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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Although the study has been conducted according to GLP guidelines, no final report was drafted. The data summary lacks detail on: identity/composition of test material, materials and methods which makes it difficult to interpret the available data and to reproduce the study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
N-[3-(dimethylamino)propyl]acrylamide
EC Number:
223-342-4
EC Name:
N-[3-(dimethylamino)propyl]acrylamide
Cas Number:
3845-76-9
Molecular formula:
C8 H16 N2 O
IUPAC Name:
N‐[3‐(dimethylamino)propyl]prop‐2‐enamide

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: sesame oil
Concentration / amount:
induction:
i.d. 0.5% (1 week)
e.c. 50% (2 weeks)
challange:
10%
Challengeopen allclose all
Route:
other: no information.
Vehicle:
other: sesame oil
Concentration / amount:
induction:
i.d. 0.5% (1 week)
e.c. 50% (2 weeks)
challange:
10%
No. of animals per dose:
10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
erythema and edema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: erythema and edema.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
erythema and edema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: erythema and edema.
Reading:
1st reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10%
No. with + reactions:
18
Total no. in group:
20
Clinical observations:
erythema and edema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 10%. No with. + reactions: 18.0. Total no. in groups: 20.0. Clinical observations: erythema and edema.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
-
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: -. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: erythema.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
-
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: -. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: erythema.
Reading:
1st reading
Hours after challenge:
72
Group:
negative control
Dose level:
-
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 72.0. Group: negative control. Dose level: -. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

   

challenge
animal observation 24h 48h 72h
control (male) 1 erythema / edema 0 / 0 0 / 0  0 / 0 
control (male) 2 erythema / edema 1 / 0  1 / 0  0 / 0 
control (male) 3  erythema / edema 0 / 0  0 / 0  0 / 0 
control (male) 4  erythema / edema 0 / 0  0 / 0  0 / 0 
control (male) 5  erythema / edema 0 / 0 0 / 0  0 / 0 
control (female) 1 erythema / edema 0 / 0  0 / 0  0 / 0 
control (female) 2  erythema / edema 0 / 0  0 / 0  0 / 0 
control (female) 3  erythema / edema 0 / 0 0 / 0  0 / 0 
control (female) 4  erythema / edema 0 / 0 0 / 0  0 / 0 
control (female) 5  erythema / edema 0 / 0 0 / 0  0 / 0 
male 1 erythema / edema 3 / 2  3 / 2 2 / 2
male 2 erythema / edema 1 / 0 1 / 0 0 / 0
male 3 erythema / edema 3 / 2 2 / 1 2 / 1
male 4 erythema / edema 1 / 1 1 / 0 0 / 0
male 5 erythema / edema 2 / 1 2 / 1 2 / 1
male 6 erythema / edema 3 / 2 3 / 2 3 / 2
male 7 erythema / edema 2 / 2 2 / 2 1 / 1
male 8 erythema / edema 2 / 2 2 / 2 2 / 2
male 9 erythema / edema 3 / 2 3 / 2 3 / 2
male 10 erythema / edema 2 / 1  2 / 1 1 / 0
female 1 erythema / edema 2 / 2 2 / 1 1 / 0
female 2 erythema / edema 4 / 3 4 / 3 4 / 3
female 3 erythema / edema 4 / 3 4 / 3 4 / 3
female 4 erythema / edema 2 / 2 2 / 2 2 / 2
female 5 erythema / edema 4 / 3 4 / 4 4 / 4
female 6  erythema / edema 3 / 2 3 / 2 3 / 2
female 7 erythema / edema 1 / 0 1 / 0 1 / 0
female 8 erythema / edema 3 / 2 3 / 2 2 / 1
female 9 erythema / edema 3 / 2  3 / 2 3 / 2
female 10  erythema / edema 4 / 3 4 / 4 4 / 4

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
At a sensitization of 100% the test material is to be considered a strong sensitizer