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EC number: 206-017-1 | CAS number: 288-13-1
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study, fully adequate for assessment.
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The source substance dimethylpyrazole differs from the target substance pyrazole in the addition of 2 methyl groups in the 1 and 4 position. This minor modification is unlikely to impede the reactivity of the source substance as compared to the target substance.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
All information available on source and target materials are provided in the section "test material" in IUCLID.
3. ANALOGUE APPROACH JUSTIFICATION
The read-across from pyrazole to dimethylpyrazole is specified for the endpoint of sensitisation. A weight-of-evidence is conducted to assess the sensitising properties of pyrazole. On the one hand, the structurally closely related dimethylpyrazole does not give rise for concern with regard to sensitization. On the other hand, QSAR modeling was performed to further evaluate and probe the sensitizing properties of the test substance. Also the QSAR modeling prediction is "not sensitizing". Therefore, the sensitization concern is considered adequately addressed, overall there is no concern for sensitization.
4. DATA MATRIX
endpoint-specific read-across combined with QSAR-modeling - please refer to the respective IUCLID datasets for more information.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Data from a maximation test conducted with dimethylpyrazole are available.
Test material
- Reference substance name:
- 1,4-Dimethyl-1H-pyrazole
- EC Number:
- 600-813-6
- Cas Number:
- 1072-68-0
- Molecular formula:
- C5H8N2
- IUPAC Name:
- 1,4-Dimethyl-1H-pyrazole
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): 1,4-Dimethylpyrazol
- Analytical purity: 98,8%
- Lot/batch No.: Lab.J. No.: TL JN 1020, Report-No.: LN 93-232
- Storage condition of test material: refrigerator
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White, Dunkin Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River GmbH - Wiga, Kisslegg, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: 331-373 g
- Housing: Makrolon, type IV
- Diet (e.g. ad libitum): Kliba Labordiät 341 (Kaninchen-Meerschweinchen-Haltungsdiät); ad libitum
- Water (e.g. ad libitum): Water ad libitumn (tap water; about 2 g of ascorbic acid per 10 L water was added to the drinking water twice a week)
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction:
test substance 1% in 0.9% aqueous NaCl-solution or in Freund's adjuvant/0.9% aqueous NaCl-solution (1 : 1) or 0.9% aqueous NaCl-solution
Percutaneous induction:
test substance unchanged
Challenge:
test substance 75% in aqua bidest.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction:
test substance 1% in 0.9% aqueous NaCl-solution or in Freund's adjuvant/0.9% aqueous NaCl-solution (1 : 1) or 0.9% aqueous NaCl-solution
Percutaneous induction:
test substance unchanged
Challenge:
test substance 75% in aqua bidest.
- No. of animals per dose:
- control group: 5 (2 control groups); test group: 10
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
INTRADERMAL INDUCTION:
- No. of exposures: 6 intradermal injections in groups of two per animal
- Site: shoulder
- Duration: 24h
Injections for the test group:
A) front row: 2 injections each of 0.1 ml Freund's adjuvant without test substance emulsified with
0.9% aqueous NaCl-solution in a ratio of 1 :1
B) middle row: 2 injections each of 0.1 ml of the test substance formulation
C) back row: 2 injections each of 0.1 ml Freund's adjuvant / 0.9% aqueous NaCl-solution (1 :1)
with test substance
Injections for control groups 1 and 2:
- The animals were given the same injections (A, B,C) but without test substance, only with the formulating agent.
PERCUTANEOUS INDUCTION:
- Percutaneous induction was carried out one week after intradermal induction.
The animals were exposed to about 0.3 g of the test substance.
- The control groups were not treated, since the test substance was applied unchanged and thus no solvent was used.
Duration of exposure:
- 48 hours
Site of application:
- shoulder, same area as in the case of the previous intradermal application
Readings:
- 48 h after the beginning of application
Assessment of skin findings:
- analogous to the pretest
B. CHALLENGE EXPOSURE
Challenge: 21 days after intradermal induction.
the animals were exposed to about 0.15 g of the test substance formulation.
- treatment of the test group and of control group 1 with the test substance formulation (control group 2 remained untreated).
Duration of exposure:
- 24 hours
Site of application:
- intact flank (occlusive dressing)
Readings:
- 24 and 48 h after the removal of the patch
Assessment of skin findings according to Draize, J.H. (1959).
Results and discussion
- Positive control results:
- A positive control (reliability check) with a known sensitizer is not included in this study. However, a separate study is performed twice a year in the
laboratory.
The positive control with Alpha-Hexylcinnamaldehyde, techn. 85% showed that the test system was able to detect sensitizing compounds under the laboratory
conditions chosen.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- test substance 75% in aqua bidest.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: test substance 75% in aqua bidest.. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- test substance 75% in aqua bidest.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: test substance 75% in aqua bidest.. No with. + reactions: 0.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- It is concluded that 1,4-Dimethylpyrazole does not have a sensitizing effect on the skin of the guinea pig in the Maximization Test under the test conditions chosen.
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