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Toxicological information

Skin irritation / corrosion

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrakis(2-ethylhexane-1,3-diolato)titanium
EC Number:
226-949-2
EC Name:
Tetrakis(2-ethylhexane-1,3-diolato)titanium
Cas Number:
5575-43-9
Molecular formula:
C32H68O8Ti
IUPAC Name:
Titanium(4+) tetrakis(2-ethyl-3-hydroxyhexan-1-olate)
Test material form:
liquid: viscous

Test animals

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

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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).

Applicant's summary and conclusion

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).