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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
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.
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.
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.

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

Eye irritation

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

Additional information

Effects on eye irritation: slightly irritating

Justification for classification or non-classification