Tall oil, maleated

Endpoint summary

Description of key information

Not acutely toxic following oral exposure or skin contact (LD50 >2000 mg/kg bw). A low vapour pressure indicates that inhalation exposure is unlikely.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

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:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

Adequate information exists to characterise the acute toxicity of distilled tall oil maleated. The maleate salts are formed when the fatty acids or rosin acids react with maleic anhydride. The available data includes results of tests conducted using Rosin, fumarated, Rosin, maleated, Rosin, fumarated, reaction products with formaldehyde, Fatty acids, tall oil, oligomeric reaction products with maleic anhydride and rosin, calcium magnesium and zinc salts, and fatty acids, C14-18 and C16-18-unsatd., maleated. This information is summarised below.

Acute Oral Toxicity

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, 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, 6 female Wistar rats were administered the test material (Fatty acids, C14-18 and C16-18-unsatd., maleated) orally via gavage in propylene glycol at a dose of 2000 mg/kg (10 mL/kg bw). A confirmatory group of 3 animals was included in the study.

All animals were observed for a period of 14 days post administration. Animals were observed for signs of clinical toxicity at 30 min., 1, 2, 3, 4, and 6 hrs post administration, and daily for a 14 day period. Body weight determinations were conducted on the day before treatment (day -1), on the day of treatment prior to dosing (day 0), and weekly thereafter. Necroscopy was also conducted at termination. No mortality was observed through the study period. Treatment with the test material at a dose of 2000 mg/kg bw caused transient decreased activity, hunched back, and in coordination in all six animals on the day of treatment. However, all animals were observed to have recovered on Day 1. Body weights remained unaffected by treatment with the test material and gross necroscopy did not reveal any remarkable findings. Based on the observations of the study, the acute oral LD₅₀ for fatty acids, C14-18 and C16-18-unsatd., maleated was determined to be >2000 mg/kg.

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.

In an acute oral toxicity study, a single dose of Rosin, fumarated, reaction products with formaldehyde was administered via gavage to six female rats 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, 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.

Acute Dermal Toxicity

The acute dermal toxicity of Rosin fumarated was evaluated using 5 male and 5 female Sprague Dawley rats. The fur was removed from the dorsal area of the trunk of the animals by clipping and a dose of 2000 mg/kg body weight was applied onto the 10% of the clear skin for 24 hrs. The treated area was covered by a semi-occlusive dressing consisting of a gauze patches hydrophilic, which was held in contact with the skin by means od 50 mm wide hypoallergenic micropore adhesive tape. After 24 hrs exposure, the gauze was removed and the treated area was rinsed with dimethyl sulfoxide. The animals were observed for 24 hrs. Signs of toxicity and behavioural effect were recorded daily, while weight gain was recorded at D0, D2, D7 and D14. No mortality occurred during the study. The results showed no signs of toxicity related to the administration of the test material. Erythema and yellow coloration of the treated area were noted from 24 hrs post-dose in all animals and were totally reversible on D8. No change in body weight was recorded and macroscopic examination did not show any treatment related changes. In conclusion, the LD50 of Rosin fumarated was higher than 2000 mg/kg body weight in this study.

Acute Inhalation Toxicity

No studies were available for review, however a low vapour pressure indicates that exposure via this route is unlikely while results from tests performed using oral and dermal exposure indicate no acute hazard.

Justification for selection of acute toxicity – oral endpoint
Based on acute toxicity data for the two main constituents and/or related materials

Justification for selection of acute toxicity – dermal endpoint
Based on acute toxicity data for the two main constituents and/or related materials

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).