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EC number: 434-280-4 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
EC 434-280-4 was negative in an OECD 471 and 473 study.
In the OECD 471 study, the test material caused a visible reduction in the growth of the background lawn to all of the Salmonella tester strains, initially at 50 and 150 micro-grams per plate with and without S9 respectively. Toxicity was also observed tp Escherichia coli strain WP2uvrA-, initially at 50 and 500 micro-grams per plate with and without S9 respectivelt. The test material was, therefore, testted up to the toxic limit. An oily precipitate was observed at 5000 micro-grams plate only, this did not prevent the scoring of relevant colonie. No signficiant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, with or without metabolic activation. The test material was considereed to be non-mutagenic under the conditions of this test.
No OECD 476 data is available on EC 434-280-4. However, there is sufficient data on the dissociation products and the functional groups that comprise the final salt reaction product to conclude that there is no potential for mutagenicity in mammalian cells. The complete assessemnt can be found in the corresponding endpoint record.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
No premature deaths were observed in any of the dose groups. The clinical sign, hunched posture, was observed in animals dosed with test material at 18 mglkg in the 48-hour
dose group only. Statistically significant decreases in the PCE/NCE ratio were obsemed in the 24-hour 4.5 and 9 mgkg test material dose groups when compared to their concurrent control group. With no statistically significant decreases in the PCE/NCE ratio being observed in either of the two 18 mgkg dose groups the validity of the responses seen in the lower dose levels may be questioned. However, both of the 18 mgkg dose groups had PCE/NCE ratio values lower than their concurrent vehicle controls and, therefore, the decreases in PCE/NCE ratios were taken to indicate that exposure to the bone marrow had been achieved.
There was no evidence of a significant increase in the incidence af micronucleated polychromatic
erythrocytes in animals dosed with the test material when compared to the concurrent vehicIe
control groups.
The positive control group showed a marked and statistically significant increase in the incidence
of micronucleated polychromatic erythrocytes hence confirming the sensitivity of the system to
the known mutagenic activity of cyclophosphamide under the conditions of the test. However, it
should be noted that the sample of cyclophosphamide used proved to be very toxic, as indicated
by the NCE values and the significant reduction in the PCElNCE ratio value. This also led to two
animals (numbers 17 and 19) having very low individual score for micronucleated PCEs,
hawever, the overall response was considered adequate and not to affect the integrity of the study.
Conclusion:. The test material was considered to be non-genotoxic under the conditions of the
test.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
In vitro study
The test material caused a visible reduction in the growth of the background lawn to all of the Salmonella tester strains, initially at 50 and 150 micro-grams per plate with and without S9 respectively. Toxicity was also observed tp Escherichia coli strain WP2uvrA-, initially at 50 and 500 micro-grams per plate with and without S9 respectivelt. The test material was, therefore, testted up to the toxic limit. An oily precipitate was observed at 5000 micro-grams plate only, this did not prevent the scoring of relevant colonie.
No signficiant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, with or without metabolic activation.
In vivo study
No premature deaths were observed in any of the dose groups. The clinical sign, hunched posture, was observed in animals dosed with test material at 18 mglkg in the 48-hour
dose group only. Statistically significant decreases in the PCElNCE ratio were obsemed in the 24-hour 4.5 and 9 mgkg test material dose groups when compared to their concurrent control group. With no statistically significant decreases in the PCE/NCE ratio being observed in either of the two 18 mgkg dose groups the validity of the responses seen in the lower dose levels may be questioned. However, both of the 18 mgkg dose groups had PCE/NCE ratio values lower than their concurrent vehicle controls and, therefore, the decreases in PCE/NCE ratios were taken to indicate that exposure to the bone marrow had been achieved.
There was no evidence of a significant increase in the incidence af micronucleated polychromatic
erythrocytes in animals dosed with the test material when compared to the concurrent vehicIe
control groups.
The positive control group showed a marked and statistically significant increase in the incidence
of micronucleated polychromatic erythrocytes hence confirming the sensitivity of the system to
the known mutagenic activity of cyclophosphamide under the conditions of the test. However, it
should be noted that the sample of cyclophosphamide used proved to be very toxic, as indicated
by the NCE values and the significant reduction in the PCElNCE ratio value. This also led to two
animals (numbers 17 and 19) having very low individual score for micronucleated PCEs,
hawever, the overall response was considered adequate and not to affect the integrity of the study.
Conclusion:. The test material was considered to be non-genotoxic under the conditions of the
test.
The test material was considereed to be non-mutagenic under the conditions of this test.
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