Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 947-819-8 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 405
- GLP compliance:
- yes
Test material
- Reference substance name:
- Iodo-tris(triphenylphosphine)copper(I)
- EC Number:
- 454-330-9
- EC Name:
- Iodo-tris(triphenylphosphine)copper(I)
- Cas Number:
- 15709-82-7
- Molecular formula:
- Hill formula: C54H45CuIP3 CAS formula: C54H45CuIP3
- IUPAC Name:
- Iodo-tris(triphenylphosphine)copper(I)
- Details on test material:
- Nature of substance: Puder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 219001
- Expiration date of the lot/batch: January 01 , 2004
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: dry, room temperature, closed container
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Species / Strain: Rabbits
breed: White New Zealanders (SPF Crl:NZW)
Rationale: The rabbit is the preferred species for acute eye irritation/corrosion studies and is acceptable to regulatory authorities.
Sex: male
Supplier: Charles River Wiga GmbH, D-97320 Sulzfeld
Hygiene status upon supply: SPF
Acclimatisation: The animals were housed 3 weeks before administration to the housing conditions of the test facility. In this time no signs were observed which indicated illness or other injury.
Body weight in g: 2.878 at the start of the study to 2.977 at the conclusion of the study (average values)
Identification: cage labelling showing the animal number, study number, time of dosing
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The test was carried out with three rabbits.
Both eyes of each animal were examined approximately 24 hours before testing. Two to three drops of a fluorescein sodium solution (0.5 % in deionised water) were instilled into the conjunctival sac and rinsed out again after 30 sec with deionised water. No ocular defects were observed in any of the animals.
0.1 g of the test item were instilled into the conjunctival sac of one eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then held together gently for some seconds in order to prevent loss of the material.
The other eye of the same animal, which remained untreated, served as control.
Administration was performed on February 11th, 2003 , 7.46 - 7.49 a.m.
After an exposure period of 24 hours the treated eyes were rinsed out with deionised water carefully.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 2 days
- Other effects:
- No systemic effects.
Any other information on results incl. tables
Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- not irritating
- Executive summary:
The acute eye irritation/corrosion of the substance was tested in three albino rabbits.
The test item was instilled as the original substance after crushing with a pestle and mortar to a fine dust at a single dose of O.1 g to one of the eyes in each animal. The untreated eye was used for control.
The animals were examined for clinical signs and the eyes were examined for lesions of the conjunctivae, cornea and iris 60 minutes, 24, 48 and 72 hours after instillation of the test item. The grades for ocular lesions were recorded in accordance with the mentioned guideline.
The instillation of the test item caused a slight redness of the conjunctivae in all animals and a slight swelling of the conjunctivae in one animal on the day of instillation. A slight redness of the conjunctivae was observed in one animal one day thereafter too.
The cornea and the iris were not affected.
48 hours after instillation no signs of irritations were observed.
None of the animals died or showed clinical signs during the course of testing.
The alterations of the eyes after instillation of the substance do not meet the criteria for
classification of a substance as an eye 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.
