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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
HST 2844 3-(dimethylamino)propylurea was tested for a possible skin-allergenic potential in male guinea pigs by means of a sensitization test (maximization test according to MAGNUSSON and KLIGMAN)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test Skin Sensitization Study in Guinea Pigs (OECD 406) is availabe.

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(dimethylamino)propylurea
EC Number:
401-950-2
EC Name:
3-(dimethylamino)propylurea
Cas Number:
31506-43-1
Molecular formula:
C6H15N3O
IUPAC Name:
3-dimethylaminopropyl urea
Test material form:
liquid
Remarks:
extremely pale straw coloured viscous liquid

In vivo test system

Test animals

Species:
guinea pig
Sex:
male
Details on test animals and environmental conditions:
Twenty test and ten control animals were used in ths study.

Study design: in vivo (non-LLNA)

No. of animals per dose:
Twenty test and ten control animals were used in ths study.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
12%
No. with + reactions:
4
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
12%
No. with + reactions:
1
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
1
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
3-(dimethylamino)propylurea is not considered to be a guinea pig skin sensitizer.
Executive summary:

The purpose of this study was to assess the potential of 3 -(Dimethylamino)propylurea to elicit skinsensitization (delayed contact hypersensitivity) in guinea pigs. Twenty test and ten control animals wereused in ths study.Based on preliminary tests the following concentrations were determined for the test material applications tobe used in the study:Intradermal induction: 0.1%,Topical induction: 12%,and Initiation: 10%.
A skin sensitization response was observed in one out of ten control animals and in four out of twenty animals treated with 3 -(Dimethylamino)propylurea.

Under the protocol (Magnusson and KligmanMaximization) a 30% response is required foramaterial to be considered a skin sensitizer. These results do not show any indication of the test material having a skin sensitizing effect inguinea pigs.