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EC number: 800-766-3 | CAS number: 1424148-97-9
- 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:
- 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study; well-performed and well-documented; the test material contained the registration substance by 40%.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- sodium/triethanolamine- 6-(2,5-dioxo-3-C12-18-alkenyl(even and odd, branched, unsaturated)-pyrrolidin-1-yl)hexanoate
- EC Number:
- 800-766-3
- Cas Number:
- 1424148-97-9
- Molecular formula:
- C22H36NO4.1/2Na.1/2C6H16NO3 - C28H48NO4.1/2Na.1/2C6H16NO3
- IUPAC Name:
- sodium/triethanolamine- 6-(2,5-dioxo-3-C12-18-alkenyl(even and odd, branched, unsaturated)-pyrrolidin-1-yl)hexanoate
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- The test meterial contained the registration substanceby ca. 40%. The remaining components were teak oil, oleyl alcohol, polypropylen, and water.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- About 24 hours before the start of the study the test eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01% fluorescein-sodium solution. Only animals without ocular abnormalities were used for the study.
0.1 ml of the test substance was applied once to the conjuctival sac of the left eye of 3 rabbits. The untreated eyes served in each case as a control.
24 hours after application and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with flourescein-sodium solution took place, the treated eyes were washed out thoroughly with physiological saline at approx. 37°C.
The eyes were examined 1, 24, 48 and 72 hours after applicaiton of the test substance. At 24 and 72 hours as well as after 7 days, the eyes were also examined for corneal leions under UV light after instillation of one drop of 0.01% fluorescein-sodium solution. Lesions in cornea, iris or conjuctivae were graded numerically. All other changes or toxic effects were recorded. Since effects were still present in the eyes of two animals after 72 hours, further examinations were carried out after 7 days.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.4
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.4
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: The values for individual animals were 1.0, 2.7, and 2.3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.9
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The eye irritation potential was investigated according to the OECD Guideline 405. The test material contained the registration substance by 40 %.
The outcome of the study corresponded to "not irritating" for the test material according to DSD 67/548/EEC. Taking account that the corresponding acid is not an irritant to eyes and no local effect was observed in the combined repeated dose and reproductive/developmental toxicity screening (OECD 422), the registraton substance is assessed to be of "not irritating".
No classification is warranted. - Executive summary:
The eye irritation potential was investigated according to the OECD Guideline 405. The test material contained the registration substance by 40 %.
The outcome of the study corresponds to "not irritating" for the test material according to DSD 67/548/EEC, whereas further evidences were considered to be necessary, because obtained scores for conjunctiva redness were near to the borderline to "irritating".
Further evidences included:
- the scores obtained for cornea, iris and chemosis were clearly indicative of "not irritating",
- the effects were fully reversible within the observation period of 7 days,
- the corresponding acid was investigated at higher concentration (> 80%) and was not irritating,
- no local effect was observed in the combined repeated dose and reproductive/developmental toxicity that were performed with the registration substance.
Taking account of the all aspects, the registration substance is assessed as "not irritating" to eyes. No classification is warranted.
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