Neodecanoic acid, zirconium salt

Endpoint summary

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 neodecanoic acid, zirconium salt are available, thus the reproductive toxicity will be addressed with existing data on the assessment entities zirconium and neodecanoate.

Neodecanoic acid, zirconium salt is not expected to show effects on reproduction, since the two moieties zirconium and neodecanoic acid have not shown toxicity to the reproduction in a range of test systems. 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

Zirconium

In a combined repeated dose toxicity study with the reproduction and developmental toxicity screening test, Sprague Dawley rats were administered zirconium acetate at 0, 100, 300 and 1000 mg/kg bw/day via gavage. The required amount of zirconium acetate solution (containing 40.7% of zirconium acetate anhydrous) was dissolved in the vehicle (purified water). 10 males per group were treated two weeks prior to pairing, throughout pairing and thereafter through the day before scheduled sacrifice (32 days of dosing). 10 females were treated two weeks prior to pairing, throughout pairing until day 3 post partum or the day before scheduled sacrifice (up to 50 days of dosing). No effects on reproduction or development were observed in any dose group or in pups. Therefore, on the basis of the results obtained in the study, the No Observed Adverse Effect Level (NOAEL) for reproductive toxicity and for developmental toxicity was considered to be >=1000 mg/kg bw/day expressed as zirconium acetate anhydrous, equivalent to >=530 mg Zr/kg bw/day.

 

Neodecanoic acid

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.

Neodecanoic acid, zirconium salt

Neodecanoic acid, zirconium salt is not expected to show effects on reproduction, since the two assessment entities zirconium and neodecanoic acid have not shown toxicity to the reproduction in a range of test systems. For further information on the toxicity of the individual moieties, please refer to the relevant sections in the IUCLID and CSR. 

Effects on developmental toxicity

Effect on developmental toxicity: via oral route

Endpoint conclusion:

adverse effect observed

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

no study available

Toxicity to reproduction: other studies

Additional information

Zirconium

An OECD 422 test performed with zirconium acetate indicates that zirconium acetate is a substance of low toxicological potential, as the NOAEL for reproductive/developmental toxicity was considered to be higher than or equal to the highest dose tested:1000 mg/kg bw/day expressed as anhydrous zirconium acetate, equivalent to 530 mg Zr/kg bw. Furthermore no effects were observed in any of the parameters evaluated for pups. In addition, and based on the assessment of all available data, low absorption of zirconium acetate is expected. Also low toxicity is expected based on the available acute and subacute experimental data with zirconium acetate. Therefore, no further testing ise required for this substance as no adverse effects or hazards need to be addressed.

 

Neodecanoic acid

In a developmental toxicity study with Carboxylic acids, C6-8- neo-, pregnant rats, n=22 per dose, were treated by oral gavage to 50, 250, 600 or 800 mg/kg/day neoheptanoic acid, a substance similar in structure to neodecanoic acid, during gestation days 6-15. On gestation day 21, the dams were euthanized and the pups were examined for signs of developmental toxicity. Under the conditions of the experimental methods, the test material produced maternal toxicity at dose levels of 600 and 800 mg/kg with maternal lethality at 800 mg/kg. The test material was severely embryotoxic at 800 mg/kg with less than 20% of embryos surviving. Offspring of the 800 mg/kg group had reduced body weight, reduced crown-rump distance, displayed variations signifying delayed development, and a significant percentage (25%) were malformed. In the 600 mg/kg group, there was an increased number of dams with 3 or more resorptions. Offspring of the 600 mg/kg group displayed significant incidences of major (hydrocephalus) and minor (knobby or angular ribs, extra lumbar vertebrae) malformations but showed few signs of delayed development and were not runted. There was no statistically significant evidence of maternal toxicity at dose levels of 50 or 250 mg/kg. There was a slight, but not statistically significant, increase in embryonic resorption noted for the 250 mg/kg group. There was no statistically significant evidence of developmental toxicity at doses for 50 or 250 mg/kg. The NOAEL for maternal toxicity is 250 mg/kg and the NOAEL for developmental toxicity is 250 mg/kg. 

 

Neodecanoic acid, zirconium salt

Neodecanoic acid, zirconium salt is not expected to show effects on developmental toxicity, since the two assessment entities zirconium and neodecanoic acid have not shown indications for develomental toxicity. For further information on the toxicity of the individual moieties, please refer to the relevant sections in the IUCLID and CSR.

Justification for classification or non-classification

In relevant and reliable repeated dose toxicity studies as well as supporting studies for both assessment entities of neodecanoic acid, zirconium salt, there were no toxicological findings reported that would justify a classification for reproductive or developmental toxicity according to the classification, labelling and packaging (CLP) regulation (EC) No 1272/2008. Hence, no classification for neodecanoic acid, zirconium salt is required.