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EC number: 235-120-4 | CAS number: 12070-08-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-11-23 to 2012-12-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24 April 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 30 May 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- August 1998
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Titanium carbide
- EC Number:
- 235-120-4
- EC Name:
- Titanium carbide
- Cas Number:
- 12070-08-5
- Molecular formula:
- CTi
- IUPAC Name:
- methanidylidynetitaniumylium
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Titanium carbide
- Substance type: inorganic
- Physical state: grey solid
- Analytical purity: ≥ 99%
- Lot/batch No.: 82496
- Expiration date of the lot/batch: not applicable
- Storage condition of test material: room temperature
Constituent 1
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- The test item was used as provided by the sponsor
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: approximately 13 weeks old
- Weight at study initiation: > 2 kg
- Housing: ABS - plastic rabbit cages, floor 4200 cm²
- Diet: Free access to autoclaved hay and to Altromin 2123 maintenance diet for rabbits (lot no. 1516), rich in crude fibre
- Water: Free access to tap water (drinking water, municipal residue control, microbiological controls at regular intervals)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Acclimation period: at least 5 days under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C (recommendations of TVT, GV-SOLAS)
- Humidity (%): 55 ± 10 °C
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 h : 12 h
TVT = TVT Tierärztliche Vereinigung für Tierschutz, Merkblatt 127 zur Tiergerechten Haltung von Versuchskaninchen, 2010
GV-SOLAS = Planung, Struktur von Versuchstierbereichen tierexperimentell tätiger Institutionen; Veröffentlichung GV-SOLAS (Gesellschaft für Versuchstierkunde, Society for Laboratory Animal Science), Mai 1988
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of each animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 72 h (the treated eye was not rinsed 24 hours after the application.)
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: none
SCORING SYSTEM: see "Any other information on materials and methods incl. tables"
TOOL USED TO ASSESS SCORE: fluorescein
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:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- - First time of effects, all animals: 1 hour post-application redness grade 1
- Last time of effects:
* animal no. 1: 48 hours post-application redness grade 1
* animal no. 2 and no. 3: 24 hours post-application redness grade 1
- Reversibility of the observed effects:
* animal no. 1: the changes were fully reversible within 72 hours post-application
* animal no. 2 and no. 3: the changes were fully reversible within 48 hours post-application - Other effects:
- After the application into the eyes of three female NZW rabbits the test item produced irritant but no corrosive effects (see Tables 3 to 5 in section "Any other information on results incl. tables").
Neither mortalities nor significant clinical signs of toxicity were observed.
The eyes were not rinsed after the application.
Upon fluorescein examinations at the end of the observation period of 72 hours no corneal lesions were found in any animal.
Conjunctival redness was observed in all animals and are individually described in Tables 3 to 5 in section "Any other information on results incl. tables".
Any other information on results incl. tables
Table 2: Mean Values of Eye Irritation Scores – (24, 48, 72 Hour Reading)
Animal No. |
Sex |
Conjunctival Redness |
Conjunctival Chemosis |
Iris Cornea |
Opacity |
1 |
female |
0.67 |
0.00 |
0.00 |
0.00 |
2 |
female |
0.33 |
0.00 |
0.00 |
0.00 |
3 |
female |
0.33 |
0.00 |
0.00 |
0.00 |
Table 3: Eye Irritation Scores – Animal No. 1
Single Data |
|||||
|
Time Post-Application |
Average Score (24, 48 and 72 hours) |
|||
1 hour |
24 hours |
48 hours |
72 hours |
||
T/C |
T/C |
T/C |
T/C |
||
Conjunctival Redness |
1/0 |
1/0 |
1/0 |
0/0 |
0.67 |
Conjunctival Chemosis |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
Iris |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
Cornea |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
T = Test item, C = control
Table 4: Eye Irritation Scores – Animal No. 2
Single Data |
|||||
|
Time Post-Application |
Average Score (24, 48 and 72 hours) |
|||
1 hour |
24 hours |
48 hours |
72 hours |
||
T/C |
T/C |
T/C |
T/C |
||
Conjunctival Redness |
1/0 |
1/0 |
0/0 |
0/0 |
0.33 |
Conjunctival Chemosis |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
Iris |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
Cornea |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
T = test item, C = control
Table 5: Eye Irritation Scores – Animal No. 3
Single Data |
|||||
|
Time Post-Application |
Average Score (24, 48 and 72 hours) |
|||
1 hour |
24 hours |
48 hours |
72 hours |
||
T/C |
T/C |
T/C |
T/C |
||
Conjunctival Redness |
1/0 |
1/0 |
0/0 |
0/0 |
0.33 |
Conjunctival Chemosis |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
Iris |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
Cornea |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
T = test item, C = control
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, titanium carbide is not irritant to the eye.
- Executive summary:
In a primary eye irritation study according to OECD 405, 0.1 g of titanium carbide was instilled into the conjunctival sac of one eye each of three female New Zealand White rabbits (age approximately 13 weeks). Eyes were not washed. Animals were observed for a total of 72 hours. Irritation was scored by evaluating conjunctival redness, conjunctival chemosis, iris, and corneal opacity.
Only slight effects visible as conjunctival redness have been observed which were fully reversible within 72 hours. Neither mortalities nor significant clinical signs of toxicity were observed.
In this study, titanium carbide is not an eye irritant.
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