Registration Dossier

Administrative data

Description of key information

Not acutely toxic following oral exposure or skin contact (LD50 >2000 mg/kg bw). Low vapour pressure precludes inhalation exposure.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Adequate information exists to characterise the acute toxicity of Rosin adduct esters. These are formed after modification of rosin with either fumaric acid or maleic anhydride followed by esterification with glycerol and/or pentaerythritol, and hence the adduct ester products therefore exhibit close structural similarities. The available data includes results of tests conducted using Resin acids and rosin acids, fumarated, esters with glycerol; Resin acids and rosin acids, maleated, esters with pentaerythritol; Resin acids and rosin acids, fumarated, esters with pentaerythritol; and Rosin, fumarated, reaction products with glycerol and pentaerythritol. This information is summarised below.

Acute Oral Toxicity

In an acute oral toxicity in the rats (Laboratoire Biogir S.A, 1994), Dertoline MG (Resin acids and rosin acids, fumarated, esters with glycerol) in paraffin oil was orally administered via gavage to Sprague-Dawley rats (5/sex) at a treatment level of 2000 mg/kg bw. The animals were then observed over a period of 14 days for mortality and signs of clinical toxicity. Based on an absence of test material related mortality and lack of adverse signs of clinical toxicity, the acute oral LD50 for Dertoline MG (Resin acids and rosin acids, fumarated, esters with glycerol) was considered to be >2000 mg/kg body weight in the rat.

In an acute oral toxicity study with Alresat KM 140 (Resin acids and rosin acids, fumarated, esters with glycerol), the test substance was administered via oral gavage to Sprague-Dawley rats (5/sex) at a dose of 2000 mg/kg bw in Sesamol (Hoechst Pharma Entwicklung Toxikologie, 1992). The animals were observed over a period of 14 days for mortality and signs of clinical toxicity. Based on an absence of test material related mortality and lack of adverse signs of clinical toxicity, the acute oral LD50 for Alresat KM 140 (Resin acids and Rrsin acids, fumarated, esters with glycerol) was considered to be >2000 mg/kg body weight in the rat.

The acute oral toxicity of Rosin, fumarated, reaction product with glycerol and pentaerythritol was evaluated in a study conducted according to OECD Guideline 423 (Phycher Biodeveloppment, 2010). Six female rats were each administered a single dose of 2000 mg/kg bw of the test substance by gavage. All animals survived to study termination. All animals gained weight normally and there were no signs of systemic toxicity. The acute oral LD50 in this study was >2000 mg/kg bw for female rats.

In an acute toxicity that examined UNI-REZ 7059 (Resin acids and rosin acids, maleated, esters with pentaerythritol) five male and five female rats received a single dose of the test substance at 5000 mg/kg bw (Food & Drug Research Laboratories, Inc., 1985a). Animals were then observed for 15 days. No mortality was observed. The acute oral LD50 in this study was > 5000 mg/kg bw for male and female rats.

In the other acute toxicity study, a single dose of UNI-REZ 757 (resin acids and rosin acids, fumarated, esters with glycerol; CAS No. 97489-11-7) was administered to five males and five females via gavage at 5000 mg/kg (Food & Drug Research Laboratories, Inc., 1985b). Animals were then observed for 15 days. No mortality was observed. The acute oral LD50 in this study was > 5000 mg/kg bw for male and female rats.

Acute Dermal Toxicity

In an acute dermal toxity study, Resin acid and rosin acids, fumarated, ester with pentaerythritol was applied at a treatment level of 2000 mg/kg bw to clipped skin on the dorsal trunk of 10 Sprague Dawley rats (5 male and 5 female) for 24 hrs under semi-occlusion (Phycher Bio Developpement, 2012). Under the conditions of the study, no mortality occurred and no dermal reactions or systemic clinical signs were observed. Body weight gain was normal. A gross pathogical examination showed no treatment- related changes. In conclusion, the acute dermal LD50 of Resin acid and rosin acids, fumarated, esters with pentaerythritol was >2000 mg/kg/bw.

Acute Inhalation Toxicity

No studies were available for review. 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).