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Key value for chemical safety assessment

Effects on fertility

Description of key information

The reproductive toxicity of palladium(II) di(4-oxopent-2-en-2-oate) (Pdacac) was assessed in a combined repeated dose toxicity study with the reproductive/developmental toxicity screening test according to OECD TG 422 and in accordance with GLP.

Rats (10/sex/group) were given daily oral gavage doses of 3, 10 or 30 mg/kg bw, throughout the pre-mating and mating periods, and (for females), throughout gestation and lactation. Two high-dose females died during the study. Males and females in the high-dose group were found to have reduced body weights relative to controls.

There were no treatment-related effects on fertility or reproductive performance, nor on the pre-natal development of pups (conceptus to birth). The NOAEL for reproductive toxicity was 30 mg/kg bw/day.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
30 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Overall, good-quality database which meets REACH Standard Information Requirements.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

No relevant data in humans were identified.

 

No reproductive toxicity studies by the inhalation or dermal route were identified, or are required.



Effects on developmental toxicity

Description of key information
The developmental toxicity of palladium(II) di(4-oxopent-2-en-2-oate) (Pdacac) was assessed in a combined repeated dose toxicity study with the reproductive/developmental toxicity screening test according to OECD TG 422 and in accordance with GLP.

Rats (10/sex/group) were given daily oral gavage doses of 3, 10 or 30 mg/kg bw, throughout the pre-mating and mating periods, and (for females), throughout gestation and lactation. Two high-dose females died during the study. Males and females in the high-dose group were found to have reduced body weights relative to controls.

There was a slight but statistically significant reduction in pup body weight observed on lactation day 13 in the intermediate-dose group. In the high-dose group, pup body weights were statistically significantly reduced on lactation days 1, 4 and 13. In all cases, the recorded pup weights were below the historical control data. There were no reported malformations in the pups.

On the basis of these effects, the NOAEL for developmental toxicity in this study was concluded to be 3 mg/kg bw/day. No developmental effects were observed in the absence of maternal effects.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
3 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Overall, good-quality database which meets REACH Standard Information Requirements.
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

No relevant data in humans were identified.

 

No developmental toxicity studies by the inhalation or dermal route were identified, or are required.


Justification for selection of Effect on developmental toxicity: via oral route:
GLP study, conducted according to OECD guidelines, and the only reproduction/developmental toxicity study available.

Toxicity to reproduction: other studies

Description of key information

No data identified.

Additional information

No data identified.

Justification for classification or non-classification

The critical effect for consideration of classification or non-classification was the pup weights. These were reduced, only at doses where body weight effects were also observed in maternal animals. As such, no classification is warranted for developmental effects. There were no effects on fertility. Increased adrenal weights and accompanying hypertrophy were seen in parental animals, but these were considered adaptive rather than adverse. On this basis, no classification for STOT RE is required for this substance.

Additional information