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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
not specified
Sex:
not specified
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
25%, 50%, 100%
No. of animals per dose:
3
Statistics:
EC3= 92.1%
Parameter:
EC3
Value:
0.921
Parameter:
other: dpm/node
Value:
942.43
Test group / Remarks:
25% concentration
Parameter:
other: dpm/node
Value:
1 746.07
Test group / Remarks:
50% Concentration
Parameter:
other: dpm/node
Value:
2 367.08
Test group / Remarks:
100% concentration
Parameter:
SI
Value:
1.25
Test group / Remarks:
25% concentration
Parameter:
SI
Value:
2.31
Test group / Remarks:
50% concentration
Parameter:
SI
Value:
3.13
Test group / Remarks:
100% Concentration

Concentration

dpm/node

Test / Control Ratio

Vehicle (acetone/olive oil 4:1)

756.88

N/A

25%

942.43

1.25

50%

1746.07

2.31

100%

2367.08

3.13

EC3= 92.1%
Interpretation of results:
sensitising
Remarks:
Migrated information weak
Conclusions:
Test substance was only postive (ratio >3) at a concentration of 100%, with an EC3 of 92.1%. While this substance is classifiable as a skin sensitiser based on these results, it would only be a weak sensitiser.
Executive summary:

TiTDP was test using the LLNA assay at concentrations of 25%, 50%, and 100%. It was only just barely positive at the 100% concentration. The calculated EC3 value is 92.1%. The results suggest that while TiTDP will be classified as a skin sensitiser (since there is only one category for skin sensitisers) it is expected to be only a weak skin sensitiser.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Local lymph node assay (LLNA) study (Harlan 2010) showed slight positive response at 100% concentration. EC3 value was determined to be 92.1%.

Migrated from Short description of key information:

Local lymph node assay (LLNA) study (Harlan 2010) showed slight positive response at 100% concentration. EC3 value was determined to be 92.1%.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classified as a skin sensitizer based on the positive LLNA study.