Proxan-sodium

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Data source

Reference

Reference 1

Reference Type:

review article or handbook

Title:

Unpublished toxicological data to C.B. Shaffer, American Cyanamid;

Author:

Dow Chemical Company, 1964

Year:

1964

Bibliographic source:

American Cyanamid; data from P. Avotin, American Cyanamid, 1982 as cited in Kirk-Othmer Encyclopaedia of Chemical

Reference 2

Reference Type:

review article or handbook

Title:

Oral toxicity of xanthates

Author:

Kirk-Othmer Encyclopaedia of Chemical Technology

Year:

1984

Bibliographic source:

Vol 24, 2nd ed, pp 645-661, John Wiley & Sons, 1984.

Reference 3

Reference Type:

review article or handbook

Title:

Priority existing chemical Report No. 5

Author:

Dep. of Health and Ageing, Australian Government

Year:

1995

Bibliographic source:

National Industrial Chemicals Notification and Assessment Scheme

Reference 4

Reference Type:

review article or handbook

Title:

Oral toxicity of xanthates

Author:

Buzina, A.Z., Burkhanov, A.I. and Abeuev, Kh.B

Year:

1977

Bibliographic source:

Zdravookhr. Kaz., 88 ascited inKirk-Othmer Encyclopaedia of Chemical Technology,Vol 24, 2nd Ed, pp645-661, John Wiley & Sons, 1984.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Proxan-sodium

EC Number:

205-443-5

EC Name:

Proxan-sodium

Cas Number:

140-93-2

Molecular formula:

C4H8OS2.Na

IUPAC Name:

sodium O-isopropyl dithiocarbonate

Test material form:

solid: compact

Details on test material:

- Name of test material (as cited in study report):Sodium Isopropyl Xanthate (SIPX)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Weight at study initiation: 200-265g

- Fasting period before study: Over night

- Water: ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

250, 500,1000, 1250, 1700, 2000 mg

No. of animals per sex per dose:

10 male

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Regular intervals on the day of dosing and daily thereafter for 14 days.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Gross necropsies were performed on all survivors and any animals which died during the observation period. Body weights of survivors were recorded prior to sacrifice.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

1 250 mg/kg bw

Based on:

test mat.

Remarks on result:

other: oral administration of Sodium Isopropyl Xanthate (SIPX) to rats produced increased motor activity, cyanosis, irritability, increased respiration and convulsions with death occurring 1 to 2 hours after administration.

Effect levels 2

Sex:

male

Dose descriptor:

LD0

Effect level:

250 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD0 Lethal dose for 0% of the animal test population

Mortality:

All death occurring 1 to 2 hours after administration.

Clinical signs:

other: Oral administration of Sodium Isopropyl Xanthate (SIPX) to rats produced increased motor activity, cyanosis, irritability, increased respiration and convulsions with death occurring 1 to 2 hours after administration.

Gross pathology:

Autopsy showed perivascular and pericellular oedema, multiple haemorrhages in the lungs, perivascular subarachnoid haemorrhages and acute
swelling of the cells of the cortex, subcortical ganglia and the brain stem. Fatty dystrophy of the liver and protein dystrophy of the twisted canaliculi of the kidneys were observed.

Other findings:

The findings of these studies indicate that Sodium Isopropyl Xanthate (SIPX) produces adverse effects on the central nervous system, liver and kidneys.

Any other information on results incl. tables

Table 3:	Oral toxicity of xanthates (from: Kirk-Othmer, 1984)16
Xanthate	Species		LD0	(mg/kg)	LD50	(mg/kg)	References
Sodium ethyl		rat	500		—		17
Potassium ethyl		Rat  mouse	500		1700 583		17, 18
Sodium isopropyl		rat	250		1250		17
Potassium isopropyl		rat mouse	— —		1700  583		18 —
Potassium n-butyl		mouse	—		411  465		19,20
Sodium isobutyl		rat			500		17
Potassium isobutyl		rat mouse	— —		1290  480		18 18
Sodium sec-butyl		rat	—		>2000		17
Potassium amyl (mixed)		rat	1000		1000–2000		17, 21
Potassium iso amyl		rat mouse	— —		765 470		18 18
C5-C6 mixture		rat	—		1500		22

 

 

The LD50 value of 1250 mg/kg in rats were determined for Sodium Isopropyl Xanthate (SIPX). This show that Sodium Isopropyl Xanthate (SIPX) is of slightly order of acute oral toxicity .

 

The LD50 of the various xanthates are similar, ranging from 411 to 583 mg/kg in mice and from 1000 to >2000 mg/kg in rats.

The acute oral toxic effects of one xanthate, potassium butyl xanthate, are providedin two summaries in Chemical Abstracts.

 Similar symptoms and pathology findings were seen in these studies carried out by Babayan.

 

References :

16.Kirk-Othmer Encyclopaedia of Chemical Technology,Vol 24, 2nd ed, pp 645-661,John Wiley & Sons, 1984.

17.Dow Chemical Company, 1964, unpublished toxicological data to C.B. Shaffer,American Cyanamid; data from P. Avotin, American Cyanamid, privatecommunication, 1982 as cited in Kirk-Othmer Encyclopaedia of Chemical

18.Babayan, E.A., 1963, “Toxicology of Potassium Butyl Xanthate” Material 2-oi[Vtoroi] Itog. Nauchn. Konf. Inst. Gigieny Truda I Prof. Zabolevan Posvyashch.Vopr. Gigieny Truda I Prof. Patol. Erevan, pp 75-77 (Pub 1964)(Russ)Chem Abstract,64, 8836e (1966).

19.Babayan, E.A., “Toxicological Characteristics of the Flotation Agent PotassiumButyl Xanthate”, Mater. Itogovoi Nauch. Konf. Vop. Gig Tr Profpatol. Khim.Gornorud. Prom., 3rd 1966 (Pub 1968) 97-102 (Russ) inChemical Abstracts,Vol 73,1970.

20.Fronk, N.G., The Dow Chemical Company, private communication, 1982, as cited inKirk-Othmer Encyclopaedia of Chemical Technology,Vol 24, 2nd Ed, pp 645-661,John Wiley & Sons, 1984.

21.Buzina, A.Z., Burkhanov, A.I. and Abeuev, Kh.B., 1977 Zdravookhr. Kaz., 88 ascited inKirk-Othmer Encyclopaedia of Chemical Technology,Vol 24, 2nd Ed, pp645-661, John Wiley & Sons, 1984.

22.Chemical Abstracts,Vol 64, 1966.

 

Applicant's summary and conclusion

Interpretation of results:

other: sligthly toxic

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The LD50 value of 1250 mg/kg was determined in a reliable study. This show that Sodium Isopropyl Xanthate (SIPX) is of a Slightly order of acute oral toxicity .
Based on the data provided in this review, Sodium Isopropyl Xanthate (SIPX) shall be classified for acute oral toxicity.