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EC number: - | CAS number: -
- 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
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- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
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- Endpoint summary
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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
- 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
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Carcinogenicity
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- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
FAT 40875/A was found to be non-irritant for skin but may cause serious damage to eyes.
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:
- 2018
- 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Test Item: 40875/A TE
Physical Appearance: Dark red powder
Purity as per Certificate of Analysis (Content): 86.4% all organic components
Batch No.: BOP 05-17 (BS-ROE 1550 NIM 25+26+27)
Manufactured Date: 20 December 2017
Expiry Date: 11 December, 2022
Recommended Storage Condition : Refrigeration (+2 to +8 °C), Protect from light
pH: 4.3 (aq. soln.(2% (w/w) at room-temperature) - Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: normal human keratinocytes
- Justification for test system used:
- The assessment of skin irritation has typically involved the use of laboratory animals (OECD TG 404). In relation to animal welfare concerns, TG 404 recommends the use of a tiered testing strategy for the determination of skin corrosion and irritation which includes the use of validated in vitro or ex vivo test methods avoiding pain and suffering of animals. One of the validated in vitro test methods adopted by the OECD TG 439 makes use of reconstructed human epidermis (RhE) which closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiSkin
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 20 - 28 °C
- Temperature of post-treatment incubation: 37 ± 1 °C
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL
- Incubation time: 42h
- Spectrophotometer: TECAN Infinite® M200 Microplate Reader
- Wavelength: 570nm
NUMBER OF REPLICATE TISSUES: Triplicate
PREDICTION MODEL / DECISION CRITERIA:
- The test substance is considered to be corrosive to skin if [complete, e.g. the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.]
- The test substance is considered to be non-corrosive to skin if [complete, e.g. the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%.] - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 10 mg/tissue of test substance was applied topically to the EpiSkin three dimensional RhE model.
Negative control : 10 microliter of Phosphated Buffered Saline (PBS).
Positive control : 10 microliter of 5% Sodium Dodecyl Sulfate (SDS). - Duration of treatment / exposure:
- Incubation for 15 minutes at room temperature (20 - 28 °C)
- Duration of post-treatment incubation (if applicable):
- Tissues were incubated with MTT solution for 4 hours and then extracted with acidified isopropanol to quantify spectrophotometrically at wavelength of 570 nm.
- Number of replicates:
- Three
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- True tissue viability
- Value:
- 131.23
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No
- Direct-MTT reduction: Yes
- Colour interference with MTT: Yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: 0.753% mean cell viability.
- Acceptance criteria met for positive control: 6.89% mean cell viability.
- Acceptance criteria met for variability between replicate measurements: Yes, the standard deviation was within the range. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean relative tissue viability for the test item, FAT 40875/A TE was 131.23 % and hence, the test item is predicted to be non-irritant.
- Executive summary:
The test item, FAT 40875/A TE was tested for its skin irritation potential using a three-dimensional Reconstructed Human Epidermis model, EpiSkin, through topical application. This test was conducted in accordance with OECD test guideline 439 in a GLP certified laboratory.
10 mg/tissue of test item, 10µL of negative control (PBS) & 10µL of positive control (5% of SDS) respectively was exposed for 15 minutes.
In the preliminary tests, FAT 40875 was identified as producing direct MTT reduction and color interference and thus adapted controls evaluation was performed.
After approximately 42-hour post incubation period, irritation potential was evaluated by assessing the cytotoxic (irritancy) effect. The cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured on formazan production from MTT and the end of treatment.
Skin irritation is expressed as the ability of the test item to reduce the cell viability after exposure to the test item. The relative mean tissue viability obtained after 15 mins of treatment with the test item is compared with negative control tissues.
The absolute mean Optical density (OD) at 570nm of negative control, positive control and test item was 0.7530, 0.0519 and 0.6733 respectively. The positive control had a mean cell viability of 6.89% after 15 mins exposure, indicating the test system functioned properly.
The true tissue viability of the test item was found to be 131.23%.
The study indicated that the test item FAT 40875/A TE is predicted to be non-irritating in this In-vitro skin irritation test using Reconstructed Human Epidermis under the condition of testing employed.
Reference
Individual tissue viability of epidermis units (relative)
% Individual Viability | |||||
R1 | R2 | R3 | Mean | SD | |
Positive control | 6.63 | 7.40 | 6.64 | 6.89 | 0.44 |
Test item | 88.07 | 88.30 | 91.89 | 89.42 | 2.14 |
% NSC living tissue | 4.13 | 4.30 | - | 4.22 | 0.12 |
% NSMTT killed tissue | 4.86 | 6.61 | - | 5.74 | 0.24 |
% NSC killed tissue color | 51.21 | 52.32 | - | 51.77 | 0.78 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Test Item: FAT 40875/A TE
Physical Appearance: Dark red powder
Purity as per Certificate of Analysis (Content): 86.4% all organic components
Batch No.: BOP 05-17 (BS-ROE 1550 NIM 25+26+27)
Manufactured Date: December, 20, 2017
Expiry Date: December 11, 2022
Recommended Storage Condition : Refrigeration (+2 to +8°C)
pH: 4.3 of 2% (w/w) aq. Solution.
Solubility: 499.9 g/l - Species:
- other: Bovine eye
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Local abattoir (Slaughter house), Near Frazer town, Bengaluru.
- Storage, temperature and transport conditions of ocular tissue: The bovine eyes were procured from local abattoir and transported in a jar containing Hank’s Balanced Salt Solution (HBSS) and penicillinstreptomycin (100 IU & 100 μg/mL) in an ice box.
- indication of any existing defects or lesions in ocular tissue samples: none - Vehicle:
- Hank's balanced salt solution
- Controls:
- yes, concurrent positive control
- Amount / concentration applied:
- 100 mg of test item per cornea
- Duration of treatment / exposure:
- 4 hours
- Duration of post- treatment incubation (in vitro):
- 10 min
- Number of animals or in vitro replicates:
- Triplicate
- Details on study design:
- Pretest examination:
Immediately after receiving the eyes in the lab, all eyes were observed for any evidence of vascularization, pigmentation, opacity or scratches.
Dissection:
Post pretest examination, selected eyes were dissected to isolate the corneas from surrounding tissue and then placed in a container with fresh HBSS (Hank’s Balanced Salt Solution).
Mounting:
The isolated corneas were mounted on the cornea holder. During mounting, it was ensured that the epithelium of the cornea projected into the anterior chamber. The EMEM without phenol red was added in to both the chambers and kept in an incubator (32°C) for 1 hour.
The blank value I0 (lux) was obtained with each of 30 available cornea holders containing medium but without cornea. The mean of the blank value obtained was 502 lux (I0). This value was considered while calculating the initial opacity and final opacity readings.
After pre-test incubation, the EMEM from both the chambers was removed and refilled with the fresh EMEM. The pre-treatment cornea reading (lux) was measured and initial opacity was calculated for all corneas.
The initial opacity was calculated. The corneas which exhibited initial opacity < 7 were considered for further experiment.
NUMBER OF REPLICATES : Three for each test group.
NEGATIVE CONTROL : Distilled water
POSITIVE CONTROL : Imidazole - Irritation parameter:
- in vitro irritation score
- Value:
- 680.328
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- Negative Control: Distilled water
The corneas treated with distilled water exhibited IVIS score of 1.234 hence classified as “No Category”.
Positive Control: Imidazole
The corneas treated with Imidazole exhibited IVIS score of 78.2905 hence classified under “Category 1”.
Test Item: FAT 40875/A TE
The corneas treated with FAT 40875/A TE exhibited IVIS score of 680.3285 hence classified under “Category 1”. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test item FAT 41047/A TE exhibited an IVIS score of 680.3285. The test item FAT 40875/A TE is predicted to cause serious eye damage.
- Executive summary:
The evaluation of the occular irritancy of “FAT 40875/A TE” was carried out using the Bovine Corneal Opacity and Permeability assay (BCOP) in accordance with OECD TG 437 in a GLP certified laboratory.
100 mg of test substance per cornea, 0.75 mL negative control per cornea and positive control (enough quantity covering the entire corneal surface) respectively were applied undiluted on the corneal surface by means of open chamber method. The control and treated corneas were then subjected to the opacity and permeability measurements.
The negative control (distilled water) was classified as UN GHS "No Category" (IVIS score 1.234) and the positive control (Imidazole) was classified under Category 1 (IVIS score 78.2905).
The test item FAT 40875/A TE exhibited an IVIS score of 680.3285 and was classified under ‘Category 1’ as per UN GHS.
From the results, it can be concluded that the test item FAT 40875/A TE can be predicted to cause serious eye damage to bovine corneal eye.
Reference
Calculation of In Vitro Irritation Score (IVIS*)
Treatment group | Mean opacity value | Mean Permeability value | IVIS | Classification |
Negative control (Distilled water) | 1 | 0.0156 | 1.234 | No category |
Imidazole | 64.33 | 0.9307 | 78.2905 | Category 1 |
FAT 40875/A TE | 680 | 0.0219 | 680.3285 | Category 1 |
*IVIS = Mean Opacity value + (15 × Mean Permeability value)
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The test item, FAT 40875/A TE was tested for its skin irritation potential using a three-dimensional Reconstructed Human Epidermis model, EpiSkin, through topical application. This test was conducted in accordance with OECD test guideline 439 in a GLP certified laboratory.
The study indicated that the test item FAT 40875/A TE is predicted to be non-irritating in this In-vitro skin irritation test using Reconstructed Human Epidermis under the condition of testing employed.
The evaluation of the ocular irritancy of “FAT 40875/A TE” was carried out using the Bovine Corneal Opacity and Permeability assay (BCOP) in accordance with OECD TG 437 in a GLP certified laboratory.
The negative control (distilled water) was classified as UN GHS "No Category" (IVIS score 1.234) and the positive control (Imidazole) was classified under Category 1 (IVIS score 78.2905). The test item FAT 40875/A TE exhibited an IVIS score of 680.3285.
From the results, it can be concluded that the test item FAT 40875/A TE can be predicted to cause serious eye damage to bovine corneal eye.
Justification for classification or non-classification
Skin: The mean relative tissue viability for the test item, FAT 40875/A TE was 131.23 % and hence, the test item is was classified as non-irritant to the skin.
Eye: The test item FAT 40875/A TE exhibited an IVIS score of 680.3285 and was classified under ‘Category 1’ as per UN GHS.
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