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Diss Factsheets
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EC number: 446-560-3 | CAS number: -
- 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
- Study period:
- 2001-07-29 to 2003-07-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 17 July 1992
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- August 1998
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A valid GPMT conducted according to guideline is available, which is reliable without restrictions and adequate for classification and labelling purposes. Potency estimation is not mandatory when existing guideline and GLP conforming data are available, which were conducted before the new annex of the REACH Regulation entered into force. For this reason and for reasons of animal welfare no additional LLNA was conducted.
Test material
- Reference substance name:
- -
- EC Number:
- 446-560-3
- EC Name:
- -
- Cas Number:
- 213265-83-9
- Molecular formula:
- C4HCl2FN2
- IUPAC Name:
- 4,6-dichloro-5-fluoropyrimidine
1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Remarks:
- Crl: HA for the main study and HsdPoc:DH for the rasnge finding study
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratory Animal Breeders in 88353 Kißlegg and Harlan Winkelmann GmbH Laboratory Animal Breeders in 33176 Borchen
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known:
- Age at study initiation: 4 weeks
- Weight at study initiation: 272-377 g
- Housing: the animals were conventionally kept in type IV Makrolon® cages, in groups of five during the adaptation period and in groups of two or three per cage throughout the study period. Low-dust wood shavings supplied by Ssniff Spezialdiaten GmbH, Soest, were used as bedding.
- Diet (e.g. ad libitum): ad libitum, "PROVIMI KLIBA 3420 - Maintenance Diet for Guinea Pigs" supplied by PROVOMI KLIBA AG
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: 5 days
- Indication of any skin lesions: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40- 60
- Air changes (per hr):10
- Photoperiod (hrs dark / hrs light):12/12
Study design: in vivo (non-LLNA)
- No. of animals per dose:
- 20 animals for the main study and treatment groups and 10 animals for the control and the range-finding experiments
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: two, epicutaneous and intradermal
- Exposure period: 48 h for epicutaneous
- Test groups:
Epicutaneous:
Test item group: 0.5 ml 1% HEC 5725-DCF-PYRIMIDINE
intradermal:
Injection site: medial/bilateral 0.5% HEC 5725-DCF-PYRIMIDINE formulated in polyethylene glycol 400
Injection site: caudal/bilateral 0.5% HEC 5725-DCF-PYRIMIDINE formulated at equal parts in polyethylene
glycol 400 and complete Freund's adjuvant
- Control group:
Epicutaneous: 0.5 ml polyethylene glycol 400
Intradermal: Injection site: cranial/bilateral complete Freund's adjuvant (DIFCO LAB.) diluted 1:1 with sterile physicological saline solution
- Site: Dorsal
- Frequency of applications: Epicutaneous once one week prior to intradermal injection.
Intradermal once 21 days before challenge
- Duration: Epicutaneous 48 h
- Concentrations: Intradermal 0.5%; Epicutaneous: 1%
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: 22nd
- Exposure period: 24 h
- Test groups: 1% test item in polyethylene glycol
- Control group: 1% test item in polyethylene glycol
- Site: the 1% test item
formulation was placed on the right flank (caudal) of the animals of the test item group and the control group and held securely in place on the skin with a ORABAND® self-adhesive tape for 24 hours.
- Concentrations: 1%
- Evaluation (hr after challenge): 21 h
Results and discussion
- Positive control results:
- alpha-Hexylzimtaldehyd formulated in sterile physicological saline solution
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 5% induction and 12% challenge
- Remarks on result:
- other: total number of animals was not reported: 100% dermal reaction to positive control
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Clinical observations:
- Appearance and behaviour of the test item group were not different from the control group.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Appearance and behaviour of the test item group were not different from the control group.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- After the intradermal induction the animals in the test item group showed strong effects up to encrustation at the injection sites of the first induction.
The challenge with the 1% test item formulation led to skin effects (grade 1-3) in 20
of 20 animals (100%) in the test item group and no skin effects were seen in the
control group animals. In summary, by comparing the results in the treatment group and in the control group under the conditions of the maximization test and with respect to the evaluation criteria the test item therefore exhibits a skin sensitization potential. - Executive summary:
In a dermal sensitization study according to OECD test guideline 406 (1992) with 4,6-dichlor-5-fluorpyrimidine (100 % a.i).] in polyethylene glycol, young adult Hartley guinea pigs(20/treatment group) were tested using the method of Magnusson and Kligman. After the intradermal induction the animals in the test item group showed strong effects up to encrustation at the injection sites of the first induction. The challenge with the 1% test item formulation led to skin effects (grade 1-3) in 20 of 20 animals (100%) in the test item group and no skin effects were seen in the control group animals.
Based on the results 4,6-dichlor-5-fluorpyrimidine is classified according to Regulation (EU) No. 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) as skin sensitizer Category 1A (May cause an allergic skin reaction).
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.
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