Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 239-898-6 | CAS number: 15793-73-4
- 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
- Study period:
- From 20 Aug 1991 to 20 Sep 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 406), GLP compliant
Data source
Reference
- Reference Type:
- study report
- 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:
- yes
- Remarks:
- reduced number of animals (sufficient, if unambiguous result)
- 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:
- The test was performed before the adoption of OECD 429 LLNA in 2002.
Test material
- Reference substance name:
- 4,4'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[2,4-dihydro-5-methyl-2-(p-tolyl)-3H-pyrazol-3-one]
- EC Number:
- 239-898-6
- EC Name:
- 4,4'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[2,4-dihydro-5-methyl-2-(p-tolyl)-3H-pyrazol-3-one]
- Cas Number:
- 15793-73-4
- Molecular formula:
- C34H28Cl2N8O2
- IUPAC Name:
- 4,4'-[(3,3'-dichlorobiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis[5-methyl-2-(4-methylphenyl)-2,4-dihydro-3H-pyrazol-3-one]
- Test material form:
- solid: nanoform
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF Zucht
- Weight at study initiation: 295-352 g
- Housing: groups of 5 animals
- Diet (ad libitum): Altromin §112 Haltungsdiät für Meerschweinchen, Altromin GmbH, Lage/Lippe, Germany
- Water (ad libitum): tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Remarks:
- for epicutaneous treatment
- Concentration / amount:
- 1% (intradermal induction), 25% (epicutaneous induction), 1% (challenge)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Remarks:
- for epicutaneous treatment
- Concentration / amount:
- 1% (intradermal induction), 25% (epicutaneous induction), 1% (challenge)
- No. of animals per dose:
- 6 for determination of the primary non-irritating concentration
3 for determination of the tolerance of the intradermal injections
10 for treated group
5 for control group
5 for accompanying group - Details on study design:
- RANGE FINDING TESTS:
The primary non-irritating concentration was determined in a pre-test in concentrations of 1, 5 and 25% test item in petrolatum, applied to the shaved left flanks of 2 animals each (0,5 g, 2 x 2 cm, occlusive, 24 h). 24 h after removal of the patch the treated areas were examined for erythema and edema.
The tolerance of the intradermal injections was tested with two injections of 0,1 ml of 0.2, 1.0 and 5.0% test item in paraffin. The injection sites (sites 1, 2 and 3) were all within a dorsal area measuring 2 x 4 cm in the vicinity of the shoulders.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: two intradermal injections per animal, one epicutaneous treatment
- Exposure period: 48 h occlusive for dermal exposure
- Test groups: 10 females
Intradermal Treatment: The injection sites (site 1, 2 and 3) were all within a shaved dorsal area of 2 x 4 cm. The injection sites were left uncovered. Two intradermal injections of 0.1 ml per animal of the following preparations were applied (day 1 of study): site 1: 50% FCA, site 2: 1% test item in paraffin, site 3: test item in 50% FCA
Epicutaneous treatment: An amount of 0.5 g of the test item preparation (25% test substance in petrolatum) was administered to a 2 x 4 cm cellulose patch. This patch covered the area where the intradermal injection had been placed. The administration area was then kept under an occlusive bandage covered with an impermeable film and an elastic bandage for 48 hours.
- Control group and accompanying group: 5 females each
Controls received the same treatment with: intradermal site 1: 50% FCA ( Freund's Complete Adjuvants); site 2: paraffin; site 3: 50% FCA;
epicutaneous: petrolatum
- Site: dorsal, in vicinity of the shoulders
- Frequency of applications: day 1: intradermal treatment, day 8: epicutaneous treament
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: day 22 of study
- Exposure period: 24 h, occlusive
- Test groups: An amount of 0.5 g of the test item preparation was administered to a 2 x 2 cm cellulose patch.
- Site: left flank
- Concentrations: 1% in petrolatum (test and control group)
- Evaluation (hr after challenge): 24 and 48 h after removal of the patch
The accompanying group was challenged in the same way as the test group, but on days 15-18 of the study
OTHER:
Evaluation of effects: The decisive criterion for evaluation of the sensitizing properties of a test substance is the number of sensitized test animals, not the intensity of the dermal reaction. The substance is considered to be sensitizing if 30 % or more of the animals in the treatment group definitely showed a positive skin reaction and at the same time no irritant effects have emerged in the control group.
Scoring system for dermal reactions: according to guideline EU B.6 and OECD 406 - Positive control substance(s):
- not specified
- Remarks:
- According to guideline, a periodic test with a positive control substance is necessary. These data are not stated in study report, but also not mentioned under "deviations from guidelines"
Results and discussion
- Positive control results:
- not stated
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no effects.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: accompanying group
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: accompanying group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- other: accompanying group
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: other: accompanying group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no effects.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this guinea pig maximisation test, the test substance was not sensitising.
- Executive summary:
Skin sensitization of the test item was performed in 15 female guinea pigs (10 test group, 5 control group) according to the method of Magnusson & Kligman according to guidelines EU B.6 and OECD 406. Intradermal induction was performed with 1% test item in paraffin, dermal induction with 25% test item in petrolatum. The challenge treatment was conducted with 1% test item in petrolatum. Under the conditions of this guinea pig maximisation test, the test substance was not sensitising.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
