Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 929-144-0 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 June to 21 July 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- 4-chloro-6-ethyl-5-fluoropyrimidine; dichloromethane
- EC Number:
- 929-144-0
- IUPAC Name:
- 4-chloro-6-ethyl-5-fluoropyrimidine; dichloromethane
- Test material form:
- liquid
- Details on test material:
- Clear yellow liquid
Storage conditions: Room temperature in the dark
Constituent 1
- Specific details on test material used for the study:
- Clear yellow liquid
Storage conditions: room temperature in the dark
Batch No: 5494/95/2
Test animals
- Species:
- rat
- Strain:
- other: Hsd:Sprague-Dawley(CD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals in the main study were in the weight range of 81 to 95 g and approximately five to seven weeks of age prior to dosing (Day 1). All the rats in the main study were acclimatised to the experimental environment for a period of five days prior to the start of the study. The rats were allocated without conscious bias to cages within the treatment group. They were housed in groups of up to five rats of the same sex in metal cages. A standard laboratory rodent diet and drinking water were provided ad libitum. Access to food only was prevented overnight prior to and for
approximately 4 hours after dosing. Thermostatic controls were set to maintain a temperature of 22 ± 3° C. Each animal was identified by cage number and ear punching.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Details on oral exposure:
- UK-103,444 was administered, as supplied, at a dose volume of 0.386 ml/kg for the animal dosed at 500 mg/kg and subsequently in the study was formulated at various w/v concentrations in 1% w/v aqueous methylcellulose and administered at a fixed dose volume of 10 ml/kg bodyweight.
- Doses:
- Preliminary Study: Initially, one female rat was treated at 500 mg/kg and for further clarification two further female rats were dosed, one at 50 mg/kg and one at 200 mg/kg bodyweight.
Main Study: A group of ten rats (five males and five females) received a single oral gavage dose of the test substance at a dose level of 50 mg/kg bodyweight. This dose level was chosen after review of findings in the preliminary investigations and in compliance with the test guidelines. - No. of animals per sex per dose:
- Preliminary Study: 500 mg/kg 1 female, 50 mg/kg 1 female, 200 mg/kg 1 female
Main Study: 50 mg/kg 5 males and 5 females - Control animals:
- yes
- Details on study design:
- The appropriate dose volume of the test substance was administered to each rat by oral gavage using a microlitre and plastic cannula (18g) or a syringe and plastic catheter (8 choke). The day of dosing was designated Day 1.
Results and discussion
- Preliminary study:
- Treatment groups each comprising one female rat were treated at 50, 200 and 500 mg/kg bodyweight.
Study findings were as follows:
Clinical signs comprised piloerection, hunched posture, waddling/unsteady gait, walking on toes and
increased sensitivity to touch, seen in all rats. These signs were accompanied in the rats dosed at 200
and 500 mg/kg only by lethargy, abnormal respiration, partially closed eyelids and increased salivation.
In addition, abnormal faeces, increased lacrimation, ungroomed appearance, prostration, blue/cold
extremities and dark colouring to eyes were noted in the animal dosed at 500 mg/kg and pallid
extremities were noted in the animal dosed at 200 mg/kg only. Recovery was complete in the rats dosed
at 50 mg/kg and 200 mg/kg by Day 5. The rat dosed at 500 mg/kg died on Day 1.
Bodyweight gain was considered satisfactory for studies of this nature and duration.
Macroscopic examination of the decedent at 500 mg/kg revealed congestion (characterised by darkened
tissues/organs and/or injected blood vessels) in the subcutaneous tissue, brain, spleen and kidneys.
Congestion, gaseous distension and fluid contents was also observed in the stomach and along the
alimentary tract. No abnormalities were evident in the other animals killed at study termination on
Day 8.
The results from this phase of the study showed the non-lethal dose to be less than 500 mg/kg and that a
systemic response to treatment was evident at 50 mg/kg bodyweight.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- 50 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths in a group of ten rats (five males and five females) following a single oral administration of UK-103,444 at a dose level of 50 mg/kg bodyweight.
- Clinical signs:
- other: Piloerection was observed in all rats within six minutes of dosing. This sign persisted and was accompanied on Days 1 and 2 by hunched posture, notable in all rats. Recovery of surviving rats, as judged by external appearance and behaviour, was complete i
- Gross pathology:
- No macroscopic abnormalities were observed for animals killed at study termination on Day 15.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The discriminating (non-lethal but clear evidence of toxicity) oral dose to rats of UK-103,444 was indicated to be 50 mg/kg bodyweight.
- Executive summary:
On the basis of findings in this study and in accordance with EU hazard classification UK-103,444 will require labelling with the risk phrase of GHS classification of acute tox. category 4, H-302: "Harmful if swallowed."
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.