Titanium 2-hydroxy-1,2,3-propanetricarboxylate (2:5)

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Example of published data on potential skin sensitisation of titanium salts

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2015

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

GLP compliance:

not specified

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Titaniumdioxide

IUPAC Name:

Titaniumdioxide

Constituent 2

Reference substance name:

Titanium dioxide

EC Number:

236-675-5

EC Name:

Titanium dioxide

Cas Number:

13463-67-7

IUPAC Name:

dioxotitanium

Specific details on test material used for the study:

Nano material used

In vivo test system

Test animals

Species:

mouse

Strain:

Balb/c

Sex:

male

Study design: in vivo (LLNA)

Vehicle:

acetone/olive oil (4:1 v/v)

Remarks:

Proportions not specified

Concentration:

0.4, 4, 40 mg/ml suspension

No. of animals per dose:

Between 4 to 9 animals

Positive control substance(s):

other: Dintrobenzene

Results and discussion

Positive control results:

Valid

In vivo (LLNA)

Results

Parameter:

SI

Value:

< 2

Variability:

Not specified

Test group / Remarks:

All groups

Any other information on results incl. tables

Considered not to induce sensitisation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Titantium salts and citrates are widley used in cosmetics and there is no indication of sensitising potential