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EC number: 234-679-1 | CAS number: 12023-27-7
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- This oral toxicity study was performed as a limit test. The study was not performed under GLP regulations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- ophthalmological examinations have not been performed; Functional : observation battery (FOB) was not performed;
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- Diiron titanium pentaoxide
- EC Number:
- 234-679-1
- EC Name:
- Diiron titanium pentaoxide
- Cas Number:
- 12023-27-7
- Molecular formula:
- Fe2O5Ti
- IUPAC Name:
- titanium(4+) diiron(3+) pentaoxidandiide
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean males: 183 g (157-212); mean females 162 g (145-184)
- Housing: individual housing of animals in Makrolon cages type III
- Diet: ad libitum, Altromin Standard Diet
- Water: ad libitum), tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-31
- Humidity (%): 40 - 75
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: feed
- Details on oral exposure:
- DIET PREPARATION
The test material was incorporated into feed pellets (Altromin standard diet TPF No. 1324) Content of test material in feed: 5% (w/w) - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- 7 days/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 000 ppm
- Remarks:
- nominal in diet
- Dose / conc.:
- 6 750 ppm
- Remarks:
- based on diiron titanium pentaoxide content
- No. of animals per sex per dose:
- feed control: 40 animals/sex
placebo group (mica): 20 animals/sex
treatment group: 20 animals/sex - Control animals:
- yes
- yes, concurrent no treatment
- Details on study design:
- Groups of 40 rats (20 males and 20 females) received the pigments incorporated into feed pellets at the highest internationally recommended concentration of 50,000 ppm, for the males and females, respectively. One placebo group (20 males and 20 females) received feed pellets containing mica only at 50,000 ppm. In addition, a control group consisting of 80 rats (40 males and 40 females) were fed exclusively with standard commercial feed pellets. Treatment was for 3 months followed by a 2-months recovery period. Hematology, clinical chemistry and urinalysis were performed on half of the animals in each group, 4 and 12 weeks after start of the study and once during the follow-up phase (20 weeks after start of the study). Half of the animals were killed at the end of the 2-months recovery phase. All animals were subjected to gross pathological and histopathological examinations.
- Positive control:
- No
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
WATER CONSUMPTION AND COMPOUND INTAKE: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: weeks 4 and 12 (during treatment) and at the end of the recovery period (week 20)
- Animals fasted: Yes
- How many animals: half of each group
- Parameters checked: hemoglobin, red blood cells, reticulocyte count, white blood cells, differential count in %
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: weeks 4 and 12 (during treatment) and at the end of the recovery period (week 20)
- Animals fasted: Yes
- How many animals: half of each group
- Parameters checked: sodium, potassium, calcium, inorganic phosphorus, glucose, urea, creatinine, bilirubin, protein, cholesterol, triglceride, glutamic pyruvic transaminase, alkaline phosphatase
URINALYSIS: Yes
- Time schedule for collection of urine: weeks 4 and 12 (during treatment) and at the end of the recovery period (week 20)
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
- Parameters checked: pH, protein, glucose, urobilinogen
NEUROBEHAVIOURAL EXAMINATION: No
IMMUNOLOGY: No - Sacrifice and pathology:
- Animals were sacrificed under CO2 anesthesia by incision of the abdominal vessels and exsanguination.
GROSS PATHOLOGY: Yes
Organ weights: Heart, liver, kidneys, spleen, thymus, testes/ovaries, prostate/uterus, adrenals, thyroids, pituitary, brain, eyes
HISTOPATHOLOGY: Yes
Organ weights: Heart, liver, kidneys, spleen, thymus, testes/ovaries, prostate/uterus, adrenals, thyroids, pituitary, brain, eyes - Statistics:
- Dunnett's multiple t-test
Bartlett's test
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, non-treatment-related
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- higher in all pigments and placebo control (mica) group. Can be explained by the 5% foreign material in food.
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Histopathological findings: neoplastic:
- not examined
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 50 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: highest dose tested
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 550 mg/kg bw/day (actual dose received)
- Based on:
- other: content of diiron titanium pentaoxide in test material
- Sex:
- male/female
- Basis for effect level:
- other: highest dose tested
- Remarks on result:
- other: Based on the concentration of diiron titanium pentaoxide (13.5%) and the food consumption the mean daily intake of diiron titanium pentaoxide can be calculated as 534 and 603 mg/kg bw/d for males and females, respectively.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No adverse effects have been observed in rats treated orally with diiron titanium pentaoxide as a component of pearlescent pigments for a time period of 90 days. Based on (i) a concentration of the pearlescent pigment in the food of 50000 ppm (ii) the concentration of diiron tiitanium pentaoxide in the pearlescent pigments and (iii) the food consumption of the rats, a NOAEL of > 550 mg/kg bw/day could be derived for diiron titanium pentaoxide.
- Executive summary:
A subchronic feeding toxicity study equal to OECD TG 408 was performed to investigate the toxicity of different mica-based pearlescent pigments.
Groups of 40 rats (20 males and 20 females) received the pigments incorporated into feed pellets at the highest internationally recommended concentration of 50,000 ppm, for the males and females, respectively. One placebo group (20 males and 20 females) received feed pellets containing mica only at 50,000 ppm. In addition, a control group consisting of 80 rats (40 males and 40 females) were fed exclusively with standard commercial feed pellets. Treatment was for 3 months followed by a 2-months recovery period. Hematology, clinical chemistry and urinalysis were performed on half of the animals in each group, 4 and 12 weeks after start of the study and once during the follow-up phase (20 weeks after start of the study. Half of the animals were killed at the end of the 2-months recovery phase. All animals were subjected to gross pathological and histopathological examinations.
No treatment related mortalities occurred during the study. A slight increase of body weights was observed in females receiving the second pigment compared to the feed control group 1. Food intake was temporarily or permanently increased in males and females of all groups treated with mica or mica-based pigments due to the 5% mineralic content in the diet. No treatment-related effects were observed in haematology or clinical chemistry. Gross pathology revealed a discoloration of the gut content in the animals of the treatment groups which was not observed in the recovery animals and which is not considered to be an adverse effect. All histopathological findings encountered were considered to have arisen spontaneously. In conclusion, no adverse effects were observed in rats treated with mica pigments at 50000 ppm. Thus, based on the results of this study the NOAEL for Fe2TiO5-containing pigments exceeds 50,000 ppm corresponding to 3,952 and 4,466 mg/kg bw/day.
Based on the concentration of Diiron titanium pentaoxide (13.5%) in this pigment and the food consumption during the subchronic toxicity study the mean daily intake of Diiron titanium pentaoxide can be calculated as 534 mg/kg bw/day and 603 mg/kg bw/day for male and female rats, respectively. As these mean daily intakes of diiron titanium pentaoxide by rats over a period of 90 days did not induce any adverse effects, a NOAEL of > 550 mg/kg bw/day can be deduced for Diiron titanium pentaoxide on the basis of this study.
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