Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011-08-10 to 2012-02-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study is regarded as reliable without restrictions because it was conducted in compliance with GLP regulation and guideline. The study is scientifically well described and complete in any parts.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted: 2001-12-17
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
adopted: 2008-05-30
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
adopted 2002-12
Deviations:
no
Qualifier:
according to
Guideline:
other: Japan MAFF TG of 12 Nosan No. 8147
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: Young adult animals (female animals approx. 10 weeks)
- Weight at study initiation: Animals of comparable weight (mean weight 171 g)
- Fasting period before study: 16 hours before administration
- Housing: Makrolon cage, type III
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water (e.g. ad libitum): Tap water
- Acclimation period: Acclimatization period of at least 5 days before the beginning of the experimental phase


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 p.m. - 6.00 a.m. / 6.00 a.m. - 6.00 p.m.)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Maximim dose volume applied: 2.30 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 femal rats per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation
- Necropsy of survivors performed: Necropsy with gross-pathology examination

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured.
Clinical signs:
Clinical signs in the first test group revealed impaired general state, dyspnoea and piloerection and were observed in all animals from hour 2, 3 or 4 until hour 5 after administration.
In the second administration group two animals showed impaired general state, dyspnoea and piloerection from hour 0 or 1 until study day 1. Non feces and exsiccosis in both animals and staggering in one animal were observed at study day 1. On study day 2 reduced feces was noted in one of these animals. In the third animal of this group dyspnoea and piloerection were observed from hour 1 until study day 3 after administration. Furthermore impaired general state was noted from hour 1 until hour 3 and at day 2 und 3, which increased temporarily to poor general state from hour 4 until study day 1.
This animal showed abdominal position from hour 4 until study day 1 and exsiccosis on study day 1 und 2.
Additionally non feces, atonia, lacrimation, pain and corneal reflex absent and narcotic like state were observed in this animal at study day 1 while reduced feces was observed on study day 2.
Body weight:
The mean body weight of the test groups increased throughout the study period within the normal range.
Gross pathology:
There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period

Applicant's summary and conclusion