Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
adequate
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Reproductive toxicity testing in vivo on DMAP is not feasible, as doses are found to likely be corrosive. The pH of 0.1 mg/ml and 100 mg/ml solutions of DMAP in deionized water were 10.23 and 11.89, respectively, too alkaline for oral administration in a reproductive toxicity study (per correspondence with the Contract Laboratory Organization). Neutralization results in salt formation and a change in the substance identity. It is necessary to comply with the introductory paragraphs to REACH Annexes VIII, IX and X which state that “in vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall be avoided.” DMAP is inactive in (Q)SAR modeling of reproductive toxicity effects. The MultiCASE models are built on large databases of reproductive toxicity guideline studies submitted to the US FDA for pharmaceuticals. All model results for reproductive toxicity were conclusive in categorizing DMAP as not having characteristics of reproductive toxicants.


Short description of key information:
DMAP in inactive in (Q)SAR modeling of reproductive toxicity effects.

Justification for selection of Effect on fertility via oral route:
validated QSAR

Effects on developmental toxicity

Description of key information
DMAP is "inactive" in a developmental toxicity QSAR model.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

DMAP is inactive in QSAR modeling of developmental toxicity effects. The MultiCASE models are built on large databases of reproductive toxicity guideline studies submitted to the US FDA for pharmaceuticals. One model result for fetal growth retardation was inconclusive. Overall, DMAP is not considered to have characteristics of developmental toxicants.


Justification for selection of Effect on developmental toxicity: via oral route:
validated QSAR

Justification for classification or non-classification

QSAR modeling of DMAP for reproductive toxicity indicates that it is not a reproductive or developmental toxicant. The workplace exposure to this substance is restricted, due to its high acute toxicity, and it is not available to the general public. The criteria for classification under Regulation EC No. 1272/2008 are not met.

Additional information