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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP.

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)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
tetralithium(1+) 3,3-di{[oxido(oxo)titanio]oxy}-1,5-dioxotrititanoxane-1,5-bis(olate)
EC Number:
619-916-2
Cas Number:
12031-95-7
Molecular formula:
Li4Ti5O12
IUPAC Name:
tetralithium(1+) 3,3-di{[oxido(oxo)titanio]oxy}-1,5-dioxotrititanoxane-1,5-bis(olate)
Test material form:
other: fine dust
Details on test material:
- Name of test material (as cited in study report): Lithium-titanium-oxide
- Physical state: white solid; a fine dust.
- Lot/batch No.: 0857 VX 037
- Expiration date of the lot/batch: 30 November 2012
- Storage condition of test material: room temperature

The pH of the test item was assessed by measurement of the supernatant from a 1% w/v mixture in distilled water. Result: pH = 5.0

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Source: S&K-LAP Kft.. 2173 Kartal, Császár út 135, Hungary
Animal health: Only animals in acceptable health condition were used for the test. Both eyes of each animal provisionally selected for testing were examined prior to starting the study. Animals showing eye irritation, ocular defects or pre-existing corneal injury were not used.
Age of animals at treatment: ~11 weeks old (adult)
Sex: Male
Body weight range at the beginning of the in-life phase: 2748 – 2799 g; end of the in-life phase: 2954 – 3027 g
Acclimatization time: 5 days

HUSBANDRY
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature during the study: 20 ± 3°C
Relative humidity during the study: 30 – 70 %
Housing/Enrichment: Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages
Ventilation: 15-20 air exchanges/hour

FOOD AND FEEDING
Animals received UNI diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum. Contents of the diet are shown in Appendix 3.

WATER SUPPLY
The animals received municipal tap water, as for human consumption, ad libitum, from an automatic system.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 g.
Duration of treatment / exposure:
The eyes of the test animals were washed out at 1 hour after application of test item.
Observation period (in vivo):
The eyes were examined at 1, 24, 48, 72 hours and 1 week after treatment.
Number of animals or in vitro replicates:
3 animals
Details on study design:
An initial test was performed using one animal. The test item was instilled into the conjunctival sac of the left eye. The eyelids were held closed for a few seconds to prevent the loss of the test item. The contra lateral eye served as the control. Immediately after the administration of the test item, an assessment of the initial pain reaction was made.
After consideration of the ocular responses produced in the first animal, one hour after the treatment of the first animal, two additional animals were treated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n.a.
Irritation parameter:
other: discharge
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n.a.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 1 week
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 1 week
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 1 week
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n.a.
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n.a.
Irritant / corrosive response data:
Initial Pain Reaction (IPR) (score 2) was observed in all animals.
One hour after the application, conjunctival redness (score 2) and discharge (score 2 or 1) were seen in all rabbits.
At 24 and 48 hours after treatment conjunctival redness (score 1 or 2) was seen in all rabbits.
At 72 hours after treatment, conjunctival redness (score 1) was seen in all rabbits.
At 1 week after treatment, no signs of eye irritation or other clinical signs were observed.
As all signs of eye irritation had fully reversed the study was terminated after a period of 1 week observation.
Other effects:
Mortality: There was no mortality observed during the study.
Body weights: The body weight and body weight change were considered to be normal with no indication of a treatment related effect.
General daily examination : There were no clinical signs observed that could be related to treatment.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Lithium-Titanium-Oxide does not require classification as an eye irritant.
Executive summary:

An acute eye irritation study with Lithium-Titanium-Oxide was performed in New Zealand White rabbits according to the OECD 405 method. Lithium-Titanium-Oxide, applied to rabbit eye mucosa, caused low grade conjunctival irritant effects at 1 to 72 h after application. The effects were fully reversible within 1 week.

According to the CLP-Regulation EC 1272/2008, Lithium-Titanium-Oxide does not require classification as an eye irritant.