Reaction Product of Rosin, fumarated, Tall-Oil Rosin, Ca(OH)2 and MgO

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route

Dose descriptor:

NOAEL

250 mg/kg bw/day

Additional information

Rosin, fumarated was administered in the diet to rats at concentrations of 0, 1000 ppm (males 72-89 mg/kg bw/d; females 79-108 mg/kg bw/d), 3000 ppm (males 221-288 mg/kg bw/d; females 196-292 mg/kg bw/d), and 10,000 ppm (males 651-889 mg/kg bw/d; females 449-995 mg/kg bw/d) (Inveresk Research, 2004). The males were treated for 2 weeks prior to mating, through until necropsy after 4 weeks of treatment. The females were treated for 2 weeks prior to mating, then through mating, gestation and until termination on at least Day 4 of lactation. At 10,000 ppm there was a slight decrease in the mean number of implant sites per pregnancy and a consequent slight reduction in litter size at birth. The slight reduction in litter size between Day1-4 of lactation at 3000 ppm reflects the loss of most pups in one litter. As there were no effects of treatment on litter survival at 10,000 ppm the findings at this level are considered to be incidental. Based on these results, the NOEL for reproductive parameters was considered to be 3000 ppm (males 221-288 mg/kg bw/d; females 196-268 mg/kg bw/d).

 

Results for the supporting repeated dose/reproductive/developmental screening study are presented below:

 

In a reproductive/developmental toxicity screening study, 10 rats/sex/group were exposed to Gum Rosin at dose concentrations of 0, 1000, 3000, or 10000 ppm for 41-45 days (females) or 30 days (males) in the diet (Inveresk Research, 2003a). Treatment with Gum Rosin at 10000 ppm was associated with reduced weight gain/weight loss and reduced food consumption in the parental generation and a slight decrease in the mean number of implantation sites resulting in a subsequent slight reduction in litter size. Body weight gain reductions were also observed in males exposed to 3000 ppm Gum Rosin. Adverse effects in the F1 pups were limited to slightly reduced litter and pup weights. Based on the results of the present study, the no-observed-effect-level (NOEL) for reproductive/developmental toxicity in Sprague-Dawley rats was considered to be 3000 ppm for males and females and the NOEL for subchronic toxicity was considered to be 1000 ppm in males and 3000 ppm in females based upon reduced feed consumption and lower weight gain in animals consuming higher dietary concentrations of the test material.  

Short description of key information:
One key screening reproductive/developmental was for identified for rosin, fumarated. One additional read-across screening reproductive/developmental studies was identified. No reproductive effects were observed in any study.

Effects on developmental toxicity

Description of key information

One key screening reproductive/developmental was identified for rosin, fumarated. No developmental effects were observed.

Effect on developmental toxicity: via oral route

Dose descriptor:

NOAEL

250 mg/kg bw/day

Additional information

Rosin, fumarated was administered in the diet to rats at concentrations of 0, 1000 ppm (males 72-89 mg/kg bw/d; females 79-108 mg/kg bw/d), 3000 ppm (males 221-288 mg/kg bw/d; females 196-292 mg/kg bw/d), and 10,000 ppm (males 651-889 mg/kg bw/d; females 449-995 mg/kg bw/d) (Inveresk Research, 2004). The males were treated for 2 weeks prior to mating, through until necropsy after 4 weeks of treatment. The females were treated for 2 weeks prior to mating, then through mating, gestation and until termination on at least Day 4 of lactation. At 10,000 ppm there was a slight decrease in the mean number of implant sites per pregnancy and a consequent slight reduction in litter size at birth. The slight reduction in litter size between Day1-4 of lactation at 3000 ppm reflects the loss of most pups in one litter. As there were no effects of treatment on litter survival at 10,000 ppm the findings at this level are considered to be incidental. Based on these results, the NOEL was considered to be 3000 ppm (males 221-288 mg/kg bw/d; females 196-268 mg/kg bw/d).

A pre-natal developmental toxicity test (OECD 414) on rosin and resin acids, fumarated (CAS 65997-04-8) has been proposed to complement this information.

Justification for classification or non-classification

Not classified for reproductive or developmental toxicity according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 or UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).