Registration Dossier
Registration Dossier
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EC number: 220-912-4 | CAS number: 2935-90-2
Endpoint summary
Administrative data
Description of key information
An appropriate oral repeated dose toxicity study is available in methods comparable to OECD guideline 407.
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
A repeat dose study was performed in male rats as a part of a Reproduction/Developmental Toxicity Screening test. 10 males per dose were treated via oral gavage with 25, 50 and 100 mg/kg bw MMP for 28 days. 50 kg bw was determined to be the NOAEL, based on four males in the high dose group displaying a minimal to slight hyperplasia of the forestomach squamous epithelium partly associated with a minimal to slight hyperkeratosis and minimal inflammatory cell infiltrations. Although these effects were considered to be treatment related, proliferative lesions of the rodent non-glandular stomach region are relatively common in gavage and feeding studies and are not relevant to humans because of lack of a forestomach. Liver weights relative to body weight and brain weight were dose-dependently increased in the mid and high dose groups, but in the absence of a histological correlation the increases were considered toxicologically irrelevant. However, the study was conducted for 28-days (instead of a 90-days) and failed to report on possible adverse histological effects at dose levels above 100 mg/kg bw. A classification for the repeat dose toxicity endpoint cannot be made due to insufficient data.
Justification for classification or non-classification
Specific target organ toxicity repeated - Reason for no classification: inconclusive.
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