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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 269-412-8 | CAS number: 68238-92-6
- 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
- Remarks:
- source of read across
- Adequacy of study:
- key study
- Study period:
- From September 21 to October 04, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted February 24, 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes F-01400 Chatillon sur Chalaronne / France.
- Age at study initiation: 15 weeks old.
- Weight at study initiation: male ca 2.7 kg; females ca 2.7-2.8 kg.
- Housing: individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with wood and haysticks for gnawing.
- Diet: pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no.65/99).
- Water: community tap water from Füllinsdorf, ad libitum.
- Acclimation period: 5 days, under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
- Health check: the eyes of the animals were examined one day prior to test article administration. Animals with overt signs of ocular injury or irritation which may have interfered with the interpretation of the results were not used in the test.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Relative humidity: 40 - 70 %
- Air changes: 10-15 air changes per hour.
- Photoperiod: 12 hour light/dark cycle.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g/animal (left eye only).
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 1 male and 2 females
- Details on study design:
- OBSERVATIONS
- Viability/Mortality: daily from delivery of the animals to the termination of test.
- Clinical signs: daily from delivery of the animals to the termination of test.
- Body weights: at start of acclimatization, on the day of application and at termination of observation.
TOOL USED TO ASSESS SCORE: eye examinations were made with a Varta Cliptrix diagnostic-lamp (A. Riegger, Basel / Switzerland).
SCORING SYSTEM
The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC. July 31,1992 at approximately 1, 24, 48 and72 hours, as well as 7 days after administration.
When present, corrosion of and/or staining of sclera and cornea by the test article were recorded and reported.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 24 hours
- Irritant / corrosive response data:
- Application of the test article to healthy rabbit conjunctivae resulted in a primary irritation score of 0.56.
Hyperemic conjunctival blood vessels were noted in all animals at the 24-hour examination and persisted through 72 hours in one animal only. This latter was observed with a slight swelling of the conjunctivae at the 1-hour examination and with a slightly reddened sclera from the 24- to the 72-hour examination. Slight to moderate watery discharge was also observed in all animals at the 1-hour examination.
All eye reactions were reversible within 7 days after treatment.
Reddish-brown remnants in eye or conjunctival sac and around eye and/or on lids were observed until the 72-hour reading.
No corrosion of the cornea was observed at any of the reading times. - Other effects:
- VIABILTY/MORTALITY AND CLINICAL SIGNS
No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.
BODY WEIGHTS
The body weight of all rabbits were considered to be within the normal range of variability.
Any other information on results incl. tables
Individual reactions
Animal N. | Reaction | After | Mean 24/48/72 hrs | ||||
1 hr | 24 hrs | 48 hrs | 72 hrs | 7 days | |||
76 male | Corneal opacity | 0 | 0 | 0 | 0 | 0 | 0.00 |
77 female | Corneal opacity | 0 | 0 | 0 | 0 | 0 | 0.00 |
78 female | Corneal opacity | 0 | 0 | 0 | 0 | 0 | 0.00 |
76 male | Iris | 0 | 0 | 0 | 0 | 0 | 0.00 |
77 female | Iris | 0 | 0 | 0 | 0 | 0 | 0.00 |
78 female | Iris | 0 | 0 | 0 | 0 | 0 | 0.00 |
76 male | Coniunctivae redness | 0 | 1 | 0 | 0 | 0 | 0.33 |
77 female | Coniunctivae redness | 0 | 1 | 0 | 0 | 0 | 0.33 |
78 female | Coniunctivae redness | 0 | 1 | 1 | 1 | 0 | 1.00 |
76 male | Coniunctivae chemosis | 0 | 0 | 0 | 0 | 0 | 0.00 |
77 female | Coniunctivae chemosis | 1 | 0 | 0 | 0 | 0 | 0.00 |
78 female | Coniunctivae chemosis | 1 | 0 | 0 | 0 | 0 | 0.00 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- Non irritating
- Executive summary:
The primary irritation potential of test item was investigated by instillation of 0.1 g into one eye of each of three young adult New Zealand White rabbits. The treated eyes were not rinsed after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7 days after test article application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion.
The primary irritation score was calculated by totaling the individual cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of data points. The primary irritation score was 0.56 (max. 13). Hyperemic conjunctival blood vessels were noted in all animals at the 24-hour examination and persisted through 72 hours in one animal only. This latter was observed with a slight swelling of the conjunctivae at the 1-hour examination.
Reddish-brown rernnants in eye or conjunctival sac and around eye and/or on lids were observed until the 72-hour reading. All eye reactions were reversible within 7 days after treatment. No corrosion was observed at any of the measuring intervals.
Conclusion
The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and chemosis, in all the tested animals. All the reactions recorded were reversible within 7 days. Therefore, the substance does not meet the criteria to be classified as eye irritating, according to the CLP Regulation (EC) No 1272/2008.
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.