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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 915-656-1 | 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
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 08 July 2008 and 10 July 2008.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in line with good scientific principles and reported to a high standard using a non-validated in vitro method.
- Remarks:
- Study conducted on read-across material
- Justification for type of information:
- A RAAF report will shortly be provided.
Cross-reference
- Reason / purpose for cross-reference:
- other: read across target
Reference
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on read-across material
- Justification for type of information:
- A RAAF report will shortly be provided.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- other: relative mean tissue viability
- Run / experiment:
- Mean
- Value:
- 68.8
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Performed using the standard protocol with the SkinEthic Model (SkinEthic Reconstituted Human Corneal model (HCE, SkinEthic Laboratories, Nice, France))
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of Signature: 15/10/2007; Date of Inspection: 21/08/2007
Test material
- Reference substance name:
- Reaction mass of sodium hydrogen N-(1-oxooctadecyl)-L-glutamate and sodium hydrogen N-(1-oxohexadecyl)-L-glutamate
- EC Number:
- 936-610-7
- Molecular formula:
- See remarks
- IUPAC Name:
- Reaction mass of sodium hydrogen N-(1-oxooctadecyl)-L-glutamate and sodium hydrogen N-(1-oxohexadecyl)-L-glutamate
- Reference substance name:
- Reaction mass of sodium hydrogen N-(1-oxooctadecyl)-L-glutamate and sodium hydrogen N-(1-oxohexadecyl)-L-glutamate
- IUPAC Name:
- Reaction mass of sodium hydrogen N-(1-oxooctadecyl)-L-glutamate and sodium hydrogen N-(1-oxohexadecyl)-L-glutamate
Constituent 1
Constituent 2
Test animals / tissue source
- Details on test animals or tissues and environmental conditions:
- In-vitro study, so no test animals used.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: 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.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 mg
- Concentration (if solution): not applicable
VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable - Duration of treatment / exposure:
- 10 minutes
- Observation period (in vivo):
- Not applicable
- Number of animals or in vitro replicates:
- Triplicate SkinEthic tissues
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsed with water.
- Time after start of exposure: 10 minutes
SCORING SYSTEM: relative mean viability
TOOL USED TO ASSESS SCORE: optical density was measured (quantitative measurement of tissue viability) at 540nm (OD540) using the Anthos 2001 microplate reader.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Relative mean tissue viability
- Run / experiment:
- Mean
- Value:
- ca. 68.8
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Assessment of Eye Irritation Potential – Viability of HCE Tissues
Material |
Individual Tissue Viability |
Mean OD540 |
% Viability |
Negative ControlÅ |
1.034 |
1.008 |
100* |
0.981 |
|||
Positive ControlÅ |
0.525 |
0.488 |
48.4 |
0.451 |
|||
Test Material |
0.793 |
0.693 |
68.8 |
0.593 |
* = The mean viability of the negative tissues is set at 100%
Å = Control group shared with another study
* = The mean viability of the negative tissues is set at 100%
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- 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 materials using the SkinEthic Reconstituted Human Corneal model (HCE, SkinEthic Laboratories) 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 by the test materials, 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 (OD540). Data are presented in the form of % viability (MTT conversion relative to negative controls).
The test material was classified according to the following criteria:
i) If the % relative mean tissue viability was ≥ 60% the test material was considered to be Non-Irritant (NI).
ii) If the % relative mean tissue viability was < 60% the test material was considered to be Irritant (I).
Results.
The relative mean viability of the test material treated tissues after a 10 minute exposure was 68.8%.
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.