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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1992-07-27 to 1992-07-31
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP study in accordance with recognised test guideline but: Lot/batch No.: not stated Expiration date of the lot/batch: not stated NOTE: study deemed acceptable because spectral data for A-3622 are available, covering approximately before and after the test period - see section 1.4 Analytical Information.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Annex V (84/449/EEC) of the Sixth Amendment (79/831/EEC) to the European Communities Council Directive 67/548/EEC
- Deviations:
- no
- GLP compliance:
- yes
Test material
Constituent 1
- Specific details on test material used for the study:
- Physic State: off-white powder
Purity: approximately 100%
Storage Conditions: at ambient temperature, in the original container
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Rosemead Rabbits, Rosemead, Waltham Abbey, Essex, England
- Age at study initiation: approximately four to four and a half months old
- Weight at study initiation: bodyweights on the day of dosing were within the range 3.17 - 3.40 kg.
- Housing: individually in suspended stainless steel cages (Type RC10/L/TR6) mounted in mobile batteries (Modular Systems and Development Company Limited, London, England). The cages measured 61 x 76 x 46 cm high and were fitted with perforated counter-sunk floor panels. A tray beneath the floor was lined with absorbent paper which was changed regularly.
- Diet (e.g. ad libitum): free access to food hoppers containing standard pelleted rabbit diet, (S.Q.C. Rabbit Diet - Special Diets Services Limited, Witham, Essex, England). The diet contains no added antibiotic or other chemotherapeutic or prophylactic treatment.
- Water (e.g. ad libitum): free access to tap water taken from the public supply
- Acclimation period: The animals were held for a period of three weeks before administration of the test material.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C (range 15-23°C)
- Humidity (%): 55% R.H. (range 40%-70% R.H.)
- Air changes (per hr): 15 complete air changes per hour without re-circulation.
- Photoperiod (hrs dark / hrs light): lighting cycle of 12 hours artificial light per day.
IN-LIFE DATES: From: 27 July 1992 To: 31 July 1992
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
- Concentration (if solution): not applicable - Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
- Time after start of exposure: not done
SCORING SYSTEM:
Darize, Refer to Attached Background Information for details of the scoring system used.
TOOL USED TO ASSESS SCORE: ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: for all three animal tested
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: for all three animal tested
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: for all three animal tested
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: for all three animal tested
- Irritant / corrosive response data:
- Injection of the conjunctival blood vessels was observed in two rabbits one hour following instillation of test item, and continued in one animal at the 24 hour examination. A crimson-red conjunctival appearance and very slight chemosis and discharge were observed in the remaining rabbit at the one hour examination; injection of the conjunctival blood vessels persisted in this animal to the 48 hour assessment.
- Other effects:
- Instillation of the test material caused practically no initial pain response.
The eyes of all rabbits were overtly normal by the 72 hour examination.
Any other information on results incl. tables
Mean values for ocular lesions 24, 48 and 72 hours after instillation.
Animal number and sex |
Corneal opacity |
Iridial lesions |
Redness of Conjunctiva |
Chemosis |
27TK 332M
27TK 338M
27TK 340M
|
0.0
0.0
0.0
|
0.0
0.0
0.0
|
0.7
0.3
0.0
|
0.0
0.0
0.0 |
Individual scores for ocular irritation response:
Animal No. |
cornea opacity |
iris |
conjunctivae |
chemosis |
||||||||||||
1h |
24h |
48h |
72h |
1h |
24h |
48h |
72h |
1h |
24h |
48h |
72h |
1h |
24h |
48h |
72h |
|
27TK332M |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
1 |
0 |
1 |
0 |
0 |
0 |
27TK338M |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
27TK340M |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
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:
- Under the conditions of this test, the test item was classified as 'non-irritant' to the eye.
- Executive summary:
The potential of test item to cause damage to the conjunctiva, iris or cornea was assessed in three New Zealand White rabbits based on OECD 405, each subject to single ocular instillation of 100 mg of the test material. Ocular reactions were examined 1, 24, 48 and 72 hours after treatment. Injection of the conjunctival blood vessels was observed in two rabbits one and/or 24 hours following instillation. The third rabbit showed a crimson-red conjunctival appearance, slight chemosis and discharge at the one hour examination and injection of the conjunctival blood vessels up to the 48 hour assessment. The eyes of all rabbits were overtly normal by the 72 hour examination. Instillation of the test material caused practically no initial pain response. Under the conditions of this test, the test item was classified as 'non-irritant' to the eye.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)
Aunque la ECHA ofrece una gran cantidad de material en su idioma, una parte de esta página está solo disponible en inglés. Más información sobre la política de multilingüismo de la ECHA.
Bienvenido a la página web de la ECHA. Este sitio no es plenamente compatible con Explorer 7 (y versiones anteriores). Por favor, actualice su Internet Explorer a una versión más reciente.
Esta web utiliza cookies para mejorar su experiencia de navegación en nuestros sitios web.
Más información sobre el uso de cookies.