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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 943-016-1 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994-12-06 - 1995-04-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Scientifically valid GLP study on the registered substance itself according to US EPA guideline 81-4.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction Products of Diphosphorus Pentaoxide with n-Alcohols, C8-10 (even), salted with Amines, C12-14, Tert-alkyl
- EC Number:
- 943-016-1
- Molecular formula:
- Too complex
- IUPAC Name:
- Reaction Products of Diphosphorus Pentaoxide with n-Alcohols, C8-10 (even), salted with Amines, C12-14, Tert-alkyl
- Test material form:
- other: liquid
- Details on test material:
- - Substance type: pure substance
- Storage condition of test material: Room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN, USA
- Age at study initiation: adult
- Weight at study initiation: approx. 2.0 - 3.5 kg
- Housing: The animals were housed individually in suspended stainless steel cages. All housing and care were based on the standards recommended by the Guide for the Care and Use of Laboratory Animals
- Diet (e.g. ad libitum): Purina Certified Rabbit Chow #5322 was provided ad libitum to the animals throughout the study.
- Water (e.g. ad libitum): Municipal tap water treated by reverse osmosis was available to the animals ad libitum throughout the study.
- Acclimation period: Min. 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 65-70°F (18.3-21.1°C)
- Humidity (%): 21-69%
- Air changes (per hr): 10-12 / h
- Photoperiod (hrs dark / hrs light): 12h / 12h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated contralateral eye of each animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml - Duration of treatment / exposure:
- single instillation, no wash-out
- Observation period (in vivo):
- at least 14 days
- Number of animals or in vitro replicates:
- 6 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
wash-out after 24h during examination with fluorescein
SCORING SYSTEM:
Ocular Grading System based on Draize method, See table 1
TOOL USED TO ASSESS SCORE: auxiliary light source, fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: ocular tissue irritation
- Remarks on result:
- other: severe irritant, see "Any other information on results incl. tables"
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 36.67
- Max. score:
- 39
- Reversibility:
- fully reversible within: 21 days in 5/6 eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 55
- Max. score:
- 61
- Reversibility:
- fully reversible within: 21 days in 5/6 eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 39.33
- Max. score:
- 55
- Reversibility:
- fully reversible within: 21 days in 5/6 eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 31.5
- Max. score:
- 55
- Reversibility:
- fully reversible within: 21 days in 5/6 eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 4 days
- Score:
- 20.83
- Max. score:
- 55
- Reversibility:
- fully reversible within: 21 days in 5/6 eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 12.17
- Max. score:
- 46
- Reversibility:
- fully reversible within: 21 days in 5/6 eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 10 days
- Score:
- 7.83
- Max. score:
- 34
- Reversibility:
- fully reversible within: 21 days in 5/6 eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 14 days
- Score:
- 2
- Max. score:
- 12
- Reversibility:
- fully reversible within: 21 days in 5/6 eyes
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 21 days
- Score:
- 1.67
- Max. score:
- 10
- Reversibility:
- fully reversible within: 21 days in 5/6 eyes
- Irritation parameter:
- cornea opacity score
- Remarks:
- corneal opacity
- Basis:
- mean
- Score:
- 2
- Reversibility:
- fully reversible within: 21 days in 5/6 eyes
- Remarks on result:
- other: irritant, see "Any other information on results incl. tables"
- Irritation parameter:
- iris score
- Remarks:
- iris lesions
- Basis:
- mean
- Score:
- 0.5
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: nonirritant, see "Any other information on results incl. tables"
- Irritation parameter:
- conjunctivae score
- Remarks:
- conjunctival redness
- Basis:
- mean
- Score:
- 2.11
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: nonirritant, see "Any other information on results incl. tables"
- Irritation parameter:
- chemosis score
- Remarks:
- conjunctival edema
- Basis:
- mean
- Score:
- 1.22
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: nonirritant, see "Any other information on results incl. tables"
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Exposure to the test article produced corneal opacity in 6/6 test eyes at the 1 hour scoring interval. The corneal opacity was confirmed by positive fluorescein dye retention at the 24 hour scoring interval. The corneal opacity resolved completely in 5/6 test eyes by study day 21. Iritis was noted in 6/6 test eyes at the 1 hour scoring interval. The iridal irritation resolved completely in all animals by study day 7. Conjunctivitis (redness, swelling and discharge) was noted in 6/6 test eyes at the 1 hour scoring interval. The conjunctival irritation resolved completely in all animals by study day 21. Additional ocular findings included sloughing, corneal neovascularization and raised area on the cornea, which were noted in 4/6, 2/6 and 1/6 test eyes, respectively.
A normal background finding of superficial stippling was observed in 1 /6 test eyes during the fluorescein examination. This finding was transient and was not considered significant. No corneal opacity, iritis or conjunctivitis was observed in the control eyes.
See "Any other information on results incl. tables" for further information.
Any other information on results incl. tables
See Attachment.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The study is well-documented and was performed according to EPA OPP 81-4 (Acute Eye Irritation), under GLP conditions. Hence, the information provided in the report can be considered reliable. In consequence, the results are suitable for the assessment of the acute dermal irritation potential of the test item. According to the Ocular Evaluation Criteria, the test item is considered to be a severe irritant to the ocular tissue of the rabbit. According to the EEC Ocular Evaluation Criteria, the test item is considered to be an irritant for corneal opacity, a nonirritant for iris lesion, a nonirritant for conjunctival redness and a nonirritant for conjunctival edema.
- Executive summary:
In a primary eye irritation study (EPA OPP 81-4), young adult New Zealand White rabbits (6 females) were exposed to 0.1 ml of the undiluted test item via single instillation into the conjunctival sac with wash-out after 24h during examination with fluorescein. Animals then were observed for 21 days.
Exposure to the test article produced corneal opacity in 6/6 test eyes at the 1 hour scoring interval. The corneal opacity was confirmed by positive fluorescein dye retention at the 24 hour scoring interval. The corneal opacity resolved completely in 5/6 test eyes by study day 21. Iritis was noted in 6/6 test eyes at the 1 hour scoring interval. The iridal irritation resolved completely in all animals by study day 7. Conjunctivitis (redness, swelling and discharge) was noted in 6/6 test eyes at the 1 hour scoring interval. The conjunctival irritation resolved completely in all animals by study day 21. Additional ocular findings included sloughing, corneal neovascularization and raised area on the cornea, which were noted in 4/6, 2/6 and 1/6 test eyes, respectively.
A normal background finding of superficial stippling was observed in 1 /6 test eyes during the fluorescein examination. This finding was transient and was not considered significant. No corneal opacity, iritis or conjunctivitis was observed in the control eyes.
In this study, the undiluted test item is severe irritant to the ocular tissue of the rabbit. According to the EEC Ocular Evaluation Criteria, the test item is considered to be an irritant for corneal opacity, a nonirritant for iris lesion, a nonirritant for conjunctival redness and a nonirritant for conjunctival edema.
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.
