Titanium tetraisopropanolate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Pre-dates GLP and pre-dates current guideline. Similar to OECD 404 but reversibility not fully investigated.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Federal Register No. 38. 187 § 1500.41 (skin) side of 27 27 019 Sept. 1973 evaluation key to Draize, J.H. (1959) DERMAL TOXICITY

Deviations:

not specified

Principles of method if other than guideline:

Study method was similar to OECD 404, Acute Dermal Irritation/Corrosion. Testing was performed on 6 New Zealand White rabbits on both abraded and unabraded skin sites with occlusive dressings. Treatment was for 24 hours. Following removal of the patches the animals were scored for erythema and eschar formation and oedema according to the grading system in OECD 404 at 24 and 72 hours post dose. The animals were killed 7 days post dose and a necropsy examination of the skin performed.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Titanium tetraisopropanolate

EC Number:

208-909-6

EC Name:

Titanium tetraisopropanolate

Cas Number:

546-68-9

Molecular formula:

C12H28O4Ti

IUPAC Name:

titanium tetraisopropanolate

Details on test material:

The test material was a liquid. Lot or batch number was not specified. Inbifo number was S 2575 A1. Purity was not specified.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Six male and female NZW rabbits were acclimatised for more than 3 days before the start of the study. The animals weighed 3 to 4 kg. They were housed in a permanent building, fully air-conditioned with filtered air. There was a 12 hour light/dark light cycle from 07:00 am to 19:00 pm. The temperature was 22+/- 1 degree C and the humidity was 55 +/- 10%. The animals were housed in stainless steel cages without litter. Standard laboratory pelleted diet and tap water were available ad-libitum.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: Test site was shaved and both abraded and non-abraded skin tested.

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin on test animals

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

24 hours

Observation period:

graded up to 72 h post dose. Animals killed at 7 d post dose and necropsy examination of skin performed.

Number of animals:

6

Details on study design:

Hair was shaved on both sides of the spine using electric hair clippers, approximately 16 hours before application. The application site was ca. 2.5 cm x 2.5 cm = 6.25 cm2. Untreated skin was used as a negative control.
The left side was abraded over an area of ca. 6.25 cm2, with 5 vertical lines.
A tuberculin syringe was used for the application of 0.5 ml of unchanged test material. Following application to the skin the site was covered with 2 layers of gauze (2.5 cm x 2.5 cm in size). These were held onto the skin with elastic bandage. This was held in place with PVC film and adhesive tape. The exposure time was 24 hours.
Scoring of the test sites was performed according to the Draize method (see table below).
The test sites were scored at 24 and 72 h post dose. After 7 days post dose the animals were killed and a necropsy examination of the skin was performed for the assessment of the intact and abraded skin, subcutaneous tissues and musculature at the application sites.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Score:

0.54

Reversibility:

other: necropsy examination performed at 7 days post dose.

Remarks on result:

other: necropsy examination of intact and abraded skin, subcutaneous tissue and underlying muscle were without findings for all animals.

Irritant / corrosive response data:

Overall mean was 0.54. Classified as not irritating.

Other effects:

A yellowish discolouration of the skin at the application sites was reported - this was possibly the test material.

Any other information on results incl. tables

Assessment levels and calculated irritation index – irritation grades

		Rabbit number
	Time after application (h)	1	2	3	4	5	6	Aggregate value	Mean
Erythema and Eschar formation Intact skin	24	0	0	0	0	0	0	0	0
	72	1	1	1	0	1	0	4	0.67
Erythema and Eschar formation Abraded skin	24	0	0	1	1	0	1	3	0.5
	72	1	1	1	1	1	1	6	1.0
Oedema formation Intact skin	24	0	0	0	0	0	0	0	0
	72	0	0	0	0	0	0	0	0
Oedema formation Abraded skin	24	0	0	0	0	0	0	0	0
	72	0	0	0	0	0	0	0	0

Necropsy findings

Rabbit 1	intact and scarified skin: Subcutaneous tissue and underlying muscles without findings
Rabbit 2	Findings as for rabbit 1
Rabbit 3	Findings as for rabbit 1
Rabbit 4	Findings as for rabbit 1
Rabbit 5	Findings as for rabbit 1
Rabbit 6	Findings as for rabbit 1