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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 two components of this reaction mass for oral and dermal routes. The acute toxicity of the two components is low for these two routes of exposure. Therefore the acute toxicity of the reaction mass is considered also to be low.

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:
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: unspecified
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.
Other findings:
No ne

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
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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-compliant guideline study, minor restrictions in reporting (lacking information on test substance purity), but otherwise acceptable for assessment.
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, England
- Weight at study initiation: males 107-127 g, females 106-121 g
- Fasting period before study: overnight
- Housing: in groups of 5, by sex, in grid bottomed popypropylene cages
- Diet: pelleted diet (SQC Rat and Mouse Maintenance Diet No. 1, Expanded, Special Diets Services Limited, Witham, England), as libitum
- Water (e.g. ad libitum): Mains tap water, in polypropylene bottles, ad libitum
- Acclimation period: 12 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24
- Humidity (%): 34-68, except one occasion when it rose to 75%
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 10 ml/kg bw

DOSAGE PREPARATION (if unusual): the test article was formulated freshly on the day of use in distilled water. For each dose level separately, a weighed amount of test article was made up to the required final volume. Preparations were mixed thoroughly by use of a pestle and mortar before use and shaking during use
Doses:
In the range-finding study: 2000, 2800, 3920, 5490 and 7680 mg/kg bw
In the main study: 2000, 2800 and 3920 mg/kg bw
No. of animals per sex per dose:
In the range-finding study: 2/sex/dose
In the main study: 5/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed continuously for the first 30 min after dosing and then 1, 2 and 4 hours after dose administration on day 1. Subsequently, animals were observed at least once daily for all visible signs of reaction to treatment and twice daily for mortality and morbidity. Animals were weighed on days 1, 8 and 15 of the sutdy. In addition, decedent animals were weighed at necropsy.
- Necropsy of survivors performed: yes
Statistics:
The acute oral median lethal dose and 95% fiducial limits were calculated using a probit method (Finney, D. J. (1964), Statistical Methods for Biological Assay, 2nd Edition, London, Charles Griffin). Values were calculated for each sex separately and also for combined male and female animals.
Preliminary study:
All animals dosed 2000 mg/kg bw survived. One out of 2 animals of each sex dosed at 2800 mg/kg bw died. Dose levels of 3920 and 7860 mg/kg bw caused death.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
2 120 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
2 361 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 518 - <= 3 191
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 301 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 455 - <= 2 781
Mortality:
2000 mg/kg bw: 2 males and one female were found dead on day 2 of the study.
2800 mg/kg bw: one male died on the day of dosing. Two males and 4 females were found dead on day 2 of the study, during which a further male died.
3920 mg/kg bw: one male died within one hour of dosing, a futher male died within 4 hours. Two males and 3 females were found dead on day 1 of the study after the 4 hour observation time. The remaining two females were found dead on day 2.
Clinical signs:
other: 2000 mg/lg bw: all animals showed lethargy, incoordination and piloerection on day 1 between 1 and 4 hours after dosing. In addition, hunced posture was seen in 4 females and excessive salivation in one male. Clinical signs observed on day 2 were piloerec
Gross pathology:
Pale and inflated lungs, reddened and thickened stomach mucosa with rugae absent, reddened mucosa with jejenum and fluid distension of the gastro-intestinal tract were observed at necropsy in decedents. The incidence of these increased with increasing dose level. In addition, red fluid contents were seen in one animal dosed 3920 mg/kg bw. An accetuated lobular pattern was seen in the livers of one animal dosed 2800 mg/kg bw and 3 dosed 3920 mg/kg bw.
In 4 animals examined at terminal necropsy the liver was pale, the stomach showed adhesions to the liver and had a thickened mucosa. In 2 animals the stomach contents were gelatinous.
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Based on the LD50 identified in this study: LD50 (male rats) = 2120 mg/kg.bw; LD50 (females rats)= 2361 mg/kg.bw ; LD50 (combined) = 2301 mg/kg.bw, calcium chloride has a low acute toxicity and it is not classified for this endpoint according to EU GHS criteria (CLP Regulation). According to UN GHS criteria calcium chloride should be classified Acute Tox. Cat. 5, H303: May be harmful if swallowed.
Executive summary:

In this study performed according to the OECD guideline 401, Crj:CD(SD) male and female rats have been exposed by gavage at different doses of calcium chloride (2000, 2800 and 2920 mg/kg. bw). The LD50 are the following: LD50 (males) = 2120 mg/kg.bw ; LD50 (females) = 2361 mg/kg.bw and LD50 (combined) = 2301 mg/kg.bw. Based on these results the acute toxicity of calcium chloride is low and no classification is required according to EU GHS criteria.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 120 mg/kg bw
Quality of whole database:
Two reports with reliability 2 are available on sodium chloride, one component of the reaction mass. 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). For calcium chloride, the second component of the reaction mass a report is also available with reliability 2. The lower LD50 was identified for male rats and was 2120 mg/kg.bw. The acute toxicity by oral route of the two components of the reaction mass is similar (LD50 = 2550 mg/kg.bw for sodium chloride compared to LD50 = 2120 mg/kg. bw. for calcium chloride) and considered to be low. Therefore the oral acute toxicity of the reaction mass itself is also considered to be low.
In a worst case approach and considering that the composition of the reaction mass is 68% of calcium chloride and 30% of sodium chloride, the LD50 of calcium chloride (2120 mg/kg.bw) (lower value) is retained for the reaction mass.

Acute toxicity: via inhalation route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
other:
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
other:
Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
Since data are available for the two other routes of exposure (oral and dermal routes) a waiving was done for inhalation.

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study report that meets generally accepted scientific principles.
Principles of method if other than guideline:
Method: other
GLP compliance:
no
Limit test:
no
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Type of coverage:
occlusive
Vehicle:
water
Duration of exposure:
24 hours
Doses:
5000 mg/kg
No. of animals per sex per dose:
2
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
other: no adverse effects 
The dermal LD50 was >5000 mg/kg.  All four rabbits topically 
treated with  the test material survived.  No adverse effects 
were observed following  treatment.  Topical responses observed 
on the application sites of test  rabbits 24 hours post-treatment 
included slight (1/4) or moderate (3/4)  redness, moderate (3/4) 
or marked (1/4) swelling and moderate (2/4) or marked (2/4) necrosis. 
Gross necropsy examination of rabbits 2 weeks post-treatment revealed 
skin lesions at or near the site of administration, characterized 
by scab formation, skin thickening and subchronic inflammation. 
Internal observations were not considered to be the result of compound 
exposure  and/or absorption.
Interpretation of results:
GHS criteria not met
Conclusions:
Based on this study the LD50 for dermal route in rabbits is higher than 5000 mg/kg.bw. Therefore according to EU and UN GHS criteria no classification is required for dermal acute toxicity.
Executive summary:

In this study males and females New Zealand rabbits were exposed dermally during 24 hours to 5000 mg/kg.bw of undiluted calcium chloride. No mortality occurred. Calcium chloride has a very low dermal acute toxicity and no classification is required according to EU and UN GHS criteria.

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
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 available
Principles of method if other than guideline:
The study methology followed appeared to be equivalent or similar to the standard acute method
GLP compliance:
not specified
Test type:
standard acute method
Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals or test system and environmental conditions:
not specified in the report
Type of coverage:
not specified
Vehicle:
water
Details on dermal exposure:
Sodium chloride was moistened with sufficient water to make a paste
Duration of exposure:
not specified in the report
Doses:
10000 mg/kg
No. of animals per sex per dose:
5 rabbits
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:
not specified
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality was observed
Clinical signs:
other: no signs of toxicity observed
Gross pathology:
no significant findings were noted at necropsy
Other findings:
slight erythema was observed

not applicable

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of the study, sodium chloride is not classified according to EU and UN criteria since the LD50 in rabbits is higher than 10000 mg/kg.bw.
Executive summary:

A dermal toxicity study was conducted in rabbits and the LD50 value was greater than 10000 mg/kg and hence not classified according to EU and UN GHS criteria.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
One report, 1981 with reliability 2 is available on calcium chloride, one component of the reaction mass. A dermal LD50 higher than 5000 mg/kg.bw was identified for male and female rabbits. The dermal LD50 calculated for sodium chloride, the second component of the reaction mass, based on a report with reliability 2 is higher than 10000 mg/kg.bw. Based on available data the two components of the reaction mass have similar acute dermal toxicity (low acute toxicity). Therefore the acute dermal toxicity of the reaction mass is considered also to be low.
In a worst case approach and considering that the composition of the reaction mass is 68% of calcium chloride and 30% of sodium chloride, the LD50 of calcium chloride (higher than 5000 mg/kg.bw) (Lower value) is retained for the reaction mass.

Additional information

Justification for classification or non-classification

Based on the data on the two components (calcium chloride and sodium chloride) the reaction mass has a low acute toxicity by oral and dermal routes and no classification is required according to EU GHS criteria.

-The oral LD50 is considered in a worst case approach to be equal to 2120 mg/kg.bw

- The dermal LD50 is considered in a worst case approach to be greater than 5000 mg/kg.bw