Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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:
2012
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

Constituent 1
Chemical structure
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
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.