Amides, mixed C16-18 and C18-unsatd. branched and linear and tall-oil fatty, N,N'-(iminodi-2,1-ethanediyl)bis-, maleated

Endpoint summary

Description of key information

The analogues of the test substance were tested in an acute oral test in rats (Stilmeadow 2001, Harlan 2012a). No mortality was observed at 2000 mg/kg bw. The LD50 is >2000 mg/kg bw. An analogue of the test substance was tested in an acute dermal toxicity study in rats (BSL 2010a). The LD50 is >2000 mg/kg bw. No inhalation study is available as exposure via the inhalation route is expected to be negligible.

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:

Study acoording to the guideline and GLP

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:

Study with analogue recently performed according to the guidelines and under GLP

Additional information

Female rats (n=5) received a single oral dose of 2000 mg/kg bw of an analogues substance. No effects on clinical signs, body weight and macroscopic examinations. No mortality was observed. The LD50 is > 2000 mg/kg bw (Harlan 2012a).

The other analogue substance was evaluated for its acute oral toxicity potential when administered to albino rats. The acute oral LD50, as indicated by the data, is greater than 2020 mg/kg in males and females (Stillmeadow 2001).

The dermal LD50 was determined to be > 2000 mg /kg body weight for an analogue (BSL 2010a).

The rationale for read-across is documented under chapter 13. Based on the similarity and the similar outcome of the results of the bridging studies (phys-chem, ecotoxicity and toxicity studies), the read-across is considered valid and the data on the analogues can be used for the test substance.

Justification for selection of acute toxicity – oral endpoint
Studies with analogues (Harlan 2012a, Stillmeadow, 2001) are available, that show an LD50 after oral application of >2000 mg/kg bw. Based on similarities between the analogues and the test substance it is concluded that the oral LD50 for the test substance is >2000 mg/kg bw (see document on read-across in chapter 13)

Justification for selection of acute toxicity – inhalation endpoint
In view of the low vapour pressure (2.4E-03 Pa at 25 °C) and the physical state of the test substance (paste), exposure via the inhalation route is expected to negligible.

Justification for selection of acute toxicity – dermal endpoint
A study with analoguous compound as indicated in the document on read-across in chapter 13. in view of the similarities between the analogue and the test substance, it is concluded that this study is sufficient to adequately assess the acute dermal toxicity of the test compound.

Justification for classification or non-classification

The test substance does not need to be classified for acute toxicity.