Frits, chemicals and bismuth oxide

Acute Toxicity: oral

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted 17 December 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

30 May 2008

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

December 2002

GLP compliance:

yes (incl. QA statement)

Remarks:

GLP-Landesleitstelle Bayern, Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Schwabach, Germany

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Frits, chemicals

EC Number:

266-047-6

EC Name:

Frits, chemicals

Cas Number:

65997-18-4

Molecular formula:

not applicable

IUPAC Name:

Frits, chemicals

Test animals

Species:

rat

Strain:

Wistar

Remarks:

WISTAR Crl: WI(Han)

Sex:

female

Details on test animals or test system 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 levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

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).