Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
Species and strain: Rat Hsd: Sprague Dawley® SD®
Sex: Female
Colour: Albino
Supplier: Envigo RMS Spain S.L.
Health status: Specific Pathogen Free (SPF). The health monitoring report provided by the animal supplier will be stored at Vivotecnia.
Rationale for selection of species / strain: Rats are a suitable rodent species, acceptable to regulatory authorities as indicators of potential hazards, and for which extensive background data are available. Literature surveys of conventional LD50 tests showed that, although there is little difference in sensitivity between the sexes, in those cases where differences were observed females are generally slightly more sensitive.
Total number of animals: 6 animals to perform 3 dose steps.
Approx. age of the animals on arrival: 8 weeks old.
Animals per cage after distribution: 3
Bedding material: Sodispan SR-CHOPO-T.
Change of cages: At least once a week
Inclusion criteria on arrival: Prior to inclusion in the study, animals were subjected to individual veterinary examination. Only animals without clear visible sign of illness that may interfere with the study were included.
Acclimatisation period and distribution: 5 days. Animals were randomly distributed by means of the body weight stratification method. 20% of the mean body weight (for the first defined dose at the beginning of the study and further dose steps).
Animal identification: Digit ink marks.


ENVIRONMENTAL CONDITIONS
Light cycle: 12:12
Temperature / Relative humidity: 19 - 25ºC / 30 – 70%

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg
No. of animals per sex per dose:
6 animals to perform 3 dose steps.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30 minutes, 2h, and 4h post-administration and once daily thereafter during the 14-day observation period
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs and body weight

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No observed
Clinical signs:
No observed
Body weight:
No observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 is > 2000 mg/kg bw.