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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 700-475-0 | CAS number: 145783-14-8
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- Principles of method if other than guideline:
- Annex V to Council Directive 67/548/EEC on the approximation of lws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, published in the twenty-second Adaption, Commission Directive 96/54/EC, 30 July, 1996, B.7, OJEC L248, 213-217 (Repeated dose (28 days) Toxicity (oral))
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 4,6-dichloro-5-nitro-2-(propylsulfanyl)pyrimidine
- EC Number:
- 700-475-0
- Cas Number:
- 145783-14-8
- Molecular formula:
- C7H7Cl2N3O2S
- IUPAC Name:
- 4,6-dichloro-5-nitro-2-(propylsulfanyl)pyrimidine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Diet (CT1) and mains water supplied by an automatic system were available ab libitum. Each batch of diet is routinely analysed for composition and for the presence of contaminants. Water is also periodically analysed for the presence of contaminants. No contaminants were found to be present in the diet or water at levels considered to be capable of interfering with the purpose or outcome of the study.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Representative samples of dosing preparations were analysed prior to dosing on day 1 of the study and at intervals during the study to verify the achieved concentration of UL111 in corn oil. Samples and standards were analysed by HPLC. The mean concentration for all batches of dosing preparations analysed and subsequently dosed on the study were within 10% of the nominal concentration.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Daily, 7 days each week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 15, 150 and 225 mg/kg bw/day (m/f)
Basis:
nominal in diet
- No. of animals per sex per dose:
- 5 males per dose
5 females per dose - Control animals:
- yes
- Details on study design:
- The dose levels selected were based on the results of a preliminary 20-day dose-range finding study consisting of 5 groups of 2 male and 2 female rats per group (study number CTL/KR1537). The dose levels in the study were 0, 50, 150, 300 and 450 mg/kg day UL111. Groups 2 - 4 were terminated after 14 days of dosing. Group 5 was added to the study on day 11 and terminated after 7 days of dosing ie. day 18. At a dose level of 15 mg/kg/day for 14 days mean bodyweights in males and females were similar to controls. Dose levels 300 and 450 mg/kg/day were considered unsustainable for a 28 day study due to the severity of the clinical changes. Both males and females given 150 mg/kg/day showed similar mean bodyweights to control values, and few clinical signs were observed. A dose level of 225 mg/kg/day was considered to be appropriate for the 28 day study.
Examinations
- Observations and examinations performed and frequency:
- Detailed clinical observations, including the finding of no abnormalities detected, were recorded daily.
Locomotor activity was monitored by an automated activity recording apparatus. All animals were tested on day 28.
At scheduled termination (day 29) all surviving rats were bled by cardiac puncture and samples were analysed by Clinical Pathology, CTL (haematology, blood clinical chemistry and urine clinical chemistry paramters. - Sacrifice and pathology:
- All animals were subjected to a full macroscopic examination post mortem. This involved an external observation and a detailed internal examination of all organs and structures. All tissues processed from the control and top dose and all abnormalities from all groups were examined by light microscopy.
- Other examinations:
- Functional observational battery: detailed clinical assessments and quantitative assessments of landing foot splay, muscle weakness and sensory perception were made on day 28 for all animals.
- Statistics:
- All data were evaluated using analysis of variance and/or analysis of covariance for each specified parameter using the MIXED procedure in SAS (1999)
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Salivation, diarrhoea at 225 and 150 mg/kg/day
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Salivation, diarrhoea at 225 and 150 mg/kg/day
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Lower bodyweight in males, 225 or 150 mg/kg/day
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- Effects were observed, but considered negligible.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- Effects were observed, but considered negligible.
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Brweight lower than control (225 and 150 mg/kg)
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- At a dose level of 225 mg/kg/day all animals of both sexes had salivation and signs of diarrhoea. Salivation (all animals) and signs of diarrhoea (2/5 males) were also seen at 150 mg/kg/day.
Bodyweights in males given 225 or 150 mg/kg/day were statistically significatnly lower than controls.
Brain weight, heart weight statistically significantly lower than controls in males given 225 mg/kg/day (brain) and 150 and 225 mg/kg/day (heart)
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 15 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male
- Basis for effect level:
- other: Toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 225 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- female
- Basis for effect level:
- other: Toxicity
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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.