Tetrazinc trioxide phosphite

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 February 2018 - 19 March 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 guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

Based on current GLP guidance, at the time of issue/approval the study plan did not contain sufficient information with regards test item identification. The required information is however included in the final study report.

GLP compliance:

yes

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

Tetrazinc trioxide phosphite

EC Number:

264-938-4

EC Name:

Tetrazinc trioxide phosphite

Cas Number:

64539-51-1

Molecular formula:

HO6PZn4

IUPAC Name:

Tetrazinc trioxide phosphite

Specific details on test material used for the study:

Batch: 1013Q17761
Purity: 100%
Physical state/Appearance: white powder
Expiry Date: 25 June 2018
Storage Conditions: room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Remarks:

(RccHan™:WIST)

Sex:

female

Details on test animals or test system and environmental conditions:

The females were nulliparous and non-pregnant. Acclimatization period of at least 5 days.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Doses:

A single animal was administered with 300 mg/kg bw.
In the absence of toxicity at a dose level of 300 mg/kg, an additional animal was administered with 2000 mg/kg bw.
In the absence of toxicity at a dose level of 2000 mg/kg, an additional group of animals (n=4) was administered with 2000 mg/kg bw.

No. of animals per sex per dose:

One animal at 300 mg/kg bw.
5 animals at 2000 mg/kg bw.

Control animals:

no

Results and discussion

Preliminary study:

There were no deaths. There were no signs of systemic toxicity were noted during the observation period. The animal showed expected gains in body weight over the observation period. No abnormalities were noted at necropsy.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: Hunched posture was in noted four animals 1 and 2 hours after dosing. No other signs of toxicity were noted.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 is >2000 mg/kg bw.

Executive summary:

In an acute toxicity study the substance was administered to female Wistar rats (5 animals/dose) by oral gavage at a dose level of 2000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was as expected and no abnormalities found at macroscopic post-mortem examination. The oral LD50 is >2000 mg/kg bw.