Registration Dossier

Administrative data

Description of key information

A Guinea Pig Maximization Test (GPMT) is available for 3-(dimethylamino)propylurea (EC 401-950-2), which is as an impurity present in the registered substance 1,3-bis[3-(dimethylamino)propyl]urea (bisDMAPU) up to approximately 15%. Based on the result of this GPMT test, 3-(dimethylamino)propylurea is not considered to be a guinea pig skin sensitizer.

 

Furthermore, as the registered substance 1,3-bis[3-(dimethylamino)propyl]urea (bisDMAPU) contains up to 5% of 3-aminopropyldimethylamine (DMAPA), CAS 109-55-7, as an impurity, which is classified as a sensitizer with H317, the registered substance also has to be classified to be a skin sensitizer with H317.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

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
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.
Species:
guinea pig
Sex:
male
Details on test animals and environmental conditions:
Twenty test and ten control animals were used in ths study.
No. of animals per dose:
Twenty test and ten control animals were used in ths study.
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
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.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The test item was a mixture of the reaction products (1-(3-(Dimethylamino)propyl)urea (CAS 31506-43-1, EC 401-950-2, mono-DMAPAU) and 1,3-bis[3-(dimethylamino)propyl]urea (CAS 52338-87-1, EC 257-861-2, bis-DMAPAU)
Both source (1-(3-(Dimethylamino)propyl)urea (CAS 31506-43-1, EC 401-950-2) )and target 1,3-bis[3-(dimethylamino)propyl]urea (CAS 52338-87-1, EC 257-861-2) substances are based on the reaction product of dimethylaminopropylamine (DMAPA) and urea.
The main product of this reaction is the singly-substituted urea product, (3-(dimethylamino)propyl) urea (or mono-DMAPAU)
However, an unavoidable side-reaction is the formation of the doubly-substituted product, 1,3-bis[3-(dimethylamino)propyl]urea, which is formed by the disproportionation of mono-DMAPAU.
The test item will contain approximately 15% of 1,3-bis[3-(dimethylamino)propyl]urea.
Read-across is also claimed based on structural similarity and properties of both reaction products. Justification attached.
Reason / purpose for cross-reference:
read-across source
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.
Species:
guinea pig
Sex:
male
Details on test animals and environmental conditions:
Twenty test and ten control animals were used in ths study.
No. of animals per dose:
Twenty test and ten control animals were used in ths study.
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
Interpretation of results:
GHS criteria not met
Conclusions:
3-(dimethylamino)propylurea is not considered to be a guinea pig skin sensitizer.
Executive summary:

A skin sensitization study was performed in guinea pigs treated with 3 -(Dimethylamino)propylurea (monoDMAPAU)

These results do not show any indication of the test material having a skin sensitizing effect in guinea pigs.

Based on the presence of approximately 15% of 1,3-bis[3-(dimethylamino)propyl]urea.(bisDMAPAU) in the test item, and according to the attached read-across justification this result is also deemed valid for 1,3-bis[3-(dimethylamino)propyl]urea (bisDMAPU).



Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Justification for classification or non-classification

As the registered substance 1,3-bis[3-(dimethylamino)propyl]urea (bisDMAPU) contains up to 5% of 3-aminopropyldimethylamine, CAS 109-55-7 (DMAPA) which is classified as a sensitizer with H317 as an impurity the registered substance has also to be classified to be a skin sensitizer with H317.