Registration Dossier
Registration Dossier
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EC number: 247-832-2 | CAS number: 26591-72-0
Endpoint summary
Administrative data
Description of key information
OECD 422 (BASF SE, 2013): NOAEL = 1000 mg/kg bw/day
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
3-Methyl-1-vinyl-1 H-imidazolium methyl sulfate was given daily as an aqueous solution to groups of 10 male and 10 female Wistar rats (F0 animals) by stomach tube at doses of 100, 300 and 1000 mg/kg body weight/day (mg/kg bw/d). The study was performed according to OECD 422 guideline and GLP (BASF SE, 2013). Control animals (10 male and 10 female Wistar rats) were dosed daily with the vehicle only (drinking water). The duration of treatment covered a 2-week pre-mating and a mating period in both sexes, approximately 3 weeks post-mating in males and in one not pregnant female, and the entire gestation period as well as approximately 2 weeks of the lactation period.
OBSERVATIONS
After 2 weeks of premating treatment the F0 animals were mated to produce F1 generation pups. Mating pairs were from the same test group. Mating was discontinued as soon as sperm was detected in the vaginal smear. F0 animals were examined for their reproductive performance including determination of the number of implantation sites and the calculation of postimplantation loss for all F0 females. A detailed clinical observation (DCO) was performed in all animals before initial test substance administration and, as a rule, thereafter at weekly intervals. Food consumption of the F0 parents was determined once weekly during premating. In dams food consumption was determined for gestation days 0 - 7, 7 - 14, 14 - 20 and lactation days 1 - 4. Body weights of F0 parents were determined once a week, in males throughout the study and in females during premating. During gestation and lactation period, F0 females were weighed on gestation days (GD) 0, 7, 14 and 20, on the day of parturition (postnatal day [PND] 0) and on PND 4. The pups were sexed and examined for macroscopically evident changes on PND 0. They were weighed on PND 1 and on PND 4. Their viability was recorded. At necropsy on PND 4, all pups were sacrificed with CO2, under isoflurane anesthesia, and examined macroscopically for external and visceral findings. Clinico-chemical and hematological examinations as well as urinalyses were performed in 5 animals per sex and group towards the end of the administration period. At the end of the administration period a functional observational battery was performed and motor activity was measured in 5 parental males and females per group.
All F0 parental animals were sacrificed by decapitation, under isoflurane anesthesia, and were assessed by gross pathology. Weights of selected organs were recorded and a histopathological examination was performed.
RESULTS
Analysis
The various analyses:
- Demonstrated the stability of the test substance in drinking water over a period of 7 days at room temperature
- Verified basically correct concentrations of the test substance in the drinking water preparations.
Effects The following test substance-related adverse effects/findings were noted:
1000 mg/kg bw/d
F0 PARENTAL ANIMALS
CLINICAL EXAMINATIONS/ REPRODUCTIVE PERFORMANCE/ CLINICAL PATHOLOGY/ PATHOLOGY
- No test substance-related adverse findings
F1 PUPS CLINICAL EXAMINATIONS/ GROSS FINDINGS
- No test substance-related adverse findings
300 mg/kg bw/d
F0 PARENTAL ANIMALS
CLINICAL EXAMINATIONS/ REPRODUCTIVE PERFORMANCE/ CLINICAL PATHOLOGY/ PATHOLOGY
- No test substance-related adverse findings
F1 PUPS CLINICAL EXAMINATIONS/ GROSS FINDINGS
- No test substance-related adverse findings
100 mg/kg bw/d
F0 PARENTAL ANIMALS
CLINICAL EXAMINATIONS/ REPRODUCTIVE PERFORMANCE/ CLINICAL PATHOLOGY/ PATHOLOGY
- No test substance-related adverse findings
F1 PUPS CLINICAL EXAMINATIONS/ GROSS FINDINGS
- No test substance-related adverse findings
CONCLUSION
Under the conditions of this OECD 422 combined repeated dose toxicity study with the reproduction/developmental toxicity screening test in Wistar rats no adverse effects were observed up to the limit dose tested (1000 mg/kg bw/d). Thereby, the following NOAEL (no observed adverse effect level) of 3-Methyl-1-vinyl-1 H-imidazolium methyl sulfate were determined:
- The NOAEL for general, systemic toxicity was 1000 mg/kg bw/d for the F0 females and males.
- The NOAEL for reproductive performance and fertility was 1000 mg/kg bw/d for the F0 parental rats.
- The NOAEL for developmental toxicity in the F1 offspring was 1000 mg/kg w/d.
Justification for classification or non-classification
Based on the available data, the test substance is not classified with regard to repeated dose toxicity according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP), respectively.
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