potassium ferrite

Endpoint summary

Description of key information

An LD50 of >2000mg/kg bw was observed in both the acute oral and acute dermal toxicity study. 

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

Acute oral toxicity:

In a GLP-compliant oral toxicity study performed according to OECD test guideline No. 420, Sprague-Dawley rats (5 animals/sex/dose) were treated with the test substance at 2,000 mg/kg bw by oral gavage followed by a 14-day observation period (Huntingdon Life Sciences, 1997). No mortality was observed. Symptoms observed after substance administration were piloerection and hunched posture, observed in all rats. In addition, soft to liquid faeces was observed in all females. During the recovery phase (14 days) all animals recovered from symptoms (day 3: females and day 5: males). In conclusion, the oral LD50 of the test substance in rats of both sexes was >2,000 mg/kg bw.

 

Acute dermal toxicity:

In a GLP-compliant acute dermal toxicity study, performed according to OECD guideline No. 402, one female Sprague-Dawley rat was treated with the test substance (2,000 mg/kg bw) (Huntingdon Life Sciences 1997). Due to the irritant characteristics of the test substance (indicated by pH of 12.9 which was measured using a 10% w/v solution in distilled water), only one animal was exposed for 24h with test substance suspended in corn oil, initially, and the dermal response was analyzed prior to treatment of further animals. One day prior to treatment, fur was removed from the dorso-lumbar region with electric clippers without damaging the animal’s skin, exposing an area equivalent to approximately 10% of the total body surface area. The test substance was applied to the prepared skin. The treatment area (approximately 50 mm x 50 mm) was then covered with porous gauze held in place with a non-irritating dressing, and was further covered by a waterproof dressing encircled firmly around the trunk of the animal. The treated skin was washed after 24h and subsequently the animal was observed for 14 days. No mortality, signs of systemic response, or macroscopic abnormalities were observed during this period. Following removal of the dressings, a severe dermal response, characterised by necrosis/whitening of the epidermis and moderate edema, was evident. A similar level of dermal response was persistent throughout the study, with some slight recovery evident by day 13. Therefore, the dermal LD50 of the test substance was estimated to be >2,000 mg/kg bw. Due to animal welfare reasons, no further animals were treated.

Justification for classification or non-classification

Based on the observed LD50 of >2000 mg/kg bw in both the acute oral and acute dermal toxicity study, the test substance does not need to be classified for acute toxicity according to Directive 67/548/EEC and according to Regulation (EC) No. 1272/2008.