reaction mass of Calcium chloride and Sodium chloride

Endpoint summary

Description of key information

No data are available on the reaction mass itself.

The reaction mass is a solution of two inorganic salts in water (68% of calcium chloride and 30% sodium chloride).

Calcium chloride dissociates into ions that are present physiologically in relatively high levels in vertebrates. In accordance with column 2 of REACH Annex VIII and IX, the repeated dose toxicity studies (required under section 8.6) are not needed where a substance undergoes immediate disintegration and there are sufficient data on the cleavage products. Therefore, repeated dose toxicity studies are considered (scientifically) not necessary for Calcium chloride and low toxicity is expected.

Three repeated toxicity studies are available on Sodium chloride. These studies have been performed in rats and Sodium chloride was administered in feed. Effects appeared at very high doses, between 1.3 and 2.5 gr/kg/day, depending on the studies.

Calcium chloride and sodium chloride have low repeated toxicity. Therefore the repeated toxicity of the reaction mass itself is also expected to be low. However, since body weight changes were noted in male rats at high dose in a 90 days study performed on sodium chloride, a DNEL was calculated for sodium chloride and use as a worst case for the risk assessment of the reaction mass.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

Reference 1

Endpoint:

sub-chronic toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1951

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted before GLP compliance. The study contains sufficient amount of information for interpretation of the results.

Qualifier:

no guideline available

Principles of method if other than guideline:

Non-iodized sodium chloride, hereafter referred to as "salt" was fed to rats in their diets for periods of 90 days. A group of 40 Carworth Farms, Wistar
strain, albino rats was selected after a preliminary observation period. The animals were randomized among the 8 cages so that each cage contained 5 male or 5 female rats. The basic diet was the modified Food Research Laboratory Diet 2C which consisted of dried whole milk, ground whole wheat, inactivatedly yeast, U.S.P liver extract,and iodised salt. The iodized salt was present as 2% of the basic diet. The diets were continuously available in McCollum-type food cups. Groups of five males and 5 females received diets that contained 32, 8, 2, and 0% added salt respectively. In terms of total salt added plus that in the basic diet of these groups the percentages were 34, 10, 4, and 2%.

GLP compliance:

not specified

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Carwoth Farms

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

DIET PREPARATION
- Mixing appropriate amounts with (Type of food):The basfe diet was the modified Food Research Laboratory Diet 2C
which consisted of dried whole milk, ground whole wheat, inactivated yeast, U.S.P. liver extract,and iodised salt. The iodized salt was present as 2% of the basic diet.

Analytical verification of doses or concentrations:

not specified

Details on analytical verification of doses or concentrations:

no data

Duration of treatment / exposure:

90 days

Frequency of treatment:

daily

Remarks:

Doses / Concentrations:
0.00, 1.33, 5.73, 31.04 gms. added salt/kg/day
Basis:
nominal in diet

Remarks:

Doses / Concentrations:
1.30, 2.67, 7.16, 32.92 gms total salt/kg/day
Basis:
actual ingested

No. of animals per sex per dose:

5 males and 5 females per dose.

Control animals:

yes, plain diet

Details on study design:

no data

Positive control:

no data

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: No data
- Time schedule:no data
- Cage side observations checked in table [No.?] were included.: No data

DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule:No data

BODY WEIGHT: Yes


FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):

Sacrifice and pathology:

GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes

Other examinations:

None of the 40 rats used in this study died. At the end of 91 days of doses, the rats were weighed and sacrificed, Portions of kidney, liver, and lung were taken for histopathological examination, Livers and kidneys were weighed and the mean organ weight, expressed as percentage of body weight, calculated. These data, as well as those obtained on body weight gain and diet consumption were satatistically analysed for the sexes separately and combined.

Statistics:

No statistical differences were found in total diet eaten (or spilled). The mean weight gain of the combined sex groups dfffered significantly from the
controls only in the 3 s group. These rats gained 82 grams in 91 days while the controls gained 174 grams. However, the rats that received 8% and 2% added salt gained only 130 and 156 grams. The correlation between weight gain and salt content of the diet was -0.969, a significant finding that could occur only 5 times in 1000 by chance. When the body weigt data were examined separately by sex, each group of rats was found to have gained statistically significantly less weight than did the male controls (+92.6, +161.6, +217.6, and +238.8 for the 32, 8, 2, and 0% added salt groups ). The females differed only in the 32% groups. when the weight gain of each group was recalculated as grams gain per 100 grams basal diet eaten, the same statistical differences in growth data were found as when the weight data were calculated as grams weight gain.

Clinical signs:

no effects observed

Description (incidence and severity):

None of the 40 rats used in this study died.

Mortality:

no mortality observed

Description (incidence):

None of the 40 rats used in this study died.

Body weight and weight changes:

effects observed, treatment-related

Description (incidence and severity):

When the body weight data were examined separately by sex, each group of male rats was found to have gained statistically significantly less weight than did the male controls (+92.6, +161.6, +217.6, and +238.8 for the 32, 8, 2, and 0% added salt groups )

Food consumption and compound intake (if feeding study):

effects observed, treatment-related

Food efficiency:

no effects observed

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

not specified

Clinical biochemistry findings:

not specified

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Organ weight findings including organ / body weight ratios:

effects observed, treatment-related

Description (incidence and severity):

Livers and Kidneys were weighed and the mean organ weight, expressed as percentage of body weight, calculated.

Gross pathological findings:

effects observed, treatment-related

Histopathological findings: non-neoplastic:

effects observed, treatment-related

Description (incidence and severity):

Portion of kidney, liver and lung were taken for histopathological examination.

Histopathological findings: neoplastic:

not specified

Details on results:

CLINICAL SIGNS AND MORTALITY: No mortality was observed in all 40 rats
BODY WEIGHT AND WEIGHT GAIN: Weight gain observed and recorded
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Food consumption and compound intake was recorded.
FOOD EFFICIENCY: increased


ORGAN WEIGHTS: Livers and kidneys were weighed


HISTOPATHOLOGY: Portions of kidney, liver and lung were taken for histopathological examination.

Key result

Dose descriptor:

LOAEL

Effect level:

1.33 other: grams per kg/day

Based on:

test mat.

Sex:

male/female

Basis for effect level:

body weight and weight gain

Remarks on result:

other:

Remarks:

only in males and at high doses.

Key result

Critical effects observed:

yes

Lowest effective dose / conc.:

1.33 other: g/kg/day

System:

other: Body weight

Organ:

other: No organ affected. Only impact on body weight change.

Treatment related:

yes

Dose response relationship:

yes

Relevant for humans:

yes

Table are attached in attached background material.

Conclusions:

The LOAEL for 91 doses of salt in the diet of rats is 2%, 1.33 grams/kg/day of added salt in male rats only. Since this doses is high, no classification is required for repeated toxicity according to UN and EU GHS criteria.

Executive summary:

In this study, a group of 5 males and 5 female rats were fed diets for 91 days that contained 32, 8, 2 and 0% salt in excess of the 2% already present as a normal constituent of basic FRL-2C rat diet.

The salt added to the dry diet in this study was Baker and Adamson crystal reagent Sodium Chloride, code 2232 from General Chemical Division of Allied Chemical and Dye Corp., New York, N.Y. It was identified as their lot E 277 and labeled as having passed A.C.S Specifications. This salt does not contain added potassium iodide as did the salt present as 2% of the basic diet.

Non-iodized sodium chloride, was fed to rats in their diets for periods of 90 days. A group of 40 Carworth Farms, Wistar strains, albino rats was selected after a preliminary observation period. The animals were randomized among the 8 cages so that each cage contained 5 male or 5 female rats. The basic diet was the modified Food Research Laboratory Diet 2C which consisted of dried whole milk, ground whole wheat, inactivated yeast, U.S.P. liver extract and iodized salt. The iodized salt was present as 2% of the basic diet. The diet were continuously available in McCollum-type food cups. Groups of five males and 5 females received diets that contained 32, 8, 2 and 0% added salt respectively. In terms of total salt added plus that in the basic diet of these groups the percentages were 34, 10, 4 and 2%.

None of the 40 rats used in the study died. At the end of 91 days of doses, the rats were weighed and sacrifice. Portions of kidney, liver, and lung were taken for histopathological examination. Livers and kidneys were weighed and the mean organ weight, expressed as percentage of the body weight, calculated. These data, as well as those obtained on body weight gain and diet consumption were statistically analyzed for the sexes separately and combined.

No statistical differences were found in total diet eaten. The mean weight gain of the combined sex groups differed significantly from the controls only in the 32% group. These rats gained 82 grams in 91 days while the controls gained 174 grams. However, the rats that received 8% and 2% added salt gained only 130 and 156 grams. The correlation between weight gain and salt content of the diet was -0.969, a significant finding that could occur only 5 times in 1000 by chance. When the body weight data were examined separately by sex, each group of male rats was found to have gained statistically significantly less weight than did the male controls (+92.6, +161.6, +217.6 and +236.8 for the 32,8,2 and 0% added salt groups.). The females differed only in the 32% group. When the weight gain of each group was recalculated as grams gain per 100 grams basal diet eaten, the same statistical differences in growth data were found as when the weight data were calculated as grams weight gain.

The mean liver weights of the 32% group of male and female rats combined and of the females separately were statistically lower than those of their respective controls. The mean kidney weights of the 32% females were significantly higher than those of the controls.

However, no pathological changes were detected by microscopic examination of these organs.

The LOAEL for 91 days of salt in the diet of rats is 2%, 1.33 grams/kg/day of added salt for male rats body weight decrease.

Reference 2

Endpoint:

chronic toxicity: oral

Type of information:

other: publication

Adequacy of study:

weight of evidence

Study period:

1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The publication contains sufficient information to permit a meaningful evaluation of study results

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)

Principles of method if other than guideline:

not applicable

GLP compliance:

not specified

Species:

rat

Strain:

Fischer 344

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Shizuka Experimental Cooperative
- Age at study initiation: 4 weeks on receipt of animals
- Weight at study initiation: not specified in the publication
- Fasting period before study: not specified in the publication
- Housing: 2 rats/cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2°C
- Humidity (%): 40%
- Air changes (per hr): not specified in the publication
- Photoperiod (hrs dark / hrs light): not specified in the publication

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

DIET PREPARATION
- Rate of preparation of diet (frequency): not specified in the publication
- Mixing appropriate amounts with (Type of food): not specified in the publication
- Storage temperature of food: not specified in the publication
- The administration was performed by mixing with the feed. MF powdered feed (oriental Kobo Co.) was used as the basal diet and appropriate amounts of either sodium chloride were added to the basal diet.

Analytical verification of doses or concentrations:

no

Details on analytical verification of doses or concentrations:

not applicable

Duration of treatment / exposure:

2 years

Frequency of treatment:

daily

Remarks:

Doses / Concentrations:
0.25% KCl, 1% KCl, 4% KCl, 4% NaCl and 2% KCl+2% NaCl
Basis:
nominal in diet

No. of animals per sex per dose:

50 rats/group

Control animals:

yes, plain diet

Details on study design:

- Dose selection rationale: not specified in the publication
- Rationale for animal assignment: not specified in the publication

Positive control:

not applicable

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily

DETAILED CLINICAL OBSERVATIONS: No data

BODY WEIGHT: Yes
- Time schedule for examinations: not specified in the publication

FOOD CONSUMPTION: Yes
- Time schedule for examinations: not specified in the publication

HAEMATOLOGY: Yes
- Time schedule for collection of blood: at termination
- Anaesthetic used for blood collection: No data
- Animals fasted: data
- How many animals: all surviving animals
- Parameters examined: Red blood and white blood cell counts, hemoglobin, hematocrit, MCV, MCH, MCHC and platelets

CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at termination
- Animals fasted: No data
- How many animals: all surviving animals
- Parameters examined: GOT, GPT, ALP, LDH, CH-E, Na, K, Ca, NU, Clu, TP and Glu

URINALYSIS: Yes
- Time schedule for collection of urine: at termination
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters examined: protein, glucose, ketone, bilirubin, urobilinogen, pH, occult blood and specific gravity

NEUROBEHAVIOURAL EXAMINATION: No

Sacrifice and pathology:

GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes

Other examinations:

Blood pressure measurements were performed 3 times, at 1 year, 1.5 year and 2 years.

Statistics:

Standard descriptive statistics were used.

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

no effects observed

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

no effects observed

Clinical biochemistry findings:

no effects observed

Urinalysis findings:

no effects observed

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

effects observed, treatment-related

Description (incidence and severity):

In the organ weight ratios, an increase in the liver weight was seen in the 4% NaCl group

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

effects observed, treatment-related

Description (incidence and severity):

Among non-tumorous lesions, nephrotic lesion was predominant in all groups, especially in the 4% NaCl group along with increased gastritis and ulcerative lesions of the stomach.

Histopathological findings: neoplastic:

no effects observed

Details on results:

At the end of the 2-year experimental period, the survival rates were 64%, 58%, 84%, 60%, 52% and 48% in 0.25% KCl, 1% KCl, 4% KCl, 4% NaCl, 2% KCl+2% NaCl and control groups. In regard to blood pressure, the level of 4% NaCl group was higher than that of the control group. Pathological non-tumorous and tumors lesions did not indicate a toxic or carcinogenic effect of KCl and NaCl. Among non-tumorous lesions, nephrotic lesion was predominant in all groups, especially in the 4% NaCl group.
Chronic gastritis and ulcer were found more in the experimental groups than in the control group. In tumorous lesions, testicular tumor developed with a high incidence in all groups and the incidence of pheochromocytoma in the adrenals was moderately high in all the groups. However, the incidence and type of tumor in experimental and control groups were comparable to those of spontaneous tumors in F344/Slc rats. Therefore, the tumors observed in the study were considered to be spontaneous in origin.

Key result

Dose descriptor:

LOAEL

Effect level:

4 other: percent in feed

Based on:

test mat.

Remarks:

4% of sodium chloride in diet corresponds to 2533 mg/kg/day.

Sex:

male

Basis for effect level:

histopathology: non-neoplastic

organ weights and organ / body weight ratios

other:

Remarks on result:

other: The only dose tested.

Key result

Critical effects observed:

yes

Lowest effective dose / conc.:

2 533 mg/kg bw/day (nominal)

System:

other: liver, stomach and Kidney

Organ:

kidney

liver

stomach

Treatment related:

yes

Dose response relationship:

no

Relevant for humans:

yes

none

Conclusions:

Based on the results of the study, NaCl was not considered carcinogenic when administered through the diet to F344/Slc rats for a period of two years. For non-carcinogenic effect 4% of Sodium chloride (corresponding to 2533 mg/kg/day) induces nephrotic lesion with an increased incidence of gastritis and ulcerative lesions of the stomach. These effects occurred at very high dose of sodium chloride (2533 mg/kg/day). Therefore no classification is required according to UN and EU GHS criteria.

Executive summary:

Chronic toxicity tests of KCl and NaCl were carried out in male F344/Slc rats for two years. Each group consisted of 50 rats and each group was fed with 0.25% KCl, 1% KCl, 4% KCl, 4% NaCl, 2% KCl+2% NaCl.

At the end of the 2-year experimental period, the survival rates were 64%, 58%, 84%, 60%, 52% and 48% in 0.25% KCl, 1% KCl, 4% KCl, 4% NaCl, 2% KCl+2% NaCl and control groups. In regard to blood pressure, the level of 4% NaCl group was higher than that of the control group. Pathological tumors lesions did not indicate carcinogenic effect of KCl and NaCl. Among non-tumorous lesions, nephrotic lesion was predominant in all groups, especially in the 4% NaCl group, along with an increased incidence of gastritis and ulcerative lesions of the stomach. Chronic gastritis and ulcer were found more in the experimental groups than in the control group. In tumorous lesions, testicular tumor developed with a high incidence in all groups and the incidence of pheochromocytoma in the adrenals was moderately high in all the groups. However, the incidence and type of tumor in experimental and control groups were comparable to those of spontaneous tumors in F344/Slc rats. Therefore, the tumors observed in the study were considered to be spontaneous in origin.

Reference 3

Endpoint:

chronic toxicity: oral

Type of information:

other: publication

Adequacy of study:

weight of evidence

Study period:

1953

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted prior to GLP and guidelines and 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 chronic adminsitration of sodium chloride throught the diet was administered to male rats and the effects on hypertension, renal and vascular lesions were evaluated

GLP compliance:

no

Remarks:

Study conducted prior to GLP

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: not specified in the publication
- Age at study initiation: not specified in the publication
- Weight at study initiation: not specified in the publication
- Fasting period before study: not specified in the publication
- Housing: housed in suspended steel wire cages
- Diet (e.g. ad libitum): not specified in the publication
- Water (e.g. ad libitum): demineralized or distilled waster was provided ad libitum
- Acclimation period: not specified in the publication

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 27
- Humidity (%): not specified in the publication
- Air changes (per hr): not specified in the publication
- Photoperiod (hrs dark / hrs light): not specified in the publication

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

DIET PREPARATION
- Rate of preparation of diet (frequency): not specified in the publication
- Mixing appropriate amounts with (Type of food): not specified in the publication
- Storage temperature of food: not specified in the publication

To a basic purified diet, finely powdered sodium chloride was added to produce six additional rations as follows -

Diet I - 0.01% Sodium chloride (low NaCl)
Diet II - 0.15% Sodium chloride (control)
Diet III - 2.8% Sodium chloride
Diet IV - 5.6% Sodium chloride
Diet V - 7.0% Sodium chloride
Diet VI - 8.4% Sodium chloride
Diet VII - 9.8% Sodium chloride

The basic purified diet was made up of -
Cane sugar - 51.9%
Caesin, Vitamin-test - 25.0%
Shortening, All-vegetable - 20.0%
Mineral mixture - 2.9%
Vitamins - 0.2%

Analytical verification of doses or concentrations:

no

Details on analytical verification of doses or concentrations:

not applicable

Duration of treatment / exposure:

nine months

Frequency of treatment:

continuous through the diet

Remarks:

Doses / Concentrations:
0.01% Sodium chloride (low), 0.15% Sodium chloride (control), 2.8% Sodium chloride, 5.6% Sodium chloride, 7.0% Sodium chloride, 8.4% Sodium chloride, 9.8% Sodium chloride
Basis:
nominal in diet

No. of animals per sex per dose:

thirty male rats/group

Control animals:

yes, plain diet

Details on study design:

- Dose selection rationale: not specified in the publication
- Rationale for animal assignment: not specified in the publication
- Rationale for selecting satellite groups: not applicable
- Post-exposure recovery period in satellite groups: not applicable
- Section schedule rationale : not applicable

Positive control:

not applicable

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: No data

DETAILED CLINICAL OBSERVATIONS: No data

BODY WEIGHT: Yes

FOOD CONSUMPTION: Yes

WATER CONSUMPTION: Yes

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: No

CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: not specified in the publication

URINALYSIS:No

NEUROBEHAVIOURAL EXAMINATION: No

Sacrifice and pathology:

GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes

Other examinations:

not applicable

Statistics:

not specified in the publication

Clinical signs:

effects observed, treatment-related

Mortality:

mortality observed, treatment-related

Body weight and weight changes:

effects observed, treatment-related

Food consumption and compound intake (if feeding study):

effects observed, treatment-related

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

effects observed, treatment-related

Ophthalmological findings:

not examined

Haematological findings:

not examined

Clinical biochemistry findings:

effects observed, treatment-related

Urinalysis findings:

not examined

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

not examined

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

effects observed, treatment-related

Histopathological findings: neoplastic:

not examined

Details on results:

Edema, hypertension, anemia, lipemia, hypoproteinemia and azotemia were observed in 18 percent of the rats exposed from 7.0 to 9.8% sodium chloride in the diet. The plasma was grossly lipemic and the blood protein levels were low. All animals has significantly increased arterial blood pressure. Gross pathologic changes although were not evident, histopathological changes were noted in kidney and the vascular system and these changes resembled human hypertension.

Dose descriptor:

NOAEL

Remarks on result:

not determinable

Remarks:

no NOAEL identified

Critical effects observed:

not specified

not applicable

Conclusions:

The results indicated that adminsitration of sodium chloride ranging from 0.01 - 9.8% via the diet to male rats over a period of approximately 9 months induced changes in growth with associated changes in water consumption. Edema was observed in 18% of the animals exposed to ranges from 7.0 to 9.8%. Pathologic changes were noted in the kidney and to a lesser extent in various other tissues consuming high levels of sodium chloride. Sustanined arterial hypertension was observed in all the rats exposed to high levels of sodium chloride.

Executive summary:

The chronic adminsitration of sodium chloride throught the diet was administered to male rats and the effects on hypertension, renal and vascular lesions were evaluated. The results indicated that adminsitration of sodium chloride ranging from 0.01 - 9.8% via the diet to male rats over a period of approximately 9 months induced changes in growth with associated changes in water consumption. Edema was observed in 18% of the animals exposed to ranges from 7.0 to 9.8%. Pathologic changes were noted in the kidney and to a lesser extent in various other tissues consuming high levels of sodium chloride. Sustanined arterial hypertension was observed in all the rats exposed to high levels of sodium chloride.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LOAEL

1 330 mg/kg bw/day

Study duration:

subchronic

Species:

rat

System:

other: Body weight and body weight gain only in males observed at high dose.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Calcium chloride, one component of the reaction mass dissociates into ions that are present physiologically in relatively high levels in vertebrates. Therefore, Calcium chloride has low toxicity after repeated exposure. Experimental data on rats showed that Sodium chloride (the second component of the reaction mass) induced effects at high doses. Since the two components, calcium chloride and sodium chloride have low repeated toxicity, it is considered that the reaction mass itself has low repeated toxicity. Therefore according to UN and EU GHS criteria no classification is required.