Fatty acids, C8-18 and C18-unsatd., reaction products with diethanolamine and propylene oxide

Endpoint summary

Description of key information

LD50 (oral) > 2000 mg/kg (BASF SE, 2009)
LD50 (dermal) > 2000 mg/kg (BASF SE, 2009)
LC50 (inhalation) > 5.3 mg/L (BASF SE, 2016)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation 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, BASF SE 2009), doses of 2000 or 300 mg/kg body weight of the test substance (undiluted or preparations in olive oil Ph.Eur.) were given to three test groups of three

fasted Wistar rats animals each (2000 mg/kg in 6 females, 300 mg/kg in 3 females) by gavage in a sequential manner.

No mortality occurred in the nine females administered 2000 and 300 mg/kg bw. The combined acute oral LD50 was calculated to be LD50, oral, rat > 2000 mg/kg bw.

No clinical signs and findings were observed in the 2000 and 300 mg/kg bw administration groups.

The mean body weights of all animals increased throughout the study period.

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

Acute dermal toxicity:

In an acute dermal toxicity study (Limit Test according to OECD 402 guideline, BASF SE 2009), 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 Kerocom FM 38 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 body surface area. The animals were observed for 14 days. No mortality occurred. Accordingly, the acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 2000 mg/kg bw.

No signs of systemic toxicity were observed in the animals.

Skin effects in the male animals at the application site comprised erythema (grade 1), scaling and incrustations and were observed from study day 1 until study day 8.

Skin effects in the female animals at the application site comprised erythema (grade 1) and scaling and were observed from study day 1 until study day 8.

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

Mean body weight of the female animals slightly increased during the first postexposure observation week but increased during the second week within the normal range.

No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

Acute inhalative toxicity:

To determine the acute inhalation toxicity (single 4-hour exposure, nose only) of Kerocom FM 38 as a liquid aerosol, a study was performed in male and female Wistar rats according to OECD-Guideline method 403, as well as EC and EPA guidelines (BASF, 2016). The actual measured concentrations were 1.028 and 5.30 mg/L (analytical concentration).

Cascade impactor measurements resulted in particle size distributions with mass median aerodynamic diameters (MMADs) between 1.5 and 1.9 μm, which are well within the respirable range.

No males and no females died at 1.028 mg/L. No males and one of the five females died at 5.30 mg/L. Lethality was observed on study day 5.

Clinical signs of toxicity in animals exposed to 1.028 mg/L comprised labored respiration, abdominal respiration, respiration sounds, colorless discharge of the nose, piloerection and substance contaminated fur. These various findings were observed from hour 3 of exposure through to study day 2 in the male animals. No abnormalities were detected in the male animals during the post exposure observation period from study day 3 onwards. These various findings were observed from hour 3 of exposure through to study day 3 and on study day 5 and 6 in the female animals. No abnormalities were detected in the female animals during the post exposure observation period on study day 4 and from study day 7 onwards. The mean body weights of the animals decreased on the first post exposure observation day and thereafter increased. No gross pathological abnormalities were noted during the necropsy at the

termination of the post exposure observation period.

Clinical signs of toxicity in animals exposed to 5.30 mg/L comprised labored respiration, abdominal respiration, gasping, respiration sounds, eyelid semiclosed, abdominal distended, colorless and red discharge of the nose, red encrusted nose, poor general state, piloerection and substance contaminated fur. These various findings were observed from hour 2 of exposure through to study day 9 in the male animals. No abnormalities were detected in the male animals during the post exposure observation period from study day 10 onwards.

Findings were observed from hour 2 of exposure until the end of the post exposure observation period of 14 days in the female animals. The mean body weights of the surviving animals decreased on the first post exposure observation day and thereafter increased. To further evaluate the macroscopic findings, histopathological examination of the respiration tract (nasal cavity, larynx, pharynx, trachea, lung) from female animal No. 409 which died on study day 5 was performed. The larynx, pharynx, trachea and the lung showed no findings. The nasal cavity showed a moderate purulent inflammation, characterized by a neutrophilic granulocytic

exudate in the lumen at all levels. Foreign bodies were entrapped in the exudate, most likely being the cause of the inflammation. The stomach, jejunum and cecum showed no correlation with the gross findings. No other findings were noted.

Under the current study conditions, the LC50 value was > 5.30 mg/L (calculated based on analytical concentration) in male and female Wistar rats after 4 hour inhalation exposure to liquid aerosol of Kerocom FM 38.

Justification for classification or non-classification

No classification and labeling is required, as both the oral and dermal LD50 was greater than 2000 mg/kg and the LC50 was greater than 5.3 mg/L/4h with no mortality observed in the studies according to 67/548/EWG and 1272/2008/EG (CLP).