Oleic acid, compound with N-(2-aminoethyl)ethane-1,2-diamine

Endpoint summary

Description of key information

LD50(oral) > 2000 mg/kg bw (Bioassay, 2012)
LD50(dermal) > 2000 mg/kg bw (Bioassay, 2012)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Acute oral toxicity

In an acute oral toxicity study performed according to the Acute Toxic Class method (OECD 423 guideline and GLP), 2000 mg/kg bw of the undiluted test item Oleic acid, compound with N-(2-aminoethyl)ethane-1,2-diamine were administered to two test groups of three fasted Wistar rats each by gavage in a sequential manner (Bioassay, 2012).

The following test substance-related clinical observations were recorded at 2000 mg/kg:
- No mortality occurred.
- No clinical signs were observed

- The mean body weight of the animals increased within the normal range throughout the study period.

- There were no macroscopic pathological findings in the surviving animals sacrificed at the end of the observation period.

The acute oral LD50 was calculated to be LD50, oral, rat > 2000 mg/kg bw.

Acute dermal toxicity

In an acute dermal toxicity study (Limit Test, according to OECD 402 guideline and GLP), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the undiluted test item Oleic acid, compound with N-(2-aminoethyl)ethane-1,2-diamine to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours (Bioassay, 2012). 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 noted.

- The following test item-related local effects were recorded during the course of the study:

- Very slight to severe erythema (grade 1 to 4)

- Very slight to moderate edema (grade 1 to 3)

- Incrustations

- Scaling

The mean body weight of the animals increased within the normal range throughout the study period. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study. Accordingly, the acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 2000 mg/kg bw.

Justification for classification or non-classification

Based on the available acute oral and dermal toxicity studies, the substance was neither classified according to Directive 67/548/EEC nor according to CLP as the LD50 values in both studies were greater than 2000 mg/kg bw.