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Administrative data

Description of key information

Acute oral toxicity: OECD TG 423: > 2000 mg/kg bw.

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:
September 05, 2002 - September 24, 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 1
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
1996
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
June 1996
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
1996
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
other: Crl:(WI)BR (outbred, SPF-Quality)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: males 311 - 369g; females 166 - 181g
- Fasting period before study: fasted overnight for a maximum of 20 hours prior to dosing
- Housing: Group housing of 3 animals per sex per cage in labelled Macrolon cages containing purified sawdust as bedding material
- Diet (e.g. ad libitum): Free access to standard pelleted laboratory animal diet ( Altromin (code VRF 1), Lage, Germany)
- Water: Free access to tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): targeted 21
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 05 September 2002 To: 24 September 2002
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Individual doses, calculated on the basis of bodyweight and test material density (0.93 g/mL), were administered by suitable intubation tube.
Dose volume: 2.15 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: The animals were observed 30 minutes, 1, 2 and 4 hours after application and thereafter daily
- Necropsy of survivors performed: yes, at the end of the observation period the animals were killed by CO2 asphyxia, necropsied and subjected to examination for gross pathological changes.
- Body weights: Individual body weights were recorded immediately before treatment and then on the 7th and 14th day of the observation period.
Statistics:
No statistical analysis was performed (The method used is not intended to allow calculation of a precise LD50 value).
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured.
Clinical signs:
Lethargy, flat posture, hunched posture and/or uncoordinated movements were noted among the animals on day 1. Hunched posture was seen in three males on day 2.
Salivation was seen in one female immediately after treatment. This finding is commonly seen after treatment by oral gavage and is considered not toxicologically significant.
Body weight:
The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.
Interpretation of results:
other: Not acutely toxic
Remarks:
According to Regulation (EC) No. 1272/2008 and its amendments
Conclusions:
The acute oral toxicity test with the substance showed an LD50 of > 2000 mg/kg bw.
Executive summary:

Acute oral toxicity: In this study, 6 rats (3 males and 3 females) were administered with the substance at dose levels of 2000 mg/kg bw. The rats showed no mortality. Lethargy, flat posture, hunched posture and/or uncoordinated movements were noted among the animals on day 1. Hunched posture was seen in three males on day 2. No effects on bodyweight gain were observed and no abnormalities were found at macroscopic post mortem examination of the animals. Based on the results in this study, the acute oral LD50 for the substance in male and female rats was determined to be >2000 mg/kg bw and the substance is not considered acutely toxic.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Acute oral toxicity: In this study, 6 rats (3 males and 3 females) were administered with the substance at dose levels of 2000 mg/kg bw. The rats showed no mortality.Lethargy, flat posture, hunched posture and/or uncoordinated movements were noted among the animals on day 1. Hunched posture was seen in three males on day 2. No effects on bodyweight gain were observed and no abnormalities were found at macroscopic post mortem examination of the animals. Based on the results in this study, the acute oral LD50 for the substance in male and female rats was determined to be >2000 mg/kg bw and the substance is not considered acutely toxic.

Justification for classification or non-classification

The substance does not have to be classified for acute toxicity by the oral route according to Regulation (EC) No. 1272/2008 and its amendments.