Registration Dossier
Registration Dossier
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EC number: 281-658-8 | CAS number: 84012-13-5 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Arctium lappa, Compositae.
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study with detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- RCC
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Arctium lappa, ext.
- EC Number:
- 281-658-8
- EC Name:
- Arctium lappa, ext.
- Cas Number:
- 84012-13-5
- IUPAC Name:
- Arctium lappa, ext.
- Details on test material:
- - Name of test material (as cited in study report): Klettenfruchtextrakt (Sample ID: 14261)
- Physical state: honey-like, yellow liquid
- Expiration date of the lot/batch: 26-SEP-2007
- Storage condition of test material: room temperature, light protected
Constituent 1
- Specific details on test material used for the study:
- - Stability: stable under storage conditions., stability of test item dilution unknown
Test animals
- Species:
- rat
- Strain:
- other: HanRcc: WIST (SPF)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Fuellinsdorf, Switzerland
- Age at study initiation: 11 weeks
- Weight at study initiation: 182.3 - 199.8 g
- Fasting period before study: 17-18 hours
- Housing: groups of 3 animals in Makrolon type-4 cages with wire mesh tops and standard softwood bedding
- Diet: Pellet standard Provimi Kliba 3433 rat/mouse maintenance diet, ad libitum
- Water: Community tap water, ad libitum
- Acclimation: Under laboratory conditions, after health examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3°C
- Humidity: 30-70% (values above 70% possible during cleaning process)
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12h light / 12 h dark. Music during light period
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Details on oral exposure:
- DOSAGE PREPARATION:
Dose formulation made shortly before each dosing occasion. Test item weighted into a glass beaker and vehicle added (weight:volume). Homogeneity of test item in vehicle maintained during administration usind a magnetic stirrer. - Doses:
- Single dose of test item (2000 mg/kg body weight) applied after being fasted. Dosing volume 10 mL/kg bw.
- No. of animals per sex per dose:
- 2 groups, 3 femalesper group
- Details on study design:
- - Frequency of observations and weighing: Mortality / Viability observed daily during acclimatization period, during the first 30 min and approx. 1, 2, 3, 5 hours after administration on test day 1 and twice daily during days 2-15. Body weight observed on test days 1, 8 and 15. Clinical signs observed daily during acclimatization period, during the first 30 min and approx. 1, 2, 3, 5 hours after administration on test day 1 and once daily during days 2-15
- Necropsy of survivors performed: yes - Statistics:
- No statistical analysis used
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- All animals survived until the end of the study period.
- Clinical signs:
- No clinical signs observed during the course the of study.
- Body weight:
- Two animals showed a slight loss of weight (0.5%) during the last week of observation. The body weight of the other animals was within the normal range.
- Other findings:
- No macroscopic findings were recorded at necropsy.
Applicant's summary and conclusion
- Conclusions:
- After single oral administration to female rats in a study according to OECD Guideline 423, all animals survived over a study period of 14 days.
LD50 > 2000 mg/kg b.w.
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