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Description of key information

Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). 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 Esters.

Acute oral toxicity

The acute oral toxicity of Resin acids and rosin acids, hydrogenated, Me esters was evaluated in a key study conducted according to OECD Guideline 401. In this study, a group of five male rats received a limit dose of 2000 mg/kg bw of the test material administered by oral gavage. All animals survived to study termination. Clinical signs indicating reversible effects on the central nervous system included excitation and piloerection. All animals gained weight normally and no gross abnormalities were observed at necropsy. Based on this information, the oral LD50 for Resin acids and rosin acids, hydrogenated, Me esters was >2000 mg/kg bw.

In an acute oral toxicity study using Zonester 25 (Resin acids and rosin acids, esters with diethylene glycol), diarrhoea (affecting two females at 2 and/or 4 hours post-dosing) was the only adverse clinical sign recorded in five male and five female rats following a single oral gavage treatment of 2000 mg/kg bw (Safepharm Laboratories Limited, 1997b). No mortality or effects on body weight were recorded during the 14 day observation period, and no target organ effects identified at gross necroscopy. The LD50 was greater than 2000 mg/kg bw for male and female rats.

In a preliminary acute oral toxicity study with Zonester 85 (Resin acids and rosin acids, esters with glycerol), three rats were administered a single dose of 5000 mg/kg bw by oral gavage (Carnegie-Mellon Institute of Research, 1977a). Since all animals survived, an additional group of ten male rats was given a single oral gavage treatment of 10000 mg/kg bw. No mortality, adverse clinical signs or effects on body weight were recorded during the 14 day observation period, and no target organ effects were identified at gross necropsy. The LD50 was greater than 10000 mg/kg bw.

In an acute oral toxicity study with Zonester 85 Resin Ester (A) (Resin acids and rosin acids, esters with glycerol), five male rats were received a single treatment via oral gavage at a dose of 5000 mg/kg bw (Huntingdon Research Center, 1978a). No mortality, adverse clinical signs or effects on body weight were recorded during the 14 day observation period, and no target organ effects were identified at gross necropsy. The LD50 was greater than 5000 mg/kg bw.

In an acute oral toxicity study using Zonester 85 NF-7015 (Resin acids and rosin acids, esters with glycerol), five rats/sex received a single oral gavage treatment of 5000 mg/kg bw (Bio/dynamics, 1979a). No mortality or adverse effects on body weight were apparent during the 14 day observation period, however clinical signs indicative of reversible CNS effects were noted in some animals during the first week of the observation period, primarily during the first 24 hours post-treatment. By study week 2, clinical signs were limited to a decrease in motor activity in 2 animals and piloerection in 1 animal. No significant target organ effects were noted at necropsy The LD50 was greater than 5000 mg/kg bw.

The acute oral toxicity of Hydrogal G5 (Resin acids and rosin acids, hydrogenated, esters with glycerol) was evaluated using five male rats given a limit dose of 2000 mg/kg bw by oral gavage (EViC-CEBA, 1989a). Animals were observed for mortality and adverse clinical signs for a period of 14 days. All animals survived to study termination, with clinical signs limited to slight piloerection immediately after treatment. All animals gained weight normally and no organ or tissue abnormalities were observed at necropsy. The oral LD50 was greater than 2000 mg/kg bw.

In an acute oral toxicity study with Dertoline G2L (Resin acids and rosin acids, esters with glycerol), five rats/sex received a single dose of 2000 mg/kg bw by oral gavage (Biogir, 1990b). No mortality or adverse clinical signs were noted during the study, and all animals gained weight normally over the 14-day observation period. No gross abnormalities were observed at study termination. The LD50 was greater than 2000 mg/kg bw.

In an acute oral toxicity study using Dertoline SG2 (Resin acids and rosin acids, esters with glycerol), no mortality, adverse clinical signs or effects on body weight were recorded in rats (five/sex) following administration of a single oral gavage dose of 2000 mg/kg bw (Biogir, 1990c). No gross abnormalities were observed at study termination on day 14. The LD50 was greater than 2000 mg/kg bw.

In an acute oral toxicity study using PC 12-99 (Resin acids and Rosin acids, esters with pentaerythritol), a group of five male and five female rats received a single oral dose at a level of 5000 mg/kg bw (Pharmakon Research International, 1982a). Transient abnormal clinical signs noted during the study were limited to exophthalmus (all animals of both sexes at the 2-hour observation only), diarrhoea (all male rats only), and hypersensitivity with vocalization to touch (all female rats only) observed on the day of dosing, and diarrhoea in 3 of 5 male rats on the day following dosing. No other abnormal signs were present, all rats of both sexes gained weight with no gross pathological lesions reported at necropsy. The acute oral LD50 value was therefore greater than 5000 mg/kg bw for male and female rats.

In an acute oral toxicity study Dertoline P2L (Resin acids and rosin acids, esters with pentaerythritol), five rats/sex were treated using oral gavage at a dose level of 2000 mg/kg bw (Biogir SA, 1990a). No mortality, clinical signs or effects on body weight were recorded during the 14 day observation period, and no target organ effects were identified at gross necropsy. The LD50 was greater than 2000 mg/kg bw.

In an acute oral toxicity study using Resin acids and rosin acids, esters with pentaerythritol, no mortality, clinical signs or effects on body weight were recorded during a 14 day observation period in five female rats given a single oral dose of 2000 mg/kg bw (Inveresk Research, 2002b). No gross pathological lesions were found at necropsy. Based on the results of this study, the acute oral LD50 value was greater than 2000 mg/kg bw for female rats.

Acute dermal toxicity

In an acute dermal toxicity study, a single treatment of Resin acids and rosin acids, hydrogenated Me esters was applied to clipped skin on the dorsal trunk of 10 Sprague Dawley rats (5 male and 5 female) at a treatment level of 2000 mg/kg bw for 24 hrs under semi-occlusion (Phycher BioDeveloppement, 2012a). No mortality occurred, and no dermal reactions or systemic clinical signs were observed, during a 14 day observation period. Body weight gain was normal. A gross pathogical examination showed no treatment- related changes. The study demonstrated that the acute dermal LD50 of Resin acids and rosin acids, hydrogenated Me esters was >2000 mg/kg/bw.

The acute dermal toxicity of Zonester 25 (Resin acids and rosin acids, esters with diethylene glycol) was evaluated in a group of five rats/sex administered a limit dose of 2000 mg/kg bw (Safepharm Laboratories Limited, 1997c). All animals survived and no significant clinical signs or other signs of systemic toxicity or skin irritation were observed during the study. All animals gained weight normally and there were no gross pathological lesions reported at necropsy. The acute dermal LD50 was greater than 2000 mg/kg bw for male and female rats.

In an acute dermal toxicity study with Zonester 85 (Resin acids and rosin acids, esters with glycerol), five male rabbits received a single treatment of 10000 mg/kg bw for 24 hours under an occlusive patch (Carnegie-Mellon Institute of Research, 1977a). No mortality or adverse clinical signs (including skin irritation) were noted during a subsequent 14 day observation period, and all animals gained weight. No target organ effects were identified at gross necropsy. The LD50 was greater than 10000 mg/kg bw.

In an acute dermal toxicity study using Zonester 85 resin ester (A) (Resin acids and rosin acids, esters with glycerol), 4 male rabbits were administered a single dose of test substance under covered contact at 5000 mg/kg bw for 24 hours (Huntingdon Research Center, 1978a). The rabbits were observed for mortality and adverse clinical signs for a period of 14 days. No mortality, clinical signs, or skin irritation were noted during the study, and all animals gained weight. No target organ effects were identified at gross necropsy. The LD50 was greater than 5000 mg/kg bw.

In an acute dermal toxicity study on PC 12-99 (Resin acids and rosin acids, esters with pentaerythritol), a group of five male and five female rabbits received a single topical treatment of 2000 mg/kg bw applied to abraded skin (Pharmakon Research International, Inc., 1982b). No signs of systemic toxicity or absorption were evident during the study. Abnormal clinical signs were limited to signs of minimal skin irritation in 3 of 5 males and 2 of 5 females. Apart from one male rabbit which lost 0.004 kg of body weight, all remaining animals of both sexes gained weight over the 14-day observation period. All animals survived to scheduled study termination, with no gross pathological lesions reported at necropsy. The acute dermal LD50 was greater than 2000 mg/kg bw for both sexes.

Acute Inhalation Toxicity

No studies were available for review. The category members possess very low vapor pressure, negligible volatility and a high boiling point. Based on these physical properties, inhalation exposure is not expected to occur.

Aspiration Hazard

The physico-chemical properties of the category members indicate no requirement for classification with regard to aspiration hazard (kinematic viscosity exceeds 20.5 mm2/s at 40°C).


Justification for selection of acute toxicity – oral endpoint
Information is available on the acute oral toxicity of Resin acids and rosin acids, hydrogenated, Me esters, Resin acids and rosin acids, esters with diethylene glycol, Resin acids and rosin acids, esters with glycerol, Resin acids and rosin acids, hydrogenated, esters with glycerol and Resin acids and Rosin acids, esters with pentaerythritol. The results demonstrate that Rosin esters are not acutely hazardous after ingestion (LD50 >2000 mg/kg bw).

The physico-chemical properties of the category members indicate that they do not present a hazard with regard to aspiration (kinematic viscosity exceeds 20.5 mm2/s at 40°C).

Justification for selection of acute toxicity – inhalation endpoint
No studies were available for review. The category members possess very low vapor pressure, negligible volatility and a high boiling point. Based on these physical properties, inhalation exposure is not expected to occur.

Justification for selection of acute toxicity – dermal endpoint
Information is available on the acute dermal toxicity of Resin acids and rosin acids, hydrogenated, Me esters, Resin acids and rosin acids, esters with diethylene glycol, Resin acids and rosin acids, esters with glycerol and Resin acids and rosin acids, esters with pentaerythritol. The results demonstrate that Rosin esters are not acutely hazardous after dermal exposure (LD50 >2000 mg/kg bw).

Justification for classification or non-classification

Not classified for acute lethality by the 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 from this study to provide a definitive classification under UN GHS.

The physico-chemical properties of the category members indicate no requirement for classification with regard to aspiration hazard (kinematic viscosity exceeds 20.5 mm2/s at 40°C).