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Administrative data

Description of key information

Skin irritation:
Not Irritating (rabbits)
Eye irritation:
Irritating (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 - 4 Dec 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
other: albino Chbb-SPF
Details on test animals or test system 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:
0.4
Max. score:
8
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
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:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
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:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
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:
GHS criteria not met
Conclusions:
The dermal irritation potential of titanium 2,2',2´´nitrilotrisethanolate was evaluated when applied to the skin of rabbits. The test material did not cause skin irritation in rabbits.

Executive summary:

Skin irritation of titanium 2,2´,2´´nitrilotrisethanolate 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 substance demonstrated a slight rritant effect on the skin of male rabbits (irritation index = 0.4 / 8).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

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 Titanium 2,2´,2´´-nitrilotrisethanolate. The substance did not show irritant effect on the skin of rabbits.

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 moderate irritant effect on the eyes of rabbits.

This substance is hydrolytically unstable, releasing triethanolamine (TEA) (CAS 102 -71 -6) and hydrated titanium dioxide, when it comes in contact with water or moisture. Thus, the intrinsic properties of this substance are related to the hazards of of these degradatino products. Both substances have no classification for any hazard class according to the CLP.

Justification for classification or non-classification

Based on the skin irritation information on the substance itself and on the degradation products, no classification is warranted according to CLP Regulation 1272/200

Based on the eye irritation information on the substance itself and on the degradation products, the substance has to be classified to hazard class Eye Irrit. Cat.2 according to CLP Regulation 1272/2008.