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EC number: 943-265-6 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 2014 - September 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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:
- Reaction mass of Phosphorous(1+), (N-ethylethanaminato) diphenyl(phenylmethyl)-(T-4)-salt with 4, 4' - [2,2,2-trifluoro-1-(trifluoromethyl) ethylidene bis[phenol] (1:1) and (4,4'-[2,2,2-Trifluoro-1-(trifluoromethyl)ethylidene]diphenol
- EC Number:
- 943-265-6
- Molecular formula:
- not applicable for a multi constituent substance
- IUPAC Name:
- Reaction mass of Phosphorous(1+), (N-ethylethanaminato) diphenyl(phenylmethyl)-(T-4)-salt with 4, 4' - [2,2,2-trifluoro-1-(trifluoromethyl) ethylidene bis[phenol] (1:1) and (4,4'-[2,2,2-Trifluoro-1-(trifluoromethyl)ethylidene]diphenol
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3706OB
- Expiration date of the lot/batch: 01 March 2019
- Purity test date: >99%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.42 to 2.79 kg
- Housing: suspended cages
- Diet / Water: Free access to mains drinking water and food was allowed throughout the study
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of test item
VEHICLE
no vehicule - Duration of treatment / exposure:
- A single application of the test item
- Observation period (in vivo):
- Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment; Additional observations were made on Days 7 and 14 to assess the reversibility of the ocular effects.
- Duration of post- treatment incubation (in vitro):
- 14 days
- Number of animals or in vitro replicates:
- Three animals : 2 females and 1 male
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No corneal effects were noted during the study.
Iridial inflammation was noted in all treated eyes 1 hour after treatment, in two treated eyes at the 24-Hour observation and persisted in one treated eye at the 48 and 72-Hour observations.
Moderate conjunctival irritation was noted in all treated eyes 1 hour after treatment. Moderate conjunctival irritation was noted in two treated eyes and minimal conjunctival irritation was noted in one treated eye at the 24, 48 and 72-Hour observations. Moderate conjunctival irritation persisted in one treated eye at the 7-Day observation.
Two treated eyes appeared normal at the 7-Day observation and one treated eye appeared normal at the 14-Day observation. - Other effects:
- Body Weight : All animals showed expected gain in body weight during the study.
Measurement of pH:
10% w/w aqueous preparation of the test item immediately after preparation = 7.33
10% w/w aqueous preparation of the test item ten minutes after preparation = 7.33
Any other information on results incl. tables
Table 1: Individual Scores for Ocular Irritation
Rabbit Number and Sex |
74530 Female |
74607 Female |
74667 Male |
||||||||||||||||||||||
IPR = 0 |
IPR = 0
|
IPR = 0 |
|||||||||||||||||||||||
Time After Treatment |
1 Hr |
24 Hr |
48 Hr |
72 Hr |
7 Dy |
1 Hr |
24 Hr |
48 Hr |
72 Hr |
7 Dy |
1 Hr |
24 Hr |
48 Hr |
72 Hr |
7 Dy |
14 Dy |
|||||||||
CORNEA |
|||||||||||||||||||||||||
Degree of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||||||||
Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||||||||
IRIS |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
|||||||||
CONJUNCTIVAE |
|||||||||||||||||||||||||
1 Redness |
2 |
2 |
1 |
1 |
0 |
2 |
2 |
2 |
2 |
0 |
2 |
2 |
2 |
2 |
2 |
0 |
|||||||||
1 Chemosis |
2 |
1 |
0 |
0 |
0 |
2 |
2 |
2 |
1 |
0 |
2 |
2 |
2 |
2 |
1 |
0 |
|||||||||
1 Discharge |
1 |
0 |
0 |
0 |
0 |
2 |
3 |
2 |
2 |
0 |
2 |
2 |
2 |
2 |
1 |
0 |
|||||||||
IPR= Initial Pain Reaction
Hr = Hours
Dy = Day
Table 2: Individual and Mean Scores for Cornea, Iris and Conjunctivae
Rabbit number and Sex |
Time After Treatment |
Corneal Opacity |
Iridial Inflammation |
Conjunctival Redness |
Conjunctival Chemosis |
74530 Female |
24 Hours |
0 |
0 |
2 |
1 |
|
48 Hours |
0 |
0 |
1 |
0 |
|
72 Hours |
0 |
0 |
1 |
0 |
Total
|
0 |
0 |
4 |
1 |
|
Mean
|
0.0 |
0.0 |
1.3 |
0.3 |
|
74607 Female |
24 Hours |
0 |
1 |
2 |
2 |
|
48 Hours |
0 |
0 |
2 |
2 |
|
72 Hours |
0 |
0 |
2 |
1 |
Total
|
0 |
1 |
6 |
5 |
|
Mean
|
0.0 |
0.3 |
2.0+ |
1.7 |
|
74667 Male |
24 Hours |
0 |
1 |
2 |
2 |
|
48 Hours |
0 |
1 |
2 |
2 |
|
72 Hours |
0 |
1 |
2 |
2 |
Total
|
0 |
3 |
6 |
6 |
|
Mean
|
0.0 |
1.0+ |
2.0+ |
2.0+ |
|
+ = Positive criterion according to CLP/GHS criteria.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the experimental conditions of this study and according to the criteria laid down in GHS, the test item is considered as as Irritating to eyes (Category 2A), due to the absence of complete reversibility 7 days following instillation.
- Executive summary:
The potential of the test item to induce eye irritation was assessed in New Zealand White rabbit according to the OECD Guidelines for the Testing of Chemicals No.405 "Acute Eye Irritation/Corrosion".The study was conducted in compliance with the principles of Good Laboratory Practice.
A single application of the test item to the non-irrigated eye of three rabbits produced iridial inflammation between 1 and 72 hours following dosing and moderate conjunctival irritation between 1 hour and 7 days following dosing. Two treated eyes appeared normal at the 7-Day observation and one treated eye appeared normal at the 14-Day observation.
The test item was classified as Irritating to eyes (Category 2A) according to the Globally Harmonized Classification System.
The Signal Word "Warning" and the Hazard Statement "H319: Causes serious eye irritation" are therefore required.
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