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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 618-281-9 | CAS number: 895520-71-5
- 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:
- From 8 January 2004 to 29 March 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Adopted the : 24th April 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 618-281-9
- EC Number:
- 618-281-9
- Cas Number:
- 895520-71-5
- Molecular formula:
- C28 H29 N5 O5
- IUPAC Name:
- 618-281-9
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: E-699-2003
- Expiration date of the lot/batch: 1 July 2004
- Purity test date: 27 and 28 October 2003
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: white to light beige powder stored at approximately 20°C in a fume cupboard
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Crl: KBL (NZW) BR (N.Zeal.White)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Deutschland
- Age at study initiation:Not specified
- Weight at study initiation: 3.2 to 3.8 kg
- Housing: In fully air conditioned romms in separate cages arranged in a battery
- Diet (e.g. ad libitum):ssniff K-H (V2333), ad libitum and hay (15g daily)
- Water (e.g. ad libitum): tap water in plastic bottles ad libitum
- Acclimation period: 1 week under study conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 deg celsius
- Humidity (%): 50±20%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12h/12h
IN-LIFE DATES: From: 13 January 2004 To: 23 January 2004
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of DP-2
VEHICLE
No vehicle was used - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1 hours, 24 hours, 48 hours and 72 hours
- Number of animals or in vitro replicates:
- 3 animals were used
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): isotonic saline solution at 37 degree celsius
- Time after start of exposure: 24 hours
SCORING SYSTEM:
Cornea
Opacity: degree of density (readings should be taken from most dense area)*No ulceration or opacity.... 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible ................ 1
Easily discernible translucent area; details of iris slightly obscured ............................................................ 2
Nacrous area; no details of iris visible; size of pupil barely discernible ...................................................... 3
Opaque cornea; iris not discernible through the opacity .............................................................................. 4
* The area of corneal opacity should be noted
Iris
Normal .......................................................................................................................................................... 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia;
or injection; iris reactive to light (a sluggish reaction is considered to be an effect .................................. 1
Hemorrhage, gross destruction, or no reaction to light ................................................................................. 2
Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris)
Normal .......................................................................................................................................................... 0
Some blood vessels hyperaemic (injected) ................................................................................................... 1
Diffuse, crimson colour; individual vessels not easily discernible ............................................................... 2
Diffuse beefy red........................................................................................................................................... 3
Chemosis
Swelling (refers to lids and/or nictating membranes)
Normal .......................................................................................................................................................... 0
Some swelling above norma ......................................................................................................................... 1
Obvious swelling, with partial eversion of lids............................................................................................. 2
Swelling, with lids about half closed ............................................................................................................ 3
Swelling, with lids more than half closed ..................................................................................................... 4
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.44
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 0.33
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- From one hour up to 48 hours after administration the conjunctivae of the animals showed sporadically definitely hyperaemic blood vessels up to diffuse crimson color. Furthermore, the animals showed slight swellings one hour up to 24 hours after administration in two animals. 72 hours after administration all signs of irritation had disappeared.
Any other information on results incl. tables
Opacity of cornea |
All animals |
0.0 |
Iris |
All animals |
0.0 |
|
animal 1 |
0.0 |
|
animal 1 |
0.0 |
|
animal 2 |
0.0 |
|
animal 2 |
0.0 |
|
animal 3 |
0.0 |
|
animal 3 |
0.0 |
Redness of conjunctiva |
All animals |
0.44 |
Chemosis of conjunctiva |
All animals |
0.11 |
|
animal 1 |
1.00 |
|
animal 1 |
0.33 |
|
animal 2 |
0.33 |
|
animal 2 |
0.0 |
|
animal 3 |
0.0 |
|
animal 3 |
0.0 |
Applicant's summary and conclusion
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.