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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Report of study using a recognised OECD method and including calculation of EC2 and EC3 concentrations

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 442A (Skin Sensitization: Local Lymph Node Assay: DA)
Deviations:
yes
Remarks:
Response measured as lymph node weight as well as ATP content
GLP compliance:
not specified
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Reference substance name:
Imidazolidinyl urea
IUPAC Name:
Imidazolidinyl urea
Constituent 2
Chemical structure
Reference substance name:
N,N''-methylenebis[N'-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]
EC Number:
254-372-6
EC Name:
N,N''-methylenebis[N'-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]
Cas Number:
39236-46-9
Molecular formula:
C11H16N8O8
IUPAC Name:
N',N'''-methylenebis{1-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea}

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
Details not given

Study design: in vivo (LLNA)

Vehicle:
dimethylformamide
Concentration:
10, 25 and 50%
No. of animals per dose:
3/test concentration, 4 vehicle controls. 4 in each positive control group
Details on study design:
Treatments applied to dorsal surfaces of mouse ears
Positive control substance(s):
other: Eugenol, tested at 10% in both dimethyformamide and in acetone/olive oil
Statistics:
Pairwise comparison of test and control groups

Results and discussion

Positive control results:
Eugenol 10%:
- in dimethylformamide, negative for lymph node weight (SI <2, not different from vehicle control) and for ATP content (SI <2, not different from vehicle control)
- in acetone/olive oil, positive for lymph node weight (SI >2.5, different from vehicle control p<0.01) and for ATP content (SI >6, different from vehicle control p<0.01)

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: 10% test group: LNW SI <2 (P<0.05), ATP SI >2 but <3 (P<0.01) 25% test group: LNW SI <2 (P<0.01), ATP SI >3 (P<0.01) 50% test group: LNW SI SI >2 but <3 (P<0.01), ATP SI >4 (P<0.01)
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Results expressed as SI values calculated for lymph node weight (LNW) and ATP content

Any other information on results incl. tables

SI values >3 reported for ATP content at both 25% and 50% test concentrations.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: other: Expert judgement: OECD 442A guideline states ATP content SI 1.8-2.5 is a borderline positive result, so SI >2.5 is clearly positive.
Conclusions:
The test substance showed evidence of contact sensitising action in this study.