Registration Dossier
Registration Dossier
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EC number: 939-220-5 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
Additional information
Produkt SPS was administered to male rats for 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum in a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test. The study was conducted according to OECD 422 guideline and GLP (Harlan, 2013).
The following dose levels were applied:
Group 1: 0 mg/kg body weight/day (control group)
Group 2: 100 mg/kg body weight/day
Group 3: 300 mg/kg body weight/day
Group 4: 1000 mg/kg body weight/day
A standard dose volume of 10 mL/kg body weight with a daily adjustment to the actual body weight was used. Control animals were dosed with the vehicle alone (Milli-Q-Water).
The following results were obtained:
Parent Animals:
General Tolerability
All animals survived until scheduled necropsy. No clinical signs were noted in males and females at any dose level.
Food Consumption and Body Weights
No adverse effects on mean food consumption and mean body weights of males and females were observed at any dose level.
Clinical Laboratory Investigations
No test item-related findings were noted during the clinical laboratory investigations.
Reproduction and Breeding Data
Mean precoital time, fertility index and conception rate were not affected by the treatment with the test item. No effects on implantation loss or postnatal loss were observed.
Organ Weights
No effects on organ weights were noted in any group.
Macroscopical Findings and Histopathological Examinations
There were no test item-related macroscopical or microscopical findings in any group.
Litter Data - F1 Pups
Findings at First Litter Check and during Lactation
The mean number of pups at first litter check was not affected by the treatment with the test item. The sex ratio was also not affected. No abnormal pup was noted at any dose level.
Pup Weights to Day 4 Post Partum
No effects on pup weight and pup weight gain were observed.
Macroscopical Findings
At necropsy of pups, there were no abnormal findings.
Conclusion
Based on these results the NOAEL (No Observed Adverse Effect Level) for general and reproductive toxicity was considered to be 1000 mg/kg body weight/day.
Short description of key information:
OECD 422 (Harlan, 2013): NOAEL = 1000 mg/kg (parental, reproduction and development)
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
Justification for classification or non-classification
Based on the available data, the test substance is not classified with regard to toxicity to reproduction according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP), respectively.
Additional information
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