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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 283-815-6 | CAS number: 84731-55-5
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 27 April 2010 and 29 April 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The protocol followed was considered to be a reliable alternative to the in vivo rabbit Draize eye irritation test in a pre-validation study. This study, using human derived keratinocytes which form a corneal epithelial tissue reconstruct, has been recommended by ECVAM for inclusion in a formal international validation study designed to offer a stand alone replacement to the in vivo test. Validation is expected to commence in 2010.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids C18-(unsaturated) lithium salts
- Cas Number:
- 502962-81-4
- IUPAC Name:
- Fatty acids C18-(unsaturated) lithium salts
- Test material form:
- solid
- Details on test material:
- - Batch number: Not reported
- Expiry date: Not reported
Constituent 1
Test animals / tissue source
- Species:
- other: Reconstructed Human Corneal Model
- Strain:
- other: Reconstructed Human Corneal Model
- Details on test animals or tissues and environmental conditions:
- Not applicable
Test system
- Vehicle:
- other: No vehicle used
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
-The test Material was applied neat.
-Amounts(s) applied (volume or weight with unit):
Triplicate tissues were treated with 30 mg of the test material.
-Concentration (if solution):
The test material was used as supplied.
VEHICLE
No vehicle used. - 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:
- TEST SITE
-Area of exposure:
Triplicate tissues were treated with 30 mg of the test material.
-% coverage:
The test material was applied topically to the corresponding tissues ensuring uniform covering.
-Type of wrap used:
None used.
REMOVAL OF TEST SUBSTANCE
-Washing (if done):
At the end of the relevant exposure period, each tissue insert was rinsed using a wash bottle containing Dulbecco’s Phosphate Buffered Saline (DPBS). Rinsing was achieved by filling and emptying each tissue insert using a constant soft stream of DPBS to gently remove any residual test material. Excess DPBS was removed by blotting the bottom of the insert with absorbent paper.
-Time after start of exposure:
10 Minutes post exposure.
SCORING SYSTEM:
The relative mean tissue viability (percentage of the negative control) was calculated as follows:
mean OD540 of test material / mean OD540 of negative control x 100 = relative mean tissue viability (percentage of negative control)
The mean tissue viability for the test material was compared to the respective untreated negative control and classified according to the following:
Tissue viability <60 = Irritant (I)
Tissue viability =60 = Non-Irritant (NI)
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Percent viability of treated cells
- Run / experiment:
- Relative mean
- Value:
- 86.5
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- 10 minute exposure on Day 2
- Other effects / acceptance of results:
- The relative mean viability of the test material treated tissues was 86.5 % after a 10-minute exposure.
Any other information on results incl. tables
RESULTS
Assessment of Direct Test Material Reduction of MTT
An assessment found the test material was able to directly reduce MTT. Therefore, an additional procedure using freeze-killed tissues was performed during the determination of eye irritation potential. However the results obtained showed that during no degree of interference due to direct reduction of MTT occurred. It was therefore considered unnecessary to use the results of the freeze-killed tissues for quantitative correction of results or for reporting purposes.
Assessment of Eye Irritation Potential
The mean OD540 values and mean viabilities for each treatment group are given in Table 1.
The relative mean viability of the test material treated tissues after a 10 minute exposure was 86.5%.
It was considered unnecessary to proceed with tissue histopathology.
Qualitative Evaluation of Tissue Viability (MTT Uptake Visual Assessment)
The qualitative evaluation of tissue viability is presented in Table 2.
The test material and negative control material treated tissues appeared blue which was considered to be indicative of viable tissue. The positive control material treated tissues appeared blue/white which was considered to be indicative of semi-viable tissue.Assay Acceptance Criterion
The quality criterion required for the acceptance of results in the test was satisfied.Table 1 Assessment of Eye Irritation Potential – Viability of RHC Tissues
Material |
Mean Tissue Viability |
Mean OD540 |
Viability (%) |
Negative Control |
0.998 |
1.026 |
100* |
1.053 |
|||
Positive Control |
0.522 |
0.481 |
46.9 |
0.439 |
|||
Test Material |
0.979 |
0.888 |
86.5 |
0.796 |
*= The mean viability of the negative control tissues is set at 100%
Table 2 Qualitative Evaluation of Tissue Viability (MTT uptake visual evaluation)
Material |
Score |
|
Tissue 1 |
Tissue 2 |
|
Negative Control |
- |
- |
Positive Control |
+ |
+ |
Test Material |
+ |
+ |
MTT Visual Scoring Scheme of SkinEthic Tissues
- = Blue tissue (viable)
+ = Blue/White tissue (semi viable)
++ = Tissue completely white (dead)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Expert judgment
- Conclusions:
- According to the protocol followed the test material was considered to be a Non-Irritant (NI)
- Executive summary:
Introduction.
The purpose of this study was to determine the eye irritation potential of the test material using the SkinEthic Reconstituted Human Corneal model (HCE, SkinEthic Laboratories, France) after a treatment period of 10 minutes. The test is based on the hypothesis that irritant chemicals are able to penetrate the corneal epithelial tissue and are sufficiently cytotoxic to cause cell death.
Methods.
The experimental design of the study consists of a test for direct reduction of MTT (3 -[4,5 -dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) by the test material followed by the main test.
For the main test, triplicate SkinEthic tissues were treated with 30 mg of the test material for 10 minutes. Triplicate tissues treated with 30 µl of Solution A served as the negative control and triplicate tissues treated with 30 µl of 1% w/v Sodium Dodecyl Sulphate served as the positive control.
At the end of the exposure period each SkinEthic tissue was rinsed. The rinsed tissues (two per group) were taken for MTT loading. The remaining tissues were retained for possible histopathology. Following MTT loading the reduced MTT was extracted from the tissues.
After extraction the absorbency of triplicate aliquots of the extracted MTT solution for each SkinEthic tissue was measured. The optical density was measured at 540 nm (OD540). Data are presented in the form of percentage viability (MTT conversion relative to negative controls).
The test material was classified according to the following criteria:
i) If the percentage relative mean tissue viability was =60% the test material was considered to be non-irritant (NI).ii) If the percentage relative mean tissue viability was <60% the test material was considered to be an irritant (I).
Results.
The relative mean viability of the test material treated tissues after a 10 minute exposure was 86.5%.
It was considered unnecessary to proceed with tissue histopathology.
Quality criteria.
The quality criteria required for acceptance of results in the test were satisfied.
Conclusion. According to the protocol followed the test material was considered to be a Non-Irritant (NI).
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.