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EC number: 232-234-6 | CAS number: 7790-94-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- The data is from peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Repeated dose oral toxicity study of the test chemical
- Author:
- Upton and L'Estrange
- Year:
- 1 977
- Bibliographic source:
- Quarterly Journal of Experimental Physiology
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- The study was performed to evaluate the toxic effects of the test chemical in rats upon repeated exposure by oral route in 90 days study
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Hydrogen chloride
- EC Number:
- 231-595-7
- EC Name:
- Hydrogen chloride
- Cas Number:
- 7647-01-0
- Molecular formula:
- ClH
- IUPAC Name:
- hydrogen chloride
- Test material form:
- liquid
- Details on test material:
- - Name of test material : Hydrochloric Acid
- Molecular formula : ClH
- Molecular weight : 36.4609 g/mol
- Substance type: Inorganic
- Physical state: Liquid
- Impurities (identity and concentrations): No Data Available
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No Data Available
- Age at study initiation: Approx. 1 year old
- Weight at study initiation: Approx. 350 grams
- Fasting period before study: No Data Available
- Housing: No Data Available
- Diet (e.g. ad libitum): Commercial rat diet ad libitum
- Water (e.g. ad libitum): Supplied daily ad libitum.
- Acclimation period: No Data Available.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No Data Available
- Humidity (%): No Data Available
- Air changes (per hr): No Data Available
- Photoperiod (hrs dark / hrs light): No Data Available
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: Commercial Rat Diet
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: The rats were offered the diet alone or supplemented with 312, 625, 937 or 1250 mmol/kg Dry matter. Batches of the diet were prepared using 125 ml of 2 5, 5-0, 7-5 or 10 0 mol /L solutions of HCl for the acid treatments respectively and 125 ml water for the control per kg basal diet. Each diet was offered ad libitum over a 9 week period to four male and four female rats in a randomized block design experiment.
DIET PREPARATION
- Rate of preparation of diet (frequency): No Data Available
- Mixing appropriate amounts with (Type of food): No Data Available
- Storage temperature of food: No Data Available.
VEHICLE
- Justification for use and choice of vehicle (if other than water): No Data Available
- Concentration in vehicle: 0, 312, 625, 937 or 1250 mmol/kg DM
- Amount of vehicle (if gavage): 0, 2.5, 5.0, 7.5 or 10.0 mol/L.
- Lot/batch no. (if required): No Data Available
- Purity: No Data Available - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No Data Available
- Duration of treatment / exposure:
- 7 weeks
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 other: mmol/ kg dry matter
- Dose / conc.:
- 312 other: mmol/kg dry matter
- Dose / conc.:
- 625 other: mmol/kg dry matter
- Dose / conc.:
- 937 other: mmol/kg dry matter
- Dose / conc.:
- 1 250 other: mmol/kg dry matter
- No. of animals per sex per dose:
- No Data Available
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No Data Available
- Positive control:
- No Data Available
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No Data Available
- Time schedule: No Data Available
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: No Data Available
- Time schedule: No Data Available
BODY WEIGHT: Yes
- Time schedule for examinations: No Data Available
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes, residues were collected weekly and intake was calculated for weekly periods
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes, intake was calculated for weekly periods
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: Intake was calculated for weekly periods
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No Data Available
- Dose groups that were examined: No Data Available
HAEMATOLOGY: Yes
- Time schedule for collection of blood: At the end of the experiment
- Anaesthetic used for blood collection: Yes, blood was collected by cardiac puncture using anesthesia.
- Animals fasted: No data available
- How many animals: No Data Available
- Parameters checked in table [No.?] were examined: No Data Available
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: At the end of the experiment
- Animals fasted: No Data Available
- How many animals: No Data Available
- Parameters checked in table [No.?] were examined. acid-base and mineral analysis
URINALYSIS: No data available
- Time schedule for collection of urine: No Data Available
- Metabolism cages used for collection of urine: No Data Available
- Animals fasted: No Data Available
- Parameters checked in table [No.?] were examined.
NEUROBEHAVIOURAL EXAMINATION: No data available
- Time schedule for examinations: No Data Available
- Dose groups that were examined: No Data Available
- Battery of functions tested: No Data Available
sensory activity / grip strength / motor activity / other: No Data Available - Sacrifice and pathology:
- Sacrifice: Rats were sacrificed using exsanguination.
GROSS PATHOLOGY: Yes, After exsanguination, the rats were slaughtered and the right femur was removed from each animal, cleansed of adherent soft tissue and dried at 100 'C. It was subjected to fat extraction by petroleum ether in a Soxhlet apparatus, dried at 100 'C, weighed and the weight was recorded as fat free solids (FFS). The FFS were ashed at 560 'C and dissolved in 2 mol/L 1 nitric acid for subsequent analysis.
HISTOPATHOLOGY: Yes - Other examinations:
- No Data Available
- Statistics:
- Where treatment effects were statistically significant the means were compared with each other using Duncan's multiple range test.
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 100% mortality was observed at higher doses of 937 and 1250 mmol/kg. There was no mortality observed at 312 and 625 mmol/kg.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- There was a significant reduction of the body weights of the animals in the higher dose groups of 937 and 1250 mmol/kg.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- There was a significant decrease in the food intake of 937 and 1250 mmol/kg.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- The water intake was significantly increased by the test chemical supplementation except on the high level of supplementation, where the animals survived for a short period.
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Blood pH was significantly reduced by the test chemical supplementation. Plasma CO2 concentration was also reduced by the test chemical supplementation but the effect was not significant.
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 625 other: mmol /kg
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- haematology
- mortality
- water consumption and compound intake
- Dose descriptor:
- LOAEL
- Effect level:
- 937 other: mmol /kg
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- haematology
- mortality
- water consumption and compound intake
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table: Live-wt. change, dry matter (DM) intake, blood and bone measurements for weanling rats given a balanced diet alone or supplemented with the test chemical at 3 different levels. (Mean of eight rats offered the diet ad lib. for 63 days).
|
0 |
312 |
625 |
938 |
1250 |
SE of treatment mean |
+F- test |
pH of diets |
5.80 |
4.17 |
2.84 |
2.23 |
1.82 |
- |
- |
Dm intake |
14.8 |
15.8 |
15.3 |
10.7 |
9.56 |
0.38 |
*** |
Liver weight change (g/d) |
-0.31 |
-0.22 |
-0.47 |
-2.40 |
-1.72 |
0.15 |
*** |
Water intake (mL/D) |
33.9 |
35.7 |
44.8 |
44.2 |
25.9 |
1.47 |
*** |
Blood measurements |
|
|
|
|
|
|
|
Blood pH |
7.38` |
7.29 |
7.29 |
- |
- |
0.025 |
* |
Plasma CO2 (mmol/L) |
23.4 |
22.7 |
20.7 |
- |
- |
1.95 |
NS |
Bone measurements |
|
|
|
|
|
|
|
Femur length (mm) |
37.3 |
36.7 |
3838 |
- |
- |
0.64 |
NS |
Wt. fat free solids (FFS) in femur (mg) |
695 |
729 |
666 |
- |
- |
26.7 |
NS |
% ash in FFS |
70.8 |
61.3 |
69.4 |
- |
- |
3.39 |
NS |
% Ca in FFS |
23.7 |
24.7 |
23.2 |
- |
- |
0.49 |
NS |
% P in FFS |
12.4 |
12.6 |
13.0 |
- |
- |
0.39 |
NS |
Applicant's summary and conclusion
- Conclusions:
- The no observed adverse effect level (NOAEL) and the low observed adverse effect level (LOAEL) for the test chemical after the administration for over 7 weeks to Wistar rats is considered to be 625 mmol /kg and 937 mmol /kg respectively.
- Executive summary:
Repeated dose oral toxicity study was conducted to identify and evaluate effects of the test chemical on male and female Wistar rats for a period of 7 weeks. In this period, the rats were administered with the test chemical which was given through the oral feed route. The test chemical was mixed with the diet in concentrations of 2.5, 5.0, 7.5 or 10.0 mol/L and dose groups ofmmol /kg. The rats were given a commercial rat diet, either alone (control) or supplemented with the test chemical at 312, 625, 937 or 1250 mmol/ kg DM. The pH reached 1.82 after using higher dietary levels of the test chemical (i.e at 1250 mmol/kg). Batches of the diet were prepared by pouring 140 ml of either 2, 3 or 4 mol /l solutions of the test chemical for the acid treatments respectively over a kg D.M. of the experimental diet and mixed thoroughly in a food mixer. The control diet was prepared by the addition of a similar amount of distilled water to the basal diet. The rats were given access to the waterad libitum.The control animals were fed with animal diets mixed with distilled water. The rats were observed for body weight gain and feed consumption throughout the study.100% mortality was observed at higher doses of 937 and 1250 mmol/kg. There was no mortality observed at 312 and 625 mmol/kg. Also, there was a significant reduction of the body weights of the animals in the higher dose groups of 937 and 1250 mmol/kg. There was a significant decrease in the food intake of 937 and 1250 mmol/kg. The water intake was significantly increased by the test chemical supplementation except on the high level of supplementation, where the animals survived for a short period. After the administration of the test chemical for 7 weeks the animals were sacrificed by exsanguination and were slaughtered to isolate the femur bones of the animals. The blood was collected at the end of the experiment under the influence of anesthesia to evaluate blood acid status and CO2levels in the blood. Also, values of the minerals were determined. Blood pH was significantly reduced by the test chemical supplementation. Plasma CO2 concentration was also reduced by the test chemical supplementation but the effect was not significant. The supplementation of test chemical did not significantly cause any changes in the levels of calcium and phosphorus in the animals. Also, There were no gross pathological changes observed in the animals due to administration of the test chemical and There were no observed changes in histopathological examination after the administration of the test chemical. From all the observations, The no observed adverse effect level (NOAEL) and the low observed adverse effect level (LOAEL) for the test chemical after the administration for over 9 weeks to Wistar rats is considered to be 625 mmol /kg and 937 mmol /kg respectively.
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