Zinc bis(dihydrogen phosphate)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

not applicable

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Test guideline 3

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Zinc bis(dihydrogen phosphate)

EC Number:

237-067-2

EC Name:

Zinc bis(dihydrogen phosphate)

Cas Number:

13598-37-3

Molecular formula:

Zn(H2PO4)2

IUPAC Name:

zinc bis(dihydrogen phosphate)

Details on test material:

name of test substance: SAT 060267
molecular weight: 259.4
description: clear colourless liquid
batch: VDE 4207-6
composition: 14.6% solution in water
test substance storage: at room temperature in the dark
stability under storage conditions: stable
expiry date: 04 July 2009
density: 1.16 g/ml (determined at NOTOX)
pH: 1.9 at concentration of 14.6%

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland , Sulzfeld, Germany
- Weight at study initiation: body weight variation did not exceed ± 20% of the sex mean
- Fasting period before study: food was withheld overnight (for a maximum of 20 hours) prior to dosing until 3-4 hours after administration of the test substance
- Housing: 3 animals per cage in labeled Macrolon cages (MIV type; height 18cm) containing sterilised sawdust as bedding material and paper as cage-enrichment
- Diet: plleted rodent diet (SM R/M-Z from SSNIFF Spezialdiäten GmbH, Soest, Germany) ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

oral gavage, using plastic feeding tubes

Doses:

300 mg/kg and 2000mg/kg active ingredient

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: up to death
- Frequency of observations and weighing:
mortality/viability: twice daily
body weights: days1 (pre-administration), days 8 and 15 and at death
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

no statistics reported

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 300 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: All six animals survived

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

< 2 000 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: 2of 3 females died

Mortality:

300mg/kg active ingredient - deaths: 0/3 (females)
300mg/kg active ingredient -deaths: 0/3 (males)
2000mg/kg active ingredient - deaths: 2/3 (females)
the decedents were found within 24 hours post-treatment

Clinical signs:

other: 300mg/kg active ingredient - lethargy, hunched posture, rales, shallow respiration, piloerection, salivation, chromodaccryorrhoea,ptosis 2000mg/kg active ingredient - lethargy, hunched posture, uncoordinated movements, piloerection, ptosis the surviving a

Gross pathology:

macroscopic post mortem examination of the animals found died during the study revealed abnormalities in the stomach (irregular surface and many black/brown foci in the glandular mucosa) and reddish discolouration of the mesenteric lymph nodes. No abnormalities were revealed in the surviving animals

Other findings:

none

Any other information on results incl. tables

none       

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The oral LD50 value of SAT 060267 (active ingredient) in Wistar rats was established to be within the range of 300-2000 mg/kg body weight.
According to OECD 423 test guideline and based on the LD50 cut-off values, the LD50 value was considered to be 1000mg/kg bw.
Based on these results:
- according to the GHS classification, SAT 060267 should be classified as : harmfull if swallowed (category 4) for acute toxicity by the oral route
- according to EC criteria for classification and labelling for dangerous substances and preparations, SAT 060267 should be labelled as: harmfull if swallowed (R22)

Executive summary:

This study report demonstrated that the sample SAT 060267 is harmful if swallowed for actue toxicity by the oral route. The oral LD50 value of SAT 060267 (active ingredient) in Wistar rats was established to be within the range of 300-2000 mg/kg body weight.

According to OECD 423 test guideline and based on the LD50 cut-off values, the LD50 value was considered to be 1000mg/kg bw.