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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | CAS number: -
- 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 July 24, 2002 to July 24, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Oligomerisation products of hexamethylene diisocyanate, isocyanurate type, reacted with 2-hydroxyethyl acrylate.
- IUPAC Name:
- Oligomerisation products of hexamethylene diisocyanate, isocyanurate type, reacted with 2-hydroxyethyl acrylate.
- Test material form:
- liquid
- Details on test material:
- CAS: 078567-28-9
Constituent 1
- Specific details on test material used for the study:
- CAS No.: 078567-28-9; Batch No.: WDJ 1853 D-3; Purity: 100 %; Appearance: yellowish liquid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- Species / strain / stock / breeder: rabbit / Himalayan / LPT Laboratory of Pharmacology and Toxicology KG branch Lohndorf, D-24601 Lohndorf/Post Wankendorf,
Number of animals examined: 3 male rabbits,
Initial age: approx. 4 - 5.5 months,
Body weight at start of study: 2.2 - 2.3 kg,
Identification: by tattooed number assigned by the Lohndorf breeding station and continuous number 1 - 3,
Duration of study: at least 20 adaptation days, 1 test day and a follow-up period of 72 hours,
Administration route: single instillation into the conjunctival sac.
Diet: ssniff K-H (ssniff Spezialdiaten GmbH, D-59494 Soest: Composition of the diet) served as food. The food was available ad libitum before and after the exposure period. At regular intervals (at least twice a year) the food is analysed for contaminants by AUA.
Drinking water: Tap water was offered ad libitum before and after the exposure period.
Samples of the drinking water are taken twice a year by the Wasserbeschaffungsverband Harburg, and are analysed according to the Deutsche Trinkwasserverordnung, Bundesgesetzblatt, 1990. In addition, drinking water samples taken at LPT are analysed by LUFA-ITL.
Housing: For 8 hours following test substance application, the animals were kept singly in special restrainers which allowed free movement of the head but prevented a complete body turn and wiping of the eyes.
During the acclimatisation period and after the 8-hour period in restrainers, the rabbits were kept separately in cages with dimensions of 425 mm x 600 mm x 380 mm at a room temperature of 20 °C ± 3 °C (maximum range). Relative humidity was 55 % ± 15 % (maximum range).
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Dose level: 0.1 mL/animal
- Duration of treatment / exposure:
- Based on most recent guidelines, the eye reactions are monitored until the changes observed have completely subsided, however not for more than 21 days after application.
- Observation period (in vivo):
- Animals that do not reveal any lesions anymore for 24 hours following the first 72 hours of observation are sacrificed.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- A dose of 0.1 ml of the test substance was administered into the conjunctival sac of the right eye of rabbits after gently pulling the lower lid away from the eyeball. The lid was then gently held together for about one second in order to prevent loss of test material. The left eye, which remained untreated, served as a control.
After the administration, the animals were kept separately in special restrainers which allowed free movement of the head but prevented a complete body turn, wiping of the eyes by the paws and excluded irritation of the eyes by excrements and urine.
Examination of the eyes: the eyes were examined ophthalmoscopically with a slit lamp prior to the administration and also 1, 24, 48 and 72 hours after the administration. The eye reactions were observed and registered.
Twenty-four (24) hours after administration, the eyes were treated additionally with fluorescein and examined. The effects observed were graded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Corneal opacity (grade 1) was observed in animal no. one 1 hour after instillation. The fluorescein test performed 24 hours after instillation did not reveal any pathological findings. The iris and conjunctivae were not affected by instillation of the test compound. There were no systemic intolerance reactions.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the test substance was not considered to be irritating to rabbit eye.
- Executive summary:
A study was conducted to determine the eye irritation potential of the test substance in male Himalayan rabbits according to OECD Guideline 405 and EU Method B.5. A dose of 0.1 mL of the test substance was administered into conjunctival sac of the right eye of the rabbits. The eyelid was then gently held together for about one second in order to prevent loss of test substance. The left eye, which remained untreated, served as a control. The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and at 1, 24, 48 and 72 h after the administration. 24 h after administration, the eyes were treated additionally with fluorescein and examined. The effects observed were graded. Under the study conditions, exposure to the test substance revealed the following effect only: Corneal opacity (grade 1) was observed in animal no. 1 at 1 h after instillation. The fluorescein test performed 24 h after instillation did not reveal any pathological findings. The iris and conjunctivae were not affected. There were no systemic intolerance reactions. Under the study conditions, the test substance was not considered to be irritating to rabbit eye (Leuschner, 2017).
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.