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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 271-676-4 | CAS number: 68603-84-9
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 18 July 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Carboxylic acids, C5-9
- EC Number:
- 271-676-4
- EC Name:
- Carboxylic acids, C5-9
- Cas Number:
- 68603-84-9
- Molecular formula:
- UVCB
- IUPAC Name:
- Carboxylic acids, C5-9
- Test material form:
- liquid
- Details on test material:
- Standard production of Matrica
Constituent 1
In vitro test system
- Test system:
- human skin model
- Cell source:
- other: commercial reconstructed human epidermis (RhE) model, EPISKIN™. from human derived epidermis keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- MTT method: The test system EPISKIN™is a reconstructed human epidermis (RhE) model, which in its overall design (the use of human derived epidermis keratinocytes as cell source and use of representative tissue and cytoarchitecture) closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e., the epidermis. The principle of the RhE test method is based on the premise that corrosive chemicals are able to penetrate the stratum corneum by diffusion or erosion and are cytotoxic to the cells in the underlying layers. Cell viability is measured by dehydrogenase conversion of the vital dye MTT [3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue; CAS N. 298-93-1] into a blue formazan salt that is quantitatively measured after extraction from tissues. Corrosive chemicals are identified by their ability to decrease cell viability below defined threshold levels.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 50 μL per well
- Duration of treatment / exposure:
- Exposure times of 3, 60±5 and 240±5 minutes were allowed in a ventilated cabinet at room temperature
- Duration of post-treatment incubation (if applicable):
- Plates were incubated for 3 hours ± 5 minutes at 37°C, 5% CO2 and saturated humidity
- Number of replicates:
- 2
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- after 3 minutes of exposition
- Run / experiment:
- Main test
- Value:
- ca. 15
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
TABLE 1 - Preliminary Test
Direct MTT reduction test (Step1)
Test item (mg) |
MTT ready to use solution(mL) |
Container |
Incubation condition |
Colour observation |
50µL |
2.0 |
well |
3h at 37°C, 100% nominal humidity, 5% CO2 |
Opaque yellow solution with oily yellow drops and crystalline precipitate (no interaction) |
Colouring potential test (Step 2)
Test item (mg) |
Water (µL) |
Container |
Incubation condition |
Colour Observation |
10 µL |
90 |
Eppendorf tube |
15’, ambient condition, in agitation |
Colourless solution (no interaction) |
TABLE 2 - Main Assay - TREATMENT TIME: 3 minutes
|
|
|
Test Item |
|
|
|
|
|
|
|
|
|
|
|
|
|
ODTI |
|
Viability(%) |
|
|
|
TI1A-1 TI1A-2 |
0.146 0.154 |
0.1083 0.1163 |
|
0.1123 |
|
14.5 |
|
|
|
TI1B-1 TI1B-2 |
0.153 0.162 |
0.1153 0.1243 |
|
0.1198 |
|
15.4 |
Mean |
0.116 |
Mean |
0.116 |
|
15 |
SD |
0.007 |
|
|
|
|
CV(%) |
5.6 |
|
|
∆(%) |
6.5 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (corrosive) based on GHS criteria
- Conclusions:
- The test item induced cell death at all treatment times. Each mean cell viability, after the concurrent blank subtraction, was as follows:
Treatment time (minutes) Mean cell viability (%)
3 15
60 1
240 2
Intra-replicate variability was acceptable with a difference of viability between the two replicates lower than 30%, for all treatment times.
Based on the results obtained, the test item MATRILOX IL001M is identified as corrosive to the skin (UN GHS Sub-category 1A). - Executive summary:
The potential of the test item MATRILOX IL001M to be corrosive to the skin was investigated through an in vitro skin corrosion study, using a commercial reconstructed human epidermis (RhE) model named EPISKIN™. The experimental procedures are based on the OECD Guideline for testing of chemicals no. 431. The test item, as well as controls, were tested for their ability to impair cell viability after an exposure period of 3, 60 and 240 minutes. The final endpoint of the assay is the colorimetric measurement of MTT reduction (blue formazan salt) in the test system, being this reaction an index of cell viability. The test item was tested as supplied by the Sponsor. A preliminary test was carried out to evaluate the compatibility of the test item with the test system. In a first step, the test item was assayed for the ability of reducing MTT per se. No interaction was recorded between the test item and MTT in test conditions similar to those of theMain Assay. In a second step, the test item was assayed for the ability of colouring water per se. No colouring potential was noted. Based on these results, no additional control were included in the main experiment. In theMain Assay, for each treatment time, the test item (physical state: liquid) was applied as supplied in two replicates, at the treatment level of 50 μL/epidermis unit, each measuring 0.38cm2 (treatment level: 131.6 μL/cm2). Positive and negative controls (Glacial acetic acid and Physiological saline, respectively) were concurrently tested, in the same number of replicates and test conditions at the treatment level of 50 μL/epidermis unit. Positive control was included only at the longest treatment time of 240 minutes, while a negative control was included for each treatment time.
In the Main Assay, the negative controls gave the expected baseline value (Optical Density values ≥ 0.6 and ≤ 1.5) and variability (difference of viability between the two replicates lower than 30%), at each treatment time, in agreement with the guideline indications. For each treatment time, the concurrent negative control mean value is considered the baseline value of the treatment series and thus represents 100% of cell viability. The positive control caused the expected cell death (1% of cell viability, when compared to the negative control). Based on the stated criteria, the assay was regarded as valid.
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.