Registration Dossier
Registration Dossier
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EC number: 271-571-3 | CAS number: 68585-64-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 March - 15 March 1986
- 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:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Test: Acute Oral Toxicity Test (OSHA) Occupational Safety & Hazards Act, Part 1910
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Dihydrogen bis[P,P-dioctyl diphosphato(2-)-O'',O''''][hydroxyacetato(2-)-O1,O2]titanate(2-), branched and linear
- EC Number:
- 271-571-3
- EC Name:
- Dihydrogen bis[P,P-dioctyl diphosphato(2-)-O'',O''''][hydroxyacetato(2-)-O1,O2]titanate(2-), branched and linear
- Cas Number:
- 68585-64-8
- Molecular formula:
- not applicable (UVCB substance)
- IUPAC Name:
- ({bis[(2-ethylhexyl)oxy]phosphoryl}oxy)[(2-{[({bis[(2-ethylhexyl)oxy]phosphoryl}oxy)(hydroxy)phosphoryl]oxy}-4-oxo-1,3-dioxa-2-titanacyclopentan-2-yl)oxy]phosphinic acid; {[({bis[(2-ethylhexyl)oxy]phosphanyl}oxy)({[({bis[(2-ethylhexyl)oxy]phosphoryl}oxy)(hydroxy)phosphoryl]oxy})[(2-hydroxyacetyl)oxy]titanio]oxy}({bis[(2-ethylhexyl)oxy]phosphoryl}oxy)phosphinic acid
1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 4, 24, 28 and 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- % coverage: semi occlusive
- Type of wrap if used: test substance was applied under gauze dressing to the clipped intact skin
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
- 4, 24, 48, and 72 hours after exposure, For classification purposes these time points were used.
- Scoring sytem: not specified - 4 -grades scoring system (Draize Rabbit Skin Irritation)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48 h
- Score:
- 1
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 2
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 1
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
Any other information on results incl. tables
Table 1: Results Skin irritation test – Draize in the rabbit
|
Erythema and Eschar (score) |
Edema (score) |
|||||||||||
Animal number |
1 |
2 |
3 |
4 |
5 |
6 |
Animal number |
1 |
2 |
3 |
4 |
5 |
6 |
4 hours |
0 |
0 |
1 |
0 |
0 |
0 |
4 hours |
0 |
0 |
0 |
0 |
0 |
0 |
24 hours |
2 |
2 |
2 |
2 |
1 |
1 |
24 hours |
0 |
0 |
1 |
1 |
0 |
0 |
48 hours |
1 |
1 |
2 |
1 |
0 |
0 |
48 hours |
0 |
0 |
1 |
0 |
0 |
0 |
72 hours |
1 |
1 |
2 |
0 |
0 |
0 |
72 hours |
0 |
1 |
2 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU classification according to Regulation(EC) No. 1272/2008
- Conclusions:
- Under the conditions of the present study, a mean irritation score ≥ 2.3 was only observed in one out of 6 rabbits. Since the observation period was less than 14 days it is not known whether all observed erythema and edema were fully reversible. Since one animal showed elevated mean scores throughout and at the end the observation period of 72 hours, the test substance is classified as irritant. CLP: Category 2, H 315
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