVE CONTROL
- Amount applied: 16 µL per tissue
- Concentration: 5% aqueous solution of sodium dodecyl sulfate in deionised water - Duration of treatment / exposure:
- 42 min (± 1 minute)
- Duration of post-treatment incubation (if applicable):
- 42 hours (± 1 hour)
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Experiment 1 / Run 1
- Value:
- 96
- Vehicle controls validity:
- not applicable
- Remarks:
- The test item was applied neat to the tissues
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Acceptability of the Quality Control Data of the Skin Model with Reference to Historical Batch Data:
The negative control OD values were 1.857, 1.830 and 1.822 and, thus, in the range of ≥ 0.8 and ≤ 3.0.
Acceptability of the Positive and Negative Control Data:
After treatment with the negative control (DPBS-buffer) the mean OD was 1.836 (standard deviation: 0.99%) and, thus, higher than the historically established threshold of 1.417.
After treatment with the positive control (5% aqueous solution of sodium dodecyl sulfate) the mean viability value was 1.25% (standard deviation: 2.51%) and, thus, lower than the historically established threshold of 3.26%.
The negative and positive control are acceptable as the difference compared with the historical data is minimal.
Variability of the Data:
The standard deviation between the three tissues replicates treated with the test item was 0.33% and, thus, ≤18%. The standard deviations between the three tissue replicates of the negative control and the positive control were 0.99% and 2.51%, respectively, and, thus, ≤18%.
The study met all acceptance criteria.
Any other information on results incl. tables
Table 1: Summary of Results
Group | Time / [min] | Mean OD | Mean Relative viability / [%] |
Negative Control | 42 | 1.836 | 100.00 |
Positive Control | 42 | 0.023 |
1.25 |
Test Material |
42 |
1.763 |
96.00 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- Under the conditions of the conducted test, the test substance did not show irritating properties towards reconstructed human epidermis tissue.
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