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EC number: 846-828-3 | CAS number: 1872341-39-3
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Feb 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:
- 29 July 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt Rheinland-Pfalz
Test material
- Reference substance name:
- (1,2-dimethylpropyl)-5-methyl-pyrazole-4-carboxylic acid
- EC Number:
- 846-828-3
- Cas Number:
- 1872341-39-3
- Molecular formula:
- C10H16N2O2
- IUPAC Name:
- (1,2-dimethylpropyl)-5-methyl-pyrazole-4-carboxylic acid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: L2018-137
- Expiration date of the Batch: 01 Feb 2021
- Purity: 99.6 % (tolerance ± 1.0 %)
- pH value: ca. 4 (undiluted test substance moistened with deionized water, determined in the lab prior to start of the GLP study)
- Physical state / color: Solid / yellowish
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
FORM AS APPLIED IN THE TEST (if different from that of starting material) : solid
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPI-200
- Tissue batch number: 28684
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: one washing step with PBS
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- Incubation time: 3 hours
- Spectrophotometer: Sunrise Absorbance Reader
- Wavelength: 570 nm
- Filter: measurement without reference filter
NUMBER OF REPLICATE TISSUES: two tissues per exposure time and test group (12 tissues per test)
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- killed tissues
- Procedure used to prepare the killed tissues (if applicable): freeze-killed at - 20 °C
- N. of replicates: two killed control tissues per exposure time were treated with the test substance and the negative control, respectively
- Method of calculation used: In case of direct MTT reduction by the test substance, the OD570 values measured in the freeze-killed control tissues (KC) will be used to correct the mean OD570 of the tissues treated with the test substance (mean corrected OD570 KC). Since killed tissues might still have a residual enzyme activity that is able to produce some formazan net, OD570 KC is calculated by subtracting the OD570 KC of the NC from the OD570 KC of the test substance. In case the net OD570 KC is greater than zero, it is subtracted from the respective mean OD570 to result in the mean corrected OD570 KC. The mean corrected OD570 KC represents the formazan production linked to the tissue viability and therefore indicates the cytotoxic potency of the test substance.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: one
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50 %, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15 %.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is greater than or equal to 15 % - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 µL
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
- Concentration (if solution): 8 N - Duration of treatment / exposure:
- 3 min and 1 h
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min exposure period
- Value:
- 95.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 h exposure period
- Value:
- 105.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Table 2: Summary of results after 3 minutes exposure period
Test substance identification |
|
|
Tissue 1 |
Tissue 2 |
Mean |
SD |
CV [%] |
NC |
Viable tissues |
Mean OD570 |
2.016 |
1.996 |
2.006 |
|
|
Viability [% of NC] |
100.5 |
99.5 |
100.0 |
0.7 |
0.7 |
||
KC tissues |
Mean OD570 |
0.114 |
0.092 |
0.103 |
|
|
|
Viability [% of NC] |
5.7 |
4.6 |
5.1 |
0.8 |
15.4 |
||
Test substance |
Viable tissues |
Mean OD570 |
1.995 |
1.849 |
1.922 |
|
|
Viability [% of NC] |
99.5 |
92.2 |
95.8 |
5.1 |
5.4 |
||
KC tissues * |
Mean OD570 KC NC corrected |
0.011 |
0.000 |
0.006 |
|
|
|
Viability [% of NC] |
0.56 |
0.00 |
0.28 |
|
|
||
Final relative mean viability of tissues after KC correction [% of NC] |
95.5 |
||||||
PC |
Viable tissues |
Mean OD570 |
0.254 |
0.216 |
0.235 |
|
|
Viability [% of NC] |
12.7 |
10.8 |
11.7 |
1.3 |
11.4 |
*negative values are set to zero for further calculation
Table 3: Summary of results after 1 hour exposure period
Test substance identification |
|
|
Tissue 1 |
Tissue 2 |
Mean |
SD |
CV [%] |
NC |
Viable tissues |
Mean OD570 |
1.854 |
1.875 |
1.864 |
|
|
Viability [% of NC] |
99.4 |
100.6 |
100.0 |
0.8 |
0.8 |
||
KC tissues |
Mean OD570 |
0.085 |
0.092 |
0.088 |
|
|
|
Viability [% of NC] |
4.5 |
4.9 |
4.7 |
0.3 |
5.6 |
||
Test substance |
Viable tissues |
Mean OD570 |
1.941 |
2.030 |
1.986 |
|
|
Viability [% of NC] |
104.1 |
108.9 |
106.5 |
3.4 |
3.2 |
||
KC tissues |
Mean OD570 KC NC corrected |
0.023 |
0.019 |
0.021 |
|
|
|
Viability [% of NC] |
1.2 |
1.0 |
1.1 |
0.1 |
11.9 |
||
Final relative mean viability of tissues after KC correction [% of NC] |
105.4 |
||||||
PC |
Viable tissues |
Mean OD570 |
0.097 |
0.106 |
0.101 |
|
|
Viability [% of NC] |
5.2 |
5.7 |
5.4 |
0.3 |
6.3 |
Table 4: Historic control data of NC and PC of skin corrosion test
|
|
Exposure Time |
Period |
Mean |
SD |
Mean + 2 SD |
Mean – 2 SD |
NC |
OD570 |
3 minutes |
Jan 2017 – Jan 2019 |
1.728 |
0.216 |
2.160 |
1.295 |
60 minutes |
1.724 |
0.252 |
2.227 |
1.220 |
|||
PC |
3 minutes |
0.222 |
0.071 |
0.363 |
0.081 |
||
60 minutes |
0.097 |
0.031 |
0.159 |
0.036 |
|||
Relative viability [%] |
3 minutes |
13.0 |
4.2 |
21.3 |
4.6 |
||
60 minutes |
5.7 |
1.8 |
9.3 |
2.2 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- no indication of skin corrosion
- Conclusions:
- Based on the results observed and by applying the evaluation criteria, it was concluded that the test substance does not show a skin corrosion potential in the EpiDerm™ in vitro skin corrosion test under the test conditions chosen.
- Executive summary:
The potential of the test substance to cause dermal corrosion was assessed by a single topical application of ca. 25 μL bulk volume (about 7 mg) undiluted test substance to a reconstructed three-dimensional human epidermis model (EpiDerm™).
For the skin corrosion test, two EpiDerm™ tissues were incubated with the test substance for 3 minutes and 1 hour, each.
Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation by using a colorimetric test. The reduction of mitochondrial dehydrogenase activity measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the epidermal tissues treated with the test substance is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability. The following results were obtained in the EpiDerm™ skin corrosion test:
The test substance is able to reduce MTT directly. Therefore, an additional MTT reduction control KC (freeze-killed control tissues) was introduced.
The final relative mean viability of the tissues treated with the test substance determined after an exposure period of 3 minutes was 95.5%, and it was 105.4% after an exposure period of 1 hour.
Based on the results observed and by applying the evaluation criteria, it was concluded that the test substance does not show a skin corrosion potential in the EpiDerm™ in vitro skin corrosion test under the test conditions chosen.
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