Reaction mass of disodium sulphide and sodium carbonate and sodium hydroxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 08-08-2013 to 10-09-2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

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:

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:

no data

EC Number:

908-531-8

Molecular formula:

No data

IUPAC Name:

no data

Test material form:

other: liquid

Details on test material:

The test item was administered undiluted.

Test animals

Species:

rat

Strain:

other: Wistar Hannover

Sex:

female

Details on test animals or test system and environmental conditions:

The rats were housed in groups of three rats per cage, during acclimatization and observation periods, in polypropylene rodents cages (41x34x19 cm) with wire mesh tops and bedding materiak (autocalved wood shavings). The bedding was regularly assayed for contaminants at the analytical laboratories of BIOAGRI Alimentos-SP/Brazil, and was considered to be suitable on the basis of analytical analyses. Results of the analyses are maintained by BIOAGRI and are available for inspection. Clean cages were provided three times per week.
In the experimental room the temperature was within 19.0 °C and 23.0 °C with a relative humidity of 34% - 57.3%, room ventilation set a 10 to 20 air changes per hour and a photoperiod of 12 hours light and 12 hours dark. Environmental control equipments were monitored and adjusted as necessary to minimize fluctuations in the animal room environment.
The food used was autoclaved pelleted diet type for rodents supplied by Supralab which was available ad libitum throughout the study, exept in the fasting period. Filtered drinking water was supplied by CAESB was supplied in water bottles for animals ad libitum. The food and water were regularly assayed for chemical and microbiological contaminants at the analytical laboratories. The food was assayed at BIOAGRI Alimetnos-SP/ Brazil for nutritional composition. Both, food ans water, were found to be suitable on the basis of the analytical analyses and the results are available for inspection.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The animals were fasted overnight before dosing, but had free access to water. On the day of dosing (Day 0), the animals were weighed and individual volume of the test item to be administered was calculated according to individual body weight. The test item was administered orally, by gavage. The maximum volume of test item administered to each animal did not exceed 1mL/100g of body weight.
Food was given back 3 hours after administration of the test item.

Doses:

300 and 2000 mg/kg body weight

No. of animals per sex per dose:

3 females

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed

Clinical signs:

other: Three females treated with dose of 300 mg/kg body weight, showed piloerection from day of the adiministration of the test item until day 1 of the observation period. Three females treated with dose of 300 mg/kg body weight showed slight apathy from day of

Gross pathology:

There were no substance-related macroscopic alterations at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this tudy, the substance is unclassified according to GHS and the estimate acute oral LD50 cut-off value for female rats is 5000 mg/kg body weight.