Sodium benzenesulphinate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from secondary literature

Data source

Reference

Reference Type:

secondary source

Title:

Initial Submission: Oral LD50 Test of Methanol, Sodium Salt in Rats with Cover Letter Dated 08/10/92

Author:

E I Dupont DE Nemours & CO

Year:

1992

Bibliographic source:

OTS0555267, Haskell Laboratory, 1992

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:

Acute oral toxicity study of Methanol, sodium salt in rats

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Methanol, sodium salt

Cas Number:

124-41-4

Molecular formula:

CH4O.Na

IUPAC Name:

Methanol, sodium salt

Details on test material:

- Name of test material (as cited in study report): Methanol, sodium salt
- Molecular formula (if other than submission substance): CH4O.Na
- Molecular weight (if other than submission substance): 54.0237 g/mole
- Substance type: Organic

Specific details on test material used for the study:

- Name of test material (as cited in study report): Methanol, sodium salt
- Molecular formula (if other than submission substance): CH4O.Na
- Molecular weight (if other than submission substance): 54.0237 g/mole
- Substance type: Organic

Test animals

Species:

rat

Strain:

other: Crl: CD

Sex:

male

Details on test animals or test system and environmental conditions:

No data available

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 1500, 1800, 2250, 2380, 2600 and 3400 mg/kg bw
- Amount of vehicle (if gavage): 2-3 ml
- Justification for choice of vehicle: corn oil

DOSAGE PREPARATION (if unusual): Methanol, sodium salt administrated as a suspension in corn oil

Doses:

1500, 1800, 2250, 2380, 2600 and 3400 mg/kg bw

No. of animals per sex per dose:

Total : 60
1500 mg/kg bw: 10 male rat
1800 mg/kg bw: 10 male rat
2250 mg/kg bw: 10 male rat
2380 mg/kg bw: 10 male rat
2600 mg/kg bw: 10 male rat
3400 mg/kg bw: 10 male rat

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Yes
- Necropsy of survivors performed: yes
- Other examinations performed: Mortality, clinical signs and body weight were examined.

Statistics:

LD50 value was calculated from the mortality data using the method of D. J. Finney.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

2 037 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 50 % mortality observed

Mortality:

When treated with 2,600 and 3,400 mg/kg bw, all animals died.

When treated with 2380 mg/kg bw, 8 animals died.

When treated with 2,250 mg/kg bw, 2 animals died.

When treated with 1,800 mg/kg bw, 5 animals died.

When treated with 1,500 mg/kg bw, 1 animals died.

Deaths occurred up to 14 day after dosing.

Clinical signs:

other: Laborad breathing, weakness and wet and stained perineal area were observed in all treated rats. When treated with 1,800 to 3,400 mg/kg bw, Salivation and lethargy were observed in treated rats. When treated with 2380 to 2600 mg/kg bw, ataxia were obs

Gross pathology:

No data available

Other findings:

No data available

Any other information on results incl. tables

Dose (mg/kg)	Average Body Weight (g)	Suspension (%)	Average dose (mL)	Mortality ratio	LD50
3,400	238	30	2.70	10/10	2037 mg/kg
2,600	244	30	2.11	10/10
2.380	2'2	30	2.00	8/10
2,250	241	20	2.72	2/10
1.800	248	20	2.23	5/10
1.500	243	20	1.83	1/10

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

LD50 was considered to be 2037 mg/kg bw when Crl: CD male rats were treated with Methanol, sodium salt orally by gavage.

Executive summary:

In a acute oral toxicity study,Crl: CDmale rats were treated withMethanol, sodium salt in the concentration of1500, 1800, 2250, 2380, 2600 and 3400 mg/kg bw in corn oilorally by gavage. All animals died at 2,600 and 3,400 mg/kg bw, 8 animals died at 2380 mg/kg bw, 2 animals died at 2,250 mg/kg bw, 5 animals died at 1,800 mg/kg bw and 1 animals died at 1,500 mg/kg bw. Deaths occurred up to 14 day after dosing. Laborad breathing, weakness and wet and stained perineal area were observed in all treated rats. Salivation and lethargywere observed in treated rats at 1,800 to 3,400 mg/kg bw, ataxiaat 2380 to 2600 mg/kg bw,Stained face at 1800, 2380, 2600 and 3400 mg/kg bw, Lacrimation at 2600 and 3400 mg/kg bw, pallor at 2600 mg/kg bw,Chromodacryorrhea and ruffled fur at 1500 to 2600 mg/kg, Diarrhea and congestion at 1500 to 2380 mg/kg, Priapism at 1800 to 2600 mg/kg and gasping was observed in treated rat at 1500, 1600 to 3400 mg/kg. Weight loss for 9-14 days after dosing was observed in treated rats. Therefore,LD50 was considered to be 2037 mg/kg bw whenCrl: CDmale rats were treated withMethanol, sodium salt orally by gavage.