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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
Endpoint summary
Administrative data
Description of key information
Two recent in vitro experimental studies carried out on the target substance according to the ECHA guidelines for skin irritation/corrosion are available (OECD 431 and OECD 435).
The results of the two studies are in contrast:
1) Corrosion category 1A for the study according to OECD 431;
2) Non-Corrosive for the study according to OECD 435.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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 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
- 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
- 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.
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- Version / remarks:
- 28 July 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- artificial membrane barrier model
- Remarks:
- CORROSITEX® is composed of two components, a synthetic macromolecular bio-barrier and a CDS (Chemical Detection System)
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- CORROSITEX® is composed of two components, a synthetic macromolecular bio-barrier and a CDS (Chemical Detection System)
Supplier in vitro INTERNATIONAL (17751 Sky Park East, Ste. G. Irvin - California 92614 - US), Batch CT061118 - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Valeroyl chloride (classified as GHS 1B substance, Fluka, batch no. BCBK1876V)) and 10% (w/v) citric acid solution (citric acid Sigma, batch no. SZBF3230V diluted in sterile water for injection (Baxter, batch no. 19B0101)).were concurrently tested as positive and negative controls.
- Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- Not applicable
- Number of replicates:
- 4
- Vehicle:
- unchanged (no vehicle)
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- Main experiment (Samples 1-4)
- Value:
- > 65
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The assay was considered valid if the following criteria were met:
– the positive control should give the expected penetration response time (historical mean value + 3 SD), based on ERBC historical control values (13.13 ± 6.48 minutes; n= 26).
– the negative control should not be corrosive within 60 minutes. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The skin corrosion potential of the test item MATRILOX IL001M was assessed with an in vitro membrane barrier assay, using the validated commercial kit CORROSITEX®.
The test item did not show the ability to penetrate the biobarrier during the whole observation interval. Positive and negative control results met the acceptance criteria indicating a good functioning of the test system.
According to OECD guideline for testing of chemicals No. 435, MATRILOX IL001M is classified as non-corrosive to the skin, based on UN GHS.
Referenceopen allclose all
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 |
Preliminary test
Results of Qualification and Categorisation tests are shown in Table 1. The test item is suitable for this test system since orange colour was recorded after adding the test item to the “Qualify” tube.
The time category was 2 since Tube A content changed the colour to pink apricot. In order to confirmthis result, pH misurement was performed. The pH value of test item solution in water (10% v/v) was 3.55 (lower than 7), hence 150 µL of the test item was added to tube A. A pH value of 6.15 was obtained, confirming a time scale category 2.
Means and standard deviations of CORROSITEX® Time were calculated for replicates of the same sample. Cut-off time values for each of the three corrosive subcategories are
established as follows:
Time category | CORROSITEX® Time (minutes) |
|||
Category 2 | 0 to 3 | >3 to 30 | >30 to 60 | >60 |
Corrosivity category |
GHS 1A (Packing Group I) |
GHS 1B (Packing Group II) |
GHS 1C (Packing Group III) |
Non corrosive |
Main Assay
The results of theMain Assay are shown in the table herein below. The test item did not show the ability to penetrate the biobarrier during the whole observation interval.
Negative control was not corrosive within 60 minutes. The UN GHS prediction for the positive control was as indicated in the relevant Guideline (Corrosive Sub-Category 1B)
and the penetration response time (13.4 minutes) was coherent with the historical control range.
Results:
Test or control item | Sample Code | Chemical/Physical changes | Breakthrough observation time (min) |
|
Values observed |
Mean ± SD |
|||
Test Item |
1 |
No change |
> 65.00 |
Not applicable |
Test Item |
2 |
No change |
> 65.00 |
Not applicable |
Test Item |
3 |
No change |
> 65.00 |
Not applicable |
Test Item |
4 |
No change |
> 65.00 |
Not applicable |
UN/GHS Prediction |
Non Corrosive |
|||
Valeroyl Chloride |
+ |
Colour change |
13.4 |
Not applicable |
10% Citric Acid |
- |
No change |
>60.00 |
Not applicable |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)
- Justification for type of information:
- According to the avilable studies according to OECD 431 and OECD 435 and the ones available on the substance constituents, this substance is classified as corrosive to the skin
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Component |
Typical Value (%) |
Range (%) | Skin corrosion/irritation classification in the relative REACH registration dossier | |
1 | Nonan-4-olide | 6 | 0 - 10 | |
EC: 203-219-1 | Not classified | |||
CAS: 104-61-0 | ||||
2 | 2-pentylcyclopentan-1-one | 1 | 0 - 5 | |
EC: 225-392-2 | Not classified | |||
CAS: 4819-67-4 | ||||
3 | 6-butyltetrahydro-2H-pyran-2-one | 0,7 | 0 - 2 | |
EC: 221-974-5 | Not classified | |||
CAS: 3301-94-8 | ||||
4 | Valeric acid | 7 | 3 20 | |
EC: 203-677-2 | Skin corrosion 1B | |||
CAS: 109-52-4 | ||||
5 | Heptanoic acid | 10 | 3 20 | |
EC: 203-838-7 | Skin corrosion 1B | |||
CAS: 111-14-8 | ||||
6 | Hexanoic acid | 18 | 5 20 | |
EC: 205-550-7 | Skin corrosion 1C | |||
CAS: 142-62-1 | ||||
7 | Octanoic acid | 34 | 15 - 80 | |
EC: 204-677-5 | Skin corrosion 1C | |||
CAS: 124-07-2 | ||||
8 | Nonanoic acid | 24 | 15 - 80 | |
EC: 203-931-2 | Skin Irritant 2 | |||
CAS: 112-05-0 |
Justification for classification or non-classification
In consideration of the different results of the two carried out studies on skin corrosion, the classification of the substance was calculated according to the chemical composition, using the in vivo data available in the art for the constituents (carboxylic acids from C5 to C9, lactones).
According to the data reported in the table herein above, the classification of the substance is: Skin corrosion, category 1B.
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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