Registration Dossier

Administrative data

Description of key information

Oral: QSAR predicted value; rat LC50: 194843.68 mg/kg. Reliability = 2

Inhalation: No study available

Dermal: No study available

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
acute toxicity: oral
Type of information:
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Composition 0
no guideline available
Principles of method if other than guideline:
Consensus model in Test v4.2.1
Model prediction report is attached in IUCLID
GLP compliance:
Test type:
other: QSAR predicition
Test material information:
Composition 1
Key result
Dose descriptor:
Effect level:
19 483.68 mg/kg bw
Remarks on result:
other: QSAR predicted value
Interpretation of results:
GHS criteria not met
LD50 (rat): 19483.68 mg/kg
Executive summary:

The consensus model in Times v4.2 was used to predict the acute toxicity to rats. The oral LD50 in rats was predicted to be 19483.68 mg/kg. Additional supporting documentation is provided in the prediction report attached in IUCLID.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
19 483.68 mg/kg bw
Quality of whole database:
QSAR predicted value

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

The consensus model in Times v4.2 was used to predict an oral LD50 in rats of 19483.68 mg/kg. Data found in the RTECS database (LD50 in mice >10000 mg/kg), as well as a review of 12 controlled clinical trials where total of 250 adults were given oral doses equal to 67 and 500 mg/kg/day over 1 to 12 months that did not report any mortality, support the low toxicity potential of the test substance via the acute oral route.

Justification for classification or non-classification

Based on the predicted oral LD50 in rats of 19483.68 mg/kg and supporting mouse and human data, no classification is required for the acute oral endpoint according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.