Rosin, fumarated, reaction products with formaldehyde

Endpoint summary

Description of key information

Not acutely toxic following oral exposure (LD50 >2000 mg/kg bw). Based on read-across to Rosin and Resin and Rosin acids, esters with pentaerythritol, not expected to be acutely toxic after skin contact (acute dermal LD50 >2000 mg/kg bw). Low vapour pressure precludes inhalation exposure.  

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Results from investigations into the acute oral toxicity of tall oil, oligomeric reaction products with maleic anhydride and rosin, calcium magnesium zinc salts; rosin, fumarated;rosin, fumarated, reaction products with formaldehyde; and rosin, maleated are summarised briefly below. This is supported by results of acute dermal toxicity testing of rosin and resin acids and rosin acids, esters with pentaerythritol.

 

Acute Oral Toxicity

In an acute oral toxicity study, a single dose fatty acids, tall oil, oligomeric reaction products with maleic anhydride and rosin, calcium magnesium zinc salts was administered via gavage to six female rats were at a concentration of 2000 mg/kg (Phycher Biodeveloppment, 2010a). One animal died prior to study termination. The only effects seen in the surviving animals were decreased spontaneous activity and piloerection in one animal at 24.5 h post dose. Body weight gain was normal and there were no macroscopic abnormalities at post mortem on completion of the study. The acute oral LD50 in this study was >2000 mg/kg bw for female rats. 

 

In an acute oral toxicity study, 5 female Sprague-Dawley rats were given a single oral dose of rosin, fumarated in maize oil at a dose of 2000 mg/kg (Inveresk Research, 2002b).  There were no treatment related clinical signs, necropsy findings or changes in body weight. The oral LD50 was determined to be > 2000 mg/kg in female rats.

In an acute oral toxicity study, 5 male and 5 female Sprague-Dawley rats were given a single oral dose of rosin, fumarated in 0.5% methylcellulose at a dose of 2000 mg/kg (Life Sciences Research, 1991b). Clinical signs of toxicity included staggered gait, piloerrection, ungroomed appearance, hunched posture, and diarrhoea; however, all animals normal by day 4. There were no treatment related changes in body weight. Gross pathology results showed two females with large mandibular lymph nodes. The oral LD50 was determined to be > 2000 mg/kg in male and female rats.

In an acute oral toxicity study, a single dose of rosin, fumarated, reaction products with formaldehyde was administered via gavage to six female rats were at a concentration of 2000 mg/kg (Phycher Biodeveloppment, 2010b). No mortality occurred and there were no treatment-related signs of toxicity.The acute oral LD50 in this study was > 2000 mg/kg bw for female rats. 

In an acute oral toxicity study, 5 female Sprague-Dawley rats were given a single oral dose of rosin, maleated in maize oil at a dose of 2000 mg/kg (Inveresk Research, 2002a). There were no treatment related clinical signs, necropsy findings or changes in body weight. The oral LD50 was determined to be > 2000 mg/kg in female rats.

In an acute oral toxicity study, groups of male and female Sprague-Dawley rats (5/sex) were given a single oral dose of rosin, maleated in 0.5% w/v methylcellulose in water at a dose of 2000 mg/kg (Life Sciences Research, 1991a).  Staggered gait, piloerrection, ungroomed appearance was observed during first 3 days. Diarrhoea also was observed in 9 animals in the same period. Males exhibited ungroomed appearance that persisted to day 6. One female gave reduced mobility, piloerrection, ungroomed appearance, hunched posture, thin body conformation from day 5 to day 10. All animals were observed to be normal for the last 5 days of observation. The oral LD50 was determined to be > 2000 mg/kg in male and female rats.

 

Acute Dermal Toxicity

No acute dermal toxicity testing has been conducted on members of this category, however information is available from equivalent studies performed on Rosin (CAS number 8050 -09 -7) and Resin and rosin acids, esters with pentaerythritol (CAS number 8050 -26 -8). The results indicated that neither substance was acutely toxic following skin contact, and are consistent with the absence of systemic effects observed following acute oral exposure to members of this category.

 

Acute Inhalation Toxicity

No studies were available for review, however a low vapour pressure indicates that exposure via this route is unlikely. 

Justification for classification or non-classification

Not classified for acute lethality by oral or dermal routes of exposure under EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. For non-EU countries, the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) defines a fifth category for acute toxicity for chemicals with oral LD50 values between 2000 and 5000 mg/kg/bw. Insufficient data were available to provide a definitive classification under UN GHS for acute oral toxicity. The physico-chemical properties of the category members indicate no requirement for classification with regard of aspiration hazard (kinematic viscosity exceeds 20.5 mm2/s at 40°C).