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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
Study period:
2003
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: 1,2-dichloropropane

In vivo test system

Test animals

Species:
mouse
Sex:
female

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
< 3
Remarks on result:
other: Because the SI values for 5, 20, and 80% PDC were all below 3, an EC3 value could not be determined. On the basis of these results, PDC did not demonstrate any contact sensitization potential.
Parameter:
SI
Remarks on result:
other: not reported in the documentation

Any other information on results incl. tables

PDC did not demonstrate any lymph node cell proliferation response, nor any LLNA results (dpm and SI) consistent with dermal sensitization as the lymph nodes draining the area of topical application did not demonstrate a proliferative response equal to or greater than the 3x threshold. SI values were consistently around 1.0 (equivalent to vehicle controls) at all doses tested:

Proliferative response

Control

A

1.0 +/- 0.7

5%

B

1.0 +/- 0.6

20%

C

1.3 +/- 0.9

80%

D

0.8 +/- 0.5

Proper conduct and responsiveness of the test was confirmed in animals treated with 30% HCA (positive control group) where proliferation (SI) was 14-fold greater than that of vehicle controls. Because the SI values for 5, 20, and 80% PDC were all below 3, an EC3 value could not be determined. On the basis of these results, PDC did not demonstrate any contact sensitization potential.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
1,2 dichloropropane did not stimulate proliferation of lymphocytes in auricular lymph nodes from mice treated with up to 80% PDC in AOO on 3 consecutive days. It was concluded that PDC was not a sensitiser under the conditions of this assay.