Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 202-111-1 | CAS number: 91-96-3
- 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:
- 11.-16.09.2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N,N'-(3,3'-dimethylbiphenyl-4,4'-ylene)di(acetoacetamide)
- EC Number:
- 202-111-1
- EC Name:
- N,N'-(3,3'-dimethylbiphenyl-4,4'-ylene)di(acetoacetamide)
- Cas Number:
- 91-96-3
- Molecular formula:
- C22H24N2O4
- IUPAC Name:
- N-{2-methyl-4-[3-methyl-4-(3-oxobutanamido)phenyl]phenyl}-3-oxobutanamide
- Details on test material:
- Purity: 99.1%
Expiry Date: 03 June 2015
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- other:
- Remarks:
- skin equivalents wetted with 25 µL DPBS
- Details on test system:
- Test System
- Epi-200-SIT Kit; Lot No.: 18371 purchased from MatTek Corporation, 82105 Bratislava, Slovakia
- EpiDerm tissue consists of normal, human-derived epidermal keratinocytes to form a multilayered, highly differentiated model of the human epidermis
Treatment
- incubation for 35 min. at 37 ± 1.5°C, 5 ± 0.5% CO2, 95 ± 5 RH
- tissues rinsed at least 15 times with DPBS
- tissues were incubated for 24 h at 37 ± 1.5°C, 5 ± 0.5%, thereafter the tissues were transferred into into wells containing fresh medium for another 19 h at 37 ± 1.5°C, 5 ± 0.5% CO2. The complete incubation time was about 43 h.
MTT assay
- 3 h at 37 ± 1.5°C, 5 ± 0.5% CO2
- extraction period of 69.5 h at room temperature - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
Test system
- Amount / concentration applied:
- Each approximately 25 mg of the neat test item were applied to three EpiDerm (MatTek) skin equivalents. Additionally, the equivalents were wetted with 25 µL DPBS.
- Duration of treatment / exposure:
- The skin equivalents were exposed to the neat test item for 60 minutes. After completion of the treatment the test item was rinsed off and the skin equivalents were incubated for further 43 hours.
- Details on study design:
- Each approximately 25 mg of the neat test item and 30 µL of the negative control (DPBS) or the positive control (5% SLS) were applied to three EpiDerm (MatTek) skin equivalents. Additionally, the test item treated tissues were wetted with 25 µL DPBS each. The test item as well as the controls were rinsed off the tissues after 60 minutes treatment. After further 43 hours incubation the tissues were treated with the MTT solution for 3 hours following approximately 70 hours extraction of the colorant from the cells. The amount of extracted colorant was detemrined photometrically at a wavelength of 570 nm.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: % Relaive Absorbance
- Run / experiment:
- 1
- Value:
- 94.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- other: % Relaive Absorbance
- Run / experiment:
- 2
- Value:
- 91.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- other: % Relaive Absorbance
- Run / experiment:
- 3
- Value:
- 100.9
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- other: % Relaive Absorbance
- Run / experiment:
- mean
- Value:
- 95.4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Compared to the relative absorbance value of the negative control the mean relative absorbance value decreased to 95.4% after exposure of the test item to the skin tissues. This value is well above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential.
Any other information on results incl. tables
Results after treatment with Naphtol AS-G trocken and the controls
Dose Group |
Treat-ment Interval |
Absorbance 570 nm |
Absorbance 570 nm |
Absorbance 570 nm |
Mean Absorbance of 3 Tissues |
Rel. Absorbance [%] Tissue 1, 2 + 3** |
Relative Standard Deviation [%] |
Mean Rel. Absorbance [% of Negative Control]*** |
Nega-tive Control |
60 min |
1.781 |
1.788 |
1.842 |
1.803 |
98.7 |
1.8 |
100.0 |
Positive Control |
60 min |
0.054 |
0.056 |
0.064 |
0.058 |
3.0 |
9.5 |
3.2 |
Test Item |
60 min |
1.698 |
1.647 |
1.819 |
1.721 |
94.1 |
5.1 |
95.4 |
* Mean
of three replicate wells after blank correction
** relative
absorbance per tissue [rounded values]
*** relative
absorbance per treatment group [rounded values]
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, Naphtol AS-G trocken is not irritant to skin.
- Executive summary:
This in vitro study was performed to assess the irritation potential of Naphtol AS-G 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.
About 25 mg of the test item were applied to each tissue, wetted with DPBS, and spread to match the tissue surface.
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 43 hours the tissues were treated with the MTT solution for 3 hours following ~ 69.5 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 OD greater or equal than 0.8 and less or equal 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 3.2% 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 10% (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.
Compared to the relative absorbance value of the negative control the mean relative absorbance value decreased to 95.4% after exposure of the test item to the skin tissues. This value is well above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.