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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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
Endpoint summary
Administrative data
Description of key information
The NOEL and NOAEL of FP-100 in rats under the present study conditions were estimated to be 1,000 mg/kg/day
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 Oct 2005 to 28 Feb 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: - Study generated according to generally valid and/or internationally accepted testing guidelines - Performed according to GLP - Test parameters based on specific testing guideline
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- Annex V
- Deviations:
- no
- Principles of method if other than guideline:
- N/A
- GLP compliance:
- yes
- Limit test:
- yes
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Full details are in the attached report
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- Method of administration:
Oral Gavage - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- HPLC was used to determine and verify the doses of the FP-100
- Duration of treatment / exposure:
- Test duration: 28 days with a 14 day recovery period
- Frequency of treatment:
- Dosing regime: 7 days/week
- Remarks:
- Doses / Concentrations:
See report
Basis:
actual ingested - 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 250 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 250 mg/kg bw/day
Female: 10 animals at 1000 mg/kg bw/day - Control animals:
- yes, concurrent no treatment
- Details on study design:
- See The attached report
- Observations and examinations performed and frequency:
- Observations and examinations are detailed in the attahced report
- Sacrifice and pathology:
- Deatiled in the attached report
- Statistics:
- Data regarding body weights, food intakes, hematological examinations, blood chemistry examinations, urine volume and specific gravity, organ weights, grip strenght and locomotor activity count were analyzed using the Bartlett's test for homogeneity of variance.
Defecation and urination were analyzed using the Kruskal-Wallis's test. - Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- LUC was decreased in the females who had received 1000 mg/kg in the recovery period
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Male Ca was increased
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Female brain increased in weight while heart and spleen decreased
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- See report
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- see report
- Details on results:
- Clinical observations:
Males: Salivation was noted in the control group.
Salivation and a reddish tear was noted in the 50
mg/kg group.
Salivation, scab formation and exudates on the neck
were noted in the 250 mg/kg group.
Females: Loss of hair was noted in the 250 mg/kg group.
Salivation and loss of hair was noted in the 1000
mg/kg group.
Laboratory findings:
Haematological examinations:
Males: No abnormalities were observed.
Females: Large unstained cells were decreased in the 1000
mg/kg group.
Blood chemical examination:
At termination of dosing period:
Males: Calcium was increased in the 50 and 1000 mg/kg
groups.
Females: No abnormailites were observed.
At termination of recovery period:
Males: Albumin:T-protein-Albumin ratio was increased in the
1000 mg/kg group.
Females: No abnormailites were observed.
Effects in organs:
Organ weights:
At termination of dosing period:
Males: No abnormalities were observed.
Females: Relative brain weight was increased in the 50
mg/kg group.
At termination of recovery period:
Males: No abnormalities were observed.
Females: Absolute heart and spleen weights were decreased
in the 1000 mg/kg group.
Necropsy:
At termination of dosing period:
Males: Whitish region in the heart was observed in the
vehicle group.
Females: Erosion on the skin was observed in the 250 mg/kg
group.
At termination of recovery period:
No abnormalities were observed in either males or females.
Histopathological examiniation:
At termination of dosing periods:
Males: Microgranuloma in the liver, focal myocarditis in
the heart, increased hyaline droplets, solitary cyst
in cortex and medulla in the kidney and aberran
craniopharyngael tissue in the pituitary gland were
noted in the vehicle control group.
Ulcer on skin was noted in the 250 mg/kg group.
Mineralisation in the glangular stomach was noted in
the 1000 mg/kg group.
Females: Mineralisation in corticomedullary junction of the
kidney and cyst formation in pars distalis gland
were noted in the vehicle control group.
Mineralisation in corticomedullary junction of the
kidney was noted in the 1000 mg/kg group.
At termination of recovery period:
No abnormalities were noted in either males or females. - Dose descriptor:
- NOAEL
- Effect level:
- ca. 1 000 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Critical effects observed:
- not specified
- Conclusions:
- Classified as: Not classified
A 28 day repeated oral dose toxicity study of FP-100 followed by a 14 day recovery study was performed in groups of five males and five females Crj:CD(SD) rats at 5weeks of age. the high dose was set a 1,000mg/kg/day and altogether 3 doses including 250 and 50 mg/kg/day were employed. Recovery gropus were also set for 1,000 mg/kg and vehicle control; groups.
No death occurred and no abnomalities were ntoed in the examinations.
No abnormalities were noted in the recovery test.
Based on these results. the NOEL and NOAEL of FP-100 in rats under the present study conditions were estimated to be 1,000 mg/kg/day - Executive summary:
FP-100 was orally administered by gavage to Crj:CD(SD) rats at doses of 50, 250 and 1,000mg/kg/day to perform a 28 day toxicity study followed by a 14 day recovery study.
The animals showed neither deaths nor any adverse effects of the treatment with the test substance in the detailed clinical observations, sensorimotor function and body weights during the dosing period, and hematology, urinalyses, organ weights and necropsy at the end of the dosing period.
Concerning the general conditions, salivation in males and females in all groups was transiently observed immediately after dosing, but it was considered to be of little toxicological significance
Concerning the food intakes, increased food intakes were noticed in males of the 1,000 mg/kg group on day 28, but it was considered to be accidental change since no abnormalities were noted in the general conditions and body weights.
Concerning the blood chemistry, Ca was increased in males of the 50 and 1,000 mg/kg group but it was not considered to be treatment related since showed no dose dependency
Concerning the histopathological examinations, mineralisation in the glandular stomach in males and mineralisation in the corticomedullary junction in the kidney of the females were noted in the 1,000 mg/kg group, but these were considered to be accidental changes since commonly observed in rat of this age and strain.
Other changes observed at the compeltion of the dosing period above mentioned ones were sporadic and showed no dose dependency, and these were considered to be accidental changes.
In the recovery test. inceased food intakes were continuously noted in males of the 1,000 mg/kg group on day 4, but it was considered to be accidental change since no abnormalities were noted in the general conditions and body weights.
Although other changes were observed only in the recovery test, these were considered to be accidental or of little toxicological significance.
The above mentioned results showed that FP-100 had no adverse affects. The NOEL and NOAEL of it in rats under the present study conditions were estimated to be 1,000 mg/kg/day
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
A 28 day repeated oral dose toxicity study of FP-100 followed by a 14 day recovery study was performed in groups of five males and five females Crj:CD(SD) rats at 5weeks of age. the high dose was set a 1,000mg/kg/day and altogether 3 doses including 250 and 50 mg/kg/day were employed. Recovery gropus were also set for 1,000 mg/kg and vehicle control; groups.
No death occurred and no abnomalities were ntoed in the examinations.
No abnormalities were noted in the recovery test.
Based on these results. the NOEL and NOAEL of FP-100 in rats under the present study conditions were estimated to be 1,000 mg/kg/day
Justification for selection of repeated dose toxicity via oral
route - systemic effects endpoint:
Key Study
Justification for classification or non-classification
NOEL and NOAEL of 1,000mg/kg/day
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.