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Description of key information

The results do not show any indication to the specimen having a skinsensitizing effect in guinea pigs.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation, other
Remarks:
Magnusson & Kligrnan Maximization
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
Qualifier:
according 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)
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.
Magnusson & Kligrnan Maximization was depleyed as per OECD 406 before 1992. This test was conducted in 1986. After 1992 the Murine Local Lymph Node Assay (LLNA) is the first-choice method for in vivo testing.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Strain: Bor: DHPW, SPF, (Winkelmann, Borchen)
Bodyweight range: 272-360 g
Age: 4 to 7 weeks
Acclimatisation: 7 days
Twenty test and ten control animals were used in ths study.
Positive control results:
Formaldehyde animal: positive in order to confirm sensitivity
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
12 %
No. with + reactions:
4
Total no. in group:
20
Clinical observations:
4 animals showed slight reversible redness
Remarks on result:
no indication of skin sensitisation
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

1 out of 10 animals of the control group showed positive reaction. (10%).

4 out 20 animals in the test group showed positive reaction (20%).

In general the reactions were very weak (mostly light redness) and could be observed at only one animal after 48 hours.

The 10 % solution was well tolerated for the choice of 4 animals without skin irritation and therefore selected.

This concentration is very close to the irritation concentration of 12 %.

Hence redness can be considered as an individual slight irritation and it can be concluded that the test substance is not a sensitizer..

Interpretation of results:
GHS criteria not met
Conclusions:
The results do not show any indication to the specimen having a skinsensitizing effect in guinea pigs.
Executive summary:

HST 2844 (N-(3-(dimethylamino)-propyl) urea) 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).

Based on the preliminary tests to determine the dosage the following concentrations were determined for the specimen applicatiofis to be used in the study:

Intradermat induction: 0.1%

Topical induction: 12%

Initiation: 10%

Upon initiation no positive reactions in the sense of a contact allergen were observed in the group induced with the specimen.

Consequently, the results do not show any indication to the specimen having a skinsensitizing effect in guinea pigs.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification