Registration Dossier

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

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