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EC number: 814-375-0 | CAS number: 67036-09-3
- 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
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Endpoint summary
Administrative data
Description of key information
Two in vitro tests were available for the testing of skin corrosion and skin irritation. Both tests showed no skin irritant or corrosive effects and were therefore considered for no classification for skin corrosion/irritation.
One in vitro test for eye irritation was performed and showed irritant effects. In addition, one test for eye corrosion was performed, which revealed no corrosive effects. Based on these information, the test item TMA-Tempo needs to be classified for Eye Irrit. 2 according to CLP Regulation (EC) No 1272/2008.
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:
- 09.03.2018 to 26.04.2018
- 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The EpiDerm Skin Model is a well-established organotypic, three-dimensional model of the human epidermis and is used for in vitro experiments since many years. It is known for its similarity to human skin.
- Vehicle:
- water
- Details on test system:
- The test was carried out with the reconstituted three-dimensional human skin model EpiDerm (TM) (MatTek). This skin model consists of normal (non-cancerous), human-derived epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis. The NHEK are cultured on chemically modified, collagen-coated cell culture inserts (Millicell (R). The EpiDerm (TM) skin model exhibits in vivo-like morphological and growth characteristics which are uniform and highly reproducible. It consists of organised basal, spinous, granular and cornified layers analogous to those found in vivo.
- Control samples:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mg test item and 25 µL H2O
- Duration of treatment / exposure:
- 3 and 60 min
- Number of replicates:
- 2
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3 min
- Run / experiment:
- mean
- Value:
- 92
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 60 min
- Run / experiment:
- mean
- Value:
- 88.6
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no corrosive effects. The test item is classified as “non-corrosive“.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23.04.2018 to 10.07.2018
- 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:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- other: Dulbecco’s phosphate buffered saline (DPBS)
- Details on test system:
- The test was carried out with the reconstituted three-dimensional human skin model EpiDerm (MatTek). This skin model consists of normal human epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis. The NHEK are cultured on chemically modified, collagen-coated cell culture inserts (Millicell). The EpiDerm epidermis model exhibits in vivo-like morphological and growth characteristics which are uniform and highly reproducible. It consists of organised basal, spinous and granular layers and a multi-layered stratum corneum analogous to patterns found in vivo.
- Control samples:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mg in 25 µL DPBS
- Duration of treatment / exposure:
- 60 min
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- after 60 min treatment and 42 h post-incubation
- Value:
- 75.8
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no irritant effects. The test item is therefore classified as “non-irritant” in accordance with UN GHS “No Category”.
Referenceopen allclose all
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:
- 06.03.2018 to 16.07.2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- The test was carried out with the EpiOcular™ reconstructed human cornea-line epithelium (RhCE) model (MatTek). The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a stratified, highly differentiated squamous epithelium morphologically similar to that found in a human cornea. The EpiOcular™ RhCE tissue construct consists of at least 3 viable layers of cells and a non-keratinized surface, showing a cornea-like structure analogous to that found in vivo.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 50 mg of test item
- Duration of treatment / exposure:
- 6 h
- Duration of post- treatment incubation (in vitro):
- 18 h
- Irritation parameter:
- other: mean relative tissue viability [%]
- Run / experiment:
- 1
- Value:
- 13.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: mean relative tissue viability [%]
- Run / experiment:
- 2
- Value:
- 8.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
-
Name
Negative Control
Positive Control
Test item
Tissue
1
2
1
2
1
2
OD570values
1.665
1.474
0.423
0.393
0.256
0.180
1.645
1.481
0.421
0.392
0.255
0.179
OD570values (blank-corrected)
1.620
1.429
0.378
0.348
0.211
0.135
1.600
1.437
0.377
0.347
0.210
0.134
mean of the duplicates
1.610
1.433
0.377
0.347
0.210
0.135
mean OD
1.521*
0.362
0.173
mean sd OD
0.125
0.021
0.053
tissue viability [%]
105.8
94.2
24.8
22.8
13.8
8.9
relative tissue viability difference[%]***
11.6
2.0
5.0
mean tissue viability [%]
100.0
23.8**
11.3
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In this study under the given conditions the test item showed irritant effects. The mean relative tissue viability (% negative control) was ≤ 60% (11.3%). The test item is classified as “irritant“ in accordance with UN GHS “Category 1” or “Category 2”. Based on this test alone, a decision on classification into one of the 2 categories is not possible.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05.04.2019 to 17.07.2019
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 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)
- Version / remarks:
- 09 October 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- eyes were collected from the slaughterhouse, A. Moksel AG, Buchloe, Germany
- Vehicle:
- physiological saline
- Amount / concentration applied:
- 20% concentration in 0.9% NaCl
- Duration of treatment / exposure:
- 4 hours ± 5 minutes
- Number of animals or in vitro replicates:
- 3 corneas
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean value
- Value:
- 1.9
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- mean value
- Value:
- 2.01
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: very slight opacity of the tissue
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the evaluation criteria the test item TMA-TEMPO is classified into UN GHS No Category (for irreversible effects on the eye/serious damage to eyes).
Referenceopen allclose all
* Corrected mean OD570 of the negative control corresponds to 100% absolute tissue viability
** Mean relative tissue viability of the positive control is < 50%
*** Relative tissue viability difference of replicate tissues is < 20%
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Corrosion - in vitro Reconstructed Human Epidermis:
This study was performed to analyse the skin corrosivity potential of TMA-Tempo on EpiDerm in vitro human epidermis model according to OECD TG 431.
In the present study TMA-TEMPO was applied topically to the EpiDerm tissue for 3 min and 60 min followed by immediate determination of cytotoxic effects via MTT reduction assay. Corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained after both treatment periods had been compared to the corresponding negative control tissues. The mean relative tissue viability (% negative control) was ≥ 50% (92.0%) after 3 min treatment and ≥ 15% (88.6%) after 60 min treatment. The test item showed no corrosive effects.
In this study under the given conditions the test item showed no corrosive effects. The test item is classified as “non-corrosive“ in accordance with UN GHS “No Category".
Skin Irritation - in vitro Reconstructed Human Epidermis:
This study was performed to analyse the skin irritatant potential of TMA-Tempo on EpiDerm-Standard Model (EPI-200) human epidermis model according to OECD TG 439.
The test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 60 min exposure and 42 h post-incubation period and compared to those of the concurrent negative controls. The test item showed no irritant effects. The mean relative tissue viability (% negative control) was > 50% (75.8%) after 60 min treatment and 42 h post-incubation.
In this study under the given conditions the test item showed no irritant effects. The relative mean tissue viability after 60 min of exposure and 42 h post-incubation was > 50%. The test item is therefore classified as “non-irritant” in accordance with UN GHS “No Category”.
Eye Irritation - in vitro EpiOccular
This study was performed to analyse the eye irritating potential of TMA-Tempo on EpiOccular in vitro human corneal epithelium model according to OECD TG 492.
Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 6 h exposure period and 18 h post-treatment period and compared to those of the concurrent negative controls.
The test item showed irritant effects. The mean relative tissue viability (% negative control) was ≤ 60% (11.3%).
In this study under the given conditions the test item showed irritant effects. The test item is classified as “irritant“ in accordance with UN GHS “Category 1” or “Category 2”.
Eye Corrosion - Bovine Corneal Opacity and Permeability Assay
This study was performed to analyse the eye irritancy potential of TMA-Tempo according to OECD TG 437.
The test item was suspended with physiological saline 0.9% NaCl to give a 20% concentration.
An intitial measurement was performed on each of the corneas using the opacitometer. The test item or control were applied to the corneae. After 4 hours incubation
32 ± 1 °C the test item or control were removed, the corneae rinsed, refilled with medium and illuminance measurement was performed. Afterwards permeability of the corneae was determined by measuring spectrophotometrically the transfer of sodium fluorescein. All 3 corneas treated with TMA-Tempo showed slight opacity of the tissue. The mean in vitro irritation score was 1.90 (≤ 3 UN GHS No Category).
According to the evaluation criteria the test item is classified into UN GHS No Category (for irreversible effects on the eye/serious damage to eyes).
Justification for classification or non-classification
Based on the available studies on skin irritation and skin corrosion, the test substance is not classified for skin corrosion/irritation according to CLP Regulation (EC) No. 1272/2008.
Based on the result of eye corrosion testing, the test substance is not classified for eye corrosion according to CLP Regulation (EC) No. 1272/2008. Based on the eye irritating effects in the respective study, the test item is classified for Eye Irrit. 2 according to CLP Regulation (EC) No. 1272/2008.
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.
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