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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Feb - Mar 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 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 Oct 2017
- 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); ca. 3.5 (20 % aqueous preparation, 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
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test substance preparation was produced on a weight per volume (w/v) basis shortly before application by stirring with a high-speed homogenizer (Ultra-Turrax) and a magnetic stirrer. The homogeneity of the test substance preparation during application was provided by stirring with a magnetic stirrer.
FORM AS APPLIED IN THE TEST (if different from that of starting material) : 20 % (w/v) suspension in deionized water
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Schlachthof Alzey, Emil Färber GmbH & Co. KG, Robert-Bosch-Straße 23, 55232 Alzey, Germany
- Characteristics of donor animals (e.g. age, sex, weight): minimum 12 months and maximum 60 months of age
- indication of any existing defects or lesions in ocular tissue samples: corneas free of defects (opacity, scratches, pigmentation etc.) were used
Test system
- Vehicle:
- water
- Remarks:
- deionized
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration (if solution): 20 %
VEHICLE
- Amount(s) applied (volume or weight with unit): 750 µL - Duration of treatment / exposure:
- 4 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
: Corneas free of defects (opacity, scratches, pigmentation etc.) were dissected with a 2 to 3 mm rim of sclera.
NUMBER OF REPLICATES : 3
NEGATIVE CONTROL USED : deionized water
POSITIVE CONTROL USED : Imidazole 20 % (w/v) in deionized water
APPLICATION DOSE AND EXPOSURE TIME : 750 µL for 4 hours
TREATMENT METHOD: open chamber
POST-INCUBATION PERIOD: no
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: one
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Before measurement, each cornea was visually observed and observations were recorded. Final corneal opacity readings were taken for each cornea with an opacitometer.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV/VIS spectrophotometry (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA:
- IVIS ≤ 3: no UN GHS Category
- IVIS > 3; ≤ 55: No prediction can be made
- IVIS > 55: UN GHS Category 1
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1st test run
- Value:
- 39.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 2nd test run
- Value:
- 36.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: 1st test run: IVIS of the test substance, the NC and the PC
Test substance identification |
Cornea-No. |
Opacity per cornea |
Permeability per cornea |
IVIS |
||
Per cornea |
Per group |
|||||
Mean |
SD |
|||||
Test substance |
19 20 21 |
30.2 41.5 46.9 |
0.003 0.003 0.000 |
30.2 41.5 46.9 |
39.5 |
8.5 |
NC |
13 14 15 |
4.3 12.0 24.2 |
0.000 0.001 0.003 |
4.3 12.0 24.3 |
13.5 |
10.1 |
PC |
16 17 18 |
51.5 256.0 61.6 |
3.670 1.982 2.385 |
106.6 285.8 97.4 |
163.2 |
106.2 |
Table 2: 2nd test run: IVIS of the test substance, the NC and the PC
Test substance identification |
Cornea-No. |
Opacity per cornea |
Permeability per cornea |
IVIS |
||
Per cornea |
Per group |
|||||
Mean |
SD |
|||||
Test substance |
7 8 9 |
37.9 37.7 32.5 |
0.004 0.005 0.000 |
38.0 37.7 32.5 |
36.1 |
3.1 |
NC |
1 2 3 |
2.3 6.7 2.9 |
0.002 0.004 0.003 |
2.3 6.7 2.9 |
4.0 |
2.4 |
PC |
4 5 6 |
96.0 96.5 104.3 |
1.360 2.012 1.569 |
116.4 126.7 127.8 |
123.6 |
6.3 |
Table 3: Historic control data of the BCOP Test: Negative control (protocol for solids), Jan 2017 - Jul 2018 (No. of tests performed: 8)
|
Mean |
SD |
Mean + 2 SD |
Mean – 2 SD |
Opacity |
9.6 |
3.7 |
17.0 |
2.1 |
Permeability [OD570] |
0.003 |
0.001 |
0.005 |
0.001 |
Table 4: Historic control data of the BCOP Test: Positive control (20 % Imidazole), Jan 2017 - Jul 2018 (No. of tests performed: 8)
|
Mean |
SD |
Mean + 2 SD |
Mean – 2 SD |
Opacity |
92.9 |
10.4 |
113.7 |
72.1 |
Permeability [OD570] |
2.307 |
0.571 |
3.449 |
1.165 |
In Vitro Irritation Score (IVIS) |
127.5 |
14.4 |
156.4 |
98.7 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not identified as corrosive or severe irritant
- Conclusions:
- Based on the results of the BCOP and by applying the evaluation criteria, it was concluded that the test substance was not identified as corrosive or severe irritant under the test conditions chosen. No further assumptions can be made based on this in vitro study alone.
- Executive summary:
The potential of the test substance to cause ocular irritation or serious damage to the eyes was assessed by a single topical application of 750 μL 20% test-substance preparation to the epithelial surface of isolated bovine corneas.
Three corneas were treated with the test-substance preparation for an exposure period of 4 hours. In addition to the test substance, a negative control (NC; deionized water) and a positive control (PC; 20% imidazole in deionized water) were applied to three corneas each. Corneal opacity was quantitatively measured as the amount of light transmitted through the
cornea. Permeability was quantitatively measured as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements were used to calculate an In Vitro Irritancy Score of the test substance. The following results were obtained in the BCOP Test:
Two test runs were performed. The results obtained in the 1st test run did not indicate a severe eye irritation potential of the
test substance. However, high variability between the individual corneas treated with the negative control (NC) and positive control (PC) were noted. Therefore, the study was repeated to verify the result and to meet the acceptance criteria of the test.
The obtained results of the test substance in the 2nd test run of the BCOP test verified the findings of the 1st experiment. All acceptance criteria of the test were fulfilled.
Based on the results of the BCOP and by applying the evaluation criteria, it was concluded that the test substance was not identified as corrosive or severe irritant under the test conditions chosen. No further assumptions can be made based on this in vitro study alone.
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