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EC number: 601-472-6 | CAS number: 117314-20-2
- Life Cycle description
- Uses advised against
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- Irritation / corrosion
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5.5.2015-9.6.2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted in accordance with recommended Guidelines (OECD Guideline for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 02 October 2012) and Method B5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008) and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Adopted 02 October 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- (EC) No. 440/2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate as an attachment to the study report
Test material
- Reference substance name:
- nonatitanium(4+) tetrasodium hydrate icosaoxidandiide
- EC Number:
- 601-472-6
- Cas Number:
- 117314-20-2
- Molecular formula:
- Sodium form: Na4Ti9O20 × n H2O Sodium/hydrogen form: 50 % Na4Ti9O20 × n H2O, 50 % Na2H2Ti9O20 × n H2O
- IUPAC Name:
- nonatitanium(4+) tetrasodium hydrate icosaoxidandiide
- Test material form:
- solid: particulate/powder
- Remarks:
- powder
- Details on test material:
- - Substance type: commercial product (pure active substance)
- Physical state: Solid powder
- Storage condition of test material: Ambient temperature, humidity and pressure. Stored in sealed containers in darkness.
- Stability under test conditions: Stable
- Purity: ca 100 %
- Particle size distribution: 2.92% <100μm
- Crystal structure: TiO6-octaedra
- Density: 2.83 x 10^3 kg/m3
- pH value: the pH value of the substance in an aqueous solution is appr. 11
Constituent 1
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: 12 to 20 weeks old
- Weight at study initiation: 2.74 or 3.29 kg
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): 2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (weight approximately 95 mg, as measured by gently compacting the required volume into an adapted syringe) - Duration of treatment / exposure:
- 1 treatment. The test item was left in the eyefor the 14-day assessment period.
- Observation period (in vivo):
- 14 days. 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. Individual body weights were recorded on Day 0 (the day of dosing) and at the end of the observation period.
- Number of animals or in vitro replicates:
- 2 (males)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing
SCORING SYSTEM:
The numerical values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letters E (degree of opacity) and F (area of cornea involved). For each tissue the score was calculated as follows:
Score for conjunctivae = (A + B + C) x 2
Score for iris = D x 5
Score for cornea = (E x F) x 5
Using the numerical data obtained a modified version of the system described by Kay J.H. and Calandra J.C. (1962) was used to classify the ocular irritancy potential of the test item. This was achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The group means of the total scores for each observation were calculated. The highest of these group means (the maximum group mean score) together with the persistence of the reactions enabled classification of the eye irritancy potential of the test item.
If evidence of irreversible ocular damage is noted, the test item will be classified as corrosive to the eye.
TOOL USED TO ASSESS SCORE:
Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- Considers: cornea, iris and conjunctivae
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 12.5
- Max. score:
- 110
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Iridial inflammation was noted in one treated eye and moderate conjunctival irritation was noted in both treated eyes. No corneal effects were noted during the study. The effects were fully reversible.
- Irritation parameter:
- cornea opacity score
- Remarks:
- Considers: degree of opacity, area of cornea involved
- Basis:
- animal #1
- Remarks:
- Male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- Considers: degree of opacity, area of cornea involved
- Basis:
- animal #2
- Remarks:
- Male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- Male
- Time point:
- 24/48 h
- Score:
- 5
- Max. score:
- 5
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- positive indication of irritation
- Remarks:
- Iridial inflammation was noted in one treated eye.
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- Male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Considers redness, chemosis and discharge
- Basis:
- animal #1
- Remarks:
- Male
- Time point:
- 24/48/72 h
- Score:
- 10.6
- Max. score:
- 12
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Moderate conjunctival irritation was noted in the treated eye.
- Irritation parameter:
- conjunctivae score
- Remarks:
- Considers redness, chemosis and discharge
- Basis:
- animal #2
- Remarks:
- Male
- Time point:
- other: 1 h
- Score:
- 12
- Max. score:
- 12
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Moderate conjunctival irritation was noted in the treated eye.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- Male
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- Male
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- No corneal effects were noted during the study.
Iridial inflammation was noted in one treated eye at the 24 and 48-Hour observations.
Moderate conjunctival irritation was noted in both treated eyes 1 and 24 hours after treatment. Moderate conjunctival irritation was noted in one treated eye and minimal conjunctival irritation was noted in the other treated eye at the 48 and 72-Hour observations with minimal conjunctival irritation noted in both treated eyes at the 7-Day observation.
Both treated eyes appeared normal at the 14-Day observation. See Tables 1 and 2, Any other information on results incl. tables. - Other effects:
- No other effects. Both animals showed expected gain in body weight during the study (see Table 3, Any other information on results incl. tables).
Any other information on results incl. tables
Table 1. Individual Scores and Individual Total Scores for Ocular Irritation
Number and Sex | 75059 Male | 75072 Male | ||||||||||
Initial pain reaction = 0 | Initial pain reaction = 0 | |||||||||||
Time After Treatment | 1 hour | 24 hours | 48 hours | 72 hours | 7 days | 14 days | 1 hour | 24 hours | 48 hours | 72 hours | 7 days | 14 days |
CORNEA | ||||||||||||
E = Degree of Opacity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
F = Area of Cornea Involved | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Score (E x F) x 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
IRIS | ||||||||||||
D | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Score (D x 5) | 0 | 5 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
CONJUNCTIVAE | ||||||||||||
A = Redness | 2 | 2 | 2 | 2 | 1 | 0 | 2 | 2 | 2 | 2 | 1 | 0 |
B = Chemosis | 2 | 2 | 2 | 2 | 1 | 0 | 2 | 1 | 1 | 1 | 1 | 0 |
C = Discharge | 2 | 2 | 1 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 0 |
Score (A + B + C) x 2 | 12 | 12 | 10 | 10 | 4 | 0 | 12 | 8 | 6 | 6 | 4 | 0 |
Total Score | 12 | 17 | 15 | 10 | 4 | 0 | 12 | 8 | 6 | 6 | 4 | 0 |
Initial pain reaction 0 = No response: No initial pain
Cornea:
(E) Degree of Opacity (most dense area used)
0 = No opacity
Iris:
(D) Values
0 = Normal
1 = Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive)
Conjunctivae:
(A) Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
0 =Vessels normal
1 = Vessels definitely injected above normal
2 = More diffuse, deeper crimson red, individual vessels not easily discernible
(B) Chemosis
0 = No swelling
1 = Any swelling above normal (includes nictitating membrane)
2 = Obvious swelling with partial eversion of lids
(C) Discharge
0 = No discharge
1 = Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2 = Discharge with moistening of the lids and hairs just adjacent to lids
Table 2. Individual Total Scores and Group Mean Scores for Ocular Irritation
Rabbit Number and Sex | Individual Total Scores At: | |||||
1 hour | 24 hours | 48 hours | 72 hours | 7 days | 14 days | |
75059 Male | 12 | 17 | 15 | 10 | 4 | 0 |
75072 Male | 12 | 8 | 6 | 6 | 4 | 0 |
Group Total | 24 | 25 | 21 | 16 | 8 | 0 |
Group Mean Score | 12.0 | 12.5 | 10.5 | 8.0 | 4.0 | 0.0 |
Table 3. Individual Body Weights and Body Weight Change
Rabbit Number and Sex | Individual Body Weight (kg) | Body Weight Change (kg) | |
Day 0 | Day 3 | ||
75058 Male | 2.74 | 3.17 | 0.43 |
75063 Male | 3.29 | 3.54 | 0.25 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Remarks:
- Eye irrit. 2 H319. Criteria used for interpretation of results: EU
- Conclusions:
- The test results are sufficient to make conclusions related to the eye irritation effects of the test item.
The test item produced a maximum group mean score of 12.5 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. According to EC No 1272/2008 the results indicate that the test item is an eye irritant (category 2, H319). - Executive summary:
Introduction
The study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit.
Results
A single application of the test item to the non-irrigated eye of two rabbits produced iridial inflammation and moderate conjunctival irritation. Both treated eyes appeared normal at the 14-Day observation.
Conclusion
The test item produced a maximum group mean score of 12.5 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
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