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EC number: 225-691-8 | CAS number: 5012-29-3
- 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:
- 07 June 2016 until 18 July 2016
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: UN GHS (2003, last rev. 2015)
- Principles of method if other than guideline:
- Based on a “Statement on the Scientific Validity of In Vitro Tests for Skin Irritation” of the European Commission (November 2008), official acceptance of the test method in the EU was achieved and implemented in EU, 2008a, Council Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to EC Regulation No 1907/2006 of the European Parliament and of the Council on REACH; 1st ATP 2009: EC Regulation No 761/2009 of 23 July 2009 amending, for the purpose of its ATP, EC Regulation No 440/2008 laying down test methods pursuant to EC Regulation No 1907/2006 of the European Parliament and of the Council on REACH, section B46.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection: 13-16 July 2015, Date of Signature: 14 September 2015
Test material
- Reference substance name:
- Pigment Additiv FGR
- IUPAC Name:
- Pigment Additiv FGR
- Reference substance name:
- N-(4-ethoxyphenyl)-3-hydroxy-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide
- EC Number:
- 225-691-8
- EC Name:
- N-(4-ethoxyphenyl)-3-hydroxy-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide
- Cas Number:
- 5012-29-3
- Molecular formula:
- C25H18Cl3N3O3
- IUPAC Name:
- N-(4-ethoxyphenyl)-3-hydroxy-4-[(2,4,5-trichlorophenyl)diazenyl]-2-naphthamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Identification: Pigment Additiv FGR
Batch: FB3212.013
CAS-No.: 5012-29-3
EINECS / EC-No.: 225-691-8
Purity: 94.51% (w/w), dose calculation was not be adjusted to purity
Appearance: Brown powder
Expiry Date: 10.05.2020 (Statement of producer)
Storage Conditions: At room temperature
Stability in Solvent: > 72 h in DMSO at room temperature
> 72 h in 1,2-propylene glycol at room temperature
Certificate of Analysis: AZ 577/Toxd2, dated 11. December 2015
Constituent 1
Constituent 2
In vitro test system
- Test system:
- human skin model
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Each approximately 25 mg (~ 39 mg/cm2 according to guideline) of the test item
- Duration of treatment / exposure:
- 60 minutes.
- Number of replicates:
- 3 tissues
Test animals
- Species:
- other: reconstituted human epidermis model
- Details on test animals or test system and environmental conditions:
- Identification: Pigment-Additiv FGR
Other name: N-(4-Ethoxylphenyl)-3-hydroxy-4-[(2,4,5-trichloro-phenyl) azo]naphthalene-2-carboxamide
Batch: FB3212.013
EINECS No.: 225-691-8
CAS No: 5012-29-3
Purity: 94.51% (w/w), dose calculation was not adjusted to purity
Appearance: Red-brown powder
Expiry Date: 10 May 2020 (statement of producer)
Storage Conditions: At room temperature
Certificate of Analysis AZ 577/Toxd2, dated 11. December 2015
Test system
- Type of coverage:
- other: Topical
- Preparation of test site:
- other: Not applicable
- Vehicle:
- other: No vehicle used
- Controls:
- yes
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
Each approximately 25 mg (~ 39 mg/cm2 according to guideline) of the test item were applied to the tissues, wetted with 25 µL DPBS, and spread to match the surface of the tissue for a complete treatment time of 60 minutes.
NEGATIVE CONTROL
- Amount(s) applied (volume or weight):
30 µL DPBS (MatTek) were used as negative control per tissue
POSITIVE CONTROL
- Amount(s) applied (volume or weight):
30 µL of a 5% SLS solution in deionised water (MatTek) were used a positive control per tissue.- Duration of treatment / exposure:
- 60 minutes
- Observation period:
- Not applicable
- Number of animals:
- Not applicable
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- This value is above the threshold for irritancy of ≤ 50% compared to result of the negg.control.
- Run / experiment:
- After treatment with the test item Pigment-Additiv FGR the mean relative absorbance value decreased to 96.5% compared to the relative absorbance value of the negative control.
- Value:
- >= 0.8 - <= 2.8
- 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:
- Compared to the relative absorbance value of the negative control the corrected mean relative absorbance value achieved 92.4% 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 Pigment-Additiv FGR (60 minutes exposure period):
Dose Group |
Tissue No |
Absorb. 570 nm |
Absorb. 570 nm |
Absorb. 570 nm |
Mean Absorb. |
Mean Absorb. of 3 Wells corrected |
Mean Absorb. of 3 tissues after blank corr.* |
Rel. Absorb. ** |
Relative Standard Deviation |
Mean Rel. Absorb. [% of Negative Control] *** |
Blank | 0.038 | 0.047 | 0.037 | 0.041 | 0.000 | |||||
Negative Control |
1 | 1.972 | 1.935 | 1.892 | 1.933 | 1.892 | 1.810 | 104.5 | 4.9 | 100 |
2 | 1.881 | 1.831 | 1.874 | 1.862 | 1.821 | 100.6 | ||||
3 | 1.788 | 1.738 | 1.746 | 1.757 | 1.717 | 94.8 | ||||
Test Item |
1 | 1.703 | 1.667 | 1.723 | 1.698 | 1.657 | 1.756 | 91.5 | 5.6 | 97.0 |
2 | 1.887 | 1.900 | 1.892 | 1.893 | 1.853 | 102.3 | ||||
3 | 1.803 | 1.768 | 1.892 | 1.798 | 1.758 | 97.1 | ||||
Positive Control |
1 | 0.093 | 0.091 | 0.091 | 0.092 | 0.051 | 0.050 | 2.8 | 7.6 | 2.8 |
2 | 0.093 | 0.094 | 0.094 | 0.093 | 0.053 | 2.9 | ||||
3 | 0.087 | 0.086 | 0.086 | 0.086 | 0.046 | 2.5 |
Dose Group | Tissue No. | Absorb. 570 nm Well 1 |
Absorb. 570 nm Well 2 |
Absorb. 570 nm Well 3 |
Mean Absorb. of 3 Wells |
Mean Wells |
Rel. Absorb. |
OD *** | Corr. Mean Contr.] |
Blank | 0.038 | 0.047 | 0.037 | 0.041 | 0.000 | 1.747 | 96.5 | ||
Negative Control | 1 | 0.038 | 0.038 | 0.039 | 0.038 | -0.002 | 100.0 | ||
Test Item | 1 | 0.049 | 0.050 | 0.051 | 0.0505 | 0.0090 | -432.3 |
* Mean of three replicate wells after blank correction
** relative absorbance per tissue [rounded values]:
*** OD=ODcoloured tissue(MTT assay)– ODcoloured tissue (no MTT assay)
****relative absorbance per treatment group [rounded values]
The optical pre-experiment (colour interference pre-experiment) to investigate the test item’s colour change potential in water led to a change in colour. An additional test with one viable tissue was necessary. The result was used for data correction of the results in the main experiment.
Optical evaluation of the MTT-reducing capacity of the test item after 1 hour incubation with MTT-reagent did not show blue colour. An additional test with freeze-killed tissues was not necessary.
The mean relative absorbance value of the test item after correction, corresponding to the cell viability, was reduced to 96.5% (threshold for irritancy: ≤ 50%) compared to the result of the negative control, consequently the test item was not irritant to skin.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritant
- Conclusions:
- Compared to the relative absorbance value of the negative control the corrected mean relative absorbance value was reduced to 96.5% 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.
- Executive summary:
This in vitro study was performed to assess the irritation potential of Pigment-Additiv FGR by means of the Human Skin Model Test.
The test item passed the MTT interference pre-test. Due to its intensive colour, an additional test with one viable tissue (without MTT addition) was necessary to correct the result in the main experiment.
Approximately 25 mg of the test item and each 30 µL of 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 43.3 hours the tissues were treated with the MTT solution for 3 hours following nearly 69 hours extraction of the colorant from the cells. The amount of extracted colorant was determined photometrically at 570 nm.
The acceptance criteria were met:
· Tissue viability was meeting the acceptance criterion if the mean OD570of the negative control tissues was³0.8 and≤2.8 (values between 1.738 and 1.972).
· The mean relative tissue viability of the positive control was£20% (2.8).
· The relative standard deviations between the % variability values of the test item and the controls in the main test were below 8% (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 corrected mean relative absorbance value was reduced to 96.5% 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.
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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