Registration Dossier
Registration Dossier
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: 216-122-4 | CAS number: 1502-47-2
- 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:
- 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
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
Test material
- Reference substance name:
- 1,3,4,6,7,9,9b-heptaazaphenalene-2,5,8-triamine
- EC Number:
- 216-122-4
- EC Name:
- 1,3,4,6,7,9,9b-heptaazaphenalene-2,5,8-triamine
- Cas Number:
- 1502-47-2
- Molecular formula:
- C6H6N10
- IUPAC Name:
- 1,3,4,6,7,9,9b-heptaazaphenalene-2,5,8-triamine
- Test material form:
- solid
- Details on test material:
- Test Item Name: Exolit 775
Sample Number: Ba-Ha-19-025-1; Deflam 20 20151106 JOB D02441
CAS No.: 1502-47-2
Chemical name (IUPAC): 1,3,4,6,7,9,9b-Heptaazaphenalene-2,5,8-triamine/Melem
CAS No.: 1502-47-2
Sample No.: Ba-Ha-19-025-1; Deflam 20 20151106 JOB D02441
Manufactured Date: 2019-09-06
Expiry Date: 2034-09-06
Purity as per Certificate of Analysis: 95.75%
Physical Appearance: Solid White
Storage Conditions: Cool and Dry (+2 to +8 °C)
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from multiple donors
- Source strain:
- not specified
- Details on animal used as source of test system:
- Not Applicable
- Justification for test system used:
- The assessment of skin irritation has typically involved the use of laboratory animals (OECD TG 404). In relation to animal welfare concerns, TG 404 recommends the use of a tiered testing strategy for the determination of skin corrosion and irritation which includes the use of validated in vitro or ex vivo test methods avoiding pain and suffering of animals.
One of the validated in vitro test methods adopted by the OECD TG 439 makes use of reconstructed human epidermis (RhE) which closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis. - Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EpiSkin kit
EpiSkin is an in vitro reconstructed human epidermis (RHE) from normal human keratinocytes cultured on a collagen matrix at the air liquid interface. This is a three-dimensional human skin model comprising a reconstructed epidermis with a functional stratum corneum. Differentiated and stratified epidermis model comprises the main basal, supra basal, spinous and granular layers and a functional stratum corneum containing intercellular lamellar lipid layers representing main lipid classes analogous to those found in vivo. - Amount/concentration applied:
- 10 mg
- Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours ± 1
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 15 minutes exposure
- Value:
- > 50
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
TABLE 1. Details of EpiSkin Test Kit
Particulars |
|
Batch No.
|
20-EKIN-038 |
Date of receipt
|
16 September 2020 |
Shipment medium color |
Orange
|
Temperature indicator |
Pale grey
|
Date of Expiry |
21 September 2020 |
Kit Compliance |
Control Certificate No.: E200879 Compliance: Yes
|
Maintenance Medium |
Batch No.: 20-MAIN3-029
Date of Expiry: 23 September 2020
Stored in Refrigerator: BPM 00382
|
Assay Medium |
Batch No.: 20 ESSC-028
Date of Expiry: 23 September 2020
Stored in Refrigerator: BPM 00382
|
TABLE 2. Mean OD Values of Individual Epidermis Units
|
Absorption (OD570) |
|
|
||
R1 |
R2 |
R3 |
Mean |
SD |
|
Negative control |
0.653 |
0.665 |
0.678 |
0.665 |
0.013 |
Positive control |
0.099 |
0.103 |
0.103 |
0.102 |
0.002 |
Test Item |
0.692 |
0.686 |
0.692 |
0.690 |
0.003 |
OD: optical density
SD: Standard deviation
R1, R2 & R3: triplicate exposures
TABLE 3. True OD Values of Individual Epidermis Units
|
Absorption (OD570) |
||||
R1 |
R2 |
R3 |
Mean |
SD |
|
Negative control |
0.604 |
0.616 |
0.629 |
0.616 |
0.013 |
Positive control |
0.050 |
0.054 |
0.054 |
0.053 |
0.002 |
Test Item |
0.643 |
0.637 |
0.643 |
0.641 |
0.003 |
Blank OD Value (mean of 6 replicate values): 0.049
OD: optical density
R1, R2 & R3: triplicate exposures
True OD value = OD Raw – OD Blank
TABLE 4. Individual Tissue Viability of Epidermis Units (Relative)
|
% Individual Viability |
||||
R1 |
R2 |
R3 |
Mean |
SD |
|
Positive control |
8.12 |
8.77 |
8.77 |
8.55 |
0.375 |
Test Item |
104.38 |
103.41 |
104.38 |
104.06 |
0.560 |
Negative control mean: 1.0863
R1, R2 & R3: triplicate exposures
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The registration substance was investigated for its skin irritation property according to the OECD Guideline 439. The registration substance is not irritating.
- Executive summary:
The registration substance was investigated for its skin irritation property according to the OECD Guideline 439(EpiSkin). 10 mg of the registration substance was applied to the skin tissues for 15 min and the cell viability was determined by the MTT assay. No reduction of the cell viability was found. The registration substance is not irritating to 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.
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.
