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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
Justification for type of information:
In accordance with REACH Regulation (EC) No. 1907/2006 Annex VII, column 2 section 8.5 (as amended by Commission Regulation (EU) 2016/863) the acute dermal toxicity (OECD TG 402) study does not need to be conducted based on available information. The data via the oral route indicates that the acute oral toxicity LD50 > 2000 mg/kg bw. There is an absence of systemic toxicity in available Skin Sensitisation tests and in acute dermal irritation tests (eq. or similar to OECD TG 404). This indicates a clear weight of evidence that the EU criteria (Acute Toxicity and STOT-SE) will not been met. Toxicity via the dermal route is not envisaged. Further testing is not scientifically justified. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.4, July 2017) the study does not need to be conducted.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion