Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
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:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Crl: WI(Han)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8 to 9 weeks old
- Weight at study initiation: 148 to 166 g for all animals
- Fasting period before study: Yes
- Housing: Full barrier in an air-conditioned room. Housed individually in IVC cages including saw fibre bedding.
- Diet (e.g. ad libitum): Free access to Altromin maintenance diet.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): 10 per hour
- Photoperiod (hrs dark / hrs light): Artificial lighting (12 hours light/dark cycles)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
Aqua ad injectionem
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2 g of substance suspended in 40 mL of water to obtain a dose of 2000 mg/kg/day.
- Amount of vehicle (if gavage): 40 mL/kg
- Justification for choice of vehicle: Standard vehicle for test type and chosen based on its non-toxic characteristics.

MAXIMUM DOSE VOLUME APPLIED: 40 mL/Kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No toxicity data available and accordingly limit dose chosen.
Doses:
The starting dose was selected to be 2000 mg/kg bw.
No. of animals per sex per dose:
3 females per step (3 at 2000 mg/kg bw followed by 3 more)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were weighed on Day 1 (prior to dosing) and days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical signs were noted on the day of dosing and then once daily during the observation period.
Statistics:
Not applicable to study type

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50 cut-off
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed at 2000 mg/kg.
Clinical signs:
Signs included prone position, reduced spontaneous activity and piloerection in the majority of animals up to 4 hours after dosing. No signs were observed 1 day after dosing.
Body weight:
Weight gain of the surviving animals was considered to be within normal ranges during the observation period.
Gross pathology:
No significant findings were noted.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A reliable, guideline study is available providing an LD50 cut-off value of > 2000 mg/kg bw to rats.