sodium 4,4-dimethyl-2,5-dioxoimidazolidin-1-ide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 9-25, 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was performed in compliance with GLP standards and in accordance with the Guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

see data source

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

476-160-4

EC Name:

-

Cas Number:

54807-34-0

Molecular formula:

C5H7N2NaO2

IUPAC Name:

sodium 4,4-dimethyl-2,5-dioxoimidazolidin-1-ide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Identification: NaDMH
Description: white powder
Storage conditions: RT, over silica gel, in the dark

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

Female CBA/Ca (CBA/CaBkl) strain mice were supplied by B&K Universal Ltd, Hull, UK. The animals were individually housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes.
The temperature and relative humidity were controlled to remain within target ranges of 19 to 25°C and 30 to 70% respectively. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continous light (06:00 to 18:00) and twelve hours darkness.

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

5%
10%
25% w/w

No. of animals per dose:

groups of four mice

Details on study design:

The mice were treated by daily application of 25 microL of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test material formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette. A further group of four mice as control group (vehicle alone).

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:

Concentration (% v/v) in dimethyl formamide Stimulation Index Result
5 2.81 Negative
10 4.20 Positive
25 13.15 Positive
Alpha-Hexylcinnamaldehyde, Tech, 85% was considered to be a sensitiser under the conditions of the test.

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: see Remark

Remarks:

Concentration (% w/w) in dimethyl formamide Stimulation Index 5 1.26 10 1.20 25 1.47

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: see Remark

Remarks:

Concentration (% w/w) in dimethyl formamide dpm dpm/Node Vehicle 3557.90 444.74 5 4487.17 560.90 10 4278.86 534.86 25 5223.92 652.99

Any other information on results incl. tables

Concentration (% w/w) in dimethyl formamide Result

5 Negative

10 Negative

25 Negative

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

The test material was considered to be a non-sensitizer under the conditions of the test.

Executive summary:

NaDMH was considered to be a non-sensitizer under the conditions of the test.