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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 700-938-7 | CAS number: 72716-26-8
- 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:
- 26 April 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- potassium (2S)-4-carboxy-2-tetradecanamidobutanoate
- EC Number:
- 700-938-7
- Cas Number:
- 72716-26-8
- Molecular formula:
- C19H34NO5K
- IUPAC Name:
- potassium (2S)-4-carboxy-2-tetradecanamidobutanoate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Physical state: White to pale yellow powder, slightly characteristic odour.
- Storage condition of test material: Room temperature.
Constituent 1
Test animals / tissue source
- Species:
- chicken
- Strain:
- other: Ross 308
- Details on test animals or tissues and environmental conditions:
- Eye Samples:
- Species of chicken: Ross 308.
- Source: Taravis KFT. 9600 Sárvár, Rábasömjéni út. 129.
- Method: Chicken heads were collected after slaughter in a commercial abattoir from chickens which are used for human consumption. Heads were transported at ambient temperature. After collection, the heads were inspected for appropriate quality and wrapped with tissue paper moistened with saline, then stored in a closed plastic box (4-5 heads per box).
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 mg - Duration of treatment / exposure:
- Single application, removed after 10 seconds.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- mean
- Value:
- 2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- mean
- Value:
- 2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- mean up to 75 minutes
- Value:
- 1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- mean up to 240 minutes
- Value:
- 1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The results suggest that the test material is moderately irritating but not a severe irritant.
Controls:
The positive control imidazole was classed as severely irritating.
The negative control Sodium chloride (Salsol solution 0.9%) had no significant effects on the chicken eye in this study.
Any other information on results incl. tables
Table 4: Test Material Results
Observations |
Value |
ICE Class |
Mean maximum corneal swelling at up to 75 min |
1 % |
I |
Mean maximum corneal swelling at up to 240 min |
1 % |
I |
Mean maximum corneal opacity |
2.00 |
III |
Mean fluorescein retention |
2.00 |
III |
Other Observations |
The test material was stuck on the cornea surface after the post-treatment rinse. All corneal surfaces were cleared 75 minutes after the post-treatment rinse. |
|
Overall ICE Class |
1 x I, 2 x III |
Table 5: Positive Control Results
Observations |
Value |
ICE Class |
Mean maximum corneal swelling at up to 75 min |
3 % |
I |
Mean maximum corneal swelling at up to 240 min |
8 % |
II |
Mean maximum corneal opacity |
4.00 |
IV |
Mean fluorescein retention |
2.83 |
IV |
Other Observations |
The Imidazole was stuck on the cornea surface after the post treatment rinse. The cornea surface was not cleared 240 minutes after the post-treatment rinse. |
|
Overall ICE Class |
1 x II 2 x IV |
Table 6: Negative Control Results
Observations |
Value |
ICE Class |
Mean maximum corneal swelling at up to 75 min |
0 % |
I |
Mean maximum corneal swelling at up to 240 min |
0 % |
I |
Mean maximum corneal opacity |
0.00 |
I |
Mean fluorescein retention |
0.00 |
I |
Other Observations |
None |
|
Overall ICE Class |
3 x I |
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating according to EU criteria
- Conclusions:
- Under the conditions of the test, the results suggest that the test material is moderately irritating.
- Executive summary:
An in vitro eye irritation study in isolated chicken eyes was conducted under GLP conditions and according to the OECD guideline 438 and EU Method B.48 to determine if the test material caused corrosion or severe eye irritation. Three chicken eyes were exposed to the test material (30 mg) for 10 seconds, rinsed with isotonic saline, and then assessed for irritation at intervals for up to 240 minutes. Toxic effects to the cornea were measured by a qualitative assessment of opacity, damage to epithelium based on application of fluorescein to the eye (fluorescein retention), and measurement of cornea thickness (swelling). Damage was assessed individually and then combined to derive an Eye Irritancy Classification. Positive and negative controls were run concurrently to assess the viability of the test system.
Under the conditions of the study, exposure to the test material resulted in an overall ICE class of 1 x I and 2 x III, which corresponds to a classification of moderately irritating in accordance with the OECD guideline. The results suggest that the test material is moderately irritating, but should not be classified as a severe eye irritant.
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.