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

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Additional information

In the 91-days repeat dose study, Sprague-Dawley rats were treated with partially unsaturated IQAC, DMS quaternised (tallow fatty acids) by application in the feed at doses of up to 1000 mg/kg bw/d of active ingredient. No treatment related effects were observed on the reproductive organs of either gender. Fertility studies are not available and not necessary at the production volume of this substance. Also, the dossier contains either the results of, or a testing proposal for, a pre-natal developmental toxicity study.

For derivation of worker and consumer DNELs an additional assessment factor of 2 has been used to account for a lower sensitivity and the limited scope of the repeated dose toxicity studies for detecting effects on reproductive organs, resulting in a DNEL for workers (DNEL _{worker fertility dermal route systemic} of 20.8 mg/kg bw/day) and DNELs for general population (DNEL _{general population fertility dermal route systemic} of 12.5 mg/kg bw/day and DNEL _{general population fertility oral route systemic} of 12.5 mg/kg bw/day). The oral exposure of workers with this substance family can be practically excluded and this is also the case for the general public as these industrial cleaners are not used in home care products or as constituents of cleaning agents in house hold products.

The dermal exposure is limited by the irritative properties of this substance family which will limit inadvertent dermal uptake.

Inhalation uptake via vapours can be excluded due to the very low vapor pressure of this substance family, which is approx. 7.5 x 10E-22 kPa.

For workers with a risk to aerosol inhalation with the undiluted test substance, personal protective equipment will be in place to avoid respiratory exposure with a priority on avoidance of respiratory tract irritation.

Short description of key information:
Concerning fertility there are no animal studies specifically investigating this endpoint. However, no effects on organ weights of ovary and testes and histopathology of gonads from a 91-day repeated dose study were reported. There is no information available in humans.
Assessment of effects on fertility via inhalation is not applicable due to the very low vapour pressure of the test substance and the absence of aerosols.

Effects on developmental toxicity

Description of key information

Partially unsaturated IQAC, DMS quaternised (tallow fatty acids) (75 %) was administered to 25 female Sprague CD rats/dose by gavage at dose levels of 0, 100, 300, and 1000 mg/kg bw /day of partially unsaturated IQAC, DMS quaternised (tallow fatty acids) (75 %) /kg bw/day referring to 100 % active substance) from day 6 through 15 of gestation. The maternal NOEL is 1000 mg active substance/kg bw/day, based on the lack of effects indicating maternal toxicity.Likewise, the embryotoxic NOEL is 1000 mg active substance/kg bw/day, based on the lack of embryotoxic effects up to the highest dose level.The teratogenic NOEL is 1000 mg active substance/kg bw/day.

Effect on developmental toxicity: via oral route

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Additional information

The test item partially unsaturated IQAC, DMS quaternised (tallow fatty acids, 75 %) possessed no teratogenic properties, not even at the highest dose tested. Embryotoxicity was not observed. Therefore the NOEL was 1000 mg partially unsaturated IQAC, DMS quaternised (tallow fatty acids) (75 %) active ingredient/kg bw/day. The NOEL for maternal toxicity was 1000 mg partially unsaturated IQAC, DMS quaternised (tallow fatty acids) (75 %) active ingredient/kg bw/day based on the lack of effects indicative of maternal toxicity.

Justification for classification or non-classification

There is no evidence for an intrinsic toxicity to reproduction of partially unsaturated IQAC, DMS quaternised from the results of a reliable oral developmental toxicity / teratogenicity study on rats at doses including the guideline limit dose of 1000 mg a. i./kg bw/day and reliable oral sub-chronic repeated dose toxicity data, where no treatment related effects were observed on the reproductive organs of either gender at 1000 mg/kg bw/day.

Therefore no classification is required for toxicity to reproduction according to CLP, EU GHS (Regulation (EC) No 1272/2008) and directive 67/548/EEC.