Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Mar 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well reported GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

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)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-({(5S)-2-Oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)-1H-isoindole-1,3(2H)-dione
EC Number:
610-201-0
Cas Number:
446292-08-6
Molecular formula:
C22 H19 N3 O6
IUPAC Name:
2-({(5S)-2-Oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)-1H-isoindole-1,3(2H)-dione
Details on test material:
Oxaphthalimid, white powder, Batch BXR34BR, content 99.8%

In vivo test system

Test animals

Species:
mouse
Strain:
NMRI
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
dimethylformamide
Concentration:
0 (vehicle control), 2, 10 and 50%
No. of animals per dose:
6 females

Results and discussion

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: NMRI mice did not show an increase in the stimulation indices for cell counts or for weights of the draining lymph nodes.

Any other information on results incl. tables

The "positive level" of ear swelling (i.e. increase of about 10% of the control values) has not been reached or exceeded in any dose group. No substance specific effects were determined for ear weights either.

The body weights of the animals were not affected by any treatment.

Tabular summary of the LLNA/IMDS results:

   Direct LLNA     Ear swelling (in 0.01 mm)        Ear weight (in mg per 8 mm diameter punch)   
 Dose (%)  Weight index (mean +/- SD in %)  Cell count index (mean +/- SD in %)  day 1 (mean +/- SD in %)  day 4 (mean +/- SD in %)  Index day 4   day 4 (mean +/- SD in %)  Index day 4
 0 (DMF)  1.00 +/- 20.14 1.00 +/- 32.96   17.33 +/- 4.49  17.67 +/- 5.02  1.00  11.30 +/- 8.54  1.00
 2  0.97 +/- 14.37  0.95 +/- 15.86  17.50 +/- 2.98  18.17 +/- 3.95  1.03  12.05 +/- 7.80  1.07
 10  1.15 +/- 22.01  1.08 +/- 20.67  17.58 +/- 5.67  18.08 +/- 3.70  1.02  11.60 +/- 5.61  1.03
 50  0.88 +/- 12.12  0.85 +/- 17.61  16.67 +/- 2.95  17.00 +/- 4.34  0.96  11.26 +/- 6.51  1.00

Applicant's summary and conclusion

Executive summary:

To determine the skin-sensitizing properties of Oxaphthalimid the LLNA was performed on female NMRI mice according to OECD guideline 429, 406 and EPA OPPTS 870.2600. The study was conducted with the following test substance concentrations: 2, 10 and 50%

The results showed that the test item has no sensitising potential in mice after dermal application of up to and including 50% concentration. No indication for a non-specific (irritating) activation was detected, too.

Categories Display