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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 based on grouping of substances (category approach)
Adequacy of study:
supporting study
Study period:
published: 2008
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment

Data source

Reference
Reference Type:
publication
Title:
Local lymph node assay (LLNA): comparison of different protocols by testing skin-sensitizing epoxy resin system components
Author:
Gamer AO, Nies E, Vohr H-W
Year:
2008
Bibliographic source:
Regulatory Toxicology and Pharmacology, 52, 290-298

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,2-Diaminocyclohexane
- Analytical purity: not mentioned

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
other: Experimant I and II: acetone, experiment III: acetone/olive oil (4:1)
Concentration:
Experiment I (Vehicle acetone): 0.1, 0.3 or 1 % (w/w)
Experiment II (vehicle acetone): 0.3, 1.0 or 3.0 % (w/w)
Experiment III (Vehicle acetone/olive oil): 0.3, 1.0 or 3.0 % (w/w)
No. of animals per dose:
6
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: Experiment I (Vehicle acetone): 0.1% = 1.19; 0.3% = 1.81; 1% = 8.39 Experiment II (vehicle acetone): 0.3% = 0.96; 1% = 1.60; 3% = 2.7 Experiment III (Vehicle acetone/olive oil): 0.3% = 1.02; 1% = 0.85; 3% = 1.29
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Experiment I (Vehicle acetone): not stated Experiment II (vehicle acetone): not stated Experiment III (Vehicle acetone/olive oil): not stated

Any other information on results incl. tables

Experiment I (Vehicle acetone): EC3 = 0.4 (EC1.5 = 0.6)

Experiment II (vehicle acetone): EC1.5 = 0.89

Experiment III (Vehicle acetone/olive oil): no EC value determined as SI of 1.5 was never exceeded

Applicant's summary and conclusion

Interpretation of results:
ambiguous
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Having the results of three independent experiments no definite conclusion can be drawn concerning the skin sensitisation properties of the test material. Overall as the sudy authors stated that results obtained with the vehicle acetone would seem to overestimate the skin sensitising potential of the tested materials, the results with acetone/olive oil are negative and a potential positive outcome is only speculative the overall evaluation of this study is ambiguous.
Executive summary:

Groups of 6 female CBA mice per dose group were used to test skin sensitisation properties of the test material in three independent experiments. Experiment I was conducted using acetone as vehicle with concentration levels of 0.1%, 0.3% or 1%. Experiment II was performed using acetone as vehicle but concentration levels of 0.3%, 1% and 3%. Experiment III was performed using the same concentration levels but instead aceton/olive oil as vehicle. Experiment I resulted in an EC3 value of 0.4%. Experiment II resulted in an EC1.5 value of 0.89%. An EC3 value could not be determined as a Stimulation index of 3 was never achieved even though higher test material concentrations were used. In Experiment III even an EC1.5 value could not be calculated as the Stimulation index of 1.5 was never exceeded. It has to be mentioned that Experiment III should have been conducted using higher test material concentration based on expected results of the pre-testing or irritant properties in the respective test vehicle. Hence a somewhat different result could be expected for Experiment III (maybe even an EC3 value).