Fatty acids, sunflower-oil, conjugated, maleated,reation products with diethanolamine, maleated tall-oil fatty acids and triethanolamine

Endpoint summary

Description of key information

LD50, rat, oral: > 2000mg/kg (BASF 2017)

LD50, rat, dermal: > 2000mg/kg (BASF 2017)

No mortality, very limited clinical signs

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 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 OECD 423, a dose of 3774 mg/kg bw of the test item Efka FA 4671 was administered by gavage to two test groups of three fasted female Wistar rats. This higher dose was selected to adjust for the water content of app. 47% in the delivered sample. By this, exposure to an actual dose of 2000mg/kg of the registered substance was ensured. None of the animals died. On the day of exposure, impaired general state and piloerection was observed, which lasted for one or two hours in most animals. There were no macroscopic pathological findings at the end of the observation period. Consequently, the oral LD50 is greater than 2000mg/kg in rats for the registered substance.

In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 3774 mg/kg bw of the test item Efka FA 4671. For the same reasons stated above, the higher dose was required to adjust for water content in the delivered sample and to ensure exposure to 2000mg/kg of the registered substance. The clipped application site (dorsal and dorso-lateral parts of the trunk, comprising at least 10% of the total body surface) was covered by semi-occlusive dressing during the 24 -hour exposure period. The animals were observed for 14 days. No mortality, no clinical signs, and no local skin changes occurred. Within the first week of the observation period, body weight gain was slightly impaired for 3 females. For all other animals and for all animals in week two, the body weight increased within the normal range. No macroscopic pathologic abnormalities were noted at the end of the study. The acute dermal LD50 is greater than 2000 mg/kg in rats.

Justification for classification or non-classification

No mortality occured after oral or dermal exposure to 2000mg/kg of the registered substance. Consequently, no classification is required according to EU GHS, Regulation (EC) 1272/2008.