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EC number: 700-457-2 | CAS number: -
Endpoint summary
Administrative data
Description of key information
28-day oral study (BASF, 2009): NOAEL males: 17 mg/kg bw/day; NOAEL females: 84 mg/kg bw/day
Key value for chemical safety assessment
Additional information
Repeated dose toxicity, oral:
LIMUS-Sambaydestillation was administered to groups of 5 male and 5 female Wistar rats by gavage at dose levels of 0 (group 0), 17 (group 1), 84 (group 2) and 416 (group 3) mg/kg body weight per day over a period of 4 weeks according to OECD 407 guideline and GLP (BASF, 2009).
Due to clinical signs of toxicity and sever reduced body weight in female animals of dose group 3, the maximum tolerated dose (MTD) was clearly exceeded in these animals. Therefore, the dose level of 416 mg/kg bw/day in female animals was reduced by half (208 mg/kg bw/day) from day 16 until the end of the administration period.
Food consumption and body weight were determined weekly. The animals were examined for signs of toxicity or mortality at least once a day. Detailed clinical examinations in an open field were conducted prior to the start of the administration period and weekly thereafter. A functional observational battery (FOB) and measurement of motor activity (MA) was carried out after about 4 weeks of treatment in males and females. Clinicochemical and hematological examinations as well as urinalyses were performed towards the end of the administration period. At the end of the study, all animals were assessed by gross pathology, followed by histopathological examinations.
The following test substance-related adverse findings were noted:
416 mg/kg body weight/day in males and 416 mg/kg body weight/day from day 0; 208 mg/kg body weight/day from day 16 in females
Clinical Examinations:
- Reduced general condition, slight in 2 female animals
- Salivation, slight in 1 male and 2 females and moderate in 1 male and 1 female
- Decreased food consumption in both sexes -19.4% in male animals on day 14 and in female animals from day 7 till day 21 up
to -11.4% on day 7
- Decreased body weight, in animals of either sex, statistically significant from day 14 till the end of administration period in male animals up to -12.4% on day 14 and in female animals up to -20.4% on day 21
- Decreased body weight change, in animals of either sex, statistically significant from day 14 till the end of the administration period in male animals up to -42.3% on day 14 and in female animals up to -97.8 % on day 14
Clinical Pathology
- Increased total white blood cell counts, relative and absolute lymphocyte counts in the males
- Decreased relative neutrophil counts in the males
Pathology
- No substance-related adverse findings were obtained
84 mg/kg body weight/day
Clinical Examinations
- Salivation, slight was observed in 1 male animal
- Decreased body weight in male animals from day 7 till the end of administration period (up to -5.6% on day 28)
- Decreased body weight change, in male animals statistically significant on day 21 and day 28 up to -16.1% on day 28
Clinical Pathology
- No substance-related adverse findings
Pathology
- No substance-related adverse findings
17 mg/kg body weight/day
Clinical Examinations
- No substance related adverse findings
- Clinical Pathology
- No substance-related adverse findings
Pathology
- No substance-related adverse findings
In conclusion, the oral administration of LIMUS-Sambaydestillation by gavage over a period of 4 weeks caused signs of general systemic toxicity obtained in high dose animals of either sex (in males 416 mg/kg body weight/day throughout the entire study; in females 416 mg/kg body weight/day from day 0-15 and 208 mg/kg body weight/day from day 16 until the end of the administration period). In mid dose males (84 mg/kg bw/day) some of these findings were still observed. Target organs could not be identified, because the pathological evaluation did not reveal any substance-related adverse findings.
Therefore, the no observed adverse effect level (NOAEL), under the conditions of the present study, was 17 mg/kg body weight/day in male and 84 mg/kg body weight/day in female Wistar rats.
Justification for classification or non-classification
Based on the available data no classification and labeling according to Directive 67/548/EEC and CLP is required.
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