Resin acids and Rosin acids, reaction products with formaldehyde, calcium salts

Endpoint summary

Description of key information

No indication of systemic toxicity was observed in guideline and GLP compliant studies for acute oral and dermal toxicity at the limit dose in rats. The study for acute dermal toxicity was performed with the analogue substance rosin.

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

In an acute oral toxicity study performed according to the Acute Toxic Class method (OECD 423, GLP), 2000 mg/kg bw of the test item Resin acids and rosin acids, reaction products with formaldehyde, calcium salts suspended in olive oil Ph.Eur. were administered to two test groups of three fasted Wistar rats by gavage (2000 mg/kg bw in 3 females, respectively) by gavage in a sequential manner.

No mortality and no macroscopic pathology findings were observed. Transient dyspnoea and piloerection was observed in some and all animals, respectively.

In an acute dermal toxicity study with gum rosin, a group of five male and five female rats was administered a single topical dose, under porous gauze dressing, at a dose level of 2000 mg/kg bw in a dimethylsulfoxide vehicle for an exposure period of 24 hours. Under the conditions of this study, the dermal LD50 of Gum Rosin in male and female Sprague-Dawley rats was > 2000 mg/kg bw. No mortality was observed in the study and, after an absence of body weight gain was noted in all males and females on Day 2, the animals recovered and gained weight normally over the rest of the study period. No systemic clinical signs related to the administration of the test substance were observed. Other than a slight dryness to dryness noted at the treatment site of one or more animals at various times during the study, there were no signs of irritation, necrosis, ulceration or evidence of tissue destruction reported. At necropsy, no gross lesions were observed. Based on the results of this study, resin acids and rosin acids, reaction products with formaldehyde, calcium salts

is not acutely toxic to rats via the dermal route and therefore is expected to present a low toxicity hazard upon skin contact under conditions of normal use. It is referred to the read-across justification at the end of the Chemical safety report.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EG.

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No. 1272/2008, as amended for the third time in Directive EC 618/2012.