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EC number: 603-923-2 | CAS number: 135590-91-9
- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was performed in 1991 before the alternative OECD guidelines (LLNA and in vitro test methods) were set into force.
Test material
- Reference substance name:
- diethyl 1-(2,4-dichlorophenyl)-5-methyl-4,5-dihydro-1H-pyrazole-3,5-dicarboxylate
- EC Number:
- 603-923-2
- Cas Number:
- 135590-91-9
- Molecular formula:
- C16H18Cl2N2O4
- IUPAC Name:
- diethyl 1-(2,4-dichlorophenyl)-5-methyl-4,5-dihydro-1H-pyrazole-3,5-dicarboxylate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF breeding colony
- Age at study initiation: about 4 weeks
- Weight at study initiation: 262.4 g mean
- Housing: in fully air-conditioned rooms in Makrolon cages (Type 4) on soft wood granulate, in groups of 5 animals
- Diet (e.g. ad libitum): Altromin 3112 for guinea pigs and rabbits, ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- Intradermal induction: 5 %
Epicutaneous induction: 25% - Day(s)/duration:
- 48 h (epicutaneous)
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 25%
- Day(s)/duration:
- 24 h
- No. of animals per dose:
- 20 (in test groups), 10 (controls)
- Details on study design:
- RANGE FINDING TESTS:
In a dermal-occlusive test for primary skin irritation, 25, 5 and 1% in paraffin were applied to the left flank of two guinea pigs. The hair on the right and left flanks of the animals was removed mechanically. 0.5 mL of the test substance preparation was applied to a 2 x 2 cm cellulose
patch, which was then fixed to the left flank and covered occlusively for 24 hours with a bandage and film. 24 hours after removal of the patches, the treated skin areas were examined for erythema and oedema.
No irritation occurred after application of any of the tested concentrations.
For this reason the 25% concentration was selected for the main study.
To determine the tolerance of intradermal injections, each of the following preparations was administered twice by intradermal injection to 3 guinea pigs. The injection sites (sites 1, 2 and 3) were all within a dorsal area measuring 2 x 4 cm in the vicinity of the shoulder.
Site 1: 2 x 0.1 ml 5.0% in paraffin
Site 2: 2 x 0.1 ml 1.0% in paraffin
Site 3: 2 x 0.1 ml 0.2% in paraffin
The injections with the 5% substance preparation in paraffin caused very slight to well-defined erythema and slight oedema. The injection sites for the 1% and 0.2% preparations showed very slight to well-defined erythema and (very) slight oedema.
Based on this preliminary test, the 5% preparation in paraffin was selected for the intradermal injections in the main test.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal day 1 and epicutaneously day 8)
- Test groups: Intradermal: 50% Freund's adjuvant alone, test substance in paraffin, test substance in 50% Freund's adjuvant; epicutaneous: test substance in paraffin
- Control group: Intradermal: 50% Freund's adjuvant alone, paraffin only, 50% Freund's adjuvant alone; epicutaneous: paraffin only
- Site: dorsal area 4 x 6 cm in the vicinity of the shoulders.
- Frequency of applications: 7 days
- Duration: day 1 to day 8
- Concentrations: Intradermal 5% test substance, epicutaneous 25 % test substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Test groups: test substance epicutaneously
- Control group: test substance epicutaneously
- Site: shaved left flank, shaved right flank remained untreated
- Concentrations: 25% test substance
- Evaluation (hr after challenge): 48 and 72 - Challenge controls:
- The control group actually is a challenge control.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 5% intradermal, 25% epicutaneous; challenge: 25% epicutaneous
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- very slight erythema
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- induction: 5% intradermal, 25% epicutaneous; challenge: 25% epicutaneous
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- very slight erythema, dry rough skin, fine scales
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
The treated animals showed no clinical signs of intoxication at any time during the study. The intradermal injections with Freund's adjuvant (with and without test substance) caused moderate oedema, well-defined to moderate erythema. The injection site revealed white discoloured areas, and the skin was encrusted and scabbed. After dermal induction treatment the tissue of these injection sites became necrotic or developed open wounds in the control as well as in the treatment group. The body weight gains of the treated animals were not impaired.
Challenge:
48 and 72 hours after removal of the occlusive bandage, 4 out of 20 animals in the treated group (20%) showed dermal reactions in the form of very slight erythema, whereas no signs of dermal irritation were noticed in the control group. Additionally the skin surface was dry, rough and covered with fine scales.
Conclusion:
Based on the results of this study, Hoe 107892 00 ZC97 0001 is non-sensitising, and thus not subject to labelling requirements according to the criteria for classification in Directive 83/467/EEC.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Conclusions:
- CLP: Not classified
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