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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March to june 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study by a laboratory having a GLP certificate

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Certificate on january 27th 2009
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:
dimethylformamide
Concentration:
Concentrations of 25, 50, 75 and 100%
No. of animals per dose:
4 animals for the preliminary test and 28 females for the main test.

Results and discussion

Any other information on results incl. tables

Due to the unsatisfactory solubility of the test item in the first recommended vehicle (acetone/olive oil (4/1, v/v)), dimethylformamide was chosen from the other proposed vehicles.

A solution was obtained at the maximum tested concentration of 75%.

Consequently, the concentrations selected for the preliminary test were 25, 50, 75 and 100%.

Since the test item was irritant in the preliminary test at the concentrations of 75 and 100%, the highest tested concentration retained for the main test was 50%.

Systemic clinical signs and mortality

Neither mortality nor clinical signs were observed during the study.

Local irritation

An erythema was noted on day 3 in 1/4 females treated at the concentration of 50% and on day 6 in 3/4 and 4/4 females treated at the concentrations of 25 and 50%, respectively. A dryness of the skin was also noted on day 6 in 1/4 females treated at the concentration of 2.5 or 5% and in all females treated at the concentration 10, 25 or 50%. A significant increase in ear thickness was observed in the animals treated at the concentration of 50%.


Proliferation assay

A significant lymphoproliferation was noted in the positive control group given HCA. The study was therefore considered valid.

A significant lymphoproliferation was noted at the tested concentrations of 25 and 50%.

The results are presented in the following table:

Treatment

Concentration

(%)

Irritation level

Stimulation Index

(SI)

Test item

2.5

slightly irritant

0.88

Test item

5

non-irritant

1.63

Test item

10

non-irritant

2.09

Test item

25

slightly irritant

6.96

Test item

50

irritant

9.01

HCA

25

-

5.79

In the absence of excessive local irritation at the concentration of 25%, the significant lymphoproliferative response observed at this concentration was attributed to delayed contact hypersensitivity.

The EC3 value for the test item EPOXY RESIN T1800 is equal to 13%.

Conclusion

Under the experimental conditions of this study, the test item EPOXY RESIN T1800 (batch No. 81016) induced delayed contact hypersensitivity in the murine Local Lymph Node Assay.

According to the EC3 value obtained in this experiment, the test item EPOXY RESIN T1800 should be considered as a weak sensitizer.

Applicant's summary and conclusion

Interpretation of results:
ambiguous
Remarks:
Migrated information
Conclusions:
Under the experimental conditions of this study, the test item EPOXY RESIN T1800 (batch No. 81016) induced delayed contact hypersensitivity in the murine Local Lymph Node Assay.
According to the EC3 value obtained in this experiment, the test item EPOXY RESIN T1800 should be considered as a weak sensitizer.