Fatty acids, C16-18 and C18-unsatd., reaction products with diethylenetriamine, di-Me sulfate-quaternized

Endpoint summary

Description of key information

From the study results it is concluded that partially unsaturated IQAC, DMS quaternised is of low toxicity when given to rats by the oral or the dermal route. The oral LD50 was > 11250 mg/kg bw and > 2000 mg/kg, respectively, referring to 100 % a.i. The dermal toxicity was > 2000 mg/kg (100% a.i.) when applied at doses of 200 and 2000 mg/kg bw, respectively, with application in corn oil. 
Generation of inhalable particles such as dust or aerosols is not relevant under the specific operational conditions. Vaporisation needs not to be considered due to the very low vapour pressure of 7.5 x 10E-22 Pa at 25°C (calculated). Therefore, inhalation is not a relevant route of exposure and testing by the inhalation route is not appropriate.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

In an acute oral toxicity study similar to the OECD Guideline 401 groups of 10 fasted adult male and female rats of the BOR: WISW, SPF TNO strain were given a single oral dose of partially unsaturated tallow fatty acid based IQAC, DMS quaternised (74 to 77% active ingredient) at 15 000 mg/kg bw and observed for 14 days. The oral LD50 for males was determined to be > 15000 mg/kg bw.

The LD50 referring to 100 % a.i. is > 11250 mg/kg bw.

No mortalities were reported.

In another acute oral toxicity study according to the OECD Test Guideline 423, three female rats of the HanRcc: WIST(SPF) strain were exposed to a single dose of 2000 mg/kg bw of palm-oil based IQAC, DMS quaternised (CAS-no. 98219-51-3). No mortalities occurred. The LD50, oral gavage in female rats was determined to be > 2000 mg/kg bw. referring to 100% active ingredient.

From the results of these studies it is concluded that partially unsaturated IQACs, DMS quaternised are not acutely toxic to rats when given by oral gavage.

 

An acute dermal toxicity study carried out with a partially unsaturated IQAC,DMS quaternised (CAS Nr 98219-51-3) showed no systemic toxicity, either at 200 or at 2000 mg/kg bw based on the absence of macroscopic findings at necropsy. 

 

Due to the severe local effects seen on the skin of the highest dose group of 2000 mg/kg bw, all animals of this group were euthanized on day 10. Even though the 14 day observation period could not be completed for the high dose group, necroscopy would have revealed the onset of systemic toxicity already after 10 days of observation. Therefore, the LD50, dermal is considered to be greater than 2000 mg/kg bw. This is supported by other study outcomes, where neither an acute oral, nor a skin sensitisation or an acute dermal irritation study gave any indication of systemic toxicity. In addition, toxicokinetic studies with a fully saturated IQAC, DMS quaternised showed very poor absorption via the dermal route. The lack of systemic toxicity has also been demonstrated in 91-day percutaneous studies in rabbits with a tallow fatty acids based IQAC, where NOELs are identical to the highest doses tested i.e. between 27 mg/kg bw and 300 to 400 mg/kg bw were determined. No effects other than skin irritation were reported.

The NOAEL for acute dermal toxicity was determined to be >2000 mg/kg bw due to the absence of systemic toxicity up to the highest dose tested. Generation of inhalable particles such as dust or aerosols is not relevant under the specific

operational conditions. Vaporisation needs not to be considered due to the very low vapour pressure of 7.5 x 10E-22 Pa at 25°C (calculated). Therefore, inhalation is not a relevant route of exposure and testing by the inhalation route is not appropriate.

Justification for classification or non-classification

The oral LD50 of partially unsaturated IQAC, DMS quaternised was determined to be > 2000 mg/kg bw. The dermal LD50 value from an acute dermal toxicity study performed with a partially unsaturated IQAC, DMS quaternised was also determined to be greater than 2000 mg/kg bw.

Inhalation is not a relevant route of exposure and testing by the inhalation route is not required.

According to Directive 67/548 EEC as well as the GHS Regulation EC No. 1272/2008, a classification for partially unsaturated IQAC, DMS quaternised is not required and labelling is not necessary.