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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Oral:LD50: >2 000 mg/kg for rat (limit test) (OECD TG401)
Dermal:LD50: >2 000 mg/kg for rat (limit test) (OECD TG402)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Value:
mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

The acute oral and dermal toxicity tests (according to OECD TG 401 and 402) were well investigated by Allen in1997, the results indicated the test material has very low oral and dermal toxicity in rats. OECD TG 401 was deleted in 2002 due to animal welfare reasons, however, the validity of the results which accomplished by TG 401 should be confirmed.

According to the nature of the substance and the likely routes of human exposure, the acute inhalation toxicity study might not be considered. Moreover, the laboratory facilities which complying with OECD Principles of Good Laboratory Practice were utilized in order to ensure the consistency and reliability. These two studies were utilized as key studies in substance acute toxicity evaluation due to their high adequation, reliability and relevance to this element.

Justification for classification or non-classification

According to the existing studies on acute oral and dermal toxicity tests (LD50 > 2000 mg/kg bw) in rats, which provide sound conclusive evidence that the substance (CAS:5945-33-5 ) does not require classification as set of risk phrases for these endpoints.