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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

Endpoint:
skin sensitisation: in chemico
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
GLP compliance:
yes (incl. QA statement)
Type of study:
direct peptide reactivity assay (DPRA)

Test material

Constituent 1
Chemical structure
Reference substance name:
(3-methoxypropyl)dimethylamine
EC Number:
827-772-9
Cas Number:
20650-07-1
Molecular formula:
C6H15NO
IUPAC Name:
(3-methoxypropyl)dimethylamine

In chemico test system

Details of test system:
cysteine peptide, (Ac-RFAACAA-COOH)
lysine peptide (Ac-RFAAKAACOOH)
Details on the study design:
The Direct Peptide Reactivity Assay was used to assess the skin sensitization potential of the test
article. Synthetic peptides containing cysteine or lysine were reacted with each test article for 24 ±
2 hours. After the incubation period, the extent of peptide depletion was analyzed using High Per
formance Liquid Chromatography (HPLC) coupled with ultra-violet (UV) spectrometric detection.

2 assays were performed.
Vehicle / solvent:
acetonitrile
Positive control:
cinnamic aldehyde

Results and discussion

Positive control results:
Mean Peptide Depletion (%): 82.0 for Cysteine, 65.0 for Lysine

In vitro / in chemico

Resultsopen allclose all
Key result
Group:
test chemical
Run / experiment:
mean
Parameter:
lysine depletion
Value:
1.76 %
At concentration:
100 mM
Positive controls validity:
valid
Key result
Group:
test chemical
Run / experiment:
mean
Parameter:
cysteine depletion
Value:
5.59 %
At concentration:
100 mM
Positive controls validity:
valid
Outcome of the prediction model:
no or minimal reactivity [in chemico]
Other effects / acceptance of results:
The assay was accepted as the following criteria were met:
1) Each standard curve must have an r2 > 0.990 => criterion met
mean peptide concentration of reference controls A and C = 0.50 ± 0.05 mM => criterion met
peak area CV for reference controls B and C must be < 15% => criterion met
2) percent peptide depletion for cysteine peptide with positive control > 60.8% => criterion met
and SD for replicates < 11.6 => criterion met
percent peptide depletion for lysine peptide with positive control: 40.2 to 69.4% => criterion met
and SD for replicates < 11.6 => criterion met
3) SD of test substance replicates <11.6% for lysine/cysteine depletion => criterion met

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

The test article, DMMOPA, was evaluated for skin sensitization potential using the
Direct Peptide Reactivity Assay (DPRA) in 2 assays. The % peptide depletion was 5.59% (Cysteine) and 1.76% (Lysine). Based on these results, DMMOPA was predicted to be a non-sensitizer.