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EC number: 235-125-1 | CAS number: 12070-14-3
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- Aquatic toxicity
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
No data is available for Zirconium carbide (target substance). Thus, to assess the mutagenicity potential of Zirconium carbide available data from Zirconium oxychloride and Zirconium disilicide (source substances) were used in a read-across approach. In a bacterial reverse gene mutation assay with Zirconium oxychloride, the source substance was tested negative in S. typhimurium strains TA1535, TA1537, TA98 and TA100. In an OECD 471 study the source substance Zirconium disilicide was not soluble in a range of solvents for preparing the dilution series of the test material. Thus, it was not possible to conduct the study. Based on the low solubility of the target substance (see IUCLID section 4.8, 7.1.1) and the results obtained from the read-across partners, Zirconium carbide can be considered as not mutagenic and no further testing is required.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- 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
- Species / strain:
- other: TA1535, TA1537, TA100 and TA98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- For detailed results please refer to table 1 in box "Any other information on results incl. tables"
- Remarks on result:
- other: non-mutagenic
- Conclusions:
- In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item can be considered as non-mutagenic.
- Executive summary:
In a reverse gene mutation assay in bacteria conducted similar to OECD test guideline 471, strains TA98, TA100, TA1535 and TA1537 of Salmonella typhimurium were exposed to Zirconium oxychloride hexahydrate in 95% ethanol at concentrations of 10, 33, 100, 333, 1000, 3333 and 6666 µg/plate in the presence and absence of mammalian metabolic activation. The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background in all tester strains. Therefore, Zirconium oxychloride hexahydrate is considered to be non-mutagenic in this Salmonella typhimurium reverse gene mutation assay.
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).
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- 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
- Species / strain:
- S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537
- Metabolic activation:
- not applicable
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Additional information on results:
- The test item could not be prepared in an appropriate solvent and diluted prior to treatment. Due to the properties of the material, Zirconium disilicide was not soluble in any of the solvents used (A. dest, DMSO, ethanol and tetrahydrofuran). No stable suspension which is suitable for the preparation of the dilution series could be obtained. Therefore it was not possible to perform any further steps in this study.
- Remarks on result:
- not measured/tested
- Conclusions:
- Zirconium disilicide was not soluble in any of the solvents used. Therefore it was not possible to perform an Ames test.
- Executive summary:
In this study, the test item Zirconium disilicide could not be prepared in an appropriate solvent and diluted prior to treatment. Due to the properties of the material, Zirconium disilicide was not soluble in any of the solvents used (A. dest, DMSO, ethanol and tetrahydrofuran). No stable suspension which is suitable for the preparation of the dilution series could be obtained. Therefore it was not possible to perform any further steps in this study. Since the test item could not be prepared in an appropriate solvent and diluted prior to treatment, it was not possible to perform an Ames test with Zirconium disilicide.
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).
Referenceopen allclose all
Table 1: Summary of Results | |||||||||||||||||||||
Concentration µg/plate |
TA100 | Concentration µg/plate |
TA1535 | ||||||||||||||||||
without S9 | with 10% hamster S9 | with 10% rat S9 | without S9 | with 10% hamster S9 | with 10% rat S9 | ||||||||||||||||
Mean | SEM | Mean | SEM | Mean | SEM | Mean | SEM | Mean | SEM | Mean | SEM | Mean | SEM | Mean | SEM | Mean | SEM | ||||
Negative Control | 142 | 4.6 | 127 | 1 | 150 | 5.5 | Negative Control | 31 | 2.6 | 9 | 1.3 | 34 | 2.4 | 24 | 3.5 | 34 | 3.3 | 29 | 1.5 | ||
Positive Control | 268 | 19.3 | 1572 | 41.5 | 742 | 48.2 | Positive Control | 344 | 6.9 | 175 | 23.2 | 505 | 12.5 | 326 | 15.2 | 223 | 19.9 | 114 | 6.1 | ||
10 | - | - | - | - | - | - | 10 | 28 | 5.2 | - | - | 36 | 2.3 | - | - | 45 | 5.8 | - | - | ||
33 | - | - | - | - | - | - | 33 | 29 | 3.5 | 36 | 3.2 | - | - | 39 | 2.2 | - | - | ||||
100 | 125 | 8.2 | 158 | 9.5 | 136 | 4.5 | 100 | 30 | 2.4 | 22 | 3.0 | 41 | 3.5 | 33 | 2.3 | 42 | 6.6 | 30 | 1.0 | ||
333 | 108 | 10.9 | 169 | 10.5 | 126 | 7.1 | 333 | 30 | 1.0 | 29 | 6.4 | 38 | 6.1 | 37 | 3.1 | 35 | 3.7 | 33 | 3.6 | ||
1000 | 116 | 13.1 | 156 | 7.0 | 134 | 3.7 | 1000 | 30p | 1.0 | 20 | 4.2 | 30p | 0.3 | 35 | 4.9 | 38p | 6.8 | 31 | 3.2 | ||
3333 | 149p | 13.5 | 144p | 14.0 | 77p | 38.8 | 3333 | - | - | 26p | 3.8 | - | - | 0p | 0.0 | - | - | 29p | 6.8 | ||
6666 | 48p | 24.0 | 126p | 5.2 | 35p | 35.3 | 6666 | - | - | 0p | 0.0 | - | - | 0p | 0.0 | - | - | 0p | 0.0 |
p= precipitation present in plates
Table 1 continued: Summary of Results | |||||||||||||
Concentration µg/plate |
TA1537 | TA98 | |||||||||||
without S9 | with 10% hamster S9 | with 10% rat S9 | without S9 | with 10% hamster S9 | with 10% rat S9 | ||||||||
Mean | SEM | Mean | SEM | Mean | SEM | Mean | SEM | Mean | SEM | Mean | SEM | ||
Negative Control | 7 | 2.9 | 7 | 0.7 | 12 | 3.2 | 25 | 0.0 | 32 | 0.9 | 30 | 3.5 | |
Positive Control | 109 | 8.7 | 536 | 34.9 | 197 | 7.6 | 793 | 25.9 | 1385 | 100.5 | 556 | 36.2 | |
10 | - | - | - | - | - | - | - | - | - | - | - | - | |
33 | - | - | - | - | - | - | - | - | - | - | - | - | |
100 | 8 | 0.9 | 13 | 4.2 | 7 | 1.2 | 21 | 4.3 | 34 | 2.7 | 30 | 0.6 | |
333 | 8 | 1.9 | 8 | 1.9 | 9 | 2.6 | 28 | 1.5 | 34 | 2.6 | 32 | 4.2 | |
1000 | 8 | 1.8 | 12 | 2.0 | 9 | 2.2 | 21 | 4.6 | 32 | 5.8 | 27 | 4.1 | |
3333 | 9p | 1.8 | 7p | 2.5 | 13p | 0.9 | 19p | 1.5 | 30p | 3.0 | 28p | 2.2 | |
6666 | 0p | 0.0 | 0p | 0.0 | 0p | 0.0 | 0p | 0.0 | 0p | 0.0 | 0p | 0.0 |
p= precipitation present in plates
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
No data is available for Zirconium carbide (target substance). Thus, to assess the mutagenicity potential of Zirconium carbide available data from the source substances Zirconium oxychloride and Zirconium disilicide were used in a read-across approach. For justification of read-across please refer to the read-across report attached to IUCLID section 13.
In a bacterial reverse gene mutation assay with Zirconium oxychloride, the source substance was tested negative in S. typhimurium strains TA1535, TA1537, TA98 and TA100. In an OECD 471 study the second source substance Zirconium disilicide was not soluble in a range of solvents for preparing the dilution series of the test material. Thus, it was not possible to conduct the study.
Based on the low solubility of the target substance (see IUCLID section 4.8) and the results obtained from a bio-elution test (see IUCLID section 7.1.1) the bioavailability of zirconium, as the toxicological relevant part of the target substance, can be expected to be very low. Based on the data obtained from read-across partners together with the low solubility and bioavailabilty of the target substance, Zirconium carbide can be considered as not mutagenic.
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 mutagenicity.
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