5,5-Dimethylimidazolidine-2,4-dione, reaction products with oxirane

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 March 2007 to 27 March 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)

Deviations:

no

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

1,3-bis(2-hydroxyethyl)-5,5-dimethylimidazolidine-2,4-dione

EC Number:

701-388-0

Cas Number:

26850-24-8

IUPAC Name:

1,3-bis(2-hydroxyethyl)-5,5-dimethylimidazolidine-2,4-dione

Test material form:

other: pale yellow solid block

Details on test material:

- Name of test material (as cited in study report): Dantocol DHE
- Physical state: pale yellow solid block
- Lot/batch No.: M5469330
- Storage condition of test material: room temperature in the dark

In vivo test system

Test animals

Species:

mouse

Strain:

CBA/Ca

Sex:

female

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

10%, 25% or 50% w/w

No. of animals per dose:

4/treatment group

Positive control substance(s):

not specified

Results and discussion

Positive control results:

Not specified.

In vivo (LLNA)

Results

Results 1

Key result

Parameter:

SI

Value:

1

Test group / Remarks:

10%

Results 2

Key result

Parameter:

SI

Value:

1.48

Test group / Remarks:

25%

Results 3

Key result

Parameter:

SI

Value:

1.36

Test group / Remarks:

50%

Any other information on results incl. tables

There were no deaths and no signs of systemic toxicity were noted in the test or control animals during the test.

Concentration (%w/w) in dimethyl formamide	Stimulation Index	Result
Vehicle	N/A	N/A
10	1.00	Negative
25	1.48	Negative
50	1.36	Negative

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance was considered to be a non-sensitiser based on a SI of less than 3 for all treatment groups.

Executive summary:

In an in vivo local lymph node assay to evaluate the sensitisation potential of the substance mice (4 animals/treatment group) were exposed to the substance for 3 consecutive days at concentrations 10%, 25% or 50% w/w. Another group of 4 animals received the vehicle alone. The SI for all treatment groups was below 3 and thus indicates that the substance is not a sensitiser.