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EC number: 209-421-6 | CAS number: 578-36-9
- 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
Endpoint summary
Administrative data
Description of key information
The acute oral toxicity profile of sodium salicylate (CAS No. 54-21-7) was studied in female wistar albino rats according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).The lethal concentration (LD50) cut-off value for acute oral toxicity test was considered to be 500 mg/kg bw. Based on structural similarity, the study result of sodium salicylate was used when evaluating the acute toxicity of potassium salicylate. Consequently, Potassium salicylate was classified as Harmful if swallowed (Acute tox. 4).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- data is from experimental report
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- Acute Oral toxicity test was carried out to study the effects of Sodium salicylate (54-21-7) on rats.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): sodium salicylate- Substance type: Organic- Physical state: solid
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Age:7 to 9 weeksSex: Female, nulliparous and non pregnant. It has been observed that females are generally more sensitive than males to toxic effectsBody weight range:200±20gIdentification:By cage tag and corresponding colour body markingAcclimation:One week in experimental room after veterinary examination.Randomization:After acclimation and veterinary examination randomly selected in groups of three females.Nutritional conditions:Fasted overnight prior to treatment. Food was offered three hours after dosing.HusbandryEnvironmental conditions:Air conditioned rooms with 10-15 air changes per hour, temperature between 22-25 0C, relative humidity 40-60% and illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.Accommodation:Groups of three animals of similar sex in polypropylene cages with stainless steel grill top, facilities for food and water bottle, and bedding of clean paddy husk.Diet:Pelleted feed Water: Aqua Guard filter water was kept in PVC bottles, ad libitum
- Route of administration:
- oral: gavage
- Vehicle:
- other: distilled water
- Details on oral exposure:
- 24 hrs.
- Doses:
- No. of dose groups:Three + one vehicle controlGroup I: Dist. water, 10ml/kg body wt.Group II : 2000 mg/kg body wt.Group III : 300 mg/kg body wt.Group IV : 300 mg/kg body wt.
- No. of animals per sex per dose:
- No. of animals per dose group:Three (3 females)/step
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days - Frequency of observations and weighing:BODY WEIGHT:The body weight of all animals was observed weekly on day 0 (pre treatment),7th and 14th (post treatment).CLINICAL SIGNS:The treated animals were closely observed for clinical signs of intoxication ,first 4 hours and every 1 hours interval for 24 hrs after dosing and thereafter twice a day for 14 days.All rats were observed at least twice daily to observe any clinical signs or behavioral changes. - Necropsy of survivors performed: yes,necropsy was carried out on all animals which died during the study or surviving animals were sacrified at the end of the study to observe any gross pathological changes. - Other examinations performed: clinical signs, body weight,organ weights, histopathology study:The organ which showed gross pathological change during necropsy subjected for histopathological study.
- Statistics:
- no data available
- Preliminary study:
- no data available
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 50% mortality was observed
- Mortality:
- Dose level 300 mg/kg b.wtStep-I: The test compound did not produce any mortality throughout observation period.Step-II: The test compound did not produce any mortality throughout the period of observation. Dose level 2000 mg/kg b.wt. All the Wistar albino rats died within the 4 hrs. of administration of test compound.
- Clinical signs:
- Dose level 300 mg/kg b.wt- Test compound did not produce any clinical signs of intoxication throughout the observation period of 14 days. Dose level 2000 mg/kg b.wt- Test compound produced high to sever signs of intoxication viz; abdominal respiration, convulsion, tremor and hind leg paralysis and finally death after 4 hrs.
- Body weight:
- All the animals treated with CAS No. 54-21-7 at the dose level of 300 mg/kg b.wt showed decrease in normal gain in body weight on day 7th as compared to control group. Whereas, on day 14th all the rats showed normal gain weight as compared to control group
- Gross pathology:
- Necropsy finding:A.EXTRENAL: i:skin: skin and hair coat was observed wet ii:all external orifices: normalB.INTERNAL: i:subcutaneous: no change was observed ii:superficial and deep lymph node: no change in mesenteric lymph nodeABDOMINAL CAVITY: i. opening and general examination: in the abdominal cavity all the organs were present in normal position ii. spleen: normal upto highest tested dose level 2000 mg/kg bw iii. digestive sysytem: no gross changes were observed in stomach and intestine upto highest tested dose level 2000 mg/kg bw iv. liver and biliary ducts: no gross pathological changes were observed v. excretory sysytem: no gross pathological changes were observed upto highest tested dose level 2000 mg/kg bw vi. adrenal: observed normal vii. male/female genital organs: showed normal color,consistancy and no inflammartory changes upto highest tested dose level 2000 mg/kg bw2. THORACIC CAVITY: i. opening and general examination: thoracic cavity was found to be normal withut any fluid,mucous or blood etc. ii. lungs: severe congestion was observed at the dose level of 2000 mg/kg bw iii. heart: no changes were observed in color and consistancy. heart found normal upto highest tested dose level 2000 mg/kg bw iv. thyroid: normal in shape,size and surface upto highest tested dose level 2000 mg/kg bw3. CRANIAL CAVITY: brain: normal in shape and size
- Other findings:
- no data available
- Interpretation of results:
- Toxicity Category IV
- Conclusions:
- The lethal concentration (LD50) cut-off value for acute oral toxicity test was considered to be 500 mg/kg bw,when female wistar albino rats were treated with sodium salicylate (CAS No. 54-21-7) orally via gavage according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).
- Executive summary:
The acute oral toxicity profile of sodium salicylate (CAS No. 54-21-7) in female wistar albino rats according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).The test substance was dissolved in Distilled water to obtain final concentration of 30 and 200 mg/ml which was administered by oral route by using oral cannula.Body weight,mortality and clinical signs were observed in treated animals.at dose level 300 mg/kg bw,Test compound did not produce any clinical signs of intoxication throughout the observation period of 14 days.atdose level 2000 mg/kg bw,Test compound produced high to sever signs of intoxication viz; abdominal respiration, convulsion, tremor and hind leg paralysis and finally death after 4 hrs.All the animals treated with CAS No. 54-21-7 at the dose level of 300 mg/kg bw showed decrease in normal gain in body weight on day 7th as compared to control group. Whereas, on day 14th all the rats showed normal gain weight as compared to control group.Hence,The lethal concentration (LD50) cut-off value for acute oral toxicity test was considered to be 500 mg/kg bw,when female wistar albino rats were treated with sodium salicylate (CAS No. 54-21-7) orally via gavage according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliant toxicity to acute oral toxicity study was used for read across and evaluation of acute oral toxicity of potassium salicylate on the basis of structural similarity.
- Justification for type of information:
- The lethal concentration (LD50) cut-off value for acute oral toxicity test was considered to be 500 mg/kg bw,when female wistar albino rats were treated with sodium salicylate (CAS No. 54-21-7). Based on structural similarity, the result can be used for read across, classification and risk assessment of potassium salisylate.
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 50% mortality was observed
Referenceopen allclose all
SUMMARY OF BODY WEIGHT (GM)
Group |
Day 0 |
Day 7 |
% Gain/loss |
Day 14 |
% Gain/loss |
Group-I distilled water 10ml/kg |
211.10 |
215.91 |
3.76 |
219.5 |
6.28 |
Group-II 2000 mg/kg b. wt |
205.11 |
- |
- |
- |
- |
Group-III 300 mg/kg b. wt |
211.91 |
215.51 |
1.69 |
218.26 |
5.99 |
Group-IV 300 mg/kg b. wt |
204.98 |
209.65 |
2.27 |
211.1 |
6.44 |
CLINICAL SIGNS AND MORTALITY
Group: I (Vehicle Control) Dose: 10 ml/kg b.wt
FEMALE RATS
Parameters |
Incidence of clinical signs observed after dosing |
Mortality |
||||||||||||||||||
Day 0 |
DAY |
|||||||||||||||||||
Min |
Hour |
|||||||||||||||||||
30 |
1 |
2 |
4 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
Total* |
|
Mortality (total) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/3
|
Clinical Signs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 = No clinical sign (Normal)
+ = Clinical Sign
CLINICAL SIGNS AND MORTALITY
Group: II Dose: 2000 mg/kg b. wt.
FEMALE RATS
Parameters |
Incidence of clinical signs observed after dosing |
Mortality |
||||||||||||||||||
Day 0 |
DAY |
|||||||||||||||||||
Min |
Hour |
|||||||||||||||||||
30 |
1 |
2 |
4 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
Total* |
|
Mortality (total) |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3/3 |
Clinical Signs |
3 |
3 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Convulsion |
++ |
+++ |
+++ |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Tremor |
++ |
+++ |
++++ |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Abdominal respiration |
+++ |
+++ |
+++ |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Paralysis |
++ |
+++ |
+++ |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 = Normal
+ = Mild
++ = Moderate
+++ = High
++++ = Severe
CLINICAL SIGNS AND MORTALITY
Group: III Dose: 300 mg/kg b.wt
FEMALE RATS
Parameters |
Incidence of clinical signs observed after dosing |
Mortality |
||||||||||||||||||
Day 0 |
DAY |
|||||||||||||||||||
Min |
Hour |
|||||||||||||||||||
30 |
1 |
2 |
4 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
Total |
|
Mortality (total) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/3 |
Clinical Signs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 = Normal
+ = Mild
++ = Moderate
+++ = High
++++= Severe
CLINICAL SIGNS AND MORTALITY
Group: IV Dose: 300 mg/kg b.wt.
FEMALE RATS
Parameters |
Incidence of clinical signs observed after dosing |
Mortality |
||||||||||||||||||
Day 0 |
DAY |
|||||||||||||||||||
Min |
Hour |
|||||||||||||||||||
30 |
1 |
2 |
4 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
Total* |
|
Mortality (total) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/3 |
Clinical Signs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 = Normal
+ = Mild
++ = Moderate
+++ = High
++++ = Severe
SUMMARY OF NECROPSY FINDINGS
S. No. |
Fate
|
Wistar albino rats |
|||
Dose (mg/kg b. wt) |
|||||
Distilled water (10 ml/kg) |
2000
|
300 |
300 |
||
1 |
Terminal sacrifice |
3/3 |
0/3 |
3/3 |
3/3 |
2 |
Found Dead |
0/3 |
3/3 |
0/3 |
0/3 |
3 |
Abnormalities detected |
NAD |
Severe congestion In lung |
NAD |
NAD |
NAD - No abnormality recorded
INDIVIDUAL ANIMAL FATE & NECROPSY FINDINGS
Group: I (Vehicle Control) Dose: 10ml/kg b.wt
FEMALE RATS
Animal ID |
Fate |
Time |
Gross Findings |
20161-1 |
TS |
Day 14 |
NAD |
20161-2 |
TS |
Day 14 |
NAD |
20161-3 |
TS |
Day 14 |
NAD |
Day 0 is the day of dose administration.
TS- Terminal Sacrifice
NAD- No abnormality Detected
INDIVIDUAL ANIMAL FATE & NECROPSY FINDINGS
Group: II Dose: 2000 mg/kg b.wt.
FEMALE RATS
Animal ID |
Fate |
Time |
Gross Findings |
20161-4 |
FD |
4 hrs. |
Severe congestion in lungs |
20161-5 |
FD |
4 hrs. |
|
20161-6 |
FD |
4 hrs. |
Day 0 is the day of dose administration.
TS- Terminal Sacrifice
NAD- No abnormality Detected
FD- Found Dead
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 500 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The acute oral toxicity profile of sodium salicylate (CAS No. 54-21-7) was studied in female wistar albino rats according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).The lethal concentration (LD50) cut-off value for acute oral toxicity test was considered to be 500 mg/kg bw. Based on structural similarity, the study result of sodium salicylate was used when evaluating the acute toxicity of potassium salicylate. Consequently, Potassium salicylate was classified as Harmful if swallowed (Acute tox. 4).
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