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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 1a GLP guideline study. Study was conducted in accordance to GLP and OECD guideline 429.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

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
Details on test material:
Pentaerythritol, propoxylated, (Molecular weight Mn = 420 g/mole)
Lot No. 0024
Storage: Room Temperature in the dark

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:
0.5%, 5% or 50%
No. of animals per dose:
5 animals per dose group.

Results and discussion

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
A stimulation index (ratio of 3H thymidine incorporation into lymph node  cells of test nodes relative to that recorded for the control nodes) of  less than 3 was recorded for the three concentrations of the test  material. The simulation index for animals given 0.5, 5 or 50 % w/v of the test item in acetone/olive oil 4:1 was 1.22, 0.97 and 1.22, respectively.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test material was considered to be a non-sensitizer under the conditions of the test.