Fatty acids, C14-18 and C16-18-unsatd., maleated

Endpoint summary

Description of key information

Acute oral and dermal toxicity of a read across substance was determined according to OECD guidelines 423 and 402 under GLP conditions. The substance was applied orally by gavage or dermally to male and female rats at concentrations of 2000 mg/kg bw. No mortalities occured. The material caused effects on skin. The acute oral and dermal LD50 was calculated to be > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

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:

adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Read across justification

The test item is an UVCB and composes mainly of modified fatty acids from sun flower oil (mSOFA) and, to a minor part, of modiefied fatty acids from tall oil (mTOFA). The fatty acids obtained from tall oil and sun flower oil are of comparable chain lenghth and are modified by the same reaction step. In contrast to mTOFA, mSOFA is also produced solely by the very same reaction as the UVCB and consists therefore of the same reaction products and similar impurities. Furthermore, mSOFA was intentively examined for its toxicological properties. Thus, it is acceptable to derive data on acute toxicity from the read across substance mSOFA.

Procedure and observations

In an acute oral toxicity study performed according to the Acute Toxic Class method (OECD guideline 423, under GLP conditions), 2000 mg/kg bw of the test item were administered by gavage to two test groups of three fasted Wistar rats by gavage. No mortality occurred. No clinical signs were observed. The mean body weight of all animals increasedwithin the normal rangethroughout the study period. There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

In an acute dermal toxicity study (Limit Test, OECD guideline 402, under GLP conditions), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of undiluted to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days. No mortality occurred. No signs of systemic toxicity were observed. Slight to moderate erythema and slight edema as well as scaling and incrustations were observed. The mean body weight of the male animals increased within the normal range throughout the study period, with the exception of one animal which showed stagnation of body weight during the second post-exposure week. The mean body weight of three female animals increased within the normal range throughout the study period, with the exception of one female, which showed stagnation of body weight during the first post-exposure observation week, but gained weight during the second week within the normal range. Another female showed stagnation of body weight during the whole observation period. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

Discussion

The acute oral and dermal LD₅₀was calculated to be > 2000 mg/kg bw.

Justification for selection of acute toxicity – oral endpoint
key study, suitable read across

Justification for selection of acute toxicity – dermal endpoint
key study, suitable read across

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 toxicity under Directive 67/548/EEC, as amended for the 30th time in Directive 2008/58/EC.

                               

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 toxicity under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).