Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

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
Type:
additive
Test material form:
liquid
Specific details on test material used for the study:
solution in ethyl acetate (about 40 % solid content)

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 165-185 g
- Housing: 3 animals per cage
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 5 °C
- Air changes (per hr): > 10 per hour
- Photoperiod (hrs dark / hrs light): 12h rhythm

IN-LIFE DATES: From: To: 28 OCT 2016 to 17 NOV 2016

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
application volume 10 mL/kg bw
The analyses of the dosage formulations revealed that the test item was stable in the concentration range used beyond the defined period of use. Homogeneity and stability testing of the test item in the administration vehicle prior to study start showed a homogeneous distribution and stability for at least 2 days. Accuracy of concentrations was checked during the in-life phase.
Doses:
2000 mg/kg
No. of animals per sex per dose:
6 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: twice daily or daily
- body weights: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy
Statistics:
not applicable

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 deaths
Clinical signs:
No clinical signs; in one animal increased salivation was observed; it remains unclear if this finding was treatment-related
Body weight:
no effects on weight gain
Gross pathology:
no findings
Other findings:
none

Any other information on results incl. tables

Dose (mg/kg bw) Toxicological results  clinical sign  Onset of mortality
(1st) 2000 0 / 1/ 3 salivation --- 
(2nd) 2000 0 / 0/ 3 --- --- 

Toxicological results:

number of dead animals / number of animals with signs after treatment / number of animals treated

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

The acute oral LD50 in rats is determined with >2000 mg/kg bw based on the results of a limit dose study performed according to OECD TG 423. The test dose of 2000 mg/kg was well tolerated, without effects on body weight development and gross pathological findings.