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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

In subchronic repeat dose studies performed in rats by oral feed and in rabbits, exposed dermally, only mild effects have been observed.
Inhalation toxicity was not determined due to the very low vapour pressure of the test substance and the absence of aerosol exposure.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
300 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

In subchronic repeat dose studies performed in rats by oral feed and in rabbits, exposed dermally, only mild effects have been observed.

In the 91-day oral study in male rats, absolute and relative liver weight decrease, a slight decrease in serum albumin concentration and higher SGPT and SGOT concentrations were observed in highest dose group (1000 mg/kg bw/day). Correlating histopathological lesions were not detected. A dose dependency for these effects was not found.

For the partially unsaturated IQAC, DMS quaternised (tallow fatty acid based; CAS-no. 68122-86-1) the NOELs reported for short term repeat dose and subchronic oral application are disparate, as the higher NOEL has been determined in the longer term, subchronic, oral feed study.

Furthermore, minor effects on liver enzyme serum levels in both genders and on serum bilirubin levels in female animals at 400 mg/kg bw/day, the highest dose tested, were reported in the 28 days study, while in the subchronic study decreased relative and absolute liver weights, a slight decrease in protein concentration and minor increases in serum enzyme levels (SGOT and SGPT) were reported for the male high dose group (1000 mg/kg bw/day), only. Findings were without histopathological correlate. These observations are in accordance with the mild and obviously not dose related and potentially reversible effects observed, the practically absent acute oral toxicity for this substance class and its low bioavailability upon ingestion as determined in the toxicokinetic studies (cf. 7.1 Summary and discussion of toxicokinetics).

The repeated dose toxicity studies, also reported by NICNAS for the oral route, are significant in showing that in consequence there is no evidence for a potential serious health risk for humans upon ingestion of members of this structure family. The studies suffer, however, from the wide dose spacing, which would not be the standard for present day testing protocols. As a consequence, the reported NOELs have been recalculated for the derivation of an acceptable DNEL longterm oral, departing from the highest dose as the LOAEL to arrive at a realistic basis for DNEL derivations.

Furthermore, no effects on reproductive organs have been reported in the oral sub-chronic study up to the highest dose of 1000 mg/kg bw/day.

In the dermal study, only irritating effects were reported without any associated systemic toxicity in the rabbits up to the highest dose of 27 mg/kg bw/day. Judged on the low dermal uptake rate observed in toxicokinetic studies this is in accordance with the low toxicity of this substance group upon acute exposure.

  

On the basis of the sub-chronic study a DNEL longterm, oral of 7.5 mg/kg bw/d has been calculated for the general population. Considering a body weight of 60 kg, the human exposure to partially unsaturated IQAC, DMS quaternised would have to amount to a daily oral intake of 0.45 g per day before reaching a level of toxicological concern.

In consideration of the use of this substance class mainly in industrial cleaning products an oral exposure of the general population appears highly unlikely. Dermal uptake by inadvertent skin contact is limited by the irritative property of this substance class, establishing a significant avoidance barrier and is further regarded as insignificant due to the proven very low cutaneous uptake shown in toxicokinetic studies.

Inhalation uptake of vapours is regarded as insignificant due to the very low vapour pressure of the substance class.

With respect to irritation, it has been shown that eye irritation effects with a 75% partially unsaturated IQAC, palm oil based did not lead to a classification with respect to eye irritation. Furthermore the observed moderate to slight eye irritation effects have a threshold level at approximately 5 % of the active ingredient. A similar threshold can be expected for other mucous membranes as the respiratory tract tissue. For irritative effects on the respiratory tract, a sufficient margin of safety is expected for this substance group. Further, from the absence of a skin sensitisation potential for this substance class, respiratory sensitisation is not expected.

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

 

Justification for classification or non-classification

The existing data do not indicate the need for a classification for repeated dose toxicity for the partially unsaturated IQAC, DMS quaternised according to Directive 67/548/EEC as well as GHS Regulation EC No 1272/2008 and therefore labelling is not necessary.