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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Epidemiological data

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Administrative data

Endpoint:
epidemiological data
Type of information:
other: Critical analysis
Adequacy of study:
key study
Study period:
2012
Rationale for reliability incl. deficiencies:
other: Critical analysis of 80 epidemiological data.

Data source

Referenceopen allclose all

Reference Type:
other: Report
Title:
Unnamed
Year:
2012
Report date:
2012
Reference Type:
other: Report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Study type:
cohort study (retrospective)
Endpoint addressed:
toxicity to reproduction / fertility
developmental toxicity / teratogenicity
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
O-acetylsalicylic acid
EC Number:
200-064-1
EC Name:
O-acetylsalicylic acid
Cas Number:
50-78-2
Molecular formula:
C9H8O4
IUPAC Name:
2-acetoxybenzoic acid

Results and discussion

Applicant's summary and conclusion

Conclusions:
There is no link between ASA use during pregnacy and reprotoxic effects. Epidemiologiocal data do not provide evidence to support the hypothesis that maternal consumption during pregnancy of NSAIDs overall (including ASA) is associated with persistent pulmonary hypertension of the newborn risk.
Executive summary:

As a final conclusion, no adverse effect of aspirin treatment can be considered as established, either at low or high dose.