Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07 Nov - 05 Dec 2017
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 (incl. certificate)
Remarks:
GLP-Landesleitstelle Bayern, Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Schwabach, Germany
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Remarks:
WISTAR 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: 8-10 weeks
- Fasting period before study: 16 to 19 hours
- Housing: IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet: Altromin 1324 maintenance diet for rats and mice, ad libitum
- Water: tap water acidified with sulphur to a pH of 2.8, ad libitum
- Acclimation period: at least five days

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqua ad injectionem (AlleMan Pharma, lot no. 511535)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2.002 g of the test item was suspended with the vehicle to gain a final volume of 10 mL
- Amount of vehicle: 0.2 g/mL
- Lot/batch no.: 511535

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 females/dose/step
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy and examined

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50 cut-off
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed during the study period.
Clinical signs:
No clinical signs were observed.
Body weight:
No effect on body weight was noted.
Gross pathology:
No specific gross pathological changes were noted.
Other findings:
no further details

Any other information on results incl. tables

Table 1: Findings of the Necropsy - Individual Data

Step

Animal No.

/ Sex

Starting Dose (mg/kg bw)

Organ

Macroscopic Findings

 

1

1 / Female

 

2000

-

nsf

2 / Female

-

nsf

3 / Female

-

nsf

 

2

4 / Female

 

2000

-

nsf

5 / Female

-

nsf

6 / Female

-

nsf

bw = body weight; nsf = no specific findings

Table 2: Findings of the Necropsy - Individual Data

 

Step

Animal No.

/ Sex

Starting Dose (mg/kg bw)

Organ

Macroscopic Findings

 

1

1 / Female

 

2000

-

nsf

2 / Female

-

nsf

3 / Female

-

nsf

 

2

4 / Female

 

2000

-

nsf

5 / Female

-

nsf

6 / Female

-

nsf

bw = body weight; nsf = no specific finding

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:
Under the conditions of the present study, a single oral application of the test item Frits to rats at a dose of 2000 mg/kg body weight was not associated with signs of toxicity or mortality.
The median lethal dose of Frits after a single oral administration to female rats, observed over a period of 14 days is: LD50 > 2000 mg/kg bw/day (LD50 cut-off > 5000 mg/ kg bw).