[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 June - 11 July 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

adopted 17 December 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Version / remarks:

30 May 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Hess. Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

1

Reference substance name:

Reaction mass of dipotassium 2-(3,4-dimethyl-1H-pyrazol-1-yl) succinate and dipotassium 2-(4,5-dimethy-1H-pyrazol-1-yl) succinate

Molecular formula:

C9H10K2N2O4

IUPAC Name:

Reaction mass of dipotassium 2-(3,4-dimethyl-1H-pyrazol-1-yl) succinate and dipotassium 2-(4,5-dimethy-1H-pyrazol-1-yl) succinate

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Han TM

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Envigo RMS B.V., Inc, AD Horst, The Netherlands
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 - 11 weeks
- Weight at study initiation: 207.6 - 274.7 g (females)
- Fasting period before study: animals were fasted overnight prior to administration
- Housing: 1 - 5 animals of the same sex per cage in Makrolon Type IV cages, with wire mesh top, granulated soft wood bedding
- Diet: 2018C Teklad Global 18% protein rodent diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 4
- Humidity (%): 28 -72
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION: DMPSA-K2 solution, dose calculation was adjusted to purity

- Rationale for the selection of the starting dose: Based on available information on the toxicity of the test item, 300 mg/kg bw was chosen as the initial starting dose, since a severe toxicity which may necessitate humane euthanasia was not expected at this dose level.

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

1 (300 mg/kg bw)
5 (2000 mg/kg bw)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations and inspections for morbidity / mortality were performed at least three times within the first six hours after application (i.e., 30 minutes and 1 hour, 2 hours and 4 – 6 hours after dosing), thereafter at least once daily for 14 days. Bodyweights were determined Day 0 (prior to dosing), Day 7, and Day 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

At both doses 300 and 2000 mg/kg bw, there were no deaths observed during the study.

Clinical signs:

other: 300 mg/kg bw: There were no clinical signs observed. 2000 mg/kg bw: One animal showed reduced activity. These signs were first noted approximately one hour after dosing. Recovery, as judged by external appearance and behavior, was complete by day 1 after

Body weight:

other body weight observations

Remarks:

The animal showed expected gains in body weight over the observation period.

Gross pathology:

300 mg/kg bw: No abnormalities were noted at the macroscopic examination at study termination.
2000 mg/kg bw: One animal showed discoloration (red dots) in the thymus. No abnormalities were noted at necropsy in the remaining animals.

Any other information on results incl. tables

Table 1: Summary of results

	Females
		Animal number	Dose [mg/kg bw]	Mortality	Clinical signs	Description	Necropsy finding	Description
				number	number		number
Sighting study		1	300	0/1	0/1	-	0/1	-
		2	2000	0/1	1/1	reduced activity within 6 h after treatment	0/1	-
Main study		3	2000	0/4	0/4	-	1/4	-
		4	2000			-		-
		5	2000			-		-
		6	2000			-		discoloration thymus (red dots)

Applicant's summary and conclusion

Interpretation of results:

other: no classification required according to Regulation (EC) No. 1272/2008

Conclusions:

CLP: not classified