Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-04-14 to 2009-05-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

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)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): L173
- Substance type: inorganic
- Physical state: solid
- Analytical purity: presumably > 99.9 %
- Lot/batch No.: DP/SL 040c/09
- Expiration date of the lot/batch: not applicable
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: animals 1 - 3: 181 - 197 g; animals 4 - 6: 174 - 177 g
- Fasting period before study: 16 - 19 h. Access to water was permitted.
- Housing: Semi-barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: all animals 6 days

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

IN-LIFE DATES: From: all animals: 2009-04-21 To: animals 1 - 3: 2009-04-29; animals 4 - 6: 2009-05-12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.2 g /mL
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: non-toxic characteristics
- Lot/batch no. (if required): B. Braun Melsungen, lot no. 7494A191

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg body weight

DOSAGE PREPARATION (if unusual): Homogeneity of the test item in the vehicle was maintained by vortexing the prepared suspension thoroughly before every dose administration.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No severe toxicity expected.
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days)
- Frequency of observations and weighing: day 0 (pre-dose, 30 minutes and 4 h post dose), day 7, day 14 as a minimum
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 cut off
Mortality:
No mortality observed
Clinical signs:
Prior to the administration a detailed clinical observation was made of all animals.
A careful clinical observation was made several times on the day of dosing; at least once during the first 30 minutes and with special attention during the first 4 hours post-dose. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period.

Clinical signs were not observed during the whole observation period.
Body weight:
Absolute body weights in g and body weight gain in %
day 0 day 7 day 14 day 0 - 14
animal 1 181 194 194 7
animal 2 186 199 199 7
animal 3 197 218 219 11
animal 4 177 208 226 28
animal 5 174 192 210 21
animal 6 177 224 245 38
Gross pathology:
No special gross pathological changes were recorded for any animal.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 cut off (rat) of L173 via the oral route was 5000 mg/kg body weight.
Executive summary:

The oral toxicity of L173 was examined in a GLP guideline study according to OECD 423.

Under the conditions of the study, a single oral application to rats at a dose of 2000 mg/kg body weight was neither associated with signs of toxicity nor mortality.

The median lethal dose of L173 after single oral administration to female rats, observed over a period of 14 days is:

LD50 cut off (rat): 5000 mg/kg body weight.

The substance does not require classification.