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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
short-term repeated dose toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
REACh Regulation No. 1907/2006, Annex IX, Sect. 8.6.2, Col. 2, states as follows: “8.6.2: Testing by inhalation route is appropriate if exposure on humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of inhalable size.” Exposure to Reaction product of Bisphenol A diglycidylether (BADGE) with IPDA and MXDA by inhalation is unlikely, as physico-chemical properties suggest no evidence of a significant absorption by inhalation. The substance is practically non-volatile, with vapour pressure estimated in the range of 2.07E-21 Pa to 5.35E-21 Pa at 25 °C (mean ca. 3.33E-21 Pa). Furthermore, from experience in use, formation of inhalable particles is not very likely. Thus, inhalation toxicity testing of Reaction Product of Bisphenol A diglycidylether (BADGE) with IPDA and MXA is not scientifically justified.

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion