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EC number: 208-341-9 | CAS number: 523-24-0
- 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
- Study period:
- The study was conducted between 11 October 2016 and 04 November 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Diammonium phthalate
- EC Number:
- 208-341-9
- EC Name:
- Diammonium phthalate
- Cas Number:
- 523-24-0
- Molecular formula:
- C8H6O4.2H3N
- IUPAC Name:
- diammonium phthalate
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- Identification: Diammonium phthalate
Batch: 7172002
Purity: 99.3%
Appearance: White crystalline powder
Expiry Date: August 2017
Storage Conditions: At room temperature, protected from moisture
Stability in Solvent: Not indicated by the Sponsor
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: epidermal keratinocytes
- Cell source:
- other: not specified
- Source strain:
- not specified
- Details on animal used as source of test system:
- The EpiDerm™ tissue consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis.
- Justification for test system used:
- In an international prevalidation study performed by ECVAM, the in vitro skin irritation test using the human skin model EpiDerm™ and EpiSkin™ and measurement of cell viability by dehydrogenase conversion of MTT into a blue formazan salt have turned out as a sufficiently promising predictor for skin irritancy potential.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Epi-200 SIT kit and MTT-100 assays diluent were purchased from MatTek Corporation (82105 Bratislava, Slovakia). The EpiDerm™ tissue consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm™ tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs, 10 mm Ø).
EpiDerm™ tissues were shipped with cool packs on medium-supplemented agarose gels in a 24-well plate and reached Envigo CRS GmbH on November 01, 2016. On day of receipt the pre-incubation phase of the EpiDerm™ tissues started.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 35 minutes at 37 ± 1.5 °C, 5 ± 0.5 % CO2. In the remaining period the plates were placed in a sterile bench at room temperature until the end of treatment.
- Temperature of post-treatment incubation (if applicable): 37 ± 1.5 °C, 5 ± 0.5 % CO2
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: tissues were gently rinsed with DPBS at least 15 times
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Spectrophotometer: Versamax® Molecular Devices, Softmax Pro, version 4.7.1
- Filter: 570 nm filter
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test chemical is considered to be irritant to skin in accordance with UN GHS and EU CLP Category 2 if the tissue viability after exposure and post-treatment incubation is less than or equal (≤) to 50%.
- The test substance is considered to be a non-irritant to skin in accordance with UN GHS and EU CLP Category 2 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
NEGATIVE CONTROL DPBS (MatTek)
- Amount(s) applied (volume or weight): 30 µL
- Concentration (if solution): as supplied
POSITIVE CONTROL SLS solution in deionised water (MatTek)
- Amount(s) applied (volume or weight): 30 µL
- Concentration (if solution): 5% - Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hrs
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 77.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The optical pre-experiment (colour interference pre-experiment) to investigate the test item’s colour change potential in water did not led to a change in colour.
Optical evaluation of the MTT-reducing capacity of the test item after 1 hour incubation with MTT-reagent did not show blue colour.
The mean relative absorbance value of the test item, corresponding to the cell viability, decreased to 77.7% (threshold for irritancy: ≤ 50%), consequently the test item was not irritant to skin.
Any other information on results incl. tables
Results after treatment with Diammonium phthalate and the controls
Dose Group |
Ex-po-sure Interval |
Tissue No. |
Absor-bance 570 nm |
Absor-bance 570 nm |
Absor-bance 570 nm |
Mean Absor-bance of 3 Wells |
Mean-Absorbance of three wells blank corrected |
Mean Absor-bance of 3 tissues after blank correction * |
Rel. Absor-bance [%] Tissue 1, 2 + 3** |
Relative Standard Deviation [%] |
Mean Rel. Absorbance [% of Negative Control]*** |
Blank |
|
|
0.037 |
0.038 |
0.038 |
0.038 |
0.000 |
|
|
|
|
Negative Control |
60 min |
1 |
2.018 |
2.011 |
2.020 |
2.016 |
1.978 |
1.998 |
99.0 |
5.4 |
100.0 |
2 |
2.227 |
2.132 |
2.098 |
2.153 |
2.115 |
105.8 |
|||||
3 |
1.995 |
1.910 |
1.913 |
1.939 |
1.902 |
95.2 |
|||||
Test Item |
60 min |
1 |
1.526 |
1.471 |
1.490 |
1.496 |
1.458 |
1.553 |
73.0 |
5.4 |
77.7 |
2 |
1.655 |
1.598 |
1.603 |
1.619 |
1.581 |
79.1 |
|||||
3 |
1.679 |
1.649 |
1.641 |
1.656 |
1.619 |
81.0 |
|||||
Positive Control |
60 min |
1 |
0.098 |
0.110 |
0.097 |
0.102 |
0.064 |
0.061 |
3.2 |
5.8 |
3.1 |
2 |
0.099 |
0.099 |
0.100 |
0.099 |
0.062 |
3.1 |
|||||
3 |
0.096 |
0.094 |
0.095 |
0.095 |
0.057 |
2.9 |
* Mean of three replicate wells after blank correction
** relative absorbance per tissue
*** relative absorbance per treatment group
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, Diammonium phthalate is not irritant to skin according to UN GHS and EU CLP regulation.
- Executive summary:
This in vitro study was performed to assess the irritation potential of Diammonium phthalate by means of the Human Skin Model Test.
The white test item did not reduce MTT (test for direct MTT reduction), and it did not change colour when mixed with deionised water (test for colour interference). Consequently, additional tests with freeze-killed or viable tissues were not necessary.
Each three tissues of the human skin model EpiDerm™were treated with the test item, the negative control (DPBS) or the positive control (5% SLS) for 60 minutes.
After treatment with the negative control the absorbance values were well within the required range of the acceptability criterion of mean OD≥
0.8 and ≤ 2.8 for the 60 minutes treatment interval, thus assuring the quality of the tissues.
Treatment with the positive control induced a sufficient decrease in the relative absorbance as compared to the negative control for the 60 minutes treatment interval, and thus assuring the validity of the test system.
After treatment with the test item Diammonium phthalate the mean relative absorbance value decreased to 77.7% compared to the relative absorbance value of the negative control. This value is above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential.
In conclusion, it can be stated that in this study and under the experimental conditions reported, Diammonium phthalate is not irritant to skin.
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