Registration Dossier

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: modern OECD guideline study performed in accordance with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

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 lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent

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, 0.25, 0.5, and 1.0%
No. of animals per dose:
5

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: control: 1.0 0.25%: 1.0 0.5%: 1.04 1.0%: 4.08
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: control: 1173.3 0.25%: 1175.8 0.5%: 1224.7 1.0%: 4783.1

Any other information on results incl. tables

EC3 = 0.8%

Applicant's summary and conclusion

Conclusions:
The test item 4,4’-Diamino-3,3’,5,5’-tetramethyl-dicyclohexylmethane was a skin sensitiser under the test conditions of this study.
Executive summary:

In order to study a possible skin sensitisation potential of 4,4’-Diamino-3,3’,5,5’-tetramethyl-dicyclohexylmethane, three groups each of five female mice were treated once daily with the test item at concentrations of 0.25, 0.5, and 1% (w/w) in acetone:olive oil (4+1 v/v) by topical application to the dorsum of each ear once daily for three consecutive days. The animals did not show any signs of systemic toxicity during the course of the study and no cases of mortality were observed. In this study Stimulation Indices (S.I.) of 1.00, 1.04, and 4.08 were determined with the test item at concentrations of 0.25, 0.5, and 1% (w/w) in acetone:olive oil (4+1 v/v), respectively. A test item is regarded as a sensitiser in the LLNA, if exposure to one or more test item concentration results in a 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated test item concentration required to produce a S.I. of 3 is referred to as the EC3 value. An EC3 value of 0.8% (w/w) was calculated.