Hydrogen tetrakis[2,2-bis[(allyloxy)methyl]butan-1-olato-O1]bis(ditridecyl phosphito -O'')titanate(2-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

no detailed information; observation period not sufficient to evaluate reversibility

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 12 May 1981

Deviations:

yes

Remarks:

no experimental details available, limited information on test material, limited data on test animals, housing or environmental conditions, observation period not sufficient to evaluate reversibility

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: US-FHSA CFR Title 16. Chap. 11, Parts 1500.3, 1500.4, 1500.41, 1500.42

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hydrogen tetrakis[2,2-bis[(allyloxy)methyl]butan-1-olato-O1]bis(ditridecyl phosphito -O'')titanate(2-)

EC Number:

264-709-9

EC Name:

Hydrogen tetrakis[2,2-bis[(allyloxy)methyl]butan-1-olato-O1]bis(ditridecyl phosphito -O'')titanate(2-)

Cas Number:

64157-14-8

Molecular formula:

not applicable (UVCB substance)

IUPAC Name:

dihydrogen 2-{[(di{[bis(tridecyloxy)phosphanyl]oxido}tris({2,2-bis[(prop-2-en-1-yloxy)methyl]butyl}oxido)titaniotetrakis(ylium))oxido]methyl}-1-(prop-2-en-1-yloxy)-2-[(prop-2-en-1-yloxy)methyl]butane

Test animals

Species:

rabbit

Strain:

not specified

Remarks:

adult albino rabbits

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

3 days
Reading time points: 4, 24, 48 and 72 h

Number of animals:

6

Details on study design:

TEST SITE
- Type of wrap if used: The test substance was applied under a gauze dressing to the clipped intact skin of the animals.

OBSERVATION TIME POINTS : 4, 24, 48 and 72 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #4, #5

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks:

within the 72 h of observation

Results 2

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.7

Max. score:

4

Reversibility:

not reversible

Remarks:

within the 72 h of observation

Results 3

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks:

within the 72 h of observation

Results 4

Irritation parameter:

edema score

Basis:

animal: #1, #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks:

within the 72 h of observation

Results 5

Irritation parameter:

edema score

Basis:

animal: #3, #5

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

not reversible

Remarks:

within the 72 h of observation

Results 6

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

not reversible

Remarks:

within the 72 h of observation

Results 7

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

not reversible

Remarks:

within the 72 h of observation

Irritant / corrosive response data:

While very slight erythrema (score 1) was observed after 4 h of exposure (4/6 animals), the erythema formation increased and was well-defined (score 2) or moderate to severe (score 3) at the reading time points 48 and 72 h (5/6 animals). Very slight edema (score 1) was observed 24 h following exposure (3/6 animals), increasing to slight to moderate edema (score 2) at 48 and 72 h (5/6 animals).

Any other information on results incl. tables

Table 1: Scores on erythema, eschar and edema formation

	Erythema and eschar formation						Edema formation
Animal No.	1	2	3	4	5	6	1	2	3	4	5	6
4 h	0	1	1	1	1	0	0	0	0	0	0	0
24 h	2	2	2	2	2	1	0	0	1	1	1	0
48 h	2	2	3	2	2	1	1	1	1	2	1	1
72 h	2	2	3	2	2	1	2	2	2	2	2	1
Score 24/48/72 h	2.0	2.0	2.7	2.0	2.0	1.0	1.0	1.0	1.3	1.7	1.3	0.7

Applicant's summary and conclusion

Interpretation of results:

other: Skin Irrit. 2 (H315) according to Regulation (EC) No. 1272/2008

Conclusions:

CLP: skin irritant Cat. 2
The observation period was limited to 72 h. Erythema and edema persisted and no reversibility was observed untl 72 h. Since erythema and edema formation enhanced throughout the whole study observation perdiod and no reversibility can be assumed, the test item is classified as skin irritant Category 2 according to Regulation (EC) No. 1272/2008 in a worst-case approach.