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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:
other: GLP, 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
Type:
Constituent
Test material form:
liquid

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
0, 25, 50, 100%
No. of animals per dose:
3
Details on study design:
After an acclimation period of 5 days, animals were randomly selected into cages and assigned a number. All animals were nulliparous and not pregnant. The mice were 8-12 weeks old at the start of the study. Based on a preliminary screening study that found no systemic toxicity or excessive loirritation, doses were set at 25%, 50%, and 100% concentrations. A control group was run in the vehicle only.

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: 25% - 1.5250% - 2.47100% - 0.87
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: 0% (Vehicle) - 2254.5925% - 3435.0350% - 5559.62100% - 1970.86

Any other information on results incl. tables

Conc

dpm/

node

Test / Control Ratio

Result

Blank

2254.59

N/A

N/A

25%

3435.03

1.52

Negative

50%

5559.62

2.47

Negative

100%

1970.86

0.87

Negative

EC3 value = Not established (all concentrations negative).

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
TNPP was not sensitising at all concentrations (25, 50 and 100%).
Executive summary:

This study indicates that TNPP is not a skin sensitiser.