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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 404-110-3 | 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 11 Apr 1989 to 14 Apr 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 405), according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (adopted 24 February 1987)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- (Commission Directive 84/449/EEC, adopted 25 April 1984)
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.3-2.9 kg
- Housing: individually
- Diet: Altromin 2123 husbandry diet - rabbit (Altromin, Lage/Lippe), ad libitum, plus hay (about 15g/day)
- Water: deionised, chlorinated water, ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as internal control
- Amount / concentration applied:
- 100 mg/eye
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Washing with physiological saline at approx. 37 °C 24 h after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution (24 and 72 h after administration) took place
- Time after start of exposure: 24 h
SCORING SYSTEM: according to guideline
TOOL USED TO ASSESS SCORE: 0.01 % solution of fluorescein sodium, under UV light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- all three animals
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all three animals
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all three animals
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all three animals
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not relevant since no effects
- Irritant / corrosive response data:
- Slight conjunctivae redness was observed in all animals one hour after application, but was no longer detectable in two animals at the 24 h reading. Only one animal revealed conjunctivae redness at the 24 h reading, but not at later time points (for details see table below). Chemosis (score 1 or 2) was observed in all animals one hour after application of the test item, but not at later time points. Iris and cornea were not affected.
A black discharge was observed in all animals at the 1 h reading. Diffuse crimson coloured conjunctivae was observed in one animal at 24 hours. No signs of irritation were apparent after 48 hours.
Any other information on results incl. tables
Time point after application |
1 h |
24 h |
48 h |
72 h |
||||||||
Animal no. |
#1 |
#2 |
#3 |
#1 |
#2 |
#3 |
#1 |
#2 |
#3 |
#1 |
#2 |
#3 |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae redness |
1 |
1 |
1 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Chemosis |
1 |
2 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was not irritating to the eyes of rabbits under the conditions of this test.
- Executive summary:
The primary irritation potential of the test item was investigated by instillation of 0.1 g into one eye of each of three young adult New Zealand White rabbits according to OECD TG 405 (adopted 24 February 1987) and GLP. The treated eyes were rinsed with distilled water approximately 24 hours after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test article application.
Slight conjunctivae redness was observed in all animals one hour after application, but was no longer detectable in two animals at the 24 h reading. Only one animal revealed conjunctivae redness at the 24 h reading, but not at later time points. Chemosis (score 1 or 2) was observed in all animals one hour after application of the test item, but not at later time points. Iris and cornea were not affected. A black discharge was observed in all animals at the 1 h reading. Diffuse crimson coloured conjunctivae was observed in one animal at 24 hours. No effects were observed at the 48 h and 72 h reading. Due to the only sligth, reversible effects observed under the conditions of this test the test item was judged not to be irritating to the eyes.
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.