Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
- 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 / corrosion: not irritating (based on the results of a reliable OECD 439 in vitro study; GLP)
- Eye irritation: not irritating (based on the results of two reliable in vitro studies: OECD 437 (BCOP) and a Human Cornea Model (similar to OECD 492))
- Respiratory irritation: no study available
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
- 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)
- Species:
- other: not applicable (Human reconstitued skin)
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- Commercially available Epi-200-SIT-Kit was used.
The EpiDermTM tissue consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi-layered, 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 EpiDermTM tissues are cultured on specially prepared cell cultures inserts.
Epi-200 tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava.
Day of delivery: 11. Dec. 2012; batch: 16865. - Type of coverage:
- open
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not applicable
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 µl/well - Duration of treatment / exposure:
- 35 - 60 min
- Observation period:
- not applicable
- Number of animals:
- three tisue were used
- Irritation / corrosion parameter:
- other: other: cell viability
- Value:
- 90
- Remarks on result:
- other: Cell viability 90% (above threshold)
- Interpretation of results:
- other: Not irritating according to EU GHS criteria
- Conclusions:
- In a GLP-study according to OECD Test Guideline 439, the registered substance was not skin irritating.
- Executive summary:
The Skin Irritation Potential of CARDOLITE NC-513 was determined in the Human Skin Model Test following EU-Method B.46 resp. OECD 439.
One valid experiment was performed. Three tissues of the human skin model EpiDermTMwere treated withCARDOLITE NC-513for 60 minutes. 30 µL of the liquid test item (using a nylon mesh) were applied to each tissue and spread to match the tissue size (0.63 cm2; as indicated by supplier). DPBS-buffer was used as negative control, 5 % SDS-solution was used as positive control.
After treatment with the negative control, the absorbance values were within the required acceptability criterion of 1.0 < mean OD < 2.5. The positive control showed clear irritating effects. Variation within tissues was acceptable (< 18 %).
After the treatment with the test item, the relative absorbance values were reduced to 90.0 %. This value is well above the threshold for irritation potential (50 %). Therefore, CARDOLITE NC-513 is considered as not irritant in the Human Skin Model Test.
Reference
% Formazan Production
Designation |
CARDOLITE NC-513 |
Positive Control |
% Formazan production (Tissue 1) |
92.3% |
6.7% |
% Formazan production (Tissue 2) |
88.8% |
6.8% |
% Formazan production (Tissue 3) |
89.1% |
7.2% |
% Formazan production Mean |
90.0% |
6.9% |
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
- 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 Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- not applicable
- Vehicle:
- other: 0.9% sodium chloride solution
- Controls:
- other: not applicable
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µl/per eye
- Concentration (if solution): 20% - Duration of treatment / exposure:
- 10 minutes
- Observation period (in vivo):
- not applicable
- Number of animals or in vitro replicates:
- not applicable
- Details on study design:
- see below
- Irritation parameter:
- in vitro irritation score
- Value:
- 0.002
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- In an in vitro eye irritation test according to OECD Test Guideline 437 (BCOP), the test item CARDOLITE NC-513 showed no severe eye irritation.
- Executive summary:
In an in vitro eye irritation test according to OECD Test Guideline 437 (BCOP), the corneal irritation and damage potential of CARDOLITE NC-513
was investigated by quantitative measurements of changes in opacity and permeability in a bovine cornea.One experiment were performed. Bovine corneas were used. They were collected from slaughtered cattle which were between 12 and 60 months old.
The test item CARDOLITE NC-513 was dissolved in olive oil (10 % solution) and brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32 ± 1 °C for one hour and whose opacity had been measured. The test item was incubated on the cornea for 10 minutes at 32 ± 1 °C. After removal of the test item and two hours post-incubation, opacity and permeability values were measured.
Olive oil was used as negative control. The negative control showed no irritating effect on the cornea.
10% sodium hydroxide solution was used as positive control. The positive control induced a severe irritation on the cornea.
The test item CARDOLITE NC-513 showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 0.002.
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item CARDOLITE NC-513 possesses no eye irritation potential (according to ICCVAM).
According to OECD Guideline no. 437 (2009), a substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant.
- Endpoint:
- eye 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:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- OECD Guideline for the Testing of Chemicals, Part 492, adopted 18. Jun. 2019, “Reconstructed Human Cornea-like Epithelium (RhCE) test method for identifying chemicals not requiring classification and labelling for eye Irritation or serious eye damage”
- Deviations:
- not applicable
- Principles of method if other than guideline:
- This study was performed in order to evaluate the potential of CARDOLITE NC-513 to evoke eye irritation in a human cornea model in an in-vitro study.
The eye irritation test refers to the production of irreversible tissue damage following the application of a test material on a human cornea model.
Irritating materials are identified by their ability to produce a decrease in cell viability as determined, by using the MTT reduction assay below defined threshold levels at specified exposure periods.
The principle of the human cornea model assay is based on the hypothesis, that irritating chemicals are able to penetrate the epithelium by diffusion or erosion, and are cytotoxic to the underlying cell layers. - GLP compliance:
- yes (incl. QA statement)
- Species:
- other: not applicable
- Strain:
- other: not applicable
- Details on test animals or tissues and environmental conditions:
- not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not applicable
- Amount / concentration applied:
- 100µl/tissue
- Duration of treatment / exposure:
- 3, 30, 60 min
- Observation period (in vivo):
- not applicable
- Number of animals or in vitro replicates:
- not applicable
- Irritation parameter:
- other: ET50
- Value:
- 107.9
- Remarks on result:
- other: 107.9% at 3mins
- Irritation parameter:
- other: ET50
- Value:
- 96.6
- Remarks on result:
- other: 96.6% at 30 mins
- Irritation parameter:
- other: ET50
- Value:
- 105.4
- Remarks on result:
- other: 105.4% at 60 mins
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- Using a Human Cornea Model following MTT ET-50 Protocol, the Eye Irritation Potential of CARDOLITE NC-513 was determined as not irritating.
- Executive summary:
The Eye Irritation Potential of CARDOLITE NC-513 was determined using a Human Cornea Model following
MTT ET-50 Protocol. One valid experiment was performed.The test item CARDOLITE NC-513 was applied to a three-dimensional human cornea model tissue for three different exposure times in duplicate (3 min., 30 min. and 60 min.).
100 µL of the liquid test item were applied to each tissue.
Deionised water was used as negative control, 0.3% Triton X 100 solution was used as positive control.
After treatment, the respective substance was rinsed from the tissue; then, cell viability of the tissues was evaluated by addition of MTT which can be reduced to a blue formazan. Formazan production was measured by measuring the optical density (OD) of the resulting solution.
After treatment with the negative control, the absorbance values were well within the historical range and showed no cytotoxic effects. The positive control showed clear irritating effects.
After 3 minutes treatment with the test item, the relative absorbance values increased to 107.9 %. After 30 minutes treatment, relative absorbance values were reduced to 96.6 %. And after 60 minutes treatment, the relative absorbance values increased to 105.4 %. These values lie within the range of the negative control.
From these values, it is assumed that the ET50of the test item CARDOLITE NC-513 is > 60 min.
Therefore, the test item CARDOLITE NC-513 is considered as not/minimal eye irritant in the Human Cornea Model test.
Referenceopen allclose all
IVIS – In Vitro Irritancy Score
Test Group | IVIS | Mean IVIS | Relative Standard Deviation IVIS |
Negative Control | 0.420 | 0.380 | 14.8% |
0.405 | |||
0.316 | |||
Positive Control | 162.467 | 149.960 | 26.0% |
106.209 | |||
181.205 | |||
Solvent Control | 0.555 | 0.533 | 10.4% |
0.574 | |||
0.469 | |||
CARDOLITE NC-513 | -0.010 | 0.002 | 2514.7% |
-0.042 | |||
0.057 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
- Skin / Eye Irritation in vitro
The registered substance did not induce skin irritation in vitro. Therefore, it can be concluded that it is also not skin corrosive.
The substance was not severly eye irritating according to the BCOP. Subsequently, using a Human Cornea model, it was shwon to be non eye irritating.
- Skin / Eye Irritation in vivo
In vivo irritation studies do not need to be conducted because the available in vitro data are adequate for classification and risk assessment.
Justification for classification or non-classification
Based on results of reliable in vitro studies, the substance does not meet the CLP classification criteria with respect to irritation or corrosion to the skin and eye, as set out in Regulation (EC) No. 1272/2008.
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.