Registration Dossier

Administrative data

Description of key information

Skin irritation:
Irritating (rabbits)
Eye irritation:
Damaging (rabbits)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 Sept 1989 - 6 Dec 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
other: albino Chbb-SPF
Details on test animals and environmental conditions:

TEST ANIMALS

- Weight at study initiation: 2,2-2,7 kg
- Diet (e.g. ad libitum): ad libitum, regular rabbit diet
- Water (e.g. ad libitum): tsp water ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1 deg C
- Humidity (%): 60 +/- 5 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,5 ml
Observation period:
At 4, 24, 48 and 72 hours and 6, 8, 10 days after test material application skin reactions were recorded
Number of animals:
3 animals
Details on study design:
Erythema and escar formation
0 no eryhema
1 very slight erythema
2 welll-defined erythema
3 moderate to severe erythema
4 Severe erythema andto slight escar formation

Oedema formation
0 no oedema
1 very slight oedema
2 slight oedema
3 moderate oedema
4 Severe oedema
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
1.7
Max. score:
8
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 dayd
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
4
Irritant / corrosive response data:
Scoring
Average (erythema + oedema)
0 - 0.5 no irritation
0.5 - 3.0 mild irritation
3.1 - 5.0 moderate irritation
5,1 - 8,0 strong irritation

Average Irritation index (oedema + erythema) 1hours - 72 hours was 1,73 (max 8).
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The dermal irritation potential of tetrakis(2-ethylhexane-1,3-diolato) titanium was evaluated when applied to the skin of rabbits. The test material caused mild irritation.

Executive summary:

Skin irritation of tetrakis(2 -ethylhexane-1,3 -diolato)titanium was tested on the back of rabbits. The product was applied undiluted and the intact skin was exposed 4 hours for the substance. The skin was washed to remove excess of test item. The erythema and oedema scores were recorded at 1, 4, 24, 48, 72 hours and 6, 8 and 10 days after test item removal. The susbstance demonstrated a slight rritant effect on the skin of male rabbits (irritatino index = 1.7 / 8).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

The key study by Murmann, P (1989) investigated skin irritation potential of tetrakis(2 -ethylhexane-1,3 -diolato)titanium. The substance demonstrated a slight irritant effect on the skin of rabbits.

The supporting study on structurally similair substance (titanium tetrakis(2 -ethylhexanolate)) was used to evaluate the skin irritation of the substance.

A skin irritation study by Ferenz, R.L. (1978) was conducted for 5% and 50% solution of titanium tetrakis(2-ethylhexanolate). The test substance was applied on the skin of six rabbits for 24 hours. Skin reactions were observed at 24 and 48 hours following application. Based on the study report, the test material in 50% suspension was considered moderately irritating and in 5% suspension not irritating to the skin of guinea pigs.

Eye irritation

The key study by Murmann, P (1990) investigated eye irritation potential of tetrakis(2 -ethylhexane-1,3 -diolato)titanium. The substance demonstrated a mild irritant effect on the eyes of rabbits.

The supporting studies are available on structurally similair substance Titanium tetrakis(2 -ethylhexanolate). In the pre-guideline eye irritation study by Gargus, J.L. (1983) Titanium tetrakis(2 -ethylhexanolate) was applied undiluted into the eyes of rabbits. Observations were made at 1 and 4 hours, and at 1, 2, 3, 7, 14, and 21 days for the treated eyes. The test substance irritated the cornea and conjunctiva of rabbit eyes. In the other pre-guideline study by Ferenz, R.L. 1978 titanium tetrakis(2 -ethylhexanolate) was applied undiluted into the eyes of two rabbits. After 20 seconds, treated eye of one rabbit was washed with water. The treated eye of the other rabbit was not washed. Observations were made at 1 and 4 hours, and at 1, 2, 3, 7, 14, and 21 days for the treated eyes. Titanium tetrakis(2-ethylhexanolate) severely irritated the cornea and conjunctiva and moderately irritated the iris of both the washed and unwashed rabbit eyes. At 21 days, the unwashed eye had slight corneal opacity and the washed eye had mild to moderate corneal irritation.

This substance is hydrolytically unstable, releasing 2-ethylhexane-1,3-diol (CAS 94-96-2) and hydrated titanium dioxide (non-hazardous), when it comes in contact with water or moisture. Thus, the intrinsic properties of this substance are related to the hazards of 2-ethylhexane-1,3-diol (EHD). EHD has harmonised classification for Eye Dam 1 H 318. This classification is also assigned for the substance.

Justification for classification or non-classification

Based on the skin irritation information on the substance itself and on the structurally similair product, the substance has to be classified to hazard class Skin Irrit. 2 according to CLP Regulation 1272/2008.

Based on the eye irritation information on the substance itself and on the decomposition product (EHD), the substance has to be classified to hazard class Eye Dam 1 according to CLP Regulation 1272/200.