Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 Oct 2017 - 22 Jan 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 17 December 2001
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
30 May 2008
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
December 2002
GLP compliance:
yes
Remarks:
GLP-Landesleitstelle Bayer, Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Germany
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:
Wistar
Remarks:
Crl: WI (Han)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
Charles River, 97633 Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation:
9-11 weeks
- Weight at study initiation:
Step 1: 191 g - 200 g; Step 2: 161 g - 168 g
- Fasting period before study: 16 to 19 hours fasting prior to the admnistration
- Housing:
Animals kept in groups in IVC cages, type III H, polysulphone cages on fibre bedding, full barrier in an air-conditioned room.
- Diet: ad libitum
- Water:
drinking water, acidified to a PH value of approximately 2.8, ad libitum
- Acclimation period:
at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr):
10 × / hour
- Photoperiod (hrs dark / hrs light):
12 hrs light/12 hrs dark.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Justification for choice of vehicle: this vehicle was chosen due to its non-toxic characteristics.
- Lot/batch no.: MKCC0462

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before administration, and 7 and 14 days after administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsic examination
Statistics:
None

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50 cut-off
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Three animals showed signs of toxicity 2 hours after administration of the test item.
The most relevant clinical findings were reduced spontaneous activity, piloerection and half eyelid-closure. All symptoms recovered within the first day post-dose.
Body weight:
The weight gain of the animals was within the normal range of variation for this strain throughout the 14-day observation period.
Gross pathology:
No macroscopic findings were observed.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008.
Conclusions:
The median lethal dose of the test item after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): > 2000 mg/kg bw.
Executive summary:

The acute oral LD50 cut-off for the test substance was determined in an OECD Guideline 423 test. Two groups, each of three female rats were successively dosed with 2000 mg/kg of test substance in corn oil. All animals surrvived until the end of the study. The acute oral LD50 cut-off of the test substance in female rats is >2000 mg/kg.