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Diss Factsheets

Administrative data

Description of key information

No test has been performed on the reaction mass itself. However acute toxicity data are available on the three components of this reaction mass for oral route (Sodium Chloride, Sodium Carbonate and Sodium Sulphate). The acute toxicity of the three components is low for this route of exposure (LD50 rats higher than 2000 mg/kg/day). Therefore the acute toxicity of the reaction mass is considered also to be low. The lowest LD50 is for Sodium Carbonate (2800 mg/kg). Therefore in a worst case approach the LD50 of Sodium Carbonate has been chosen as the LD50 for the reaction mass.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
not specified in the report
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The report contains sufficient information to permit a meaningful evaluation of study results
Qualifier:
no guideline followed
Principles of method if other than guideline:
The study methodology followed appeared to be similar to the standard acute method.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
male
Details on test animals or test system and environmental conditions:
not specified in the report
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25% concentration (water solution)
Doses:
2150, 3160, 4640 and 6810 mg/kg
No. of animals per sex per dose:
5 male rats/dose
Control animals:
not specified
Details on study design:
not specified in the report
Statistics:
not specified in the report
Preliminary study:
not applicable
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
3 550 mg/kg bw
Based on:
test mat.
Mortality:
Cummulative mortality -
2150 mg/kg - 0/5
3160 mg/kg - 1/5
4640 mg/kg - 5/5
6810 mg/kg - 5/5
Clinical signs:
other: Hypoactivity, muscular weakness, sedation and ruffled fur
Gross pathology:
No significant findings noted in those animals sacrified at termination and inflammation of gastrointestinal tract was noted in those decedents during the course of the study.
Other findings:
not specified in the report

not applicable.

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute oral LD50 of sodium chloride (administered as 25% water solution) was 3550 mg/kg to male rats and based on the results; sodium chloride is not classified for oral acute toxicity according to EU GHS criteria (CLP Regulation). According to UN GHS criteria, sodium chloride should be classified Acute. Tox. Cat. 5, H303: May be harmful if swallowed.
Executive summary:

In this study, the acute oral LD50 of sodium chloride was evaluated in male Wistar rats at doses of 2150, 3160, 4640 and 6810 mg/kg, adminsitered as a 25% water solution. 100% mortality was observed at the 4640 and 6810 mg/kg dose groups. The LD50 was 3550 mg/kg with fiducial limits of 3040 -4140 mg/kg. Based on these results sodium chloride is not classified for oral acute toxicity according to EU GHS (CLP Regulation).

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1960
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was conducted prior to GLP and test guidelines.
Qualifier:
no guideline available
Principles of method if other than guideline:
Rats (2 per dose) were exposed (single exposure) to 3980 mg/kg of sodium chloride (administrated as 20% water solution). Mortality and gross pathology were observed.
GLP compliance:
no
Test type:
other: The test was conducted prior to GLP and test guidelines.
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data
Route of administration:
oral: feed
Vehicle:
water
Details on oral exposure:
Rats were fed 20% solution of Cubidow (sodium chloride) in water at the dose of 3.98 g/kg.
Doses:
3.98 g/kg (20% solution in water)
No. of animals per sex per dose:
2
Control animals:
not specified
Details on study design:
no data
Statistics:
no data
Preliminary study:
No data
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 3 980 mg/kg bw
Based on:
test mat.
Remarks on result:
other: The LD50 value was for 20% solution of cubidow in water
Mortality:
No mortality
Clinical signs:
other: No data
Gross pathology:
Extensive liver and kidney damage were observed at autopsy. No serious untoward reactions were observed.

None

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Cubidow has low acute oral toxicity. LD50 for 20% solution of cubidow in water is greater than 3980 mg/kgbw.
Executive summary:

Cubidow has low acute oral toxicity. LD50 for 20% solution of cubidow in water is greater than 3980 mg/kgbw.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-comparable guideline study, no restrictions, fully adequate for assessment. In the OECD SIDS on sodium carbonate (2002) a similar reliability was assigned.
Principles of method if other than guideline:
Groups of 5 male and 5 female rats were dosed with a 20% solution of sodium carbonate in water by intubation, in concentrations of 1300, 1800, 2600, 3600, and 5000 mg/kg bw, and LD50 was calculated.
GLP compliance:
no
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.
Route of administration:
oral: gavage
Vehicle:
water
Doses:
1.3, 1.8, 2.6, 3.6, 5.0 g/kg
No. of animals per sex per dose:
5/sex/dose
Details on study design:
CONTROLS: Not reported.
ADMINISTRATION: Oral, by intubation.
- Doses: 1.3, 1.8, 2.6, 3.6 and 5.0 g/kg.
- 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.
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:
STATISTICAL METHODS: Not reported.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 800 mg/kg bw
Mortality:
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:
other: 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
Gross pathology:
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.
Other findings:
POTENTIAL TARGET ORGANS: Not reported. SEX-SPECIFIC DIFFERENCES: Not reported.
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Based on this study a LD50 of 2800 mg/kg has been identified for Sodium Carbonate. According to EU GSH criteria this substance is not classified. According to UN GHS criteria this substance is classified Acute. Tox. Cat. 5, H303.
Executive summary:

In a acute oral toxicity study, Groups of 5 male and 5 female Wistar rats were dosed with a 20% solution of sodium carbonate in water by intubation, in concentrations of 1300, 1800, 2600, 3600, and 5000 mg/kg bw, and LD50 was calculated. The LD50 for male and female rats has been identified to be 2800 mg/kg.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
18-Feb-2010 to 11-Mar-2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
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].
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- 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)

ENVIRONMENTAL CONDITIONS
- 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
Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
(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.

TEST MATERIAL
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.
Doses:
2000 mg/kg at a dose volume of 10 mL/kg
No. of animals per sex per dose:
3 females
Control animals:
no
Details on study design:
Three 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
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
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.
Interpretation of results:
GHS criteria not met
Conclusions:
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 in PEG300 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.

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
See Read-across justification attached.
Data on the reaction mass itself are not available. Therefore data on the three components (Sodium Chloride, Sodium Carbonate and Sodium Sulphate) are used. Based on the available studies the LD50 for the three components are higher than 2000 mg/kg/day. The lowest LD50 is for Sodium Carbonate. Therefore in a worst case approach the LD50 of Sodium Carbonate has been chosen as the LD50 for the reaction mass.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 800 mg/kg bw
Based on:
test mat. (total fraction)
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Not classified according to the CLP criteria. Classified Acute Tox Cat. 5, H303 according to the GHS UN criteria.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 800 mg/kg bw
Quality of whole database:
The substance is a solution of inorganic salts in water. The constituents are inorganic substances which are naturally occuring and their toxicity is expected to be low.
Reliable studies and peer reviewed studies (i.e. secondary literature) are available for each component of the reaction mass.
Two reports with reliability 2 are available on sodium chloride. In the first report the LD50 in male rats (25% water solution) was 2550 mg/kg.bw. In the second study the LD50 was greater than 3980 mg/kg.bw (20% water solution). One study with reliability 1 is available for sodium carbonate sodium carbonate, LD50 of sodium carbonate was 2800 mg/kg bw.
One reliable study (Klimish 1) on sodium sulphate shown also a low acute oral toxicity, the LD50 is higher than > 2000 mg/kg bw. And according to the OECD SIDS Dossier, two other reliable studies shown that the LD50 is higher than 5000 mg/kg bw.

Additional information

Justification for classification or non-classification

No classification is required according to the CLP criteria based on the data on the components (The LD50 of the three components are higher than 2000 mg/kg/day). Based on the LD50 of sodium carbonate (component with the lower LD50), the reaction mass is classified Acute Tox. Cat. 5, H303 according to the UN GHS criteria.