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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
478-310-4
EC Name:
-
Cas Number:
53803-13-7
Molecular formula:
C9H21NO2
IUPAC Name:
Methanaminium N,N,N-trimethyl-, salt with 2,2-dimethylpropanoic acid
Test material form:
other: liquid
Details on test material:
Test was performed using commercial product DABCO TMR-7 which is 50% solution of Methanaminium N,N,N-trimethyl-, salt with 2,2-dimethylpropanoic acid in 1,2-ethandiol, Batch #19847-85

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: 1,2-ethandiole
Controls:
no
Amount / concentration applied:
Volume applied was 0.5 ml/site
Duration of treatment / exposure:
3 minute exposure- 1 h exposure and 4 hour exposure was used.
Observation period:
The site was scored for skin reaction 1 hour after exposure.
Number of animals:
3 animals
Details on study design:
Prior to application,3 sites (3x3 cm) at the back of each animal were clipped to be free from hair. 0.5 ml /site of test article was dosed and covered by 2.2x2.5 cm piece of 4 ply surgical gauze. Plastic covering was then applied in semmioclusive way. The site was scored for skin reaction 1 hour after patch removal and washing of the exposed skin with distilled water. Sites 2 and 3 were scored 1 hour after exposure end and then 24, 48 and 72 hours postdose.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 3 min
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 3 min
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
There was observed no erythema or edema response during the test with the exception of one very slight erythema appearing after 1 h exposure.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Modified primary irritation index for Methanaminium N,N,N-trimethyl-, salt with 2,2-dimethylpropanoic acid was determined to be 0, substance is not irritant/corrosive.
Executive summary:

Modified primary irritation index for Methanaminium N,N,N-trimethyl-, salt with 2,2-dimethylpropanoic acid was determined to be 0, substance is not irritant/corrosive.