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EC number: 927-248-0 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13th to 14th August 1998
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
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:
- Study was conducted prior to approved LLNA method
Test material
- Reference substance name:
- 6-(1-bromoethyl)-4-chloro-5-fluoropyrimidine
- Cas Number:
- 188416-28-6
- Molecular formula:
- C6H5BrClFN2
- IUPAC Name:
- 6-(1-bromoethyl)-4-chloro-5-fluoropyrimidine
- Test material form:
- liquid
- Details on test material:
- Amber Oil
Constituent 1
- Specific details on test material used for the study:
- Identification: UK134,821
Appearance: Clear Yellow Liquid
Batch: 5494/96/1
Purity/Composition: 95.5%
Test item storage: At room temperature in the dark
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- The animals were approximately four to seven weeks of any on arrival and were acclimatised to the
experimental environment for five days prior to the start of the main study. The guinea-pigs were
within the weight range 332 -to 385g at the start of the study (Day 1). The guinea-pigs were housed ni groups of five in suspended nu.‘,tal cages with wire mesh floors in
Building R17 Room 14.
A vitamin C enriched guinea-pig diet (Harlan Teklad 9600 FD2 SQC) and drinking water were
provided ad hbittan. Hay was given thrice weekly.
The batch of diet used fbr the study was analysed for nutrients, possible contaminants or microorganisms,
likely to be present in the diet, and which, if in excess, may hase had an undesirable effect
on the test system. The certificates of analyses were lodged in Huntingdon Life Sciences Limited
Archives. There were no known contaminants present in the diet which were expected to be capable of
interfering with the study outcome.
Results of routine physical and chemical examination of drinking water, as conducted by the supplier
are made available to Huntingdon Life Sciences Ltd as quarterly summaries.
Animal room temperature was controlled within the range 16.5 to 30T and relative humidity within the
range 43 to 70%. These environmental parameters were recorded daily. Air exchange was maintained
at approximately 15 air changes per hour and lighting was controlled by means of a time switch to give
12 hours of artificial light (0700 - 1900 hours) in each 24 hours period.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- 0.01% in Alembicol D
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- 1%
- Day(s)/duration:
- 48 hrs
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- other: Topical
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- 0.1 and 0.05%
- Day(s)/duration:
- 24 hrs
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10
- Positive control substance(s):
- yes
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: Indermal Induction
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.01% in Alembicol D
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Necrosis at sites receiving Freund's Adjuvant in test and control animals.Slight to well-defined irritation in test animals at sites receiving 0,01% v/v UK 134,821 and Alembicol D, slight irritation was observed in control animals receiving Alembicol D.
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- other: Induction Topical Induction
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% in Alembicol D
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Slight erythema was observed in test animals following topical application with UK-134,821, 1% v/v Alembicol D, Slight erythema was seen in the control guinea-pigs.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1% and 0.05% in Alembiol D
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
There were no signs of ill health or toxicity throughout the study.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- UK-134,821 produced evidence of skin sensitization (delayed contact hypersensitivity) in all of the ten test animals.
- Executive summary:
This study was performed to assess the skin sensitization potential of UK-134,821 usina the guinea-pig. The method followed was that described in: EEC Methods for the determination of toxicity. Annex to Directive 96/54/EEC (Official Journal No. L248., 30.9.96), Part B, Method B.6. Skin sensitiz,ation, OECD Guideline for Testing of Chemicals No. 406 Skin Sensitization". Adopted: 17 July 1992. MAGNUSSON, B. And KLIGMAN, A.M. (1970) Allergic Contact Dermatitis in the Guineapg: Identification ofeoniaet allergens, Thomas, C.C., Springfield, Illinois, U.S,A. The guinea pigs were dosed by intrademial injection and topical application as these are the routes of exposure required by the test guideline and method.
Based on the results of a preliminary study and in compliance with the guideline, the following dose levels were selected:
Intradermal injection: - 0.01% v/v in Alembicol D
Topical application: 1% v/v in Alernbicol D
Challenge application: 0.1 and 0.05% v/v in Membicol D
Ten test and five control guinea-pigs were used in this study. in this study UK-134,821 produced evidence of skin sensitization (delayed contact hypersensitivit).') in all of the ten test animals.
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