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EC number: 600-813-6 | CAS number: 1072-68-0
- 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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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment
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:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- .
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
- Details on test material:
- - Name of test material (as cited in study report): 1,4-Dimethylpyrazol
- Batch No.: Lab.J.No.: TL JN 1020, Report-No.: LN 93-232
- Degree of purity: 98.8%
- Physical state/appearance: liquid, achromatic-yellowish
- Storage: refrigerator
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- 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 adults
- Weight at study initiation: 331 – 373 g
- Housing: five animals housed together in Markolon type IV cages; Granulate Type 3/4 bedding (staubfrei), SSNIFF
- Diet: ad libitum, Kliba Labordiät 341 (Kaninchen-Meerschweinchen-Haltungs-diät), Firma Klingentalmühle AG, Kaiseraugst, Switzerland
- Water: ad libitum, tap water
- Acclimation period: 7 days before beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air: fully air-conditioned
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- - Intradermal induction: 5%
- Epicutaneous induction: unchanged
- Challenge: 75%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- - Intradermal induction: 5%
- Epicutaneous induction: unchanged
- Challenge: 75%
- No. of animals per dose:
- - Test material: 10
- Control: 5 - Details on study design:
- RANGE FINDING TESTS
A: PERCUTANEOUS INDUCTION
- Amount applied: 2 x 2 cm filter paper strips were applied to the skin of the flanks under an occlusive dressing (the bandage consists of rubberized linen patches 4 x 4 cm from Russka, test patch 5 x 5 cm of Idealbinde from Pfälzische Verbandstoff-Fabrik, and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG). The test filter paper strip was soaked in the test substance or test substance formulation; thus, the animals were exposed to about 0.15 g of the test substance resp. the test substance formulation. For detecting a possible influence an irritating effects of previous intradermal treatment with Freund's adjuvant, animals pretreated with Freund's adjuvant / 0.9% aqueous NaCl-solution (1 : 1) each, in the same manner as intradermal induction about 3 weeks prior to the application of the test substance were used.
- Exposure period: 2 times for 24 hours within a period of 96 hours in order to detect non-specific phenomena that are not caused by a sensitization reaction but could possibly be attributed to a shift in the irritation threshold.
- Site of application: flank, respective on the same area
- Number of test animals: 4 per test concentration
- Concentrations: 100, 75, 50, 25%
- Readings: 24 and 48 h after the beginning of application
B: INTRADERMAL INDUCTION
- Amount applied: A) Freund's adjuvant / 0.9% aqueous NaCl-solution (1 :1); B) Substance 5% in 0.9% aqueous NaCl-solution; C) Substance 5% in A)
- Readings: 24h after intradermal induction
- Number of test animals: 2
- Concentrations: 5%
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (day 0 intradermal injections + day 7 epicutaneous exposure)
- A row of six intradermal injections in groups of two per animal was made. These injections were: 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.
- Epicutaneous exposure: 2 x 4 cm filter paper strips were applied to the skin of the shoulder under an occlusive dressing (the bandage consists of rubberized linen patches 4 x 6 cm from Russka and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG). The filter paper strip was soaked in the test substance; thus, the animals were exposed to about 0.3 g of the test substance.
- Exposure period (epicutaneous): 48 hours
- Control group: The animals were given the same injections (A, B, C) but without test substance, only with the formulating agent. For epicutaneous exposure the control groups were not treated.
- Site: shoulder
- Evaluation: 24 h after intradermal injections, and 48 h after epicutaneous exposure.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure: 2 x 2 cm filter paper strips were applied to the skin of the flank under an occlusive dressing (the bandage consists of rubberized linen patches 4 x 4 cm from Russka, test patch 5 x 5 cm of Idealbinde from Pfälzische Verbandstoff-Fabrik, and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG). The test filter paper strip was soaked in the test substance formulation. Thus the animals were exposed to about 0.15 g of the test substance formulation.
- Day(s) of challenge: 21
- Exposure period: 24 h
- Site: intact flank
- Evaluation (hr after challenge): 24 and 48 after the removal of the patch - Challenge controls:
- Treatment of control group 1 with the test substance formulation (control group 2 remained untreated)
- Positive control substance(s):
- yes
- Remarks:
- Alpha-Hexylcinnamaldehyde, techn. 85%
Results and discussion
- Positive control results:
- In a positive control test with Alpha-Hexylcinnamaldehyde, techn. 85%, performed 7 months before this study, in 14 out of 17 animals tested sensitisation was observed.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- 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: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- 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: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
PRE-TESTS
- In the pretest after two 24-hour percutaneous occlusive applications within 96 hours, the minimum irritant concentration was found to be the unchanged test substance. The maximum non-irritant concentration ge was found to be a 75% test substance preparation in aqua bidest.
- Due to distinct necrotic skin changes 1% test substance preparations have been chosen for the intradermal induction.
INDUCTION
- After intradermal induction well-defined erythema and slight edema were observed at the injection sites of all control group animais and all test group animals at which only Freund's adjuvant / 0.9% aqueous NaCl-solution (1:1) was applied.
- Injection of 1% test substance preparations in 0.9% aqueous NaCl-solution or in Freund's adjuvant / 0.9% aqueous NaCl-solution (1:1) caused well-defined erythema and slight edema in all test group animals.
- The injection sites of the control group animals, which were applied with 0.9%aqueous NaCl-solution, did not show any skin reactions.
- After percutaneous induction with the unchanged test substance incrustation, partially open (caused by the intradermal induction) was observed in addition to well defined erythema and slight edema in all test group animals.
CHALLENGE
The challenge with a 75% test substance preparation in aqua bidest. did not cause any skin reaction in all animals of control group1and the test group.
BODY WEIGHT
The expected body weight gain has generally been observed in the course of the study.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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