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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test was conducted according to OECD 429 and compliant with GLP. Read-across from supporting substance (structure analogue or surrogate). Test substance (source substance): CAS No. 135452-43-6

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Chivacure 300P

In vivo test system

Test animals

Species:
mouse
Strain:
other: CBA/CaOlaHsd
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
dimethylformamide
Concentration:
The test item in the main study was assayed at 10, 25 and 50% (w/w).
No. of animals per dose:
Number of animals for the pre-test: 2 females
Number of animals for the main study: 16 females
No. of animals per dose (main study): 4 females
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: In this study Stimulation Indices (S.I.) of 0.84, 0.75 and 1.22 were determined with the test item at concentrations of 10, 25 and 50%(w/w) in DMF, respectively.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: The proliferative response of the lymph node cells is expressed as the number of radioactive disintegrations per minute per lymph node (DPM/lymph node)

Any other information on results incl. tables

 Test item concentration % (w/w)

 Group

 Measuremenr DPM

  Stimulation Index

 0

 1

 1333

 1.00

 10

 2

 1119

 0.84

 25

 3

 1006

 0.75

 50

 4

 1616

 1.22

The EC3 value could not be calculated, since all S.I .’s are below the threshold value of 3.

In this study Stimulation Indices of 0.84, 0.75 and 1.22 were determined with the test item at concentrations of 10, 25 and 50% (w/w) in DMF. The EC3 value could not be calculated, since non of the tested concentrations induced a S.I. greater than the threshold value of 3.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is not a skin sensitiser under the test conditions of the this study.