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EC number: 210-283-4 | CAS number: 611-92-7
- 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

Endpoint summary
Administrative data
Description of key information
Two studies are available.
GLP studies.
The test Skin Irritation:
The test was performed according to the OECD Test GuidelineNo.439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method(2015) and Protocol for: In Vitro EpiDermTMSkin Irritation Test
BCOP test:
The test was performed according to the OECD Test Guideline No. 437, Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage, Adopted 26thJuly 2013
Klimish score 1.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26.07.-29.07.2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- yes
- Remarks:
- One tissue was rejected from evaluation due to having much higher OD570 than the other two. As absorbances of these two tissues were close together and not close to cut-off value, this deviation had no impact on the outcome of the study.
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: normal human-derived epidermal keratinocytes
- Cell source:
- skin obtained from plastic surgery from multiple donors
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: model EpiDermTM
- Tissue: The reconstructed human epidermal model EpiDerm™ (EPI-200 ver. 2.0, MatTek, Bratislava, Slovakia); Lot No. 23347 kitL)
- Date of initiation of testing: 26.7.2016
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37±1°C - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 25 g
NEGATIVE CONTROL
PBS (phosphate buffered saline) prepared 25/02/2016, exp. 25/08/2016 and prepared 23/03/2016 exp. 23/09/2016
- Amount(s) applied: 25 µL
POSITIVE CONTROL
5 % SDS (sodium dodecyl sulphate), MatTek, Lot No. 012616TMB, exp. 26/01/2017 - Duration of treatment / exposure:
- 60 min.
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 100
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the above-described experimental design, average viability of tissues treated by the test substance Methylcentralit was 100.0 % of negative control average value. No correction was done.
The test item is considered to have no category:
(ii) if the tissue viability after exposure and post-treatment incubation is more than (>) 50 %.
Even if the value obtained lay close cut-off value for the test, the effect of the test item was negative in EpiDermTM model.
According to the classification criteria given in chapter 4.5. of this report, the test item, Methylcentralit, is considered to have no category in accordance with UN GHS 1. - Executive summary:
The test item, Methylcentralit, was assayed for the in vitro skin irritation
in human epidermal model EpiDermTM.The test was performed according tothe OECD Test Guideline No.439:In VitroSkin Irritation: Reconstructed Human Epidermis Test Method (2015) and Protocol for: In Vitro EpiDermTMSkin Irritation Test For use with MatTek Corporation’s Reconstructed Human Epidermal Model EPI-200-SIT (see par. 1.4).After pre-incubation of tissues, 25 mg of the test substance was placed directly a top to the previously moistened tissue and it was spread on the entire tissue surface. Length of exposition was 60 minutes. Three tissues were used for the test substance and every control.
After removal of the test substance, tissues were post-incubated for approximately 42 hours due to leave of damage reparation. Three hours incubation with MTT and two hours extraction period with shaking followed then. Optical density (OD570) of isopropyl alcohol extracts was measured on a spectrophotometer. Relative cell viability was calculated for each tissue as % of the mean viability of the negative control tissues.
Isopropyl alcohol extract of one of three tissues was much higher than those of the other two. The outlying tissue was rejected from evaluation.
Average viability of the two evaluated treated tissues was 100.0% i.e. viability was >50 %.
The effect of the test item was negative in EpiDermTMmodel (tissues were not damaged).
According to the classification criteria given in chapter 4.5.,the test item, Methylcentralit, is considered to have no categoryin regard to skin irritation.
Reference
Table No. 1: OD570values obtained at the MTT test, their averages, standard deviations (%) and relative viabilities
|
Treatment |
OD570 |
Avg |
SD |
Average viability |
||
|
1 |
2 |
3 |
|
|
(% NC) |
|
NC
|
PBS |
1.926 |
1.806 |
1.646 |
1.793 |
0.115 |
100.0 |
viability (%) |
107.4 |
100.7 |
91.8 |
100.0 |
6.4 |
||
C4
|
322/16 |
1.763 |
1.822 |
2.942 |
1.793 |
0.030 |
100.0 |
viability (%) |
98.3 |
101.6 |
164.1 |
100.0 |
1.6 |
||
PC
|
5% SDS |
0.052 |
0.052 |
0.046 |
0.050 |
0.003 |
2.8 |
viability (%) |
2.9 |
2.9 |
2.6 |
2.8 |
0.16 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03.08.-04.08.2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: Bovine eye
- Details on test animals or tissues and environmental conditions:
- Bovine eyes source: Breeding service CHOVSERVIS a.s., division TORO® Hlavečník, Hradec Králové, Czech Republic
Eyes were collected by slaughterhouse employees The eyes were enucleated as soon as possible after death. No detergent was used. Only healthy animals (12 to 30 months old) considered suitable for entry into the human food chain were used as a source of corneas for use in the BCOP test. The risk of contamination was minimized (e.g., by keeping the container containing the eyes on ice, by adding antibiotics to the HBSS used to store the eyes during transport (e.g., penicillin at 100 IU/mL and streptomycin at 100 μg/mL). - Vehicle:
- Hank's balanced salt solution
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- The test substance was tested as suspension prepared from test substance at 20% concentration in a 0.9% sodium chloride solution. 2g of the test substance was suspended in 10 mL of 0.9% sodium chloride solution.
- Duration of treatment / exposure:
- 4hr
- Duration of post- treatment incubation (in vitro):
- 1,5 hr
- Number of animals or in vitro replicates:
- Exposed group (test substance) - 3 corneas (No. 1, 2, 4)
Positive control group (20% Imidazole) – 3 corneas (No. 12, 14, 16)
Negative control group (0.9% NaCl) – 3 corneas (No. 5, 7, 13) - Details on study design:
- PROCEDURE SCHEME
Selection of corneas, mounting in holders → incubation with EMEM 1hour (32 ± 1°C) → removed EMEM, measurement of baseline opacity → treatment by positive and negative control substances and test substance (incubation 4 hours) → washing of epithelium, measurement of opacity after application → application of sodium fluorescein (5 mg/ml), incubation 1.5 hour (32 ± 1°C) → measurement of absorbance (490 nm).
SELECTION AND PREPARATION OF CORNEAS
The eyes, once they arrive at the laboratory, were carefully examined for defects including scratched, and neovascularisation. Only corneas from eyes free of such defects were used.
The isolated corneas, after achieve normal metabolic activity (inductive incubation at 32 ± 1°C for one hour), were examined again. The corneas that show macroscopic tissue damage (e.g., scratches, pigmentation, neovascularization) or an opacity >7 opacity units were discarded.
From 21 eyes the 6 eyes were eliminated after inductive incubation, because the baseline opacity values were >7. Nine corneas were used for the study (the corneas No. 1, 2, 4, 5, 7, 12, 13, 14 and 16,), 3 eyes was superfluous and remaining 3 were used for the testing of another substance.
QUALITY CHECK OF THE ISOLATED CORNEAS
The risk of contamination was minimized (e.g., by keeping the container containing the eyes on ice, by adding antibiotics to the HBSS used to store the eyes during transport (e.g., penicillin at 100 IU/mL and streptomycin at 100 μg/mL).
NEGATIVE CONTROL USED: YES
Name: 0.9% NaCl
Lot: 162748131
Expiration: 6/2019
Supplier: B.Braun Melsungen, Germany
POSITIVE CONTROL USED: YES
Name: Imidazole
Lot no: WXBC1234V
Expiration: 01/2024
Supplier: Sigma-Aldrich - Irritation parameter:
- in vitro irritation score
- Value:
- 0.32
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The In Vitro Irritancy Score (IVIS) for Methylcentralit was 0.32.
This value of IVIS is ≤ 3 therefore the classification according to UN GHS criteria for eye irritation or serious eye damage is: No category. - Executive summary:
The test substance, Methylcentralit, was tested for the evaluation the potential ocular corrosivity or severe irritancy as measured by its ability to induce opacity and increased permeability in an isolated bovine cornea.
The test was performed according to the OECD Test Guideline No. 437, Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage, Adopted 26thJuly 2013
The test was performed using nine isolated bovine corneas. The testing was performed on three groups of corneas: test substance treatment group, positive control group and negative control group. Three corneas per group were used.
Closed-chamber method was used, because the test substance was applicable by micropipette. The opacity and permeability of each cornea were measured.The In Vitro Irritancy Score (IVIS) was calculated from the values of opacity and permeability.
The In Vitro Irritancy Score (IVIS) forMethylcentralit,was 0.32.
This value of IVIS is≤ 3 therefore the classification according to UN GHS criteria foreye irritation or serious eye damage is: No category.
Reference
Table No. 3: Appearance of corneas
Group |
Cornea No. |
Appearance after exposure |
Negative control |
5 |
Without macroscopic damage |
|
7 |
Without macroscopic damage |
|
13 |
Without macroscopic damage |
Positive control |
12 |
Corneal opacity |
|
14 |
Corneal opacity |
|
16 |
Corneal opacity |
Test substance |
1 |
Without macroscopic damage |
|
2 |
Without macroscopic damage |
|
4 |
Without macroscopic damage |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
Based on the available results of the test substance Methylcentralit is not classified
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