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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 01 - December 20, 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
2002
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
sodium (5s,8s)-8-methoxy-2,4-dioxo-1,3-diazaspiro[4.5]decan-3-ide
EC Number:
929-513-6
Cas Number:
1400584-86-2
Molecular formula:
C9H13N2O3 · Na
IUPAC Name:
sodium (5s,8s)-8-methoxy-2,4-dioxo-1,3-diazaspiro[4.5]decan-3-ide
Test material form:
solid: bulk

In vivo test system

Test animals

Species:
mouse
Strain:
CBA:J
Sex:
female

Study design: in vivo (LLNA)

Concentration:
0, 2.5, 5 and 10%
No. of animals per dose:
5

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
1
Test group / Remarks:
10% in DMSO
Key result
Parameter:
SI
Value:
0.7
Test group / Remarks:
5% in DMSO
Key result
Parameter:
SI
Value:
0.9
Test group / Remarks:
2.5% in DMSO
Parameter:
SI
Test group / Remarks:
vehicle control
Remarks on result:
other: Control group: 1773 2.5 % in DMSO: 1665 5 % in DMSO: 1174 10 % in DMSO: 1716

Any other information on results incl. tables

Up to the highest concentration tested of 10%, the test substance did not induce any lymphoproliferative response.

There were no confounding effects of irritation or toxicity, so the proliferation values are considered to reflect the sensitization potential of the test substance.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was found to be a non-sensitizing substance in the Local Lymph Node Assay at all concentrations tested.
Executive summary:

Twenty female CBA/J mice were allocated to 4 groups of five animals each:
- three groups received the test substance at a concentration of 2.5, 5 or 10% in vehicle,
- one control group received the vehicle, Dimethyl sulfoxide (DMSO).
The test substance or the vehicle were applied on external surfaces of each ear (25 ul/ear) for three consecutive days (Days 0, 1 and 2) at the appropriate concentrations. On Day 5, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated thymidine and the obtained values were used to calculate proliferation indices.
No mortality and no clinical signs were observed during the study.
No cutaneous reactions were observed in the vehicle or treated groups.
The proliferation index values of the test substance were 0.9, 0.7 and 1.0 at treatment concentrations of 2.5, 5 and 10%, respectively.
BYI 08330 c-HYDANTOIN Na-Salz was found to be a non-sensitizing substance in the Local Lymph Node Assay at all concentrations tested.