Registration Dossier

Diss Factsheets

Administrative data

Description of key information

No data is available for Zirconium carbide (target substance). Thus, to assess the acute oral toxicity potential of Zirconium carbide available data from Zirconium disilicide (source substance) was used in a read-across approach. In an acute oral toxicity study in rats conducted according to OECD test guideline 423, the source substance Zirconium disilicide (99.47% purity) showed no adverse effects at the limit dose of 2000 mg/kg bw. Hence, the LD50 value is considered to be greater than 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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
For justification of read-across please refer to the read-across report attached to IUCLID section 13.
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed
Clinical signs:
No specific findings in any test animal during the whole observation period
Body weight:
No specific findings in any test animal during the whole observation period
Gross pathology:
No specific findings
Other findings:
N.A.
Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study in rats conducted according to OECD 423, no adverse effects were observed for Zirconium disilicide at the limit dose of 2000 mg/kg bw. Hence, the LD50 value is determined to be greater than 2000 mg/kg bw.
Executive summary:

In an acute oral toxicity study (OECD 423), 6 fasted, 8-11 weeks old, female Wistar rats were given a single oral dose of Zirconium disilicide (99.47% purity) in sterile water at the limit dose of 2000 mg/kg bw and were observed for 14 days. All animals survived until the end of the study without showing any test item related signs of toxicity. Throughout the 14-day observation period, the body weight gain of the test animals was within the normal range of variation for this strain. At necropsy, no treatment-related macroscopic findings were observed in any animal of any step. Based on the results from this study, the oral LD50 in rats is considered to be greater than 2000 mg/kg bw.

This information is used in a read-across approach in the assessment of the target substance.

For justification of read-across please refer to the attached read-across report (see IUCLID section 13).

Additional information

No data is available for Zirconium carbide (target substance). Thus, to assess the acute oral toxicity potential of Zirconium carbide available data from Zirconium disilicide (source substance) was used in a read-across approach. For justification of read-across please refer to the read-across report attached to IUCLID section 13.

In an acute oral toxicity study in rats conducted according to OECD test guideline 423, the source substance Zirconium disilicide (99.47% purity) showed no adverse effects at the limit dose of 2000 mg/kg bw. Hence, the LD50 value is considered to be greater than 2000 mg/kg bw.

Justification for classification or non-classification

Based on available data from a suitable read-across partner, the target substance Zirconium carbide does not warrant classification for acute oral toxicity.

Categories Display