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Toxicological information

Acute Toxicity: oral

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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:
comparable to guideline study with acceptable restrictions

Data source

Referenceopen allclose all

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Unpublished toxicological data to C.B. Shaffer, American Cyanamid;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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Method: other
GLP compliance:
no
Test type:
other: LD50
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
disodium 2-methylpropan-1-ol [(2-methylpropoxy)methanethioyl]sulfanide hydroxide
EC Number:
904-290-8
Molecular formula:
C5H10OS2.Na
IUPAC Name:
disodium 2-methylpropan-1-ol [(2-methylpropoxy)methanethioyl]sulfanide hydroxide
Test material form:
solid: compact
Details on test material:
- Name of test material (as cited in study report):Sodium isobutyl xanthate

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 200-265g

- Fasting period before study: Over night

- Housing: Group housing (5 of each sex per cage), in metal cages provided with white pine and cheddar shavings.

- Diet: Purina Laboratory Chow, ad libitum.

- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Exploratory doses were administered to 8 rats to estimate the order of toxicity of the test compound. Based on the preliminary estimation, groups of 10 rats (5M, 5F) were administered the test compound at graded dosage levels designed to blanket the toxicity range.
Doses:
500,2000 mg
No. of animals per sex per dose:
5 female, 5 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 levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: The findings of this study indicate that Sodium Isobutyl Xanthate produces adverse effects on the central nervous system, liver and kidneys.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: The findings of this study indicate that Sodium Isobutyl Xanthate produces adverse effects on the central nervous system, liver and kidneys.
Mortality:
All death occurring 1 to 2 hours after administration.
Clinical signs:
Oral administration of Sodium Isobutyl Xanthate to rats produced increased motor activity, cyanosis, irritability, increased respiration and convulsions with death occurring 1 to 2 hours after administration.
Body weight:
Weight gain amongst survivors was within normal limits.
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 this study indicate that Sodium Isobutyl Xanthate 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

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 500 mg/kg was determined for Sodium Isobutyl Xanthate. This show that Sodium Isobutyl Xanthate is of a moderately order of acute oral toxicity .

 

The LD50 of the various xanthates are similar, ranging from 411 to 583mg/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 pathologyfindings 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:
moderately toxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 value of 500 mg/kg was determined in a reliable study. This show that Reaction mass of SIBX is of a moderately order of acute oral toxicity .
Based on the data provided in this review, SReaction mass of SIBX e shall be classified for acute oral toxicity.