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Diss Factsheets
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EC number: 406-860-7 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 24 July 1990 to 4 September 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): FAT 40'400/A
- Lot/batch No.: BG 3247/TV 6
- Expiration date of the lot/batch: March 1995
- Stability: Stable
- Stability of test article dilution: at least 2 hours
Constituent 1
- Specific details on test material used for the study:
- Test substance: FAT-40400/A
Expiry Date: 3/95
Stability of test article: Stable
Stability of test article in vehicle: stable for at least 2 hours
Storage: in the original container, at room temperature, protected from light
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at acclimation: 6 weeks
- Weight at acclimatization: males: 159 - 177 g, females: 161 - 175 g
- Housing: Individually in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz)
- Diet: Pelleted standard Kliba 343, Batches 70/90, 71/90, 73/90 rat maintenance diet ("Kliba" Klingentalmuehle AG, CH-4303 Kaiseraugst), available ad libitum
- Water: Community water from Itingen, available ad libitum
- Acclimation period: Seven days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10mL/kg bw
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentration, homogeneity and stability of the mixtures were determined during acclimatization. Further samples for analysis were taken during
acclimatization and during week 3 of the test, than kept deep frozen until later determination of analysis. - Duration of treatment / exposure:
- up to 28 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Remarks:
- Control
- Dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Remarks:
- Low dose
- Dose / conc.:
- 200 mg/kg bw/day (actual dose received)
- Remarks:
- Middle dose
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Remarks:
- High dose
- No. of animals per sex per dose:
- The number of rats assigned to toxicity and recovery testing per group were:
- 5 per sex for 50 and 200 mg/kg bw for the toxicity test
- 5 per sex for 0 and 1000 mg/kg bw for the recovery test - Control animals:
- yes, concurrent vehicle
- Details on study design:
- FAT 40400/A was administered to SPF-bred Wistar rats by repeated oral gavage, for a period of 28 days. The study was comprised of four groups, each containing five male and five female rats. The test article/vehicle mixture was administered on a mg/kg bw basis by oral gavage. The dose was based upon data received from acute studies and a 5-days oral (range-finding) gavage study. The animals of the control group were treated similarly with the vehicle alone. For the post-exposure recovery period two satellite groups exposed to 0 and 1000 mg/kg bw for 28 days consisting of five male and five female rats each were monitored for an additional 14 days after the end of the 28-days treatment period.
Examinations
- Observations and examinations performed and frequency:
- - Mortality/viability: Observations for mortality were recorded once daily.
- Clinical signs: Signs of toxicity were assessed once daily. Descriptions of all abnormalities were recorded and the subsequent progress was monitored.
- Food consumption: The food consumption was recorded once during the acclimatization period and weekly thereafter.
- Body weights: The body weight of each animal was recorded on the same days as the food consumption.
- Ophthalmoscopic examination: Ophthalmoscopic examinations were performed on all animals. A description of any abnormality was recorded. Examinations were performed at termination of treatment and a second time on the recovery individuals of groups 1 and 4 at termination of the recovery period. Ten minutes after the application of a mydriatic solution (Dispersa AG, CH-8400 Winterthur) the cornea, lens, anterior chamber, vitreous body and ocular fundus of both eyes were examined under dimmed light using a Heine Miroflex 2 Ophthalmoscope (Eisenhut Vet. AG, CH-4123 Allschwil).
- Haematology/clinical chemistry: Blood samples for hematology and clinical biochemistry were collected from all animals under light ether anesthesia at termination of treatment. The animals were fasted for approximately 18 hours before blood sampling but water was provided. Blood samples were collected from each animal between the hours of 7.00 and 9.30 a.m. to reduce biological variation caused by circadian rhythms. Blood samples were drawn from the retro-orbital plexus. Parameters being measured: erythrocyte count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, reticulocyte count, nucleated erythrocytes normoblasts, heinz bodies, methemoglobin, total leukocyte count, differential leukocyte count, red cell morphology, thromboplastin time, activated partial thromboplastin time, glucose, urea, creatinine, uric acid, bilirubin, cholesterol, triglycerides, phospholipids, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, creatine kinase, alkaline phosphatase, gamma-glutamyl-transferase, calcium, phosphorus, sodium, potassium, chloride, albumin, protein total.
- Urinalysis: Urine was collected during the 18-hour fasting period into a specimen vial using a metabolism cage, during which time the animals were deprived of food but allowed access to water ad libitum. Parameters being measured: volume (18 hour), specific gravity, pH, color, protein, glucose, ketone, bilirubin, blood, urobilinogen, urine sediment. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
- All animals were necropsied and descriptions of all macroscopic abnormalities were recorded. The following organ weights were taken from all animals necropsied at termination of treatment or recovery: adrenals, brain, heart, kidneys, liver, ovaries, pituitary gland, spleen, testes, thyroid gland.
HISTOPATHOLOGY: Yes
- Slides of adrenals, heart, kidneys, liver, spleen and stomach collected at terminal sacrifice from the animals of the control and high-dose groups were examined by a pathologist. The same applied to all gross lesions and to all animals which died spontaneously or had to be killed in extremis. Upon detection of treatment-related morphologic changes in the organs of any high-dose animal, histologic evaluation of the same organs in all dose groups were performed. All abnormalities were described and included in the report. - Statistics:
- The following statistical methods were used to analyze the body weights, food consumption, organ weights and clinical laboratory data: Univariate one-way analysis of variance was used to assess the significance of intergroup differences. If the variables could be assumed to follow a normal distribution, the Dunnett-test (many to one t-test) based on a pooled variance estimate was applied for the comparison between the treated groups and the control groups for each sex. The Steel-test (many-one rank test) was applied when the data could not be assumed to follow a normal distribution.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The lower values seen in males receiving 50 mg/kg FAT 40400/A are considered not to be due to treatment because of the lack of a dose-relationship.
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- The lower values seen in males receiving 50 mg/kg FAT 40'400/A are considered not to be due to treatment because of the lack of a dose-relationship.
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- However, in the urinalysis 5 out of 10 male rats of group 4 (1000 mg/kg) indicated a deep yellow urine discoloration at termination of the treatment. This observation was attributed to the high concentration and yellowish nature of the test article and is not an indication of renal insufficiency. At termination of the treatment-free recovery period this finding was no longer observed.
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The following conclusions are based on examination of absolute organ weights, organ/body weight ratios and organ/brain weight ratios. In males, although there were no statistically significant differences in absolute organ weight between treated and control group means, there was evidence from organ/body and organ/brain weight ratios of a slight increase in liver and heart weights at 1000 mg/kg FAT 40400/A after 4 weeks of treatment. After the 14-day treatment-free recovery period there was no evidence of a treatment-related effect. In females, heart weight in rats receiving FAT 40'400/A was lower than in controls after 4 weeks of treatment but the fact that the differences were greater in the groups receiving 50 or 200 mg/kg than in the high dose group receiving 1000 mg/kg FAT 40400/A suggests that this was not due to treatment. Similarly, although liver weight in high dose females after the 14-day treatment-free recovery period was higher than in control females, the absence of any treatment-related difference at the end of the dosing period suggest that this was not due to the administration of FAT 40400/A.
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Effect level based on clinical symptoms, body weight, food consumption, ophthalmoscopic examination, clinical laboratory investigations, and pathology
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) of FAT 40400/A was determined to be 1000 mg/kg/bw.
- Executive summary:
In a GLP-compliant repeated dose toxicity study, performed according to OECD guideline 407 and EU method B.7. Wistar rats were treated with the test substance (50, 200, and 1000 mg/kg bw) by repeated oral gavage, for a period of 28 days. The study was comprised of four groups, each containing five male and five female rats. For the post-exposure recovery period two satellite groups exposed to 0 and 1000 mg/kg bw for 28 days consisting of five male and five female rats each were monitored for an additional 14 days after the end of the 28-days treatment period. No treatment-related effects were observed on mortality, clinical signs, food consumption, body weight, ophthalmoscopic examinations, clinical laboratory investigations, macroscopic and microscopic findings. The lower values of food consumption seen in males receiving 50 mg/kg FAT 40400/A are considered not to be due to treatment because of the lack of a dose-relationship. However, in the urinalysis 5 out of 10 male rats of group 4 (1000 mg/kg) indicated a deep yellow urine discoloration at termination of the treatment. This observation was attributed to the high concentration and yellowish nature of the test article and is not an indication of renal insufficiency. At termination of the treatment-free recovery period this finding was no longer observed. There was evidence that treatment of male rats with 1000 mg/kg of the test substance for 4 weeks was associated with a slight increase in liver weight which regressed during the treatment-free recovery period. There were no other differences in organ weight which could be attributed to treatment with the test substance. So, based on the study results, the No Observed Adverse Effect Level (NOAEL) of FAT 40400/A was determined to be 1000 mg/kg/bw.
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.
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