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Toxicological information

Endpoint summary

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Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

No toxicity data on adverse effects on sexual function and fertility with bismuth (3+) neodecanoate are available, thus the reproductive toxicity will be addressed with existing data on the individual moieties bismuth and neodecanoate.

Bismuth (3+) neodecanoate is not expected to impair fertility, since the two moieties bismuth and neodecanoate have not shown adverse effects on reproduction. Additionally, no adverse effects were observed in a prenatal developmental toxicity study with bismuth. However, no information on the developmental toxicity of the moiety neodecanoic acid is available, thus no final conclusion on classification and labelling can be made.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Bismuth

The oral (gavage) administration of read-across substance, Bismuth Subnitrate, to male and female Wistar Han™:RccHan™:WIST strain rats for 90 days at dose levels up to 1000 mg/kg bw/day was well tolerated.

There was no adverse effect of treatment on body weight development and dietary intake in animals of either sex. Hematology, blood chemistry, testosterone hormone assessment, estrus cycle assessment in females, sperm analysis in males and microscopic examination of the selected tissues did not identify any findings of toxicological relevance. A dose level of 1000 mg/kg bw/day is therefore considered to be the ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity within the confines of this type of study.

The oral administration of read-across substance, Bismuth Subnitrate, to pregnant rats by gavage during gestation at dose levels of 100, 300 or 1000 mg/kg bw/day was well tolerated. The ‘No Observed Effect Level’ (NOEL) for maternal toxicity was considered to be 1000 mg/kg bw/day. No treatment-related changes were detected in the offspring parameters measured. The ‘No Observed Effect Level’ (NOEL) for developmental toxicity, was therefore, considered to be 1000 mg/kg bw/day.

 

Neodecanoate

In a modified three-generation reproductive toxicity study, male and female Sprague-Dawley rats were administered neodecanoic acid at 0, 100, 500 and 1500 ppm (approximately 0, 5, 25 and 75 mg/kg-bw/day, respectively) in the diet. No adverse effects were observed on survival, appearance, behaviour, body-weight gain and food consumption in the parental, F1 or F2 generations. The reproductive performance of the parents was not affected. No treatment-related gross or microscopic pathological findings were observed at any of the dietary levels.

 

No classification for reproductive or developmental toxicity is indicated according to the classification, labelling and packaging (CLP) regulation (EC) No 1272/2008.

 

Bismuth (3+) neodecanoate

Bismuth (3+) neodecanoate is not expected to show effects on reproduction or development, since the two moieties bismuth and neodecanoic acid have not shown toxicity to the reproduction in a range of test systems. No information on the developmental toxicity of the moieties neodecanoic acid and bismuth is available, thus no final conclusion on classification and labelling can be made.For further information on the toxicity of the individual moieties, please refer to the relevant sections in the IUCLID and CSR.

 

Information on the individual moieties bismuth and neodecanoic acid will be used for the hazard assessment and, when applicable, for the risk characterisation of bismuth (3+) neodecanoate. For the purpose of hazard assessment of bismuth (3+) neodecanoate, the point of departure for the most sensitive endpoint of each moiety will be used for the DNEL derivation. In case of neodecanoic acid in bismuth (3+) neodecanoate, the NOAEL of 75 mg/kg bw/day for the reproductive toxicity will be used. In case of bismuth the NOAEL of 714,7 mg/kg bw/day obtained in a repeated dose toxicity study will be used.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Bismuth (3+) neodecanoate is not expected to impair fertility, since the two moieties bismuth and neodecanoate have not shown adverse effects on reproduction. Additionally, no adverse effects were observed in a prenatal developmental toxicity study with bismuth. However, no information on the developmental toxicity of the moiety neodecanoic acid is available, thus no final conclusion on classification and labelling can be made.

Additional information