Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The study will be available 30/08/2019
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

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

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: Females (nulliparous and non-pregnant)
Age: 6 to 7 weeks old
Weight range at arrival: 155 to 160 grams
Acclimatisation period: At least 5 days
Veterinary health check: During acclimatisation period

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
Dosing method: The formulated test item was administered, by gavage, at a dose volume of 20 mL/kg using a plastic feeding tube attached to a graded syringe.
Doses:
2000mg/kg
No. of animals per sex per dose:
An initial sighting study was performed on a single female animal which was dosed at 2000mg/kg. No mortality occurred and the animal was observed for a period of 14 days. A main study was then performed on a group of 4 females, dosed at 2000mg/kg and observed for a period of 14 days.
Control animals:
no
Details on study design:
Frequency of treatment: Once only, on the day of dosing.
Fasting procedure: Food was removed fromthe cages overnight prior to dosing (Day -1) and was made available approximately 4 hours after dosing.
Dose calculation: On the day of dosing (Day 1), the amount of the formulated test item to be administered was calculated for each fasted animal according to body weight.
Dosing method: The formulated test item was administered, by gavage, at a dose volume of 20 mL/kg using a plastic feeding tube attached to a graded syringe

Results and discussion

Preliminary study:
An initial sighting study was performed on a single female animal which was dosed at 2000mg/kg. No mortality occurred and the animal was observed for a period of 14 days.
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Mortality and morbidity: Throughout the study all animals were checked twice daily.
Clinical signs:
Clinical signs
Animals were observed for clinical signs as indicated below:
– Day of dosing
– · Session 1: on dosing
– · Session 2: approximately 0.5 hour after dosing
– · Session 3: approximately 2 hours after dosing
– · Session 4: approximately 4 hours after dosing
– Daily thereafter for a total of 14 days (Session 1)
Body weight:
All animals were weighed at allocation to the study (Day -1), on the day of dosing (Day 1) and on Days 2, 8 and 15. Body weight change calculated for Days 2, 8 and 15 of the dosing phase was relevant to Day 1 of the phase.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Classification: No category
Signal word: No signal word required
Hazard statement: No hazard statement required