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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented publication/study report which meets basic scientific principles.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
not specified
Principles of method if other than guideline:
Nothing to add in this field.
GLP compliance:
yes
Type of study:
mouse local lymphnode assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
TCPP
There are differences in the isomer content from each supplier,but these are not important given that the properties of the isomers are expected to be very similar.
Purity
A typical purity(total of the four isomers)is>97.9%.All testing described in this report is for the commercial product.
Impurities
The impurity profile of the commercial product TCPP is specific to individual manufacturers. It is not likely that the impurities will have had particular influence on any of the results obtained.
Additives
No additives are used.

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
not specified
Details on test animals and environmental conditions:
no data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: acetone:olive oil 4:1
Concentration / amount:
undiluted TCPP, concentrations of 50% or 25% v/v in acetone:olive oil 4:1 and 100%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: acetone:olive oil 4:1
Concentration / amount:
undiluted TCPP, concentrations of 50% or 25% v/v in acetone:olive oil 4:1 and 100%
No. of animals per dose:
No data.
Details on study design:
Nothing to add in this field.
Challenge controls:
Nothing to add in this field.
Positive control substance(s):
no

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
0%, 25%, 50% and 100%
No. of animals per dose:
4 per dose.
Details on study design:
no data
Positive control substance(s):
not specified
Statistics:
no data

Results and discussion

Positive control results:
No positive control group in this study, so there is noting should add to this field.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: 25%:1.55, 50%: 1.97, 100%:1.56
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: 2.0

Any other information on results incl. tables

Nothing should add to this field.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
According to this study the substance is not sensitising to skin.
Executive summary:

There were no mortalities or clinical observations and all bodyweights were comparable to those of the control animals.