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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 255-490-0 | CAS number: 41672-81-5
- 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:
- 2007-12-11 to 2008-03-03
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- trans-1-(1-oxohexadecyl)-4-[(1-oxohexadecyl)oxy]-L-proline
- EC Number:
- 255-490-0
- EC Name:
- trans-1-(1-oxohexadecyl)-4-[(1-oxohexadecyl)oxy]-L-proline
- Cas Number:
- 41672-81-5
- Molecular formula:
- C37H69NO5
- IUPAC Name:
- 1-palmitoyl-4-(palmitoyloxy)-L-proline
- Details on test material:
- - form: powder
- colour : white
- batch number: 0724300010
- re-test date: 2010-08-30
- storage: room temperatue
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Three male albino New Zealand rabbits were supplied by the Elevage de Gérome (Quartier Labaste –F40260 Linxe). They were kept during a minimal 5-day acclimatisation period. During the test, the animals weighed between 2.99 kg and 3.45 kg. At the beginning of the test, the animals were 13 to 14 weeks old.
Each animal was kept in an individual box installed in conventional air conditioned animal
husbanding; the environmental conditions were:
- temperature : between 19°C and 22°C
- relative humidity : between 40% and 67%
- lighting time: 12 hours daily
Drinking water (tap-water from public distribution system) and foodstuff were supplied freely.
Microbiological and chemical analyses of the water were carried out once every six months by the Institut Européen de l'Environnement de Bordeaux (I.E.E.B.).
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 g of the test item was instilled into the conjunctival sac of one eye.
- Duration of treatment / exposure:
- One instillation, no rinsing.
- Observation period (in vivo):
- observation until 7 days after the instillation
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- After the 5-day acclimation period of the animals, 0.1 g of the test item was instilled into the conjunctival sac of one eye. The other eye remained untreated serving as control. Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal at D7, two additional animals were treated.
Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment according to the following s
Eye examinations are carried out using the scale of lesion scores in the following scale :
CHEMOSIS (A)
• No swelling .................................................................................................................................. 0
• Slight swelling, including the nictitating membrane.............................................................. 1
• Swelling with eversion of the eyelid ......................................................................................... 2
• Swelling with eyelid half-closed ............................................................................................... 3
• Swelling with eyelid more than half-closed ............................................................................ 4
DISCHARGE (B)
• No discharge ............................................................................................................................... 0
• Slight discharge (normal slight secretions in the inner corner not to be
taken into account) ........................................................................................................................ 1
• Discharge with moistening of the eyelids and neighbouring hairs..................................... 2
• Discharge with moistening of the eyelids and large areas around the eye........................ 3
REDNESS (C)
• Blood vessels normal ...................................................................................... ........................... 0
• Vessels significantly more prominent than normal ............................................................... 1
• Vessels individually distinguishable with difficulty
- Generalised red coloration....................................................................... ................................ 2
- Generalised deep red coloration ........................................................................... ................... 3
IRIS (D)
• Normal ....................................................................................................................... .................. 0
• Iris significantly more wrinkled than normal, congestion,
swelling of the iris which continues to react to light, even slowly............................................ 1
• No reaction to light, haemorrhage, significant damage
(any or all of these characteristics)................................................................................................ 2
CORNEA: DEGREE OF OPACITY (E)
• No modification visible either directly or after
instillation of fluorescein (no loss of glint or polish) .................................................................... 0
• Translucent areas (diffuse or disseminated), iris details clearly visible .................. ............... 1
• Easily identifiable translucent area, iris details slightly obscured............................................. 2
• Opalescent area, no iris details visible, pupil outline scarcely distinguishable ...................... 3
• Total corneal opacity, completely obscuring the iris and pupil................................................. 4
CORNEA: EXTENT OF OPACITY (F)
• Opaque area present but covering one quarter or less............................................ ............... 1
• Between one quarter and half................................................................................................ ........ 2
• Between half and three quarters .................................................................................................... 3
• Between three quarters and the entire surface............................................................................. 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 1.23
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.23
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 1.57
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The ocular reactions observed during the study have been slight to moderate, and totally reversible in the three animals:
- at the conjunctivae level: a slight to moderate redness, noted 24 hours after the test item instillation and totally reversible between D6 and D9, associated with a slight to moderate chemosis, noted 1 hour after the test item instillation and totally reversible between D4 and D7,
- at the corneal level: a moderate opacity, registered 24 hours after the test item instillation and totally reversible between D4 and D21,
- at the iris level: a congestion noted between D2 and D4 in one animal.
It was noted in one animal a corneal neo-vascularisation between D2 and D4. Moreover, it was noted a whitish secretion, requiring a physiological saline rinse, in only one animal at D2.
Any other information on results incl. tables
The results obtained, under these experimental conditions, enable to conclude that the test substance: - is moderately irritant for the eye (Max. O.I = 20.0) according to the classification established in the Journal Officiel de la République Française dated July 10th, 1992. - and, must not be classified according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directive n° 67/548, 2001/59 and 99/45. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must be classified in category 2 “Irritating to eye”. The signal word “Warning” and hazard statement H319 “Causes serious eye irritation” are required.
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results obtained, under these experimental conditions, enable to conclude that the test substance:
- is moderately irritant for the eye (Max. O.I = 20.0) according to the classification established in the Journal Officiel de la République Française dated July 10th, 1992.
- and, must not be classified according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directive n° 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must be classified in category 2 “Irritating to eye”. The signal word “Warning” and hazard statement H319 “Causes serious eye irritation” are required. - Executive summary:
The results obtained, under these experimental conditions, enable to conclude that the test substance: - is moderately irritant for the eye (Max. O.I = 20.0) according to the classification established in the Journal Officiel de la République Française dated July 10th, 1992. - and, must not be classified according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directive n° 67/548, 2001/59 and 99/45. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must be classified in category 2 “Irritating to eye”. The signal word “Warning” and hazard statement H319 “Causes serious eye irritation” are required.
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.