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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: -
Endpoint summary
Administrative data
Description of key information
The test substance is of low oral acute toxicity with an oral LD50 (rat) of > 2000 mg/kg bw (LPT, 2013).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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
- 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
- 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 - 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
- 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
- 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.
Reference
no other information
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study is valid without restriction (Klimisch score 1).
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Only one study available.
Justification for classification or non-classification
Based on the results of the acute oral study and according to the criteria of EC Directive 67/548/EEC and EC Regulation 1272/2008 the test item has a low acute toxicity if swallowed (LD50(rat) > 2000 mg/kg bw). Therefore, the test substance must not be classified.
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.
