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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 220-036-2 | CAS number: 2611-82-7
- 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 May 10 to 13, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- Version / remarks:
- 2015
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 2009
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Acid Red 018
- IUPAC Name:
- Acid Red 018
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on test system:
- PREPARATION
- Procedure used: on day of receipt, tissues were conditioned by incubation to release transport stress related compounds and debris. Duration of pre-incubation before treatment was 60 min.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 25 min at room T, 35 min at 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: after 60 ± 1 min from start of exposure, tissues were rinsed with PBS and transferred to a fresh medium; after 24 ± 20 min of post-incubation period, the medium was replaced by a fresh-one
- Observable damage in the tissue due to washing: no
- Modifications to validated SOP: no
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Spectrophotometer: Libra S22
- Wavelength: 570 nm
- Filter: no external filter
- Filter bandwidth: 2-3 nm
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION: single experiment, composed of 3 replicate tissues
PREDICTION MODEL / DECISION CRITERIA
- In case the test chemical is found to be non-corrosive (e.g. based on guideline 430, 431 or 435) and tissue viability after exposure and post-treatment incubation is less than (<=) 50 %, the test chemical is considered to be irritant to skin in accordance with UN GHS category 2.
- The test test chemical may be considered as non-irritant to skin in accordance with UN GHS no category, if the tissue viability after exposure and post-treatment incubation is more than (>) 50 %. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 25 mg atop previously moistened tissue with 25 µl PBS
POSITIVE CONTROL
- Concentration: 5 % SDS in aqueous solution - Duration of treatment / exposure:
- 60 minutes: 25 minutes at room temperature and 35 minutes at culture conditions
- Duration of post-treatment incubation (if applicable):
- 24 h and 20 minutes, then medium was replaced by a fresh one and tissues were incubated for 19 h and 7 minutes.
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 90.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: no
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes (OD570 is 1.682)
- Acceptance criteria met for positive control: yes (% of negative control tissues in 2.9 %)
- Acceptance criteria met for variability between replicate measurements: yes (SD of 3 identically treated replicates is < 18 % in all cases)
Any other information on results incl. tables
Average viability of treated tissues was 91.4 % of negative control viability. Negligible OD570 was observed in colorant control tissues extract though correction could be done.
True tissue viability = 91.4 % - 1.1 % = 90.3 %.
OD570 values obtained at MTT test, averages, standard deviations (%) and relative viabilities
treatment | OD570 | avg | SD | average viability (% NC) | |||
1 | 2 | 3 | |||||
NC | PBS | 1.752 | 1.728 | 1.567 | 1.682 | 0.082 | 100 |
% viab. NC | 104.1 | 102.7 | 93.1 | 100 | 4.882 | ||
C1 | PBS | 1.529 | 1.601 | 1.483 | 1.538 | 0.049 | 91.4 |
% | 90.9 | 95.2 | 88.2 | 91.4 | 2.887 | ||
C1 CC |
medium, no MTT | 0.019 | 0.018 | - | 0.018 | 0.001 | 1.1 |
% | 1.129 | 1.011 | - | 1.1 | 0.059 | ||
PC | 5 % SDS | 0.065 | 0.069 | 0.066 | 0.067 | 0.002 | 4.0 |
% | 3.9 | 4.1 | 3.9 | 4.0 | 0.101 |
C1 test substance
CC colorant control
NC negative control
PC positive control
SD standard deviation
Applicant's summary and conclusion
- Interpretation of results:
- other: non classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Average tissue viability upon treatment with test substance is 90.3 %.
Effect of test substance in EpiDermTM model was negative. - Executive summary:
Method
In vitro skin irritation study according to OECD guideline 439. One single experiment was run, using 3 replicates for test substance, positive and negative control. After pre-incubation of tissues, 25 mg test substance were spread on the tissue surface. Exposure duration was 60 minutes. After substance removal, tissues were post-incubated for ca. 42 hours. Afterwards, 3 hours incubation with MTT and 3 hours extraction followed. Optical density (OD570) of isopropyl alcohol was measured on a spectrophotometer.
Controls for colour interference and direct MTT reduction were also carried out.
Results
Slight colour interfernce and no direct MTT reduction were found.
Average cell viability was 90.3 %, i.e. above 50 %. Therefore, effect of the substance in EpiDermTM model was negative.
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.