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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 695-745-7 | CAS number: 1079221-49-0
- 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 06 Mar.2006 to 09 Mar.2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: the test substance was applied diluted at 10%
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
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 (incl. QA statement)
Test material
- Reference substance name:
- 2-({3-aminopyrazolo[1,5-a]pyridin-2-yl}oxy)ethan-1-ol hydrochloride
- EC Number:
- 695-745-7
- Cas Number:
- 1079221-49-0
- Molecular formula:
- C9 H11 N3 O2, ClH
- IUPAC Name:
- 2-({3-aminopyrazolo[1,5-a]pyridin-2-yl}oxy)ethan-1-ol hydrochloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: CEGAV breeding establishment - Les Hautes Noës, Saint Mars d0Egrenne, 61350 Passais la Conception, France
- Age at study initiation: Between 12 and 16 weeks at the start of the experiment
- Weight at study initiation: Between 2.9 kg and 3.3 kg at the start of the experiment
- Housing: Animals were housed individually in cages of standard size. Excreta were removed by unrolling plasticised brown paper, previously placed under cages. These cages were placed in an airconditioned (17- 21 ° C) animal house kept at between 45 % and 65 % relative humidity (except during the cleaning slot) in which non-recycled filtered air is changed approximately ten times per hour. The artificial day/night cycle was 12 hours light and 12 hours darkness with light on at 7.30 a.m.
- Diet (e.g. ad libitum): SDS/DIETEX STANRAB (P) SQC feed was available ad libitum. The criteria for acceptable levels of contaminants were within the limits of the analytical specifications established by the diet manufacturer.
- Water (e.g. ad libitum): Drinking water was available ad libitum in polycarbonate feeder bottles with a stainless steel nipple. A specimen of water is sent every 6 months to the Laboratoire Départemental d'Analyse du Cher - 216 rue Louis Mallet, 18014 Bourges Cedex, France - for analysis. The criteria for acceptable levels of contaminants in the water supplied were within the limits of the analytical
- Acclimation period:For at least 5 days before the treatment, in the area where the experiment took place.
ENVIRONMENTAL CONDITIONS, see above
IN-LIFE DATES: period not clearly mentionned, but according to study plan probabaly at the end of the 72h observation period.
Test system
- Vehicle:
- water
- Controls:
- other: The non-treated right eye was used as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit) and Concentration (if solution): As required by the guideline, 0.1 mL of the test item diluted at 10% in sterile water was instilled
VEHICLE
- Amount(s) applied (volume or weight with unit): see above
- Concentration (if solution):/
- Lot/batch no. (if required):/
- Purity:/ - Duration of treatment / exposure:
- 0.1 mL of the test item diluted at 10% in sterile water was introduced once only into the conjunctival sac of the left eye of each of the animals. The conjunctival sac was opened by gently pulling the lower lid away from the eyeball. Eyelids were held closed for approximately 1 second in order to avoid any loss of test item diluted at 10% in sterile water. The non-treated right eye was used as control. Following treatment, animals were kept for approximately one hour in a restraint cage, in order to prevent rubbing
of the eye. - Observation period (in vivo):
- Lesions of the conjunctiva, iris and cornea were monitored by direct examination. One hour, 24 hours, 48 hours and 72 hours approximately after the instillation of the test item diluted at 10% in sterile water, all possible conjunctival, iris or corneal lesions were evaluated on the left eye of each animal.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):No
- Time after start of exposure:/
SCORING SYSTEM: Ocular lesions were graded using the following scoring system in accordance with the OECD Guideline No. 405.
Calculation of ocular primary irritation indices: Mean indices were calculated from results obtained for each rabbit by direct examination at times 24 hours, 48 hours and 72 hours. The surface area of corneal opacity and the lacrimation were not taken into account in the calculation of mean index. For each parameter, mean of indices for each rabbit for the three times was noted (Mean index per parameter, per animal for the three times = Mi). The maximum theoretical score was 4 (chemosis), 3 (redness), 2 (iris lesions) and 4 (corneal lesions).
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: No, lesions of the conjunctiva, iris and cornea were monitored by direct examination
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72H
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72H
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72H
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72H
- Score:
- 0
- Irritant / corrosive response data:
- The application of the test item did not induce colouring of the application site and did not interfere with grading of any eye lesion.
Any conjunctival, iris and corneal lesion was evaluated approximately one hour, 24 hours, 48 hours and 72 hours after instillation of test item diluted at 10% in sterile water.
No ocular reaction was observed during the study on the three animals treated up to the end of the exposure time (i.e. at time 72 hours).
Mean scores calculated for each animal over 24, 48 and 72 hours were 0, 0 and 0 for chemosis, for redness of the conjunctiva, for iris lesions, and for corneal opacity.
Any other information on results incl. tables
Body weight (individual values in Kg)
Treatment | Animal number | Day 1 | Day 4 |
Test item diluted at 10% | 20060073 | 2.943 | 2.968 |
20060074 | 3.233 | 3.257 | |
20060075 | 3.160 | 3.191 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No ocular reaction was observed during the study on the three eyes of animals with the test susbtance applied at 10% in sterile water. Mean scores calculated for each animal over 24, 48 and 72 hours were 0, 0 and 0 for chemosis, for redness of the conjunctiva, for iris lesions, and for corneal opacity.
Under the experimental conditions adopted, the test item applied diluted at 10% in sterile water to rabbit eye was non-irritant. - Executive summary:
At the Sponsor's request, any irritant property and/or degree of corrosion of the test item diluted at 10% in sterile water was evaluated following a single ocular instillation in the rabbit in accordance with the General Requirements of O.E.C.D Guideline No. 405 (April 24, 2002) and method B5 of Commission Directive No. 92/69/EEC (July 31, 1992) adapting to technical progress for the 17th time Council Directive No. 67/548/EEC and subsequent amendments (GLP study, scored as validity 2 according to Klimisch criteria).
Three animals were used for the study. 0.1 mL of test item diluted at 10% in sterile water was introduced into the conjunctival sac of the left eye of each of the animals. The untreated right eye served as a control.
The application of the test item did not induce colouring of the application site and did not interfere with grading of any eye lesion.
Any conjunctival, iris and corneal lesion was evaluated approximately one hour, 24 hours, 48 hours and 72 hours after instillation of the test item diluted at 10% in sterile water.
No ocular reaction was observed during the study on the three animals treated up to the end of the exposure time (i.e. at time 72 hours). Mean scores calculated for each animal over 24, 48 and 72 hours were 0, 0 and 0 for chemosis, for redness of the conjunctiva, for iris lesions, and for corneal opacity.
Under the experimental conditions adopted, the test item applied diluted at 10% in sterile water to rabbit eye was non-irritant.
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.