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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
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)

Test material

Constituent 1
Chemical structure
Reference substance name:
Triisotridecyl phosphite
EC Number:
278-758-9
EC Name:
Triisotridecyl phosphite
Cas Number:
77745-66-5
Molecular formula:
C39H81O3P
IUPAC Name:
tris(2-methylnonacosyl) phosphite

In vivo test system

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
25%, 50%, 100%
No. of animals per dose:
3
Statistics:
EC3= 92.1%

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
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

Any other information on results incl. tables

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%

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated informationweak
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.