Sodium hydroxymethanesulphinate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 2008 - March 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study; the study was conducted on the basis of the official method as defined in the O.E.C.D. guideline N° 423 dated December 17'h, 200 land the test method B.I tris of the Directive N° 2004173/EC.

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium hydroxymethanesulphinate

EC Number:

205-739-4

EC Name:

Sodium hydroxymethanesulphinate

Cas Number:

149-44-0

Molecular formula:

CH4O3S.Na

IUPAC Name:

sodium hydroxymethanesulphinate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Elevage JANVIER (53940 Le Genest St lsle - France)
- Age at study initiation: 8 weeks
- Weight at study initiation: 189-208 g
- Fasting period before study: food was removed at day 1 and then redistributed 4 hours after the test item administration.
- Housing: Three healthy female rats were kept in solid-bottomed cJear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week.
- Diet (e.g. ad libitum): M20-rat/mouse maintenance (Speciel Diets Service)
- Water (e.g. ad libitum): tap-water from public distribution system
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 20°C and 22°C
- Humidity (%): between 36% and 57%
- Air changes (per hr): conventional air conditioning
- Photoperiod (hrs dark / hrs light): lighting time: 12 hours daily

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000 mg/kg bw.
- Amount of vehicle (if gavage): 10 mL/kg bw.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 female rats were treated

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
1. Daily examination: systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions 14 days after administration of the test item. This examination focuses particularly on a list of symptoms, recorded as "present" or "absent" on the observation sheet. Observations and a mortality report were then carried out every day for 14 days.
2. Periodical examinations: the animals were weighed on day 0 (D0)(just before administering the test item) then on D2, D7, and D14. Weight changes were calculated and recorded.
3. Examination at the end of the test: on D14, the animals were anaesthetised with sodiun pentobarbital and administration continued to
fatal levels. Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of aeute toxicity were examined. Those presenting macroscopic anomalies can be removed and preserved in view to microscopic exanimations.

- Necropsy of survivors performed: yes

Statistics:

no data given in the test report

Results and discussion

Preliminary study:

no preliminary study was conducted

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study.

Clinical signs:

other: No clinical signs related to the administration of the test item were observed.

Gross pathology:

The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test item is > 5,000 mg/kg body weight by oral route in the rat

Executive summary:

The test item was administered by oral route to a group of 6 female Sprague Dawley rats at the single dose of 2,000 mg/kg body weight.

No mortality occurred during the study.

No clinical signs related to the administration of the test item were observed.

The body weight evolution of the animals remained normal throughout the study.

The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

In conclusion, the LD₅₀of the test item is > 5,000 mg/kg body weight by oral route in the rat.