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Description of key information

Subchronic toxicity after repeated oral exposure (gavage) was evaluated  on the basis of a 90 day study according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents) in rats (Sprague-Dawley; male/female) with daily exposure. 
The dose range was:
Low: 5 mg/kg bw/day (actual ingested)
Medium: 50 mg/kg bw/day (actual ingested)
High: 750 mg/kg bw per day ; reduced to 500 mg/kg bw/day on day 56 due to severe effects (actual ingested)
Parameters examined were: Mortality, clinical signs, FOB, body weights, food consumption, clinical chemistry, hematology, necropsy, histopathology
Dermal exposure: The test material is a highly polar salt with a poly-anion of high molecular weight. It is used exclusively in aqueous solutions and completely ionised. Therefore, a significant skin penetration (bioavailability) and adverse effects via dermal exposure are not expected. Additionally the test material did show adverse systemic effects only after high doses (500-750 mg/kg bw) by oral gavage for prolonged periods and a structurally closely related substance did not cause skin irritation or sensitisation. Thus, no adverse effects are expected after dermal exposure with low bio-availability and no in vivo study (animal use) is justified.
Inhalation: The test material is produced and handled in industry exclusively in aqueous solutions. There are no spraying operations. Thus neither exposure nor risks are expected via the inhalation route.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

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

Additional information

The broad and unspecific spectrum of findings in a large number of organs indicate an unspecific disturbation of well being of the animals by the application of high doses of the substance ov

er an extended period of time. The main targets most probably are liver and kidneys as these organs handle and excrete xenobiotic material. Most of the other changes can be interpreted as secondary effects of the reduced performance of these organs.

As no effects were detected at the mid and low dose levels the effects in the high dose group are seen as an effect of metabolic overload of the rat organism.


Repeated dose toxicity: via oral route - systemic effects (target organ) cardiovascular / hematological: hematopoiesis; cardiovascular / hematological: lymph nodes; cardiovascular / hematological: spleen; digestive: liver; respiratory: lung; urogenital: kidneys; urogenital: prostate; urogenital: testes

Justification for classification or non-classification