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Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
The modified local lymph node assay (IMDS) was performed on 24 female NMRI mice (6 animals/test item group and 6 control animals) with the following test item concentrations: 0 (vehicle control), 1, 3 and 10%. The modification refer to the measurement of cell proliferation by cell counting instead of radioactive labelling. In addition , the acute inflammatory skin reaction is determined to discriminate specific from non-specific activation of immune competent cells in the draning lymph nodes. The aim of these investigations was to establish whether there is any specific (sensitizing) or non-specific (irritant) stimulating potential of the test item 3.5-Dichlorphenylisocyanat.
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3-dichloro-5-isocyanatobenzene
EC Number:
252-276-9
EC Name:
1,3-dichloro-5-isocyanatobenzene
Cas Number:
34893-92-0
Molecular formula:
C7H3Cl2NO
IUPAC Name:
1,3-dichloro-5-isocyanatobenzene
Details on test material:
content: 99.9%
solid, white powder

In vivo test system

Test animals

Species:
mouse
Strain:
NMRI
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
0, 1, 3, or 10%
No. of animals per dose:
6 animals/test item group and 6 control animals

Results and discussion

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
Tabular summary: Direct LLNA (NMRI mice, female, 6 animals/group) dose (%) = 0 weight index , cell count index 0 1.00 1.00 1 2.47 2.61 3 3.28 3.36 10 4.09 3.88 The NMRI mice showed a clear increase in the weights of the draining lymph nodes and in the stimulation indices for cell counts in all dose groups, which are of statistical significance, compared to control animals after application of the test item 3,5 -Dichlorphenylisocyanat. The positive level, which is 1.4 for cell count indices, has been exceeded in all dose groups

Any other information on results incl. tables

The positive level for ear swelling which is 2x10E-2 mm increase, i.e. about 10% of the control values, has just been exceeded in the high dose group. Statistically significant increases of the ear swelling were determined for the mid and the high dose group animals compared to the vehicle treated animals. A statistically significant increase of the ear weight was determined for the high dose group animals compared to vehicle treated animals.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Executive summary:

The modified local lymph node assay (IMDS) was performed on 24 female NMRI mice (6 animals/test item group and 6 control animals) with the following test item concentrations: 0 (vehicle control), 1, 3 and 10%. The modification refer to the measurement of cell proliferation by cell counting instead of radioactive labelling. In addition , the acute inflammatory skin reaction is determined to discriminate specific from non-specific activation of immune competent cells in the draning lymph nodes. The aim of these investigations was to establish whether there is any specific (sensitizing) or non-specific (irritant) stimulating potential of the test item 3.5-Dichlorphenylisocyanat.

Beside a non-specific irritant property of the test item, a specific activation of the cells of the immune system via dermal route was determined after application of 1, 3, and 10% 3,5 -Dichlorphenylisocyanat by the method used. Thus, 3,5 -Dichlorphenylisocyanat has to be classified as at least a strong skin sensitizer.