Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April - August 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
OECD423, version 2001-12-17
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 0015064167
- Expiration date of the lot/batch: March 01, 2018
- Purity test date: Aug 02, 2017 (date of report 17L00118)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- 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: Envigo RMS GmbH, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 184.7 g (mean experiment 1, n = 3); 184.3 (mean experiment 2, n = 3)
- Fasting period before study: at least 16 hours before administration
- Housing: Single housingin Makrolon cage, type III
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 30 - 70 %
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

IN-LIFE DATES: From: To: April/May 2017

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE: no
DOSE VOLUME APPLIED: 1.75 ml/kg bw
Doses:
2000 mg/kg bw
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: Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter. Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality, gross-pathology, no histological examination

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no
Clinical signs:
impaired general state and piloerection were observed until study day 1 after administration
Body weight:
normal increase of bodyweight throughout the study period
Gross pathology:
no macroscopic pathological findings in any animal sacrificed at the end of the observation period

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
virtually non-toxic
Executive summary:

In an acute oral toxicity study in 2017 (GLP, OECD423 ATC method), a dose of 2000 mg/kg of the undiluted test substance was administered by gavage to two test groups of three fasted Wistar rats each (6 females). No mortality occured, but impaired general state and piloerection until day 1 after administration were observed in all animals. The body weights increased within the normal range throughout the study period. There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period. Therefore, the acute oral LD50 (rat) was calculated to be > 2000 mg/kg bw.