Registration Dossier
Registration Dossier
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EC number: 240-015-1 | CAS number: 15879-01-3
Endpoint summary
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
- 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).
Reference
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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