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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 430-900-2 | CAS number: 192725-50-1
- 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:
- 17 September 1997 - 06 February 1998
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 92/69/EEC
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 430-900-2
- EC Name:
- -
- Cas Number:
- 192725-50-1
- Molecular formula:
- Hill formula: C9H16N2O3 CAS formula: C9H16N2O3
- IUPAC Name:
- 3-methyl-2-(2-oxo-1,3-diazinan-1-yl)butanoic acid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Six male rabbits from Covance Research Products Inc, Kalamazoo, Michigan weighing 2- 2.5 kg (approx. 14 weeks old) on arrival were allowed to acclimatise for 14 days before treatment. 5 animals were assigned to the study.
The animals were housed in individual stainless steel ventilated hanging cages. 100 -130g Certified High Fibre Rabbit Chow was provided each day and water ad libitum. The temperature was maintained at 67 - 70°F. The animal room was on a 12 hour daily light cycle.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other: right eye of each animal was untreated
- Amount / concentration applied:
- 53mg (which, when gently compacted, occupied approx.0.1ml)
- Duration of treatment / exposure:
- 53mg test material was instilled into the lower everted lid of the left eye. The material was placed in the conjuctival sac of the left eye after gently pulling the lower eye lid away from the eyeball. The upper and lower eyelid were held closed for about one or two second after treatment to prevent loose of material and then released. The right eye was left untreated to serve as the control.
- Observation period (in vivo):
- After the 24hr observation period the eyes of all rabbits were washed with lukewarm water.
All animals were observed daily forsurvival and general body condition.
Evaluations made at 1, 24, 48, 72 hrs and days 4, 7, 14 and 21 after treatments. - Number of animals or in vitro replicates:
- 5 male rabbits
- Details on study design:
- Prior to treatment the eyes were checked by a veterinarian.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: na
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: max irritation observed
- Score:
- > 1 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: na
- Score:
- >= 2 - <= 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: na
- Score:
- >= 2 - <= 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: na
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: na
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 21 d
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 21 d
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 21 d
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 21 d
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 21 d
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritant / corrosive response data:
- The maximum irritation grades observed in the treated eye of rabbits in this study were: corneal opacity (grades 1 or 2), involving at least ¾ of the cornea was observed in the treated eye of 3 rabbits; iritis (grade 1), in 1 of the above 3 rabbits; conjunctival redness (grades 2 or 3), conjunctival chemosis (grades 2, 3 or 4) and conjuctival discharge (grades 2 or 3).
Signs of irritation were completely reversible by 72 hrs after initial instillation in two rabbits and by day 7 in a third rabbit.
Corneal opacity (grade 1), conjunctival chemosis (grade 1) and conjunctival discharge (grade 1) were observed in the eye of the remaining 2 rabbits on day 21. In addition, grade 1 conjunctival redness wase noted in one of the same two rabbits on day 21.
Any other information on results incl. tables
Body weights ranged from 2.2 to 2.6kg on the day of treatment. No apparent treatment-related body weight changes were observed during the observation period following treatment.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information
- Conclusions:
- Abbott-164220 produced irritation in the treated eye of rabbits in this study.
- Executive summary:
Abbott-164220 produced irritation in the eye of rabbits in this study.
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.