Lithium titanium oxide (Li4Ti5O12)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013

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:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

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:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Product name: Lithium-Titanium-Oxide
Batch number: 0857 VX 037
CAS number: 12031-95-7
Purity: > 98 % (known from the eye irritation study in vitro with the same batch)
Appearance: white, solid
Expiry date: 30 November 2013
Storage conditions: Room temperature (15-25 °C), below 70 RH%

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Source: S&K-LAP Kft. 2173 Kartal, Császár út 135, HUNGARY.
Age of animals at treatment: ~12 weeks old
Sex: Male
Body weight range at the beginning of the in-life phase: 2817 – 3161 g; at the end of the in-life phase: 2896 – 3195 g.
Acclimatization time: 14 days

Lighting periods: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature during the study: 17.1 – 19.8 °C
Relative humidity during the study: 37 – 85 %
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

Animals received UNI diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi út, Hungary, ad libitum.
Water Supply: The animals received municipal tap water, as for human consumption, ad libitum, from an automatic system.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

0.5 g/site

Duration of treatment / exposure:

4 h.

Observation period:

3 days.

Number of animals:

3

Details on study design:

An initial test was performed using one animal. No severe irritation or corrosive effect was found in the initial test after 1 h exposure, therefore the bandage was replaced and the exposure continued for a further 3 hours (a total 4 hours exposure). Two additional animals were then included in the study.
The test item was applied to an approximately 6 cm² area of intact skin.
After the treatment period, the test item was removed with water at body temperature.
Animals were examined for signs of erythema and oedema, and the responses scored at 60 minutes and then at 24, 48 and 72 hours after patch removal.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not relevant

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not relevant

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not relevant

Irritant / corrosive response data:

At observation 1, 24, 48 and 72 hours after patch removal, there were no observed clinical signs noted on the skin of the treated animals.
As no clinical signs were observed at 72 hours after patch removal, the study was terminated after the 72 hours observation.

The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema were 0.00, 0.00 and 0.00 respectively.
The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for oedema were 0.00, 0.00 and 0.00 respectively.

The Primary Irritation Index (considering readings at 24, 48 and 72 hours after patch removal) was calculated as 0.00.

Other effects:

MORTALITY: There was no mortality observed during the study.
BODY WEIGHTS: There was no test item related effect on body weight.
General Daily Examination: There were no test item related clinical signs noted.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No irritation was observed on 3 rabbits after the dermal application of the test substance according to the OECD 404 method.

Executive summary:

An acute skin irritation study was performed with Lithium-Titanium-Oxide in New Zealand White rabbits. Parameters monitored during this study included mortality, body weight measurements and clinical observations. The irritancy of the test item was evaluated according to the method OECD 404 of 2002.

No skin irritation was observed in 3 rabbits after the dermal application of the test substance.

The Primary Irritation Index (considering readings at 24, 48 and 72 hours after patch removal) was calculated as 0.00.