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EC number: 690-512-6 | CAS number: 1271172-98-5
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to OECD guidelines and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- Study pre-dates OECD 439 guideline, but is considered to be equivalent
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction products of 1,3,5-triazine-2,4,6-triamine and zinc bis(dihydrogen phosphate)
- EC Number:
- 690-512-6
- Cas Number:
- 1271172-98-5
- Molecular formula:
- Zn(C3H7N6)2(P2O7)
- IUPAC Name:
- Reaction products of 1,3,5-triazine-2,4,6-triamine and zinc bis(dihydrogen phosphate)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- other: EpiDerm tissue, human derived
- Details on test animals or test system and environmental conditions:
- ENVIRONMENTAL CONDITIONS
All incubations, were carried out in a controlled environment.
- Atmosphere containing 5.0 CO2 in air in the dark.
- Temperature: 37.0°C
Test system
- Vehicle:
- other: DPBS-buffer
- Controls:
- yes
- Amount / concentration applied:
- In the main test, 27.7, 27.5 and 24.3 mg were applied. Initially, the pre-incubated tissues were wetted with 25 uL of DPBS buffer before applying the test substance, which was evenly spread to match the tissue size.
- Duration of treatment / exposure:
- 35 minutes
- Details on study design:
- Test system:
Name: Commercially available Epi-200-SIT-kit.
Source: MatTek corporation, Ashland, USA.
Rationale: One of the validated in vitro skin irritation tests is the EpiDerm test, which is recommended in international guidelines (e.g. OECD, EC and
validated by ECVAM).
Pre-test:
The test item was tested for forming a colour without MTT addition. This pre-test provided a colourless solution. Afterwards the test item was tested for the ability of direct formazan reduction. The MTT solution (with test material) didn't change its colour within one hour, which meant that direct MTT reduction had not occured.
Treatment:
All tissues used were pre-incubated; eight 6-well plates were prepared with 0.9 mL assay medium in 3 of the 6 wells. The tissues were inspected for viability. Viable tissues were transferred in the wells with the medium using sterile forceps in place in an incubator for 1 hour. After this period another three wells of each plate were filled with medium and then further incubated for 18 hours.
The pre-incubated tissues were placed into fresh 6-well plates containing 0.9 mL medium per well. Seperate plates were used for the negative, positive and treatment groups using 30 uL DPBS buffer, 30 uL SDS solution or 25 uL (before applying the test item) respectively. Tissues were dosed in 1 minute intervals. After dosing the last tissue, all plates were transferred into an incubator for 35 minutes. Tissues were then rinsed, dried, fresh medium added and further incubated for 24 hours (excess test material was removed).
The tissue inserts were then transferred into a new 6-well plate and incubated for a further 18 hours (post-incubation).
Cell viability measurement (MTT assay):
After the incubation period (a total of ca. 42 hours) a 24-well plate was prepared with 300 uL freshly prepared MTT-reagent in each well. The tissues were blotted onto the bottom and then transferred. The 24-well plate was placed in the incubator for 3 hours. After this time the MTT reagent was aspirated and replaced by PBS buffer. this was replaced several times. Each insert was throughly dried and set into the empty pre-warmed 24-well plate. Into each well, 2 mL isopropanol were added and shaken for 2 hours at room temperature. After two hours, the insertes in which formazan had been produced were pierced with an injection needle, extracting all the colour. the inserts were then discarded and the contents mixed to ensure homogenisation. Frome ach well, two replicates with 200 uL were added into a 96-well plate which was read in a plate spectral photometer at 570 nm.
Formazan production was calculated as a % photometric absorption compared with the negative control.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 94.4
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
In vivo
- Irritant / corrosive response data:
- See below for mean tissue viability scores ('Any other information on results incl. tables').
After treatment, the relative absorbance values were decreased to 94.4%, which is above the threshold for irritation (50%). The OD of the negative control was within the required acceptability criteria of 1 < mean OD < 2.5 (2.156) as cited in the report, and also with the range in the most recent OECD guideline ( 0.8 < mean OD < 2.8).
Any other information on results incl. tables
Mean tissue viability score in the in vitro skin irritation test (mean of three replicates):
|
Mean tissue viability (percentage of control) |
Negative control |
100 |
Test substance |
94.4 |
Positive control |
7.3 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.
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