Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-03-28 to 2013-03-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well documented and controlled GLP based 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 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
up-and-down procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
Batch No.: 110526S
Expiry date: 26.05.2013
Purity: 99,24% (taken as 100%)
Instructions for storage: Room temperature, tighly closed container, cool, dry, only in original container
State of material: crystalline, damp, not dusty
Colour: white
Odour: odourless

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
Strain: Rat Wistar SPF Charles River Germany D- 97633 Sulzfeld- Facility,
Species: Rattus norvegicus ssp.alba
Environmental conditions were monitored and recorded continuously over the study. The temperature in the animal room was in-between 20°C and 24°C and the relative humidity was in-between 40% and 70% . A 12/12h light/dark cycle was set.

During the study, the study rats were housed in TECHNIPLAST cages Type 2145 F. The cages measured 480 x 265x 210 mm (floor area 940 cm2). As bedding, sterilized sawdust was used. Two and three animals were housed per cage, respectively.

Diet and water:
For feeding, a standard pelleted diet (M3) of monitored quality was used. Potable water from the local mains of monitored quality was supplied ad libitum. Water bottels were changed daily.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The test substance was administered orally by a stomach tube (gavage). The substance was applied as a suspension in water. The applied volume was 20 ml/ kg body weight per animal. The dose (2000 mg/kg) was given in two fractions over a period of 4 hours. Dosing was performed sequentially: on day 1 three animals were treated and on day 5 two animals were treated.
Doses:
The dose (2000 mg/kg) was given in two fractions over a period of 4 hours. Dosing was performed sequentially: On day 1 three animals were treated and on day 5 two animals were treated. Dosing was done using a suspension of ASC plus in water with 20 ml suspension/kg body weight per rat.
No. of animals per sex per dose:
5 females were treated with one dose
Control animals:
no
Details on study design:
A dose of 2000 mg/kg ASCplus was administered in 2 fractions to 5 female rats using a stomach tube. The animals were caged in a group of 3 and in one of 2 animals. The observation period was 14 days. Prior to the beginning of the study, animals were acclimated for 5 days in their cages. Each rat was individually marked by a code on the tail. The environmetal conditions as well as the mortality, clinical effects and animal health were monitored over the whole test period. At the beginning and at the end of the study the body weight of all animals was measured. Moreover, a necropsy was performed on all animals after termination of the study and the organs were examined macroscopically.
Statistics:
Data recorded during the study were tabulated.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no toxicity observed
Mortality:
No moribund animals were observed within the test period of 14 days.
Clinical signs:
No clinical signs have been detected during and at the end of the exposure period.
Body weight:
All exposed rats showed an increase (same tendency) of the body weight over the 14 days of exposure.
Gross pathology:
No macroscopically detected pathological changes in organs or tissues of the animals were observed.
Other findings:
None of the animals showed any toxicity symptoms or behavioral changes over the whole observation period.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance ASC plus did not cause any symptoms of toxicity after an oral dosage of 2000mg/kg. Therefore, the lethal doses are higher than 2000 mg/kg bw..
Executive summary:

The oral toxicity of ASC plus was determined using the up- and down procedure in rats according to the OECD guideline 425.

An oral dosage of 2000 mg/kg of ASC plus was administered in 2 fractions during 4 hours to 5 female rats.The test article was suspended in water and an administration volume of 20 ml/kg bw. was used. During the observation period of 14 days environmental conditions as well as the animal health, clinical effects, mortality and body weight were monitored. At termination of the study, a necropsy was performed with all ainmals and the major organs were examined macroscopically.

The oral administration of ASC plus did not cause any toxic symptoms at a dosage of 2000 mg/kg bw.

Therefore, the LD 50 of ASC plus is higher than 2000 mg/kg bw.