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Description of key information

Acute toxitity test results:
KMPS (triple salt) was tested in a number of studies for acute toxicity on oral, dermal, and inhalation exposure.
The acute oral LD50 and LOAEL for KMPS (triple salt) was determined to be 500 mg/kg bw in the rat. The acute dermal LD50 and LOAEL was determined to be greater than 2000 mg/kg bw and 2000 mg/kg bw in the rat respectively. The acute inhalation LC50 (4 h) and LOAEL was determined to be 1850 mg KMPS (triple salt)/m³ and 1250 mg/m³ respectively. In another acute inhalation study the obtained LC50 (4 h) was > 5 mg/L with KMPS (Oxone Monopersulfate).
Classification and Labelling:
Based on the acute oral toxicity results KMPS triple salt is classified as acute tox. cat. 4 (H302) according to Regulation 1272/2008/EC (CLP) and with Xn, R22 according to Directive 67/548/EC (DSD). No classification and labelling is required based on the results of dermal and inhalation toxicity studies.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
500 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
1 850 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Oral toxicity:

KMPS triple salt was tested in an acute oral toxicity study in rats (EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method). Six (three male and three female) Sprague Dawley (CD) rats received a single dose of 200 mg KMPS triple salt/kg bw and another group of three females received 2000 mg KMPS triple salt/kg bw. The substance was administered by gavage at a constant volume of 10 mL/kg bw in distilled water as the vehicle. Animals were fastened over night prior to administration of the test material. Post-observation period was 14 days. A regular examination on clinical signs of toxicity and mortality/viability was performed. Body weights were determined pre-treatment on day 1, on days 8 and 15, or at death. All animals were subjected to a macroscopic examination on day 15.

No deaths occurred at a dose level of 200 mg/kg bw. All animals died following administration of 2000 mg/kg bw. The LD50 (oral) was determined at 500 mg/kg bw.

Inhalation toxicity:

KMPS triple salt was tested in an acute inhalation toxicity study in rats (EU Method B.2 (Acute Toxicity - Inhalation). Three groups of five male and five female Crl:CD BR rats were exposed nose-only to an atmosphere with a test substance containing 50 % KMPS for a duration of 4 hours at chamber concentrations of 2.5, 3.1 and 4.8 mg/L. Chamber concentrations were determined twice per hour, sampling for particle size distribution was also performed. During exposure and the following 14-day observation period, rats were regularly inspected for clinical signs of toxicity and mortality/viability. Body weights were determined daily. On termination of the study after 14 days, all rats were subjected to a gross pathological examination. MMAD of the dust was determined to be 3.1 to 3.8 µm, with 1 to 2.1 % of the particles less than 1 µm, 34 to 48 % of the particles less than 3 µm, and 92 to 99 % of the particles less than 10 µm. The MMAD was well within the respirable range for rats.

The LC50 (4-hour inhalation) of a dust aerosol of was determined at 3.7 mg/L, corresponding to 1.85 mg/L pure KMPS triple salt/L, after linear extrapolation and taking the KMPS triple salt content of the test substance into account (50 %).

Following Regulation 1271/2008/EC (CLP), KMPS triple salt would have to be classified as harmful by inhalation (cat. 4 (H332) and following Directive 67/548/EC (DSD) as Xn, R20.

However, as only a low proportion of the particles of KMPS triple salt is in the respirable range under real case conditions and taking into consideration the available particle size distribution data, KMPS triple salt does not present an acute inhalation hazard. For this reason, no classification and labelling with respect to acute inhalation toxicity is proposed for KMPS triple salt.

The absence for a need to classify KMPS triple salt with respect to acute inhalation is further substantiated by the availability of an older, but valid acute inhalation toxicity study performed with Oxone Monopersulfate compound (identical to KMPS triple salt). In this study, male rats which appeared to be the more sensitive gender when the results of the acute inhalation toxicity study performed with KMPS triple salt are considered, were exposed for 4 hours to a dust aerosol consisting of particles in the respirable range (MMADs < 4µm) The results obtained showed that KMPS triple salt did not reveal an inhalation hazard up to and including the highest exposure level of 5 mg/L tested. Thus, no C&L with respect to acute inhalation toxicity is required for KMPS triple salt.

Dermal toxicity:

KMPS triple salt was tested in an acute dermal toxicity study in rats (EU Method B.3 (Acute Toxicity - Dermal). A single dose of 2000 mg of KMPS/kg bw was topically applied under occlusive conditions onto the clipped dorsal skin of 5 male and 5 female Sprague Dawley (CD) rats for a period of 24 hours. Animals were regularly observed for clinical signs of toxicity, mortality/viability and local reactions. Body weights were recorded on day 1, 8 and 15, respectively. Following a 24 hour exposure period, the test material was removed and animals observed for another 14 days. Thereafter, animals were necropsied and examined macroscopically.

No deaths and no clinical signs of systemic toxicity were reported following administration of a single dermal dose of 2000 mg KMPS/kg bw to 5 male and 5 female Sprague Dawley (CD) rats.

Severe dermal irritation was seen in three animals following removal of the dressings persisting until study termination. Slight to well‑defined dermal irritation was observed in six animals following removal dressings. These reactions had resolved completely by Day 3 in one animal, Day 5 in one animal and Day 8 in four animals. In addition, localised necrosis, localised spots and/or scabbing, spots and/or scabbing over the majority of the treatment site, blanching over the majority of the treatment site, cracking of the skin at the edge of the blanched area and wet ulceration on the dose site were noted in a number of animals during the study.

Loss of body weight was recorded for one female and low body weight gains were recorded for two females on day 8. Macroscopic examination revealed a necrotic area on the dose site of three animals and scabbing on the dose site of two animals.No abnormalities were recorded for the remaining animals.

Justification for classification or non-classification

Oral:

Based on Directive 67/548/EC and Regulation 1272/2008/EC, KMPS triple salt is classified as harmful if swallowed (cat 4 (H302); Xn, R22).

Inhalation:

Based on Directive 67/548/EC and Regulation 1272/2008/EC, KMPS triple salt is not classified.

 

Dermal:

Based on Directive 67/548/EC and Regulation 1272/2008/EC, KMPS triple salt is not classified.