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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 442-680-5 | CAS number: 443688-20-8
- 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:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 7th to August 2nd, 2002
- 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:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Version / remarks:
- 96/54/EC
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Guideline for Screening, Toxicity Testing of chemicals
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Red LF 6339
- IUPAC Name:
- Red LF 6339
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HanBrl: Wist; SPF
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Biotechnology and animal breeding division, CH-4414 Fullindsorf, Switzerland
- Age at study initiation: 6 weeks
- Weight at study initiation: 129.6 - 158.5 g (mean 145.3 g) for males, 112.8-134.0 g (mean 124.8 g) for females
- Housing: in groups of five in Makrolon type-4 cages with wire mesh tops and standardised softwood bedding
- Diet (e.g. ad libitum): pelleter standard Provini Kliba 3433, ad libitum
- Water (e.g. ad libitum): community tap water, ad libitum
- Acclimation period: 7 days. under test conditions after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature: 22±3 °C
- Humidity: 30-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- bidistilled
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- HPLC - dose formulations taken during week 3 of treatment
- Duration of treatment / exposure:
- Exposure: 28 days
Recovery: 14 days - Frequency of treatment:
- 7 days/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Male: 10 animals at 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 200 mg/kg bw/day
Male: 10 animals at 1000 mg/kg bw/day
Female: 10 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 200 mg/kg bw/day
Female: 10 animals at 1000 mg/kg bw/day - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on results of a non-GLP 5-day dose range finding test
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes / No / Not specified
- Time schedule: one before administration, twice daily on days 1-3, once daily on days 4-28 and once daily during days 29-42 (recovery)
MORTALITY/VIABILITY
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS:
- Time schedule: once weekly
BODY WEIGHTS
- Time schedule for examinations: weekly during pretest, treatment and recovery and before necropsy
FOOD CONSUMPTION AND COMPOUND INTAKE
- Time schedule for examinations: once during pretest and weekly thereafter
FUNCTIONAL OBSERVATIONAL BATTERY
- Grip strength
- Locomotor activity
HAEMATOLOGY: Yes
CLINICAL CHEMISTRY:
- Time schedule for collection of blood: after 4 and 6 weeks
- Animals fasted: Yes. 18 hrs before blooed sampling
- How many animals: from all animals
URINALYSIS:
- Time schedule for collection of urine: after 4 and 6 weeks
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes. 18 hrs before blooed sampling
- How many animals: from all animals - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
sacrifice after 4 and 6 weeks. all macroscopic abnormalities were recorded
absolute and relative organ weights were determined
HISTOPATHOLOGY and HISTOTECHNIQUE: Yes. on organs and tissues from all control and high dose animals - Statistics:
- Dunnett-test, Steel-test, Fischer's exact test, Armitage/Cohran Trend test
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- slightly bent tail and slight red scab
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- The mean body weights and the mean body weight gain compared well with those of the controls.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- The mean daily and relative food consumption of the test item-treated animals compared well to those of the control animals.
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No test item-related changes in parameters of hematology were noted in males or females after four or six weeks when compared with controls.
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No test item-related changes in parameters of clinical biochemistry were noted in males or females after four or six weeks when compared with controls.
- Urinalysis findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no toxicologically relevant changes to urine analysis parameters.
- Behaviour (functional findings):
- effects observed, non-treatment-related
- Description (incidence and severity):
- GRIP STRENGTH: No test item-related changes in fore- or hind-limb grip strength were observed.
LOCOMOTOR ACTIVITY: It could not be excluded that the decrease of locomotor activity, seen in rats treated with 1000 mg/kg/day was test item-related, but in the absence of clear changes in the rats treated with 200 mg/kg/day, the changes seen at 50 mg/kg/day were considered to be incidental. - Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No test item-related changes in the relative or absolute organ weights were noted when compared with the controls.
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The continuous, daily, administration of the test item to Wistar rats at doses of 50, 200 and 1000 mg/kg/day, for 28 days produced no treatment-related histopathological findings at terminal or recovery necropsy. At terminal necropsy all of the animals given 1000 mg/kg/day were noted to have red discolouration. This change was not observed in animals given 50 or 200 mg/kg/day. Red discolouration was confined to the kidneys of all the animals given 1000 mg/kg/day at recovery necropsy.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- behaviour (functional findings)
- Dose descriptor:
- NOEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- behaviour (functional findings)
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL = 200 mg/kg bw/day
NOEL = 50 mg/kg bw/day - Executive summary:
Oral administration of the test item to Wistar rats at doses of 50, 200 and 1000 mg/kg/day, for 28 days resulted in no effects upon:
Mortality, clinical signs (daily, weekly), grip strength, hematology, clinical biochemistry or urinalysis, changes in absolute or relative organ weights, macroscopic or microscopic changes which were related to test item treatment.
It could not be excluded that the decrease of locomotor activity, seen in rats treated with 1000 mg/kg/day was test item-related, but in the absence of clear changes in the rats treated with 200 mg/kg/day, the changes seen at 50 mg/kg/day were considered to be incidental.
Based on the results of this study, 50 mg/kg body weight/day of the substance was established as the no-observed-effect-level (NOEL) and 200 mg/kg body weight/day of the test item as the no-observed-adverse-effect-level (NOAEL).
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.