Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
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 the dermal route is appropriate if: (1) skin contact in production and/or use is likely; and (2) the physicochemical properties suggest a significant rate of absorption through the skin; and (3) one of the following conditions is met: toxicity is observed in the acute dermal toxicity test at lower doses than in the oral toxicity test, or systemic effects or other evidence of absorption is observed in skin and/or eye irritation studies, or significant dermal toxicity or dermal penetration is recognised for structurally-related substances. ” Exposure to Reaction Product of Bisphenol A diglycidylether (BADGE) with IPDA and MXDA by the dermal route is unlikely, as: 1) Reaction Product of Bisphenol A diglycidylether (BADGE) with IPDA and MXDA is manufactured and formulated in completely closed systems. Thus, exposure via the dermal route during manufacturing and formulation is unlikely. 2) Use of formulated Reaction Product of Bisphenol A diglycidylether (BADGE) with IPDA and MXDA is also unlikely to result in exposure via the dermal route. During use Reaction Product of Bisphenol A diglycidylether (BADGE) with IPDA and MXDA is included in three-dimensional matrices of resinous material and completely retained. Therefore, exposure via the dermal route is practically negligible. For more details on exposure assessment see the risk assessment report in section 13. 3) Finally, none of the conditions indicating significant dermal toxicity was met.

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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