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Diss Factsheets
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EC number: 947-979-9 | 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:
- 2016-05-17 to 2016-05-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guidline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for the Testing of Chemicals No. 492: (Reconstructed human Cornea-like Epithelium (RhCE) test method)
- Qualifier:
- according to guideline
- Guideline:
- other: EURL ECVAM DB-ALM Method Summary No. 164: EpiOcular™ Eye Irritation Test - Summary
- Qualifier:
- according to guideline
- Guideline:
- other: EpiOcular™ Eye Irritation Test (OCL-200-EIT) For the prediction of acute ocular irritation of chemicals
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Germany)
Test material
- Reference substance name:
- Amines, N-C8-22-alkylpolytrimethylenepoly-, carboxymethyl derivs., sodium salts
- EC Number:
- 307-458-3
- EC Name:
- Amines, N-C8-22-alkylpolytrimethylenepoly-, carboxymethyl derivs., sodium salts
- Cas Number:
- 97659-53-5
- Details on test material:
- Name: Sodium oleylamphopolycarboxyglycinate
Common Name: AMPHOLAK XO7/C
Batch No.: 1297986
CAS No.: Active ingredient: CAS RN 97659-53-5
Aggregate State at RT: liquid
Active Components: 29.8% Sodium oleylamphopolycarboxyglycinate
59.8% Water
10.4% NaCl
Purity: 40% (Qualitatively estimated)
Stability: stable
Storage Conditions: room temperature
Expiry Date: 02 August 2017
Constituent 1
Test system
- Amount / concentration applied:
- 50 µL (undiluted)
- Duration of treatment / exposure:
- incubation: 30 min.
- Observation period (in vivo):
- post soak: 12 +/- 2 min.
post treatment: 120 min. - Details on study design:
- The test was performed on EpiOcular, a reconstituted three-dimensional human corneal epithelium model. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 30 min exposure period and 120 min post-treatment period and compared to those of the concurrent negative controls.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Mean Relative Tissue Viability [%] from two tissues
- Run / experiment:
- In-vitro Eye Irritation: Ocular Irritation Assay using the EpiOcular Human Tissue Model
- Value:
- 10.7
- Negative controls validity:
- valid
- Remarks:
- Aqua dest.
- Positive controls validity:
- valid
- Remarks:
- Methyl acetate
- Remarks on result:
- positive indication of irritation
Any other information on results incl. tables
The mixture of 50 µL test item per 1 mL MTT medium showed no reduction of MTT as compared to the solvent. The mixture turned to dark red, but not blue/purple.
Although the absorption spectra of the mixture showed a peak at 555 nm with an OD of 2.5296, the NSMTT was not determined since the viability of the test item treated tissues (TM) was below 60%.
The mixture of 50 µL test item per 1 mL A. dest. and per 2 mL isopropanol showed no colouring as compared to the solvent.Therefore, NSC equaled 0%.
Applicant's summary and conclusion
- Conclusions:
- In this study under the given conditions the test item showed irritant effects. The test item is classified as “irritant“ in accordance with UN GHS “Category 1” or “Category 2”.
- Executive summary:
Ocular irritation potential of the test item was predicted from the relative mean tissue viabilities compared to the negative control tissues concurrently treated with Aqua dest.
The test item showed irritant effects. The mean relative tissue viability (% negative control) was ≤ 60% (10.7%).
The controls confirmed the validity of the study. The mean absolute OD570of the two negative control tissues was> 0.8 and < 2.5 (2.082). The mean relative tissue viability (% negative control) of the positive control was < 50% (32.5%). The maximum inter tissue difference of replicate tissues of all dose groups was < 20% (0.1 – 9.4%).
This study is classified as acceptable. This study satisfies the requirement for OECD Guideline for the Testing of Chemicals No. 492: (Reconstructed human Cornea-like Epithelium (RhCE) test method).
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