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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The read-across from the two source substances is considered to give a reliable estimation of the acute oral toxicity potential of the target substance. Both source substances are found to have an LD50oral >2000 mg/kg bw and >16000 mg/kg bw, respectively.
The LD50 oral of 9000 mg/kg bw in the read-across study has been estimated for hazard classification and chemical safety assessment.


In conclusion, a LD50oral >2000 mg/kg bw is taken for the target substance.
According to the LD50 values described above, both analogues and the target substance are associated with the same GHS/CLP classification (not classified).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
A detailed read-across justification in-line with the ECHA RAAF guidelines is provided as an attached document.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
GHS criteria not met
Conclusions:
The read-across from the two source substances is considered to give a reliable estimation of the acute oral toxicity potential of the target substance. Both source substances are found to have an LD50oral >2000 mg/kg bw and >16000 mg/kg bw, respectively.
The LD50 oral of 9000 mg/kg bw in the read-across study has been estimated for hazard classification and chemical safety assessment.

In conclusion, a LD50oral >2000 mg/kg bw is taken for the target substance.
According to the LD50 values described above, both analogues and the target substance are associated with the same GHS/CLP classification (not classified).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 2 000 mg/kg bw

Additional information

Justification for classification or non-classification

Based on the data available, the substance has shown no acute systemic toxicity potential and should therefore not be classified for acute toxicity according to the (EC) No 1272/2008 Regulation (CLP).