Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-11-07 to 2013-11-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- (2010)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Purity: Approx. 92%
Physical form: crude powder
Odour: weak, not specific
Colour: slightly yellow
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Rattus norvegicus CD / Crl: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Source: Charles River Deutschland, Sulzfeld
- Strain: Rattus norvegicus CD / Crl: CD(SD)
- approx. 8 weeks
- body weight: 167 - 202 g
- Fasting period before study: 16 hours
- Diet: ad libitum, ssniff R/M-H V 1534
- Water: ad libitum
- Acclimatisation period: at least 5 days
- Temperature (°C): 22 °C +/- 3° C
- Humidity (%): 55% +/- 15 %
- Illumination: 12 hours artifical fluorescent light and 12 hours dark
- Air change: 12 to 18-fold/per hour
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- ADMINISTRATION:
- Frequency: single dosage on day 1
- Dose volume: 10 ml/kg b.w.
- Dose: 2000 mg/kg/bw
- DOSAGE PREPARATION: the substance was suspended in sesame oil1 to a concentration of 200 mg/mL. The administration volume was 10 mL/kg b.w., p.o. (resulting in a dose level of 2000 mg/kg b.w.).
- CLASS METHOD: acute-toxic-class methode
first step 3 female rats are treated with 2000 mg/kg b.w., no signs of toxicity were observed
second step (after 24 h) 3 female rats are treated with 2000 mg/kg b.w. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 6 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: before administration, immediatly, 5, 10, 30 and 60 min, 3, 6 and 24 h after administration and at least once daily
thereafter, until day 14
- Body weight: days 0 (pre-administration) 7 and 14
- Necropsy: All survived animals were necropsied at the end of the observation period - Statistics:
- not required
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- No signs of toxicity.
- Body weight:
- No apparent changes were found in body weight.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Other findings:
- no other findings
Any other information on results incl. tables
no other information
Applicant's summary and conclusion
- Conclusions:
- Under the present test conditions, the test item requires no labelling, as LD50 > 2000 mg/kg b.w., p.o.
- Executive summary:
The test item is given to female rats by oral administration to obtain information on the toxicity, in particular, lethality of a test item
Under the present test conditions, a single oral administration of 2000 mg test substance to female rats did not reveal any signs of toxicity. No animal died prematurely. All animals gained the expected body weight. No pathological changes were observed at necropsy
Therefore, the test substance is n o n - t o x i c if swallowed, as LD50 > 2000 mg/kg b.w., p.o.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
