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Description of key information

Repeated dose toxicity results:
KMPS triple salt was tested in repeated dose toxicity studies for oral and inhalation toxicity.
Oral administration:
KMPS triple salt was tested in a 14-days subacute study and in a 13-weeks subchronic study in rats. The NOAEL observed in both studies was 200 mg/kg bw/day.
Inhalation:
KMPS triple salt was tested in a 14-days subacute inhalation study in rats. The NOAEC observed in this study was 1.4 mg/m³ air.
Classification and labelling:
Oral Toxicity:
Based on the results of the oral Repeated Dose Toxicity testing, KMPS triple salt is not liable to classification and labelling for repeated dose toxicity if swallowed according to Regulation 1272/2008/EC (CLP) and Directive 67/548/EC (DSD).
Inhalation:
Based on the results of the Repeated Dose Toxicity testing by inhalation, KMPS triple salt is not liable to classification and labelling for repeated dose toxicity by inhalation according to Regulation 1272/2008/EC (CLP) and Directive 67/548/EC (DSD).

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
200 mg/kg bw/day

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEC
1.4 mg/m³

Additional information

KMPS triple salt was tested for repeated dose toxicity by oral administration and inhalation.

Repeated dose oral toxicity studies
14-days study:

The repeated dose oral toxicity of KMPS triple salt was investigated in a range finding study (similar or equivqlent to OECD Guideline 407 – Repeated 28-Day Oral Toxicity in Rodents) in male and female CD rats by daily administration of dose levels of 0, 50, 400 and 1000 mg/kg bw/day via gavage for a period of 14 days. Dose levels were based on a acute oral toxicity study (Doc. D_K1.Oral.Gav.R.DPT 567/012267/AC; IUCLID section 7.2.1). In the 14-day study, animals had free access to food and drinking water during the study. Clinical signs and mortality/viability were observed at regular intervals following dosing each day. Body weights recorded daily during treatment Week 1 and before necropsy.
On termination of the study a macroscopic examination of all animals was performed.
In the 14-day dose-range-finding study, there were no treatment related effects observed on the recorded parameters.

13-weeks study:
The subchronic toxicity of KMPS triple salt was assessed in a 90-day study according OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents). Oral administration to male and female Crl:CD(SD) IGS BR rats for a period of 13 weeks was performed by gavage in water as the vehicle. Dose levels administered were 0, 25, 200 and 1000 mg/kg bw/day (dose volume: 10 ml/kg bw/day). Following 4 weeks of treatment at 1000 mg/kg bw/day, this dosage level was reduced to 600 mg/kg bw/day due to 4 unscheduled deaths and adverse clinical signs.
Histopathological change was evident in animals receiving 1000/600 mg/kg bw/day for 13 weeks.
The target organ was identified as the stomach with inflammatory, degenerative and hyperplastic changes mainly in the nonglandular stomach, the principal findings of which were inflammation, epithelial necrosis and ulceration, and epithelial hyperplasia in the nonglandular stomach.
No pathological changes related to treatment were identified in animals receiving 200 mg/kg bw/day.
Therefore, the NOAEL was determined as 200 mg/kg bw/d.

Repeated dose inhalation:
The repeated dose inhalation toxicity was tested in male rats in a
 study similar or equivalent to OECD Guideline 412 (Repeated Dose Inhalation Toxicity: 28/14-Day). Despite some deviations to the guideline (only male rats were used, particle size was not analysed, no individual animal data available, food consumption not investigated), the study was considered valid.
In a 14-day inhalation toxicity study (6 hours per day, 5 days per week), 10 male Crl:CD rats per group were exposed to dust aerosol of KMPS triple salt at exposure levels of 0, 0.0014, 0.0101 and 0.0431 mg KMPS triple salt/L (head only exposure). Animals were examined for clinical signs and mortality. Body weight was examined daily. Haematology and clinical chemistry was performed after the 10th exposure and the 13th observation day. All animals were subjected to gross pathology. Selected organs were weighed.
The following results were observed in this study:
14-days LOAEC: 0.0101 mg/L (10.1 mg/m³) corresponding to 2.73 mg/kg bw/d (assuming a respiratory volume of 86.4 L/rat/d and a body weight of 320 g)
14-days NOAEC: 0.0014 mg/L (1.4 mg/m³) corresponding to 0.38 mg/kg bw/d (assuming a respiratory volume of 86.4 L/rat/d and a body weight of 320 g), based on histological findings in the eyes at the next higher dose level.

Justification for classification or non-classification

Based on the results of repeated oral and inhalation toxicity testing, KMPS triple salt has not to be classified in regard of repeated dose toxicity according to Regulation 1272/2008/EC (CLP) and Directive 67/548/EC (DSD).