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EC number: 235-002-2 | CAS number: 12053-27-9
- 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
Skin irritation: not irritating (OECD 439; GLP compliant)
Eye irritation: not irritating (OECD 405; GLP compliant)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-12-20 to 2017-12-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2015-07-28
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 2012-07-06
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MatTek Corporation Protocol for: In Vitro EpiDermTM Skin Irritation Test (EPI-200-SIT) For use with MatTek Corporation’s Reconstructed Human Epidermal Model EpiDerm (EPI-200-SIT)
- Version / remarks:
- 2014-11-07
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2015-06-05
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, keep dry in closed container - Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: normal, human epidermal keratinocytes
- Cell source:
- other: humans
- Source strain:
- other: not applicable
- Details on animal used as source of test system:
- not applicable
- Justification for test system used:
- This test uses the EpiDerm™ reconstructed human epidermis model (MatTek) which consists of normal human epidermal keratinocytes (NHEK) and therefore represents in vitro the target organ of the species of interest and resembles the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis.
- Vehicle:
- other: Dulbecco's phosphate buffered saline
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDermTM (EPI-200-SIT; MatTek)
- Tissue lot number: 25867
TEST FOR DIRECT MTT REDUCTION
- to check the non-specific MTT-reducing capability of the test item 25 mg of the test item was mixed per 1 mL MTT medium and incubated for 60 min at 37 ± 1 °C in the incubator (5 % CO2, 95 % RH).
- untreated MTT medium was used as control.
- if the mixture turns blue/purple, the test item is presumed to have reduced MTT and the part of absorption due to the non-specific reduction of MTT (NSMTT) was determined by using freeze-killed tissues.
TEST FOR COLOUR INTERFERENCE
- to check the colouring potential of the test item 25 mg of the test item was mixed per 300 µL aqua dest. and per 300 µL isopropanol each in a transparent recipient and incubated at 37 ± 1°C for 60 min (5 % CO2, 95 % RH).
- if the test item is classified as non-irritant and colouring is detected by unaided eye-assessment, and the chemical in water and/or isopropanol absorbs light in the range of 570 ± 30 nm, the test item was checked for its tissue-colouring potential using additional living tissues treated with the test item.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1 °C for 35 ± 1 minutes followed by incubation at room temperature until the 60 ± 1 minute treatment period was completed
- Temperature of post-treatment incubation: 37 ± 1 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- after the end of the treatment period the tissues were washed 15 times with DPBS.
- subsequently, the inserts were submerged three times in DPBS and shaken to remove rests of the test item.
- then inserts were rinsed once from the inside and the outside with sterile DPBS.
- inserts were placed in prepared 6-well plates containing pre-warmed fresh assay medium per well.
- plates were post-incubated at 37 ± 1 °C, 5.0% CO2, humidified to 95%, for 24 ± 2 h. Following this incubation the tissues were transferred to new wells containing fresh assay medium and incubated for additional 18 ± 2 h.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL (300 µL/well)
- Incubation time: 3 hours ± 5 minutes
- Extraction of formazan: after the MTT incubation period, the tissues were rinsed three times with DPBS and allowed to dry. The tissues were transferred into 12-well plates and immersed in 2 mL isopropanol, sealed to inhibit evaporation. Extraction was carried out protected from light at room temperature at least for 2 hours with shaking on a plate shaker.
Before using the extracts, the plate was shaken for at least 15 minutes on a plate shaker and the inserts were pierced with an injection needle. The extract was pipetted up and down 3 times before 2 x 200 µL aliquots per each tissue were transferred into a 96-well plate. Optical density (OD) was measured with a filter band without reference wavelength in a plate spectrophotometer using isopropanol as a blank.
- Wavelength: 570 nm
- Filter bandwidth: maximum ± 30 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: tissues pass analysis for tissue viability
- Barrier function: tissues pass analysis for tissue functionality
- Morphology: presence of a functional stratum corneum, a viable basal cell layer, and intermediate spinous and granular layers.
- Contamination: absence of bacteria, yeast, and other fungi (long term antibiotic, antimycotic free culture) as well as absence of HIV1-virus, Hepatitis B virus and Hepatitis C virus
Please also refer to the field "Attached background material" below.
PREDICTION MODEL / DECISION CRITERIA
The mean optical density (OD) of the three negative control tissues was calculated after blank correction. This value corresponds to 100 % tissue viability in the current test. For each individual tissue treated with the test item or the positive control, the individual relative tissue viability is calculated according to the following formula:
Relative viability (%) = [mean ODtest item / positive control / ODmean of negative control] * 100
Irritant potential of the test item will be predicted from the relative mean tissue viabilities compared to the negative control tissues. The test item is considered to be irritant to skin in accordance with regulation EC 1272/2008 (UN GHS “Category 2”), if the tissue viability after exposure and post-incubation is less or equal to 50%. The test substance may be considered as non-irritant to skin in accordance with regulation EC 1272/2008 and UN GHS “No Category” if the tissue viability after exposure and post-treatment incubation is more than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg (39 mg/cm²) of the test item
VEHICLE
- Amount(s) applied (volume or weight with unit): 25 µL of the vehicle
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL DPBS
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL of 5 % sodium dodecyl sulfate solution (TC-SDS-5 %) - Duration of treatment / exposure:
- 60 ± 1 minute
- Duration of post-treatment incubation (if applicable):
- approx. 42 hours
- Number of replicates:
- triplicates
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- (mean)
- Value:
- 97
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: mixture of 25 mg test item per 1 mL MTT medium showed no reduction of MTT compared to the solvent. The mixture did not turn blue/purple.
- Colour interference with MTT: mixture of 25 mg of the test item per 300 µl aqua dest. and/or per 300 µL isopropanol showed no colouring detectable by unaided eye-assessment.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: mean absolute OD570 of the three negative control tissues was ≥ 0.8 and ≤ 2.8 (value: 1.865).
- Acceptance criteria met for positive control: mean relative tissue viability (% negative control) of the positive control was ≤ 20% (3.1%)
- Acceptance criteria met for variability between replicate measurements: standard deviation of viability of replicate tissues of all dose groups was ≤ 18% (0.2 % - 5.2 %).
Please also refer to the field "An other information on results incl. tables" below. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not irritating to the skin.
According to the Regulation (EC) No 1272/2008 and subsequent regulations, the test item is not irritating to the skin.
Reference
Table 1: Result of the test Item dichromium nitride
Name |
Negative Control (NK) |
Positive Control (PC) |
Test Material (TM) |
||||||
Tissue |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
Absolute OD570 |
1.956 |
1.874 |
1.856 |
0.096 |
0.102 |
0.099 |
1.780 |
1.748 |
1.942 |
1.969 |
1.899 |
1.889 |
0.097 |
0.103 |
0.102 |
1.815 |
1.837 |
1.987 |
|
OD570(Blank Corrected) |
1.913 |
1.832 |
1.814 |
0.053 |
0.059 |
0.057 |
1.737 |
1.706 |
1.899 |
1.926 |
1.856 |
1.846 |
0.055 |
0.061 |
0.059 |
1.773 |
1.795 |
1.945 |
|
Mean OD570of the Duplicates (Blank Corrected) |
1.920 |
1.844 |
1.830 |
0.054 |
0.060 |
0.058 |
1.755 |
1.750 |
1.922 |
Total Mean OD570of 3 Replicate Tissues (Blank Corrected) |
1.865* |
0.057 |
1.809 |
||||||
SD OD570 |
0.048 |
0.003 |
0.098 |
||||||
Relative Tissue Viability [%] |
103.0 |
98.9 |
98.1 |
2.9 |
3.2 |
3.1 |
94.1 |
93.9 |
103.1 |
Mean Relative Tissue Viability [%] |
100.0 |
3.1** |
97.0 |
||||||
SD Tissue Viability [%]*** |
2.6 |
0.2 |
5.2 |
||||||
CV [% Viabilities] |
2.6 |
5.4 |
5.4 |
* Blank-corrected mean OD570 nmof the negative control corresponds to 100% absolute tissue viability.
** Mean relative tissue viability of the three positive control tissues is£ 20%.
*** Standard deviation (SD) obtained from the three concurrently tested tissues is≤ 18%
Table 2: Historical data
|
Mean OD570±30nm Negative control (NK) |
Mean Relative Viability [%] Positive control (PC) |
SD Viability [%] |
Mean |
1.843 |
4.3 |
4.2 |
SD |
0.286 |
2.2 |
4.7 |
n |
22 |
22 |
84 |
Historical data were generated from 2015 to 2017.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-12-12 to 2018-02-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2017-10-09
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2017-05-08
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at +10 °C to +25 °C, in the closed original container in a dry, well-ventilated place. - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Manfred Bauer Kaninchen, Lohe 7/1, 74632 Neuenstein, Germany
- Age at study initiation: approx. 7 - 8 months
- Weight at study initiation: 3.7 to 4.7 kg
- Housing: kept singly in cages with dimensions of 823 mm x 660 mm x 500 mm (Scanbur, Denmark)
- Diet (ad libitum): commercial diet, ssniff® K-H V2333 (ssniff Spezialdiäten GmbH)
- Water (ad libitum): tap water
- Acclimation period: at least 20 adaptation days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C ± 3 °C (maximum range)
- Relative humidity: 30 % - 70 % (maximum range)
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of the test item - Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after the administration
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- INITIAL AND CONFIRMATORY TEST
The test was performed initially using one animal. As no corrosive or severe irritant effects were observed in the animal treated in the preliminary test, 2 further animals were employed 24 hours after start of the initial test.
USAGE OF ANAESTHETICS AND SYSTEMIC ANALGESICS
Sixty minutes prior to test item administration, 0.01 mg Buprenovet®/kg bw were administered by subcutaneous (s.c.) injection to all animals to provide a therapeutic level of systemic analgesia to avoid or minimize pain and distress.
Five minutes prior to the test item administration, two drops of Conjuncain®EDO, a topical anaesthetic, were applied to each eye of all animals, to the right eye, in which the test item was to be applied, and to the left eye, which served as control.
Eight to 9 hours after administration, Acticam® 0.5 mg/kg, s.c. was administered to provide a continued therapeutic level of systemic analgesia.
REMOVAL OF TEST SUBSTANCE
- Washing: eyes were rinsed with 20 mL 0.9 % aqueous NaCl solution
- Time after start of exposure: 1 hour
SCORING SYSTEM: according to the Draize scale and a scale scoring the degree of staining (Fluorescein-test)
TOOL USED TO ASSESS SCORE: slit lamp and fluorescein
The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48 and 72 hours after the administration. The eye reactions were observed and registered.
24, 48 and 72 hours after administration, fluorescein was applied to the eyes before being examined to aid evaluation of the cornea for possible lesions.
OBSERVATIONS
- body weight: at the beginning and at the end of the study.
- behaviour and food consumption were monitored
- any adverse systemic effects were recorded - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: slight corneal opacity was observed at the 1 hour observation.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- - slight corneal opacity (grade 1) was observed in one animal 1 hour after administration. The effect was fully reversible within 24 hours after application of the test item.
- fluorescein test performed 24, 48 and 72 hours after administration did not reveal any changes.
- irises and the conjunctivae were not affected by administration of the test item. - Other effects:
- - Lesions and clinical observations: no systemic intolerance reactions were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to the eyes.
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as eye irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation
The substance was not observed to be irritating to the skin in a reliable in vitro skin irritation study according to OECD 439.
Eye irritation
The substance was tested for its eye irritation properties according to OECD 437, but the result cannot be used for classification since the result was equivocal. Furthermore, an in vivo eye irritation test according to OECD 405 (2017) was conducted. The results showed that the substance was not irritating to the eyes.
Justification for classification or non-classification
Skin irritation
The substance does not possess an skin irritating potential based on an in vitro OECD 439 (2015) test and does not require classification as skin irritating according to Regulation (EC) No 1272/2008 and its subsequent adaptations.
Eye irritation
The substance does not possess an eye irritating potential based on an in vivo OECD 405 (2017) test and does not require classification as eye irritating according to Regulation (EC) No 1272/2008 and its subsequent adaptations.
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