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EC number: 235-402-7 | CAS number: 12217-80-0
- 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 / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- yes
- Remarks:
- See below
- Qualifier:
- according to guideline
- Guideline:
- other: Method B.40bis of Commission Regulation (EC) No 440/2008, of 30 May 2008, laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on REACH.
- Deviations:
- yes
- Remarks:
- See below
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4,11-diamino-2-(3-methoxypropyl)-1H-naphth[2,3-f]isoindol-1,3,5,10(2H)-tetrone
- EC Number:
- 235-402-7
- EC Name:
- 4,11-diamino-2-(3-methoxypropyl)-1H-naphth[2,3-f]isoindol-1,3,5,10(2H)-tetrone
- Cas Number:
- 12217-80-0
- Molecular formula:
- C20H17N3O5
- IUPAC Name:
- 4,11-diamino-2-(3-methoxypropyl)-1H-naphtho[2,3-f]isoindole-1,3,5,10(2H)-tetrone
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EpiDerm™ Reconstructed Human Epidermis Model Kit
Supplier: MatTek
Date received: 14 April 2015
EpiDermTM Tissues (0.5cm2) lot number: 21654
Assay Medium lot number: 040915TMA
Upon receipt of the EpidermTM tissues, the sealed 24-well plate was placed into a refrigerator. - Amount/concentration applied:
- 25 mg of the test item
- Duration of treatment / exposure:
- 3-Minute and 60-Minute exposure periods
- Duration of post-treatment incubation (if applicable):
- 3 hours
Test system
- Observation period:
- None
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min incubation time
- Value:
- 101.1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes incubation time
- Value:
- 103.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
In vivo
- Irritant / corrosive response data:
- The relative mean viabilities of the test item treated tissues were as follows:
60 minute exposure: 101.1%
3 minute exposure: 103.3% - Other effects:
- None
Any other information on results incl. tables
Direct MTT Reduction
The direct MTT reduction test was inconclusive due to the dark blue color of the test item. Therefore, an additional procedure using freeze killed tissues was performed to assess for the possibility of direct MTT reduction. An additional procedure was also performed using viable tissues to assess for the possibility of color interference. The results of the additional procedures showed a negligible degree of interference due to possible direct reduction of MTT or color interference. It was therefore considered unnecessary to use the results of the additional procedures for quantitative correction of results and reporting purposes.
Quality Criteria
The relative mean tissue viability for the positive control treated tissues was 2.4% relative to the negative control treated tissues following the 3-Minute exposure period. The positive control acceptance criterion was therefore satisfied.
The mean OD562 for the negative control treated tissues was 2.004 for the 3-Minute exposure period and 2.005 for the 60-Minute exposure period. The negative control acceptance criteria were therefore satisfied.
Mean OD562 values and viabilities for the negative control item, positive control item and test control item
Item |
Exposure time |
Mean OD5621 |
Percentage viability |
Negative control† |
3 minutes |
2.004 |
100* |
60 minutes |
2.005 |
100* |
|
Positive control† |
3 minutes |
0.049 |
2.42 |
60 minutes |
0.048 |
2.43 |
|
Test item |
3 minutes |
2.074 |
103.32 |
|
60 minutes |
2.026 |
101.11 |
* = The mean viability of the negative control tissues is sent at 100 %
1 = Mean of EpidermTM tissues tested in duplicate
2 = Viability expressed as a percentage of the 3 minute negative control tissues
3 = Viability expressed as a percentage of the 60 minute negative control tissues
† = Control data was shared with Harlan Laboratories Ltd. study number 41500291
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 36152/M was considered to be non-corrosive to the skin.
- Executive summary:
A key study was performed to evaluate the corrosivity potential of FAT 36152/M using the EpiDerm™ Human Skin Model after treatment periods of 3 and 60 minutes.
Corrosion is directly related to cytotoxicity in the EpiDerm™ tissue. Cytotoxicity is determined by the reduction of MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to formazan by viable cells in the test item treated tissues relative to the corresponding negative control. The results are used to make a prediction of the corrosivity potential of the test item.
Duplicate tissues were treated with the test item for exposure periods of 3 and 60 minutes. The direct MTT reduction test was inconclusive due to the dark blue color of the test item. There was a possibility that if the test item could not be totally rinsed off the tissues, any residual test item present on or in the tissue may directly reduce MTT or cause color interference and could have given rise to a false negative result. Therefore, an additional procedure using freeze killed tissues was performed to assess for the possibility of direct MTT reduction. An additional procedure was also performed using viable tissues to assess for the possibility of color interference.
At the end of the exposure period the test item was rinsed from each tissue before the tissues were taken for MTT-loading. After MTT loading each tissue was placed in 2 mL Isopropanol for MTT extraction.
Data are presented in the form of percentage viability (MTT reduction in the test item treated tissues relative to negative control tissues).
The results of the additional procedures showed a negligible degree of interference due to possible direct reduction of MTT or color interference. It was therefore considered unnecessary to use the results of the additional procedures for quantitative correction of results or for reporting purposes.
The relative mean viabilities of the test item treated tissues were as follows:
60 minute exposure: 101.1%
3 minute exposure: 103.3%
The quality criteria required for acceptance of results in the test were satisfied.
In conclusion, FAT 36152/M was considered to be non-corrosive to the skin.
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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