Reaction mass of sodium hydrogensulfide and sodium carbonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD SIDS evaluation: Comparable to guideline study

Data source

Reference

Reference Type:

publication

Title:

Acute Oral Toxicity Study in Rats

Author:

Rinehart, WE

Year:

1978

Bibliographic source:

Toxicological Resources Unit, Bio/dynamics Inc., May 15, 1978.

Materials and methods

Principles of method if other than guideline:

Method: other

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

sodium carbonate monohydrate

IUPAC Name:

sodium carbonate monohydrate

Details on test material:

TS-Freetext:
SOURCE: Not reported.
PURITY: Not reported.
IMPURITY/ADDITIVE/ETC.: Not reported.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ORGANISMS: Wistar albino rats.
- Source: Marland Breeding Farms, Inc., Hewitt, NJ.
- Age: Not reported.
- Weight at study initiation: 187-296 g.
- Controls: Not reported.

Administration / exposure

Route of administration:

oral: drinking water

Vehicle:

water

Details on oral exposure:

ADMINISTRATION: Oral, by intubation.
- Doses per time period: One dosing only.
- Volume administered or concentration: The test material was administered by oral intubation as a 20% w/v solution in tap water. 
- Post dose observation period: 14 days.

Doses:

1.3, 1.8, 2.6, 3.6, 5.0 g/kg

No. of animals per sex per dose:

50

Details on study design:

EXAMINATIONS: Following dosing the rats were observed for mortality and overt signs of effects at 0-2 and 4-6 hrs following dosing and daily thereafter for 14 days.  Body weight was recorded initially and terminally.

Statistics:

Not reported

Results and discussion

Preliminary study:

Not reported

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 800 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

RS-Freetext:
MORTALITY: 
- Time of death: The time of death is listed by dose. 1.8
g/kg: day 8.  2.6 g/kg: day 1-2.  3.6 g/kg: day 1.  5.0g/kg:
day 1.
- Number of deaths at each dose: 1.3 g/kg: 0/10. 1.8 g/kg:
1/10. 2.6 g/kg: 4/10. 3.6 g/kg: 7/10. 5.0 g/kg: 10/10. 
CLINICAL SIGNS: All animals that died during the observation
period had reduced body weight or no body weight gain. The
animals that survived until the study termination, gained
weight compared to the initial weight at study start. Signs
of effects observed included: ataxia, muscle tremors, red
nasal discharge, urinary staining of the abdomen, soft
stool, piloerection, prostration, lethargy, faecal staining
of the abdomen and dyspnoea.  All animals surviving the
study were clear of signs of effect by day 5.
NECROPSY FINDINGS: The necropsy findings are listed by dose.
 1.3 g/kg: 4/10 rats had a mottled liver only. 1.8 g/kg:
5/10 rats hands a mottled liver, one of these had air filled
intestines.  2.6 g/kg: 2/10 had a mottled liver.  4/10 had a
mottled liver, mottled or pale kidneys, nasal or oral
discharge, red intestines, stomach with a red pyloric region
or containing red fluid.  3.6 g/kg: 2/10 had a mottled liver
only.  The remaining animals, with one exception, had most
of the following lesions: mottled or pale kidneys, nasal or
oral discharge, red intestines, stomach with a red pyloric
region or containing red fluid, mottled or dark red lungs,
mottled liver. 5.0 g/kg: The animals in this dosing group
all had most of the following lesions: mottled or pale
kidneys, nasal or oral discharge, intestines filled with
fluid, stomach with a red pyloric region or containing red
fluid, mottled or dark red lungs, mottled liver, air in the
intestines. 
POTENTIAL TARGET ORGANS: Not reported.
SEX-SPECIFIC DIFFERENCES: Not reported.

Applicant's summary and conclusion

Conclusions:

The LD50 of sodium carbonate monohydrate was found to be 2800 mg/kg bw. for rats in an oral intubation study.