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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)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
mouse
Strain:
CBA/Ca
Sex:
female
Details on test animals and environmental conditions:
Animals were nulliparous and non-pregnant.

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
0, 2.5, 5, 10%
No. of animals per dose:
4

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
5.16
Test group / Remarks:
Concentration: 2.5%
Key result
Parameter:
SI
Value:
7.79
Test group / Remarks:
Concentration: 5%
Key result
Parameter:
SI
Value:
7.84
Test group / Remarks:
Concentration: 10%
Key result
Parameter:
EC3
Value:
0.014
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: 0% (Vehicle) - 783.39 2.5% - 4041.29 5% - 6099.18 10% - 6143.04

Any other information on results incl. tables

Conc

dpm/

node

Test / Control Ratio

Result

Vehicle (acetone/olive oil 4:1)

783.39

N/A

N/A

2.5%

4041.29

5.16

Positive

5%

6099.18

7.79

Positive

10%

6143.04

7.84

Positive

EC3= 1.4% (Calculated using log equation method)

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
TPP was sensitising at all dose levels (2.5, 5, and 10%). The EC3 value is 1.4% from this study.
Executive summary:

The EC3 value is 1.4%, indicating that TPP is a sensitiser.