Tris(isooctadecanoato-O)(propan-2-olato)titanium

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Deviations:

no

Principles of method if other than guideline:

0.5 ml under gauze dressing to the clipped intact skin of adult albino rabbits for a period of 4 hr with observations for erythema and edma at 4, 24, 48 and 72 hr. Score of 5 or more is considered a primary irritant.

GLP compliance:

yes

Specific details on test material used for the study:

Ken-React KR TTS
Lot R-1082S

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 hr.

Observation period:

4, 24, 48 and 72 hr

Number of animals:

6

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0.3

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Remarks on result:

no indication of irritation

Other effects:

Non observed

E

	Erythema & Eschar
Animal #	1	2	3	4	5	6
4 hr	1	1	1	1	1	1
24 hr	1	1	1	0	0	0
48 hr	0	0	0	0	0	0
72 hr	0	0	0	0	0	0

Edema score

0 for animals during the test.

Interpretation of results:

GHS criteria not met

Conclusions:

The target substance is not irritating to skin with irritation score of 0.3.

Reference 2

Endpoint:

skin corrosion: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Justification for type of information:

As there is an in vivo study available, the in vitro study is not needed.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

GLP compliance:

yes

Specific details on test material used for the study:

Ken-React KR TTS Lot 22059
Reddish-brown liquid

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

1 hr

Observation period (in vivo):

24, 48, 72 hr

Number of animals or in vitro replicates:

3 animals. 1 male, 2 females

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1 hr

Score:

ca. 10

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

ca. 0.7

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

48 h

Score:

ca. 0

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Score:

ca. 0

Interpretation of results:

GHS criteria not met

Conclusions:

The target substance is classified as minimally irritating to the eye.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Justification for type of information:

As there is an in vivo study available, the in vitro study is not needed.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Two in vivo studies were available for the target substance and both indicated non-irritant to skin and eyes (Prince, 1986, & Wnorowski 2003). The hydrolysis product isostearic acid also produced no significant skin or eye irritation in Draize rabbit irritation tests (CIR, 1983).

Based these findings, there is no need to classify the target substance as irritant to skin and eyes.