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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 245-224-1 | CAS number: 22794-26-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Protocol published at official journal of French Republic (Official journal of 24 october 1984)
- Version / remarks:
- Protocol has some similarities with OECD guideline 405.
- Deviations:
- not specified
- Principles of method if other than guideline:
- Unique instillation of a precise dose of the product in right conjunctival sac of 6 animals, left eye is acting as control.
Animals are observed at 1 hour, D1, D2, D3 up to D7.
If no reaction is visible at D2, the observation is stopped at D3.
Calculation of the ocular index after summing according to the scale in the following charts for each animal on the cornea, iris, cunjunctive areas. - GLP compliance:
- no
- Remarks:
- GLP not mandatory at this date
Test material
- Reference substance name:
- Dodecyl 5-oxo-L-prolinate
- EC Number:
- 245-224-1
- EC Name:
- Dodecyl 5-oxo-L-prolinate
- Cas Number:
- 22794-26-9
- Molecular formula:
- C17H31NO3
- IUPAC Name:
- dodecyl 5-oxo-L-prolinate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- 6 mâle New-Zealand breed rabbits with perfect eyes state with an average weight about 2.5, 3 Kgs from : Elevage Scientifique D es Dombes (C.E.G.A.V.).
Aniamls are placed in sanitary quarantine during at least one week prior to every experimentation.
The animals are housed in individual plastic standardised cages.
The premises are under air pressure with renewing cycles of 3000 cubic meter/ hour.
The illumination period is electronically regulated providing 12 hours of daylight every day.
Water is supllied "ad libidum"
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 1 hour after treatment until Day-7
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): eyes were not rinsed
TOOL USED TO ASSESS SCORE: ophtalmoscop
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.28
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.28
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- not specified
- Irritant / corrosive response data:
- At 48h, the following results are obtained :
- A corneal opacity mean score >=1.0 was observed in 3 animals
- A conjunctival redness (enanthema) mean score >= 2.0 was observed in all animals
- A conjunctival oedema (chemosis) mean score >= 2.0 was observed only in 1 animal
Effects are fully reversible within on Day-5
The OI (Ocular Index) max has a value of 40, whereas the O.I.48h has a value of 12.66
According to criteria set in the official journal of French Republic (Official journal of 24 october 1984) the test item Lauryle Pidolate is considered as irritating.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The product examined in ocular instillation according to the described protocol, in normal use conditions, undiluted, provokes specific significant medium value irritative injuries of the ocular mucous membrane.
Under tests conditions, the test item Lauryle Pidolate is considered as irritating and required a classification as Eye. Irrit. cat.2, H319 based on redness of conjonctiva according to CLP regulation.
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.