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EC number: 871-500-1 | CAS number: 2268679-24-7
- 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:
- From 28 November 2012 to 30 November 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2010
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-3(Diphenylguanidinium) m-[[p-anilinophenyl]azo]benzenesulfonate
- EC Number:
- 941-151-0
- Molecular formula:
- C31H28N6SO3
- IUPAC Name:
- 1-3(Diphenylguanidinium) m-[[p-anilinophenyl]azo]benzenesulfonate
- Test material form:
- solid: particulate/powder
1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: reconstructed epidermis of normal human keratinocytes.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: SkinEthic RHE/S/17
- Tissue batch number(s): 12 022A 1103
- Certificate of analysis of reconstructed human epidermis date: 2012-11-26
- Delivery date: recevied on 2012-11-27
- Expiration date : 2012-12-03
- Date of initiation of testing: 2012-11-28
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 25 x 1 mL with PBS
- Observable damage in the tissue due to washing: 1 of the replicate was compromised.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 hr
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant to skin if the tissue viability after 42 minutes exposure and 42 hrs of post-treatment incubation is < than 50%.
- The test substance is considered to be non-corrosive to skin if the tissue viability after 42 minutes exposure and 42 hrs of post-treatment incubation is > than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 16 mg
NEGATIVE CONTROL : PBS - Pan BIOTECH GmbH - in the same experimental conditions
POSITIVE CONTROL : 5% SDS CAS 151-21-3 (0.5 g SDS in a 10 mL volumetric flask qsp 10 mL distilled water), in the same experimental conditions. - Duration of treatment / exposure:
- 42 min
- Duration of post-treatment incubation (if applicable):
- 42 hrs
- Number of replicates:
- 3 replicates
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- replicate 1 (skin #7)
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: aberrants values
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- replicate 2 (skin #8)
- Value:
- ca. 76
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- replicate 3 (skin #9)
- Value:
- ca. 96.6
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: mean valibility = 100 %
- Acceptance criteria met for positive control: mean viability = 1.2 %
Any other information on results incl. tables
Individual and average values of OD after 42 minutes of exposure:
|
Skin |
OD |
Mean OD/disc (Mean of the 3 OD measurements) |
Mean OD/ product |
Viability % |
Mean Viability % |
SD |
Conclusion |
Negative Control |
1 |
1.041 1.100 1.138 |
1.093 |
1.031* |
106.0 |
100.0 |
5.9 |
|
2 |
0.961 1.039 1.092 |
1.030 |
99.9 |
|||||
3 |
0.908 0.976 1.029 |
0.971 |
94.1 |
|||||
Positive Control |
4 |
0.012 0.014 0.013 |
0.013 |
0.013 |
1.3 |
1.2 |
0.1 |
Irritant |
5 |
0.011 0.013 0.012 |
0.012 |
1.2 |
|||||
6 |
0.013 0.012 0.014 |
0.013 |
1.3 |
|||||
Test Item |
7 |
0.216 0.243 0.250 |
0.236 – Aberrant values |
|
|
|
|
|
8 |
0.763 0.761 0826 |
0.783 |
0.890 |
76.0 |
86.3* |
14.6* |
Non irritant |
|
9 |
0.918 1.030 1.040 |
0.996 |
96.6 |
* The result is based on two tissues replicates (n° 8 and 9) instead of three as initially scheduled in the study plan. The rinsing of the epidermises in view to eliminate the test item after treatment was difficult and required more rinsing with PBS than usually. The first treated epidermis was compromised during this rinsing step and was not taken into account for the classification of the test item.
Negative control and positive control are in the expected range.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item must not be classified, in accordance with the Regulation EC No. 1272/2008.
- Executive summary:
The aim of the study was to evaluate the possible irritating effects of the test item after topical administration on in vitro human reconstructed epidermis (RHE® model). The test item was applied, as supplied, at the dose of 16 mg, to 3 Reconstructed Human epidermis small during 42 minutes, followed by a 42 hours postincubation period at 37°C, 5% C02.
The elimination of the test item on the epidermis after treatment was difficult. Even after a rinse with 35 mL of PBS, there was remaining test item. The first epidermis was compromised during rinsing and was not taken into account for the classification of the test item.
The experimental protocol was established in accordance with OECD guideline No. 439 adopted 22 July 2010 and the Test method B.46 of Council regulation No. 761/2009 dated 23 July 2009 (EU Journal L220)-ATP Council regulation No. 4401/2008 of 30 May 2008 (E. U. Journal L142).
The mean viability ofthe epidermis skins was 86.3%, versus 1.2% in the positive control (5% Sodium Dodecyl Sulfate ).
The results obtained, under these experimental conditions, enable to conclude that in accordance with the Regulation EC No. 1272/2008, the test item must not be classified. No signal word or hazard statement is required.
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