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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-12-18 to 2013-03-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Bioassay Labor für biologische Analytik GmbH, Im Neuenheimer Feld 515/519, 69120 Heidelberg, Germany
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: COD-001701
- Expiration date of the lot/batch: 2014-11-01
- Purity test date: 2012-10-24

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature (or cooler)


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
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 weeks
- Weight at study initiation: 170 g to 194 g
- Fasting period before study: 16 h before administration
- Housing: single (Makrolon cage, type III
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany (ad libitum)
- Water: tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 to 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 2013-01-14 to 2013-02-05

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20 g/100 mL
- Purity: 0.5% solution in deionised water

MAXIMUM DOSE VOLUME APPLIED: 10 mL

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: request of the sponsor
Doses:
2000 mg/kg body weight
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: Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
- Frequency of weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Not applicable

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
discriminating dose
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Mo mortality occurred
Clinical signs:
In the first 2000 mg/kg bw test group impaired general state and piloerection were observed in two animals from hour 2 until hour 5 after administration. One animal did not show any symptoms.
In the second 2000 mg/kg bw test group no clinical signs were observed during clinical examination in all animals.
Body weight:
The mean body weight increased within the normal range throughout the study period. Two animals showed only a small weight gain during the second post-exposure week.
Gross pathology:
There were no macroscopic pathological findings at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met