Registration Dossier

Diss Factsheets

Administrative data

Description of key information

LD50 oral rat>2000 mg/Kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
other: expert statement
Adequacy of study:
weight of evidence
Study period:
2019
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
For more information see document attached in section 13. (Collection of information for weight of evidence approach – “Information on WoE”)
Reason / purpose for cross-reference:
read-across: supporting information
Guideline:
other: REACH GUIDANCE ON WOE
GLP compliance:
no
Key result
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
GHS criteria not met
Executive summary:

Based on overall information LD50 is higher than 2000 mg/Kg bw

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on conclusion coming from a weight of evidence assessment, LD50 is estimated to be >2000 mg/Kg bw. No classification for acute toxicity oral is warranted under Regulation 1272/2008.