Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline study conducted in accordance to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1-dimethoxytrimethylamine
EC Number:
225-063-3
EC Name:
1,1-dimethoxytrimethylamine
Cas Number:
4637-24-5
Molecular formula:
C5H13NO2
IUPAC Name:
1,1-dimethoxy-N,N-dimethylmethanamine
Details on test material:
IUCLID4 Test substance: as prescribed by 1.1 - 1.4

In vivo test system

Test animals

Species:
guinea pig
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
polyethylene glycol
Concentration / amount:
The intradermal and the epicutaneous induction were performed with a 1% test substance preparation in paraffin, highly liquid. For the first challenge a 0.1% test substance preparation in paraffin, highly liquid was chosen. The second challenge was performed with a 0.05% test substance preparation in polyethylene glycol.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Concentration / amount:
The intradermal and the epicutaneous induction were performed with a 1% test substance preparation in paraffin, highly liquid. For the first challenge a 0.1% test substance preparation in paraffin, highly liquid was chosen. The second challenge was performed with a 0.05% test substance preparation in polyethylene glycol.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
other: control
Dose level:
polyethylene glycol
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no skin findings
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control. Dose level: polyethylene glycol. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no skin findings.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: control
Dose level:
polyethylene glycol
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no skin findings
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control. Dose level: polyethylene glycol. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no skin findings.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.05% test substance preparation in polyethylene glycol
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
discrete (3/10 animals) up to moderate and confluent eryhema (3/10 animals)
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.05% test substance preparation in polyethylene glycol. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: discrete (3/10 animals) up to moderate and confluent eryhema (3/10 animals).
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.05% test substance preparation in polyethylene glycol
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
discrete or patchy eryhema (1/10 animals)
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.05% test substance preparation in polyethylene glycol. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: discrete or patchy eryhema (1/10 animals).

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Based on the results of this study it was concluded that N, N-Dimethylformamide dimethyl-acetal has a sensitizing effect on the skin of the guinea pig in the Maximization Test under the test conditions chosen.
Executive summary:

After the first challenge interpretation of the results was complicated by the interference of primary skin irritation effects induced by the vehicle paraffin oil, which led to very similar high incidences of skin reactions in control group 1 and the test group at the test substance treated application sites. Very high incidences of skin reaction at the vehicle treated application sites were observed in all groups, additionally. In order to enhance evaluation, a second challenge was performed using another vehicle (Lutrol E 400). As after the second challenge no skin reactions occurred in the control groups but 6 of 10 animals in the test group showed findings, the test substance is considered to possess a skin sensitizing potential. Reactions in some animals of the test group at the vehicle treated application site indicate a possible influence of the induction treatment by the test substance on the skin irritation threshold.