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EC number: 272-713-7 | CAS number: 68909-79-5 An inorganic pigment that is the reaction product of high temperature calcination of principally chromium (III) oxide forming a crystalline hematite. Its composition may include any one or a combination of the modifiers Al2O3, Fe2O3, or Mn2O3.
- 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

Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2020-02-24 to 2020-03-02
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- This study was conducted as a dose range finding study, with limited study design focussing on assessing local effects of five different inorganic pigment substances. The non-physiological route of administration via intratracheal instillation is not guideline conform and not suitable to assess acute inhalation toxicity. The investigated mechanistic parameters (bronchoalveolar lavage (BAL) fluid analyses have no direct value for fullfilling data requirements under the REACH regulation.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline No. 412 (28-day (subacute) inhalation toxicity study)
- Version / remarks:
- 2018-06-15
- Deviations:
- yes
- Remarks:
- The study was conducted as range-finding study. Therefore, it has a limited study design.
- Principles of method if other than guideline:
- Female Wistar rats were exposed to chromium iron oxide at doses of 0.2, 0.8 or 3.2 mg by intratracheal instillation (total dose was instilled on two consecutive days) to investigate the lung toxicity potential with a bronchoalveolar lavage (BAL) analysis.
- GLP compliance:
- no
- Remarks:
- The investigations in this study were conducted under non-GLP conditions because of the screening, dose-range finding nature of the experiments. However, the experimental procedures followed the GLP rules (e.g. use of SOPs and documentation/archiving).
- Limit test:
- no
Test material
- Reference substance name:
- Chromium iron oxide
- EC Number:
- 235-790-8
- EC Name:
- Chromium iron oxide
- Cas Number:
- 12737-27-8
- Molecular formula:
- Fe(x)Cr(2-x)O3 0,65≤x≤1,75
- IUPAC Name:
- Chromium iron hematite
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Chemical description: Chromium iron oxide
- Substance type: inorganic pigment
- State of aggregation: solid, black powder, odourless, Hematite-corundum structure
- Storage condition of test material: at room temperature
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature, dry, protected from light
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI (Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 8 weeks old
- Weight at study initiation: approx. 182 g
- Housing: housed in Makrolon® (polycarbonate) cages type Ill, four rats per cage in the treated groups and three rats per cage in the vehicle control group; absorbing softwood ('ssn BK 8-15') bedding material.
- Diet: commercial chow in pellet form (ssniff”V1534; supplier: ssniff Spezialdiäten GmbH, Soest, Germany)
- Water: tap water
- Acclimation: approximately one week the animals were allowed to adjust and become acclimatized to the Fraunhofer ITEM environment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- other: intratracheal instillation
- Vehicle:
- other: saline solution
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test item was suspended in vehicle, each aliquot in a volume of 0.3 mL. After gentle shaking all samples were sonicated for 2 minutes to guarantee a homogeneous suspension. After sonication samples were shaken again to perpetuate the homogeneity until administration to the animals.
The total dose was instilled in two aliquots on two consecutive days to achieve a homogeneous distribution of the test material in lungs. - Doses:
- 0.2, 0.8 and 3.2 mg
- No. of animals per sex per dose:
- 4 females intreated group; 6 females in control group
- Control animals:
- yes
- Remarks:
- vehicle control
- Details on study design:
- - Duration of observation period following administration: 3 days
- Frequency of observations and weighing: all animals were clinically observed in their cages at least twice a day. Before sacrifice, they were inspected outside their home cages and carefully examined for clinical symptoms, i.e. abnormalities concerning their general condition. On the treatment days, the animals were clinically observed before and after treatment.
Individual body weight was recorded on day -1 before treatment and on day 3 at sacrifice for all animals.
- Necropsy of survivors performed: yes, all animals were subjected to a complete necropsy.
ORGAN WEIGHT:
the lungs were weighed, and the relative lung weight was calculated.
BRONCHOALVEOLAR FLUID (BALF) ANALYSIS:
analysis was performed in all rats 3 days after the last instillation. The total cell count and differential cell count were determined. The method of Henderson et al. (1987) was used with minor modifications.*
Following preparation, the lungs were lavaged with saline using two lavages of 4 ml (if half lung will be used only: 2 ml). The pooled lavage fluid was collected in calibrated tubes and the harvested volume was recorded. Until processing the lavage fluid was kept on ice. Leukocyte concentration of the lavagate was determined using a counting chamber and two cytoslides were prepared with a cytocentrifuge for differential cell count (macrophages, neutrophils, eosinophils, lymphocytes).
*Reference:
Henderson, R.F., Mauderly, J.L. Pickrell, J.A., Hahn, R.F., Muhle, H., and Rebar, A.H. (1987): Comparative study of bronchoalveolar lavage fluid: Effect of species, age and method of lavage. Exp. Lung Res. 13, 329 342. - Statistics:
- Differences between groups were considered statistically significant at p < 0.05. Body weight and lung wet weight data were calculated using a two-sample t-test assuming equal variances. BAL data were analyzed using analysis of variance. If the group means differ significantly by the analysis of variance the means of the treated groups were compared with the means of the control groups using Dunnett's test.
Results and discussion
Effect levels
- Remarks on result:
- not determinable because of methodological limitations
- Mortality:
- All animals survived the study.
- Clinical signs:
- All animals tolerated well the exposure to the test item at all concentrations. No clinical observations outside the normal range were recorded.
- Body weight:
- Body weight development did not show any statistically significant changes as compared to concurrent controls.
- Gross pathology:
- Upon necropsy, test item- or dose-related macroscopical findings were observed. The lung associated lymph nodes (LALN) were moderately enlarged in one animal of the mid-dose group, and slightly to moderately enlarged in two animals of the high-dose group. There were some dark grey areas on whole lung in all animals of the mid- and high-dose group.The animals in the low-dose group, were without any special findings.
- Other findings:
- ORGAN WEIGHT:
The absolute lung weight was statistically significant increased in the low- and high-dose group (1.065 ± 0.028 g and 1.070 ± 0.046; P< 0.05) compared to the controls (0.985 ± 0.051 g), but the relative lung weight was not increased.
BRONCHOALVEOLAR LAVAGE FLUID ANALYSIS:
At day 3 post-treatment, a statistically significant increase in the percentage of lymphocytes were observed in the animals of the high-dose group (1.31 ± 0.55 %; P < 0.05) compared to the controls (0.08 ± 0.20 %). The low- and mid-dose animals showed %lymphocyte values in the range of the control animals (1.13 ± 1.27 and 0.31 ± 0.38 %).
Applicant's summary and conclusion
- Conclusions:
- Female Wistar rats were exposed to chromium iron oxide at doses of 0.2, 0.8 or 3.2 mg by intratracheal instillation (total dose was instilled on two consecutive days) to investigate the lung toxicity potential with a bronchoalveolar lavage (BAL) analysis. A vehicle control group was run concurrently.
This study was conducted as a dose range finding study, with limited study design focussing on assessing local effects of five different inorganic pigment substances.
The highest dose in this instillation experiment was assumed to lead to an overload condition (by way of read-across from other PSLT substances), which leads to an inflammatory response inter alia characterised by an increase of granulocytic cells.
Upon necropsy, test item- or dose-related macroscopical findings were observed, like enlarged lung associated lymph nodes (LALN), and some dark grey areas on whole lung in all animals of the mid- and high-dose group. The absolute but not the relative lung weights were increased in the animals of the low- and high-dose groups compared to controls.
At day 3 post-treatment, a statistically significant increase in the percentage of lymphocytes were observed in the animals of the high-dose group (1.31 %; P < 0.05) compared to the controls (0.08 %). The low- and mid-dose animals showed %lymphocyte values in the range of the control animals (1.13 and 0.31%).
On the basis of the results obtained in the BALF analysis after in vivo instillation of five different inorganic pigments combined with deposition modelling (using the MPPD model), the pigment with the highest reactivity in the respiratory tract was used for a subsequent 14-day inhalation dose-range finding study.
For the other four inorganic pigments, the concentrations for the main 90-day study was based on the results obtained in this instillation experiments combined with deposition modelling (using the MPPD model).
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