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Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 April to 9 May 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Data have been generated according to current internationally recognised study guidelines and in accordance with GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
other: CRL:(WI)
Sex:
female
Details on test animals or test system and environmental conditions:
Species and strain: CRL:(WI) rats
Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
Hygienic level at arrival: SPF
Hygienic level during
the study: Standard housing conditions
Number of animals: 6 animals, 3 animals/group
Sex: Female, nulliparous and non-pregnant.
Age of animals at dosing: Young healthy adult rats, 9 weeks old
Body weight at treatment: 193 – 203 g
Acclimation period: At least 5 days
Animal health: Only healthy animals were used for the test. The veterinarian certified health status.
Number of animal room: 522/6
Housing: 3 animals / cage
Cage type: Type II polypropylene/polycarbonate
Bedding: Lignocel Bedding for Laboratory Animals was available to animals during the study.
A copy of the Certificate of Analysis is retained in the archive at CiToxLAB Hungary Ltd.
Lighting period: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 – 70 %
Ventilation: 15 – 20 air exchanges/hour
Enrichment: Animals were housed by group to allow social interaction and with deep wood sawdust bedding to allow digging and other normal rodent activities.
Animals received ssniff® SM R/M-Z+H "Autoclavable complete diet for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany ad libitum, and tap water from the municipal supply, as for human consumption from 500 ml bottle ad libitum. The food is considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study
Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Doses:
concentration of 200 mg/mL at a dosing volume of 10 mL/kg bw
No. of animals per sex per dose:
3 female
Control animals:
no
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
other: None
Gross pathology:
There was no evidence of the macroscopic observations at a dose level of 2000 mg/kg bw.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 is >2000 mg/kg bodyweight.
Executive summary:

The acute oral toxicity was assessed by gavage dosing to female CDR:(WI) rats at a dose level of 2000 mg/kg bodyweight according to the OECD 423 test guideline and in compliance with GLP. No mortality, effects to bodyweight or clinical signs were observed and the LD50 is >2000 mg/kg bodyweight

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
K1: Data have been generated according to current internationally recognised study guidelines and in accordance with GLP

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

Justification for selection of acute toxicity – oral endpoint
No mortality, effects to bodyweight or clinical signs were observed and the LD50 is >2000 mg/kg bodyweight

Justification for classification or non-classification

The acute oral toxicity was assessed by gavage dosing to female CDR:(WI) rats at a dose level of 2000 mg/kg bodyweight according to the OECD 423 test guideline and in compliance with GLP. No mortality, effects to bodyweight or clinical signs were observed and the LD50 is >2000 mg/kg bodyweight