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EC number: 947-794-3 | CAS number: -
- Life Cycle description
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- 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
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- 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
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
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- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
HPP 12879-1 is not corrosive but irritant to the skin in tests using reconstructed human epidermis (Wingenroth, 2016a+b). An in vitro test with HPP 12879-1 on a human corneal epithelium (HCE) cell model does not reveal irritant effects to the eyes (Wingenroth, 2016c).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- August 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: test item was melted in a hot cabinet at 90 °C.
FORM AS APPLIED IN THE TEST (if different from that of starting material): liquid - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- commercially available test system
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: epiCS® (CellSystems, Troisdorf, Germany).
- Tissue batch number(s): Cat.-No.CS-1001
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature for 3 min- exposure and incubator (37 ± 2° C) for 60 min- exposure
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1mg/ml
- Incubation time: 3 hours
- Spectrophotometer: EL808, Bio-Tek
- Wavelength: 570 nm
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION:
the optical density of the isopropanol-extracts of 3 inserts was determined by duplicate per insert = 6 OD values.
PREDICTION MODEL / DECISION CRITERIA:
- The mean optical density (OD) value obtained with the test item was used to calculate the percentage of viability relative to the negative control, which is set at 100 %.
- classification according to UN GHS: if the mean percent tissue viability after 3 min-exposure is less than (<) 50 % the test item is classified as corrosive (Category 1A); if the mean percent tissue viability after 3-min-exposure is greater than or equal (≥) to 50 % AND < 15% after 60-min exposure the test item is classified as corrosive (Category 1B/1C); if the mean percent tissue viability after 60-min-exposure is ≥ 50 % after 3-min exposure AND ≥ 15% after 60-min exposure the test item is considered as non-corrosive
The corrosive potential of the test item is assessed by determination of its cytotoxic effect on an in vitro reconstructed human epidermis. The test principle is based on the MTT assay reflecting the cell viability after exposure to the topically applied test item.
All tests were performed in triplets for each time point. The test item was applied undiluted , i.e. 50 µl of the melted and cooled down test item per insert for 3 min. (room temperature) and 60 min. Cell viability was measured by the amount of MTT reduction (calculated on the basis of optical density of the negative control). - Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 μl
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 μl
- Concentration (if solution): 0.9% NaCl in water - Duration of treatment / exposure:
- 3 min and 60 min
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- exposure period: 3 min.
- Value:
- ca. 104.58
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not specified
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- exposure period: 60 min.
- Value:
- ca. 71.42
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not specified
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY:
- Reliability of the test was previously confirmed by interlaboratory validation
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes, within regular intervals in the lab
- Acceptance criteria met for variability between replicate measurements: yes - Interpretation of results:
- other: negative
- Executive summary:
A study was performed for the assessment of the skin corrosion of the test item with reconstructed human epidermis (RhE). The experiment was carried out using the commercially available test method epiCS®. The study was conducted in accordance with OECD TG 431 and EU Test Method B.40 bis. The mean value of cell viability was recorded to be 105 % (3 min. exposure) and 71% (60 min. exposure). The test item was thus shown to be not corrosive to reconstructed human skin in vitro.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- September 2014
- 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)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: test item was melted in a hot cabinet at 90 °C
FORM AS APPLIED IN THE TEST (if different from that of starting material): viscous liquid (melted and cooled down test item) - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- commercially available test system
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: epiCS® (CellSystems, Troisdorf, Germany).
- Tissue batch number(s): Cat.-No.CS-100
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: RT (room temperature)
- Temperature of post-treatment incubation (if applicable): Incubator temperature: 37 ± 2° C (CO2 gas concentration: 5 %; Humidity: maximum)
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1mg/ml
- Incubation time: 3 hours
- Spectrophotometer: EL808, Bio-Tek
- Wavelength: 570 nm
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION:
the optical density of the isopropanol-extracts of 3 insert was determined by duplicate per insert = 6 OD values.
PREDICTION MODEL / DECISION CRITERIA:
- The mean optical density (OD) values obtained with the test item was used to calculate the percentage of viability relative to the negative control, which is set at 100 %.
- According to UN GHS (Category 2 or Category 1) if the mean percent tissue viability after exposure and post treatment incubation is less than or equal (≤ ) to 50 %. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 30 μl
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 μl
- Concentration (if solution): 0.9% NaCl in water
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µl
- Concentration (if solution): 5% SDS in physiological saline - Duration of treatment / exposure:
- 20 min
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- three
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY:
- Reliability of the test was previously confirmed by interlaboratory validation
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
OTHER EFFECTS:
- Direct-MTT reduction: In the control on freeze killed tissue the test item did not lead to significant OD values. This demonstrated that no direct MTT reduction is occuring. - Interpretation of results:
- other: positive
- Executive summary:
A study was performed for the assessment of the skin irritancy of the test item with reconstructed human epidermis (RhE). The experiment was carried out using the commercially available test method epiCS®. The study was conducted in accordance with OECD TG 439 and EU Test Method B.46. The mean value of cell viability was recorded to be 2 %. The test item was thus shown to be irritating to reconstructed human skin in vitro.
Referenceopen allclose all
Table 1: Tabular Summary of the results
Sample No. | Test item | Expousre time [min] | OD mean* | StdDev | % Viability |
1 -3 | negative control, 0.9% NaCl | 60 | 2.34 | 0.38 | 100 |
7 -9 | HPP 12879 -1 | 60 | 1.67 | 0.22 | 71.42 |
10 -12 | negative control, 0.9% NaCl | 3 | 2.21 | 0.39 | 100 |
16 -18 | HPP 12879 -1 | 3 | 2.31 | 0.20 | 104.58 |
*6 values
Table 1: Tabular Summary of the results
Sample No. | Test item | OD mean* | StdDev | % Viability |
1 -3 | negative control, 0.9% NaCl | 2.03 | 0.15 | 100 |
7 -9 | positive control, 5% SDS | 0.03 | 0.01 | 1.66 |
10 -12 | HPP 12879 -1 | 0.04 | 0.01 | 1.88 |
freezed killed tissue | Test item | OD mean* | StdDev |
4 -6 |
negative control, 0.9% NaCl |
0.03 |
0.00 |
13 -15 |
HPP 12879 -1 |
0.02 |
0.00 |
*6 values
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- October 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Principles of method if other than guideline:
- PRINCIPLE of TEST:
Assessment of ocular irritation potential of the test substance by determination of cytotoxic effects on a human corneal epithelium (HCE) cell model (similar to EpiOcular).
The HCE model is currently involved in the eye irritation validation conducted by COLIPA following ECVAM guidelines. Furthermore, it is routinely used by the major Cosmetic and Pharmaceutical companies, and has already been prevalidated in 2004 (van Goethem et. al., Tox in Vitro 20, 2006, 1-17). This model is recognized as the model of choice and scientifically relevant as documented by several publications (e.g. Alepee et. al., Toxicology in Vitro 34 (2016) 55–70). - GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: test item was melted in a hot cabinet at 90 °C
FORM AS APPLIED IN THE TEST (if different from that of starting material): melted and cooled down viscous liquid - Species:
- other: human corneal epithelial cells
- Strain:
- other: not applicable
- Details on test animals or tissues and environmental conditions:
- The experiment was carried out on a Human Corneal Epithelial (HCE) Model, which is standardized and commercially available (SkinEthicTM Human Corneal Epithelial Model (HCE), SkinEthic, France). Inserts were of 0.5 cm² size. When cultivated at the air-liquid interface in a chemically defined medium, the immortalized human cornea epithelial cells reconstruct a corneal epithelial tissue (mucosa), without a stratum corneum, ultra-structurally (tissue morphology and thickness) similar to the corneal mucosa of the human eye.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 30 µl per insert
- Duration of treatment / exposure:
- 60 min at room temperature
- Duration of post- treatment incubation (in vitro):
- 16 hours in the incubator (37°C, 5% CO2, maximum humidity)
- Number of animals or in vitro replicates:
- three
- Details on study design:
- The irritation potential of the test item is assessed by determination of its cytotoxic effect on an reconstructed human ocular epithelium. The test principle is based on the MTT assay reflecting the cell viability after exposure of the cornea equivalent to topically applied test item.
The test item is applied pure. Since the test item is a solution (ca. 40% in ethyl acetate) the solvent is tested in parallel to distinguish potential toxic effects of the test item from the effects of the solvent.
After the post-exposure incubation of 16 hours in the incubator (37 +/- 2 °C, 5 % CO2, maximum humidity) MTT reduction is performed. Cell viability is measured by the amount of MTT reduction, i.e. an OD value following exposure to the negative or positive control substances or the test item.
A test substance is predicted to be an ocular irritant if the mean relative tissue viability (%) exposed to the test substance is ≤ 50 %. - Irritation parameter:
- other: cell viability (%)
- Value:
- ca. 77
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system:
As the test item solidified again after application to the surface of the HCE, it was difficult to properly remove the substance during the subsequent washing procedure. Due to that, part of the tissue could be lost from one of the wells explaining the outlier triplicate value for one well (sample 7). Therefore one mean value is based on duplicate instead of triplicate measurements - Interpretation of results:
- other: negative
- Executive summary:
The reconstructed human corneal epithelial tissue-based in vitro test method (SkinEthic™ HCE) was conducted with the test item. The undiluted test item was applied topically to the reconstructed HCE tissue. After an exposure period of 60 minutes followed by a 16 hours post-treatment incubation period the cell viability was measured to be about 77% by the MTT conversion assay. Thus the test item is predicted as non-irritant under the conditions of this test method.
Reference
Table 1: Tabular Summary of the results
Sample No. | Test item | OD mean* | StdDev | % Viability |
1 -3 | negative control, PBS | 1.09 | 0.08 | 100.00 |
4 -6 | positive control, 0.3% SDS | 0.22 | 0.08 | 20.25 |
8 -9 | HPP 12879 -1 | 0.84* | 0.23 | 77.05 |
*6 values/*4 values
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A study was performed for the assessment of the skin corrosion of the test item with reconstructed human epidermis (RhE). The experiment was carried out using the commercially available test method epiCS®. The study was conducted in accordance with OECD TG 431 and EU Test Method B.40 bis. The mean value of cell viability was recorded to be 105 % (3 min. exposure) and 71% (60 min. exposure). The test item was thus shown to be not corrosive to reconstructed human skin in vitro (Wingenroth, 2016a).
A study was performed for the assessment of the skin irritancy of the test item with reconstructed human epidermis (RhE). The experiment was carried out using the commercially available test method epiCS®. The study was conducted in accordance with OECD TG 439 and EU Test Method B.46. The mean value of cell viability was recorded to be 2 %. The test item was thus shown to be irritating to reconstructed human skin in vitro (Wingenroth, 2016b).
The reconstructed human corneal epithelial tissue-based in vitro test method (SkinEthic™ HCE) was conducted with the test item. The undiluted test item was applied topically to the reconstructed HCE tissue. After an exposure period of 60 minutes followed by a 16 hours post-treatment incubation period the cell viability was measured to be about 77% by the MTT conversion assay. Thus the test item is predicted as non-irritant under the conditions of this test method (Wingenroth, 2016c).
.
Justification for classification or non-classification
Based on the available study results a classification with Skin Irritation Cat. 2 (H315: Causes skin irritation) according to Regulation (EC) No. 1272/2008 (CLP) is required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

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