Fatty acids, C16-18 and C18-unsatd., branched and linear, reaction products with diethanolamine

Endpoint summary

Description of key information

ACUTE TOXICITY: ORAL
- LD50 >2000 mg/kg bodyweight to female Wistar strain rats
ACUTE TOXICITY: DERMAL
- LD50 >2000 mg/kg bw in male and female New Zealand white rabbits

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The key study was conducted under GLP conditions in accordance with the standardised guidelines OECD 420 and EU Method B.1 bis. It was assigned a reliability score of 1 in accordance with the criteria detailed by Klimisch (1997).

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:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The key study was conducted under GLP conditions in accordance with the standardised guideline OECD 402. It was assigned a reliability score of 1 in accordance with the criteria detailed by Klimisch (1997).

Additional information

Acute Toxicity: Oral

The acute oral toxicity potential of the test material to female Wistar strain rats was assessed in accordance with the standardised guidelines OECD 420 and EU Method B.1bis under GLP conditions.

Following a sighting test in a single animal at a dose level of 2000 mg/kg, the test material was administered by gavage at the same dose level to an additional four animals. The animals were observed for 14 days.

There was no mortality and no clinical signs were observed. All animals showed the expected gains in bodyweight throughout the observation period.

Under the conditions of this study, the acute oral LD50 was >2000 mg/kg bodyweight and the test material requires no classification in accordance with EU criteria.

 

Acute Toxicity: Inhalation

In accordance with the Column 2 adaptation of Annex VIII of Regulation (EC) 1907/2006 (REACH), it is considered justified to omit the acute toxicity by the inhalation route study (required under point 8.5.2) as testing by this route is inappropriate. Exposure via the inhalation route is not relevant due to the substance being a viscious liquid with a low vapour pressure; therefore the acute oral and acute dermal studies are deemed more appropriate to address acute toxicity exposure.

 

Acute Toxicity: Dermal

This endpoint was addressed using a standard OECD 402 acute dermal toxicity test. New Zealand White rabbits were subjected to 24 hours of occlusive contact with the test material (2000 mg/kg, 5 animals per sex per dose). Observations for toxicity and skin reactions were made at one hour, 7 days, and 14 days after the contact period. Animal weights were recorded at 0 days (before dose), 7 days and 14 days (just prior to termination). At death or termination, each animal was subjected to a gross pathologic evaluation. No mortality or serious adverse effects were seen at any time during the study. Erythema, edema, and desquamation were seen in some animals up to day 12. By day 12, all animals appeared normal and healthy. Under the conditions of this study the test material requires no classification in accordance with EU criteria.

Justification for selection of acute toxicity – oral endpoint
Only one study available.

Justification for selection of acute toxicity – inhalation endpoint
A data waiver has been submitted to address this endpoint.

Justification for selection of acute toxicity – dermal endpoint
Only one study available.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for acute toxicity.