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Key value for chemical safety assessment

Effects on fertility

Additional information
The performance of a 2-generation study is waived on the basis of existing toxicological information.

KMPS is not systemically available. The effects in repeated dose toxicity studies demonstrated to be restricted to the site of first contact and limited to local irritation/corrosion. As no systemic toxicity was evident in these studies, the results of a multigeneration study are largely predictable on the basis of the existing studies. Any findings are anticipated to be related to the primary oxidising effects at the site of first contact. Furthermore, mammalian systems are equipped with effective biological detoxification mechanisms against reactive oxygen species which maintain hydrogen peroxide at physiological levels. For these reason, the conduct of a reproductive toxicity study with KMPS (triple salt) is not considered to be required for animal welfare reasons and based on the information available: KMPS is not considered to represent a specific hazard with regard to reproductive toxicity.


Short description of key information:
A performance of a 2-generation study is waived as no effects on reproduction are expected, on the basis of existing toxicological information . Thus, no descriptors for fertility effects are available.

Effects on developmental toxicity

Description of key information
Developmental toxicity/teratogenicity:
KMPS triple salt was tested for developmental toxicity/teratogenicity by oral exposure in the rat.
The observed LOAEL for maternal toxicity/embryotoxic/teratogenic effects was >= 750 mg/kg bw/d.
The maternal and foetal NOAEL for oral exposure was determined to 250 mg/kg bw/d.
Classification and Labelling:
Based on the results for developmental toxicity/teratogenicity testing, KMPS (triple salt) is not classified and labelled according to Regulation 1272/2008/EC (CLP) and Directive 67/548/EC (DSD).
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
250 mg/kg bw/day
Additional information

Developmental toxicity/teratogenicity:

KMPS triple salt was tested for developmental toxicity/teratogenicity in a study according to OECD Guideline 414 (Prenatal Developmental Toxicity Study) in rats. KMPS triple salt was applied by gavage from day 6 to 20 of gestation to Crl:CD(SD)IGS BR rats at dose levels of 0, 75, 250, and 750 mg/kg bw/day.

Adverse test substance related maternal toxicity occurred at 750 mg/kg bw/day. There were no test substance and/or dose related foetal malformations or variations observed at any dosage level.

Under the conditions of the study, the maternal and foetal NO(A)EL was 250 mg/kg bw/day, based on decreased maternal body weight gain, food consumption, and mortality at 750 mg/kg bw/day, and based on the slightly lower foetal weight at 750 mg/kg bw/day. Therefore, the test substance is not uniquely toxic to the conceptus.

Justification for classification or non-classification

Based on the results of a teratogenicity study was not classified according to Regulation 1272/2008/EC (CLP) and Directive 67/548/EC (DSD).

Additional information