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EC number: 700-603-5 | CAS number: 908145-87-9
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 3 to 4 December 2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Some deviation to Good Lab Practices. Study director was not supplied with test article characterisation information. Therefore the effect of the lack of test article characterization cannot be fully assessed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,5-diethyl (2S)-2-{[4-(4-oxobutyl)phenyl]formamido}pentanedioate
- EC Number:
- 700-603-5
- Cas Number:
- 908145-87-9
- Molecular formula:
- C20 H27 N O6
- IUPAC Name:
- 1,5-diethyl (2S)-2-{[4-(4-oxobutyl)phenyl]formamido}pentanedioate
- Details on test material:
- Analytical purity - assume 100% potency
Lot Number Z84-H70580-095
Constituent 1
Test animals / tissue source
- Species:
- other: Bovine
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- This is an in vitro study. Bovine eyes were received from Spear Products on 4 December 2009.
Test system
- Vehicle:
- water
- Amount / concentration applied:
- Corneas were dosed with 0.75ml of a mixture of Intermediate 2945989 and MEM (Minimum Essential Media) solution. Constituents of the MEM solution are - MEM powder; sodium bicarbonate; L-Glutamine; Fetal Bovine serum & distilled water.
- Duration of treatment / exposure:
- Four hours + 90 minutes
- Observation period (in vivo):
- two hours
- Number of animals or in vitro replicates:
- n/a this is an in vitro study
- Details on study design:
- Two corneas were dosed only with the MEM solution to act as controls and placed in an incubator at 32oC. The Intermediate 2945989 MEM solution mixture was applied to five test corneas, which were also placed in an incubator. After four hours both the controls and the test articles were washed with pure MEM solution so that opacity measurements could be taken.
Sodium fluorescein dye in a phosphate buffered saline was then applied to both the controls and test corneas, which were placed in the incubator at 32oC for a further 90 minutes. Optical density of the fluid removed from the cornea holders of both the controls and test articles was measured using a spectrophotometric analysis.
The corrected mean opacity score was calculated using the control and treated cornea opacity values as determined from the OP-KIT. The corrected Mean Optical Density Score was calculated using the control and treated Opacity Density Values from the fluorescein permeability analysis. The in vitro score was calculated as follows:
In Vitro Score = Corrected Mean Opacity Score + 15 (Corrected Mean Optical Density Score)
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: In vitro score
- Score:
- ca. 1.97
- Reversibility:
- not specified
- Remarks on result:
- other: General classification scheme of Gautheron et al. (1992)
- Irritant / corrosive response data:
- Corrected mean opacity score was 1.5.
Corrected mean optical density (permeability) score was 0.031.
Therefore the in vitro score was calculated as 1.97 - Other effects:
- No other additional effects were observed during the course of this study.
Any other information on results incl. tables
Results after treatment with the test substance:
Cornea # |
O.D. Scores |
Control Score |
Corrected O.D. Score |
|
1 |
0.025 |
0.018 |
0.007 |
|
2 |
0.125 |
0.018 |
0.107 |
|
3 |
0.028 |
0.018 |
0.010 |
|
4 |
0.034 |
0.018 |
0.016 |
|
5 |
0.031 |
0.018 |
0.013 |
|
Corrected Mean Optical Density Score= |
0.031 |
|||
Corrected Mean Opacity Score = |
1.5 |
|||
Calculated In Vitro Score 1.5 + 15 (0.031) = 1.97 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: General classification scheme of Gautheron et al. (1992)
- Conclusions:
- Under the experimental conditions of this study, Intermediate 2945989, is considered non-irritating to the eyes.
- Executive summary:
Five corneas were dosed with 0.75 ml of a 20% suspension of Compound 2945989, Lot# Z84-H70580-095. Opacity measurements and sodium fluorescein permeability were determined.
The corrected mean opacity score was 1.5. The corrected mean optical density (permeability) score was 0.031.
The in vitro score was calculated as 1.97, therefore Compound 2945989, Lot# Z84-H70580-095 is considered to be non-irritating.
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