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Toxicological information

Acute Toxicity: oral

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Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18-Feb-2010 to 11-Mar-2010
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
This study has been performed in compliance with the Swiss Ordinance relating to Good Laboratory Practice, adopted May 18th, 2005 [SR 813.112.1]. This Ordinance is based on the OECD Principles of Good Laboratory Practice, as revised in 1997 and adopted November 26th, 1997 by decision of the OECD Council [C(97)186/Final].
Justification for data waiving:

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guidelineopen allclose all
according to guideline
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
according to guideline
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
Test type:
acute toxic class method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium sulphate
EC Number:
EC Name:
Sodium sulphate
Cas Number:
Molecular formula:
disodium sulfate

Test animals

Details on test animals or test system and environmental conditions:
- Source: Harlan Laboratories B.V., Kreuzelweg 53, 5961 NM Horst / The Netherlands
- Age when treated: 10 weeks
- Body Weight when treated: 170.3 g – 187.4 g
Housing: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding (‘Lignocel’ J. Rettenmaier&Söhne GmbH&CoKG, 73494 Rosenberg / Germany, imported by Provimi Kliba AG, 4303 Kaiseraugst / Switzerland).
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 60/09 (Provimi Kliba AG, 4303 Kaiseraugst / Switzerland) ad libitum (except for the overnight fasting period prior to intubation and approximately 3-4 hours post dose).
Water: Community tap water from Füllinsdorf ad libitum.
-Acclimatization period: 18-Feb-2010 to 22-Feb-2010 (the first three females), 18-Feb-2010 to 24-Feb-2010 (the remaining three females)

- Temperature: 22 ± 3 °C
- Humidity: between 30 - 70%
- Air changes: 10 - 15 air changes per hour
- Photperiod: 12 hours light and 12 hours dark

IN-LIFE DATES: 23-Feb-2010 to 11-Mar-2010

Administration / exposure

Route of administration:
oral: gavage
polyethylene glycol
(PEG 300)
Details on oral exposure:
The animals received a single dose of the test item by oral gavage administration at 2000 mg/kg body weight after being fasted for approximately 17 to 20 hours (access to water was permitted). Food was provided again approximately 3 hours after dosing.

Dose levels were in terms of the test item as supplied by the Sponsor.
The dose formulations were prepared shortly before each dosing occasion using a magnetic stirrer, a spatula and an Ultra-Turrax as homogenizers.

The dosing volume was 10 mL/kg body weight.
2000 mg/kg at a dose volume of 10 mL/kg
No. of animals per sex per dose:
3 females
Control animals:
Details on study design:
Threee females were first treated.Since no relevant clinical signs were observed and no death occurred 48 hours after test item administration, the test was completed using the three remaining females.
- Duration of observation period following adminsitration: 15 days
- Frequency of observation period following administration: within the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15.
- Necropsy of survivors performed: yes
- Other examinations performed: viability/ Mortality, clinical signs, body weights

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
All animals survived until the end of the study period with the exception of one animal, which spontaneously died shortly after administration due to application in wrong way.
Clinical signs:
other: Slight sedation was observed in two animals from 1 to 2 hours after administration and persisted as moderate in one animal up to the 5-hour reading. Hunched posture was also noted in the two animals at the 2-hour reading and persisted in one animal up to
Gross pathology:
Dark red lungs congested, in which contained dark red hemorrhagic-watery fluid, were noted at necropsy in the animal which died spontaneously due to a technical failure.

The remaining animals were devoid of any macroscopic findings at the scheduled necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: EU
The median lethal dose of Sodium Sulphate after single oral administration to female rats, observed over a period of 14 days, is:
LD50 (female rat): greater than 2000 mg/kg body weight
Executive summary:

Two groups, each consisting of three female RccHan:WIST (SPF) rats, were treated with Sodium Sulphate by single oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was formulated inPEG300 at a concentration of 0.2 g/mL and administered at a dosing volume of 10 mL/kg.


The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs within the first 30 minutes and approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded within the first 30 minutes and approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15.All animals were necropsied and examined macroscopically.


All animals survived until the end of the study period with the exception of one animal, which spontaneously died shortly after administration due to a technical failure.


Clinical signs, including sedation, hunched posture and ruffled fur, were noted in two animals on test day 1 and were distributed from the 1- to the 5-hour post-dose. Both animals were devoid of any clinical signs from test day 2 to the end of the study. No clinical signs were observed in the surviving females throughout the observation period.


The body weight of the animals was within the range commonly recorded for this strain and age.


Dark red congested lungs, with dark red hemorrhagic-watery fluid, were noted at necropsy of the animal which died spontaneously immediately after gavage. These findings clearly suggested technical failure during the gavage procedure.