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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
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- 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
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- Nanomaterial pour density
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- 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
Acute Dermal Irritation/corrosion Study of Sodium Salicylate, a structurally similar substance to Potassium salicylate, was performed in an OECD GLP laboratory as per OECD guideline No. 404. Three healthy young adult male rabbits were used for conducting acute dermal irritation/corrosion study. In animal no. 2 and 3 at 1 hour observation post patch removal, revealed very slight erythema (barely perceptible) and no oedema. At 24, 48 and 72 hour post patch removal, animals showed no erythema and no oedema. Hence, it was concluded that Sodium salicylate was Non-Irritating to the skin of male New Zealand White rabbits under the experimental conditions tested and classified as "Not Classified" as per CLP criteria. Consequently, also potassium salicylate can be regarded as non-irritating to skin.
Acute Eye Irritation/Corrosion Study of Sodium Salicylate (CAS: 54 -21 -7) in Rabbits, was performed in a OECD GLP laboratory.The study was performed according to OECD 405 Guidelines. 3 female young adult rabbits were used for the study. Under the experimental conditions tested, eye irritation and reversibility of effects on eyes of rabbits was observed within day 7. Hence, “Sodium salicylate (CAS No. – 54-21-7) is “Mildly Irritating to eyes” of New Zealand White female rabbit eyes and is being classified "Category 2"as per the CLP regulation. Consequently, also potassium salicylate can be classified as Category 2 Eye irritant.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- 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 skin irritation/corrosion study was used for read across and evaluation of skin irritation/corrosion of potassium salicylate on the basis of structural similarity.
- Justification for type of information:
- It was concluded that Sodium salicylate was Non-Irritating to the skin of Male New Zealand White rabbits under the experimental conditions tested. 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
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- data is from experimental reports
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- The objective of the study was to assess the irritant and/or corrosive effects of Sodium salicylate (CAS No. 54-21-7) after topical application on the intact skin in rabbits.
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Sodium salicylate - Name of test material (as cited in study report): Sodium salicylate - Molecular Formula: C7H6O3.Na- Molecular Weight: 160.105 g/mol- Smiles Notation: c1(c(cccc1)O)C(=O)[O-].[Na+]- InChI: 1S/C7H6O3.Na/c8-6-4-2-1-3-5(6)7(9)10;/h1-4,8H,(H,9,10);/q;+1/p-1- Substance Type: Organic- Physical State: Solid- AI Content (assay): 99.8%- Manufactured data: March, 2013- Expiry Date: February, 2015- Storage conditions: Room temperature (20 - 30 °C)Handling and DisposalSafety precautions : Aprons, masks, caps, gloves and goggles were used to ensure the health and safety of the personnel.Disposal : The remaining unused test item was disposed as per internal SOPs
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Sex: Male- Source: LIVEON BIOLABS PVT LTD- Age at study initiation: 3 to 4 Months (Approximately)- Weight at study initiation: Minimum: Minimum: 1.764 kg & Maximum: 2.384 kg (Prior to Treatment)- Housing: The animals were housed individually in stainless steel cages.- Room Sanitation:The experimental room floor and work tops were swept and mopped with disinfectant solution every day. - Cages and water bottle:All the cages and water bottles were changed minimum twice a week.- Diet (e.g. ad libitum): All animals were provided conventional laboratory rabbit diet ad libitum- Water (e.g. ad libitum): Aqua guard filtered tap water was provided ad libitum- Acclimation period: Rabbits were acclimatised to the test conditions for a period of 6 days (Animal No.-1) and 8 days (Animal No.-2 and 3) prior to the application of the test item.ENVIRONMENTAL CONDITIONS- Temperature (°C): Minimum: 20.30 °C Maximum: 22.70 °C- Humidity (%):Minimum: 48.30 % Maximum: 68.30 %- Air changes (per hr): More than 12 changes per hour- Photoperiod (hrs dark / hrs light):12:12 hours
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 g moistened with 0.5 ml distilled waterVEHICLE- Amount(s) applied (volume or weight with unit): 0.5 ml- Concentration (if solution):no data- Lot/batch no. (if required): no data- Purity: no data
- Duration of treatment / exposure:
- 4-hour exposure period
- Observation period:
- 72 hours
- Number of animals:
- Three male rabbits
- Details on study design:
- TEST SITE- Area of exposure: dorsal lumbar region at contralateral sites - % coverage: approximately 6 X 6 cm- Type of wrap if used: porous gauze dressing and non-irritating tape (Micropore 3”) REMOVAL OF TEST SUBSTANCE- Washing (if done): test substance was removed by using cotton soaked in distilled water- Time after start of exposure: 4 hrsSCORING SYSTEM: Grading of irritation lesions was carried out as per Draize Method
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Animal 1,2,3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Animal 1,2 and 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Animal No. 1, showed very slight erythema (barely perceptible) and no oedema at 1 hour of observation. At 24, 48 and 72 hour observation no erythema and oedema was observed in animal No 1.In Animals No. 2 and 3 at 1 hour observation post patch removal, revealed very Slight erythema (barely perceptible) and no oedema. At 24, 48 and 72 hour post patch removal, animals showed no erythema and no oedema..The individual mean score at 24, 48 and 72 hours for Animal Nos. 1, 2 and 3 were 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively
- Other effects:
- Clinical ObservationNo systemic toxicity was observed at treated rabbits during the experimental period.MortalityNo mortality was observed during the observation periodBody WeightsBody weights were increased as compared to day 0 in all the three animals
- Interpretation of results:
- other: not irritating
- Conclusions:
- No erythema and oedema (skin irritation) were found at the end of 72 hour observation period after patch removal.The individual mean score at 24, 48 and 72 hoursfor Animal Nos. 1, 2 and 3 were 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively Hence, it was concluded that Sodium salicylate was Non-Irritating to the skin of Male New Zealand White rabbits under the experimental conditions tested
- Executive summary:
Acute Dermal Irritation/corrosion Study of Sodium Salicylate (CAS: 54 -21 -7) in Rabbits, was performed in an OECD GLP laboratory (Sustainability Support Services (Europe) AB has the letter of access,2014) as per OECD guideline No. 404. Three healthy young adult male rabbits were used for conducting acute dermal irritation/corrosion study.
The hairs of all the rabbits were clipped at contralateral sites, approximately 24 hours prior to treatment. A dose of 0.5 g of test item (moistened with 0.5 ml distilled water) was applied to the skin, over an area of approximately 6 x 6 cm clipped of hair on one side of rabbits. The other untreated side was kept as control area and0.5 ml of distilled water was applied at this site. At the end of 4 hours, the gauze patch was removed and test item application site was wiped with water without altering the integrity of the epidermis. Initially, the test item was applied to the clipped area of skin of one rabbit. The test site was covered with gauze patch. After 4 hours of exposure in animal no. 1, very slight erythema (barely perceptible) and no oedema observed at 1 hour of observation. At 24, 48 and 72 hours observation no erythema and oedema was observed in animal no 1. No severe skin lesions were observed hence a confirmatory test was conducted on additional two rabbits (No. 2 and 3) after 24 hours to confirm the non irritant nature of the test item. The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours post patch removal, evaluated and graded as per Draize method. In animal no. 2 and 3 at 1 hour observation post patch removal, revealed very slight erythema (barely perceptible) and no oedema. At 24, 48 and 72 hour post patch removal, animals showed no erythema and no oedema. The individual mean score at 24, 48 and 72 hours for Animal Nos. 1, 2 and 3 were 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively
Hence, it was concluded that Sodium salicylate was Non-Irritating to the skin of male New Zealand White rabbits under the experimental conditions tested and classified as "Not Classified" as per CLP criteria.
Referenceopen allclose all
Table 1: Skin Reaction
In Treated area
Dose:500 mg of test item (moistened with 0.5 ml distilled water)
Sex:Male
Animal No. |
Test |
Treated area* |
Erythema score |
Oedema score |
||||||
1h |
24h |
48h |
72h |
1h |
24h |
48h |
72h |
|||
1 |
Initial |
Left |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
Confirmatory |
Right |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Right |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
In Control area
Dose:0.5 ml of distilled water
Sex:Male
Animal No. |
Test |
Treated area* |
Erythema score |
Oedema score |
||||||
1h |
24h |
48h |
72h |
1h |
24h |
48h |
72h |
|||
1 |
Initial |
Right |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
Confirmatory |
Left |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Left |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Key: h = Hour.
Erythema Oedema
0 =No erythema 0 =No oedema
1 = Very slight erythema(barely perceptible)
Mean Individual Animal Score at 24, 48 and 72 hours
Animal Number Observations |
1 |
2 |
3 |
Erythema |
0.00 |
0.00 |
0.00 |
Oedema |
0.00 |
0.00 |
0.00 |
Table 2: Individual Animal BodyWeight
Sex:Male
Animal No. |
Body Weight (kg) |
|
Prior to Dosing |
At termination |
|
1 |
2.314 |
2.360 |
2 |
2.384 |
2.420 |
3 |
1.764 |
1.836 |
Individual Animal Clinical Signs
Sex:Male
Animal No. |
Days (Post dosing Observation) |
|||
0 |
1 |
2 |
3 |
|
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
3 |
1 |
1 |
1 |
1 |
Key: ./. = Not Applicable. 1 = Normal.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- data is from experimental reports
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- The objective of the study was to assess the irritant and/or corrosive effects of “Sodium Salicylate (CAS: 54-21-7)” on eye, when exposed by the ocular route in rabbits.
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Sodium salicylate - Molecular Formula: C7H6O3.Na- Molecular Weight: 160.105 g/mol- Smiles Notation: c1(c(cccc1)O)C(=O)[O-].[Na+]- InChI: 1S/C7H6O3.Na/c8-6-4-2-1-3-5(6)7(9)10;/h1-4,8H,(H,9,10);/q;+1/p-1- Substance Type: Organic- Physical State: Solid
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: LIVEON BIOLABS PVT. LTD- Age at study initiation: 3 to 4 Months (Approximately)- Weight at study initiation: Minimum: 2.120 kg and Maximum: 2.448 kg (Prior to Treatment)- Housing: The animals were housed individually in stainless steel cages.- Room Sanitation : The experimental room floor and work tops were swept and mopped with disinfectant solution every day. - Cages and water bottle : All the cages and water bottles were changed minimum twice a week- Diet (e.g. ad libitum): All animals were provided conventional laboratory rabbit diet - Water (e.g. ad libitum): Aqua guard filtered tap water was provided ad libitum- Acclimation period: Rabbits were acclimatised to the test conditions for a period of 7 days (Animal No.-1) and 9 days (Animal No. 2 and 3) prior to the application of the test itemENVIRONMENTAL CONDITIONS- Temperature (°C): Minimum: 20.30 °C Maximum: 22.70 °C- Humidity (%): Minimum: 48.30 % Maximum: 68.30 %- Air changes (per hr): More than 12 changes per hour- Photoperiod (hrs dark / hrs light): 12:12
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 100 mg
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- All the animals were observed at 1, 24, 48 and 72 hours and on day 7 after instillation of test item.
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- Three female rabbits
- Details on study design:
- Details on study designREMOVAL OF TEST SUBSTANCE- Washing (if done):The treated eye of rabbit was washed with normal saline.- Time after start of exposure:24 hoursSCORING SYSTEM:Grading of irritation lesions was carried out as per Draize Method TOOL USED TO ASSESS SCORE: Ophthalmoscope and fluorescent strips.REMOVAL OF TEST SUBSTANCE
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- Animal 1,2 and 3
- Time point:
- 24/48/72 h
- Score:
- > 0.67 - <= 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days observation period
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- Animal 1,2 and3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 1,2 and 3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days observation period
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Animal 1, 2 and 3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days observation period
- Remarks on result:
- probability of mild irritation
- Irritant / corrosive response data:
- The following were observed in treated rabbits.Observation at 1 hour after instillation of test item revealed: Cornea- No ulceration or opacity in all 3 animals; Area of Opacity- Zero in all the animals; Iris: Normal in all the animals. Conjunctivae - Some blood vessels definitely hyperaemic (injected) was observed in all the animals; Chemosis: Some swelling above normal (includes nictitating membranes) was observed in all the animals.Observation at 24 hours after instillation of test item revealed: Cornea- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible in animal no. 1 whereas animal no. 2 and 3 showed no ulceration or opacity; Area of Opacity- One quarter (or less) but not zero in animal no. 1 and Zero in animal no. 2 and 3; Iris: Normal in all the animals. Conjunctivae – Diffuse, crimson color; individual vessels not easily discernible was observed in all animals; Chemosis: Some swelling above normal (includes nictitating membranes) was observed in all animals.At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 40%, 20%, 20% damage in animal no. 1, 2 and 3 respectively. Observation at 48 hour after instillation of test item revealed: Cornea- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible in all animals; Area of Opacity- One quarter (or less) but not zero in all 3 animals; Iris: Normal in all the animals. Conjunctivae – Diffuse, crimson color; individual vessels not easily discernible was observed in all animals; Chemosis: Some swelling above normal (includes nictitating membranes) was observed in all animals.Observation at 72 hour after instillation of test item revealed: Cornea- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible in all animals; Area of Opacity- One quarter (or less) but not zero in all 3 animals; Iris: Normal in all the animals. Conjunctivae – Diffuse, crimson color; individual vessels not easily discernible was observed in all animals; Chemosis: Some swelling above normal (includes nictitating membranes) was observed in all animals.Observation on day 7 after instillation of test item revealed: Cornea- No ulceration or opacity in all the animals; Area of Opacity- Zero in all 3 animals; Iris: Normal in all the animals. Conjunctivae – Blood vessels were normal in all 3 animals; Chemosis: No swelling (Normal) was observed in all 3 animals.The individual mean score for animal nos. 1, 2 and 3 at 24, 48, 72 hours for corneal opacity, iris, conjunctiva and chemosis were found 1.00, 0.00, 2.00, 1.00; 0.67, 0.00, 2.00, 1.00 and 0.67, 0.00, 2.00, 1.00 respectively
- Other effects:
- Clinical ObservationNo systemic toxicity was observed in treated rabbits during the experimental periodMortalityNo mortality was observed during the observation periodBody weightAll rabbits were weighed on test day 0 (prior to application) and at termination
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The individual mean score for animal nos. 1, 2 and 3 at 24, 48, 72 hours for corneal opacity, iris, conjunctiva and chemosis were found 1.00, 0.00, 2.00, 1.00; 0.67, 0.00, 2.00, 1.00 and 0.67, 0.00, 2.00, 1.00 respectively. Under the experimental conditions tested, eye irritation and reversibility of effects on eyes of rabbits was observed within day 7. Hence, under the experimental test conditions, “Sodium salicylate (CAS No. – 54-21-7) is “Mildly Irritating to eyes” of New Zealand White female rabbit eyes and is being classified "Category 2"as per the CLPregulation.
- Executive summary:
Acute Eye Irritation/Corrosion Study of Sodium Salicylate (CAS: 54 -21 -7) in Rabbits, was performed in a OECD GLP laboratory (Sustainability Support Services (Europe) has letter of access).The study was performed according to OECD 405 Guidelines. 3 female young adult rabbits were used for the study.
Rabbits free from injury of eye were selected for the study. The eyes of all the rabbits were examined 24 hours prior to treatment. One eye of each rabbit served as control and other as treated. Control eye was left untreated whereas; 100 mgof test itemwas instilled in the other (treated) eye of each rabbit.The eye was observed at 1, 24, 48, 72 hour and on day 7 after test item instillation.Ophthalmoscope was used for scoring of eye lesions.
In the initial test,100 mg of test item (pulverized form)was instilled into the conjunctival sac of the right eye of animal no.1 whereas the left eye of the rabbit served as the control. As animal no. 1 showed no severe ocular lesions a confirmatory test was conducted on additional two rabbits (animal no. 2 and 3);100 mgof test itemwas instilled into the conjunctival sac of right eye of both the rabbits and left eye served as the control. Ocular lesions were seen in animal no. 2 and 3 at 1, 24, 48 and 72 hour observation which recovered at day 7.
Untreated eye of all the three rabbits was normal throughout the experiment.
The following grading scores were observed in treated eye of treated rabbits.
Observation at 1 hour after instillation of test item revealed: Cornea-No ulceration or opacity in all 3 animals; Area of Opacity-Zero in all the animals;Iris:Normal in all the animals.Conjunctivae -Some blood vessels definitely hyperaemic (injected) was observed in all the animals;Chemosis:Some swelling above normal (includes nictitating membranes) was observed in all the animals.
Observation at 24 hours after instillation of test item revealed: Cornea-Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible in animal no. 1 whereas animal no. 2 and 3 showed no ulceration or opacity; Area of Opacity-One quarter (or less) but not zero in animal no. 1 and Zero in animal no. 2 and 3;Iris:Normal in all the animals.Conjunctivae –Diffuse, crimson color; individual vessels not easily discernible was observed in all animals;Chemosis:Some swelling above normal (includes nictitating membranes) was observed in all animals.
At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 40%, 20%, 20% damage in animal no. 1, 2 and 3 respectively.
Observation at 48 hour after instillation of test item revealed: Cornea-Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible in all animals; Area of Opacity-One quarter (or less) but not zero in all 3 animals;Iris:Normal in all the animals.Conjunctivae –Diffuse, crimson color; individual vessels not easily discernible was observed in all animals;Chemosis:Some swelling above normal (includes nictitating membranes) was observed in all animals.
Observation at 72 hour after instillation of test item revealed: Cornea-Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible in all animals; Area of Opacity-One quarter (or less) but not zero in all 3 animals;Iris:Normal in all the animals.Conjunctivae –Diffuse, crimson color; individual vessels not easily discernible was observed in all animals;Chemosis:Some swelling above normal (includes nictitating membranes) was observed in all animals.
Observation on day 7 after instillation of test item revealed: Cornea- No ulceration or opacity in all the animals; Area of Opacity- Zero in all 3 animals; Iris: Normal in all the animals. Conjunctivae – Blood vessels were normal in all 3 animals; Chemosis: No swelling (Normal) was observed in all 3 animals.
The individual mean score for animal nos. 1, 2 and 3 at 24, 48, 72 hours for corneal opacity, iris, conjunctiva and chemosis were found 1.00, 0.00, 2.00, 1.00; 0.67, 0.00, 2.00, 1.00 and 0.67, 0.00, 2.00, 1.00 respectively. Under the experimental conditions tested, eye irritation and reversibility of effects on eyes of rabbits was observed within day 7.
Hence, under the experimental test conditions, “Sodium salicylate (CAS No. – 54-21-7) is “Mildly Irritating to eyes” of New Zealand White female rabbit eyes and is being classified "Category 2"as per the CLP regulation.
- Endpoint:
- eye irritation: in vivo
- 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 eye irritation study was used for read across and evaluation of eye irritation of potassium salicylate on the basis of structural similarity.
- Justification for type of information:
- Sodium salicylate (CAS No. – 54-21-7) is “Mildly Irritating to eyes” of New Zealand White female rabbit eyes and is being classified "Category 2"as per the CLP regulation. 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
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- Animal 1, 2 and 3
- Time point:
- 24/48/72 h
- Score:
- > 0.67 - <= 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days observation period
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- Animal 1, 2 and 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- Animal 1, 2 and 3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days observation period
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Animal 1, 2 and 3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days observation period
- Remarks on result:
- probability of mild irritation
- Irritant / corrosive response data:
- The following were observed in treated rabbits.Observation at 1 hour after instillation of test item revealed: Cornea- No ulceration or opacity in all 3 animals; Area of Opacity- Zero in all the animals; Iris: Normal in all the animals. Conjunctivae - Some blood vessels definitely hyperaemic (injected) was observed in all the animals; Chemosis: Some swelling above normal (includes nictitating membranes) was observed in all the animals.Observation at 24 hours after instillation of test item revealed: Cornea- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible in animal no. 1 whereas animal no. 2 and 3 showed no ulceration or opacity; Area of Opacity- One quarter (or less) but not zero in animal no. 1 and Zero in animal no. 2 and 3; Iris: Normal in all the animals. Conjunctivae – Diffuse, crimson color; individual vessels not easily discernible was observed in all animals; Chemosis: Some swelling above normal (includes nictitating membranes) was observed in all animals.At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 40%, 20%, 20% damage in animal no. 1, 2 and 3 respectively. Observation at 48 hour after instillation of test item revealed: Cornea- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible in all animals; Area of Opacity- One quarter (or less) but not zero in all 3 animals; Iris: Normal in all the animals. Conjunctivae – Diffuse, crimson color; individual vessels not easily discernible was observed in all animals; Chemosis: Some swelling above normal (includes nictitating membranes) was observed in all animals.Observation at 72 hour after instillation of test item revealed: Cornea- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible in all animals; Area of Opacity- One quarter (or less) but not zero in all 3 animals; Iris: Normal in all the animals. Conjunctivae – Diffuse, crimson color; individual vessels not easily discernible was observed in all animals; Chemosis: Some swelling above normal (includes nictitating membranes) was observed in all animals.Observation on day 7 after instillation of test item revealed: Cornea- No ulceration or opacity in all the animals; Area of Opacity- Zero in all 3 animals; Iris: Normal in all the animals. Conjunctivae – Blood vessels were normal in all 3 animals; Chemosis: No swelling (Normal) was observed in all 3 animals.The individual mean score for animal nos. 1, 2 and 3 at 24, 48, 72 hours for corneal opacity, iris, conjunctiva and chemosis were found 1.00, 0.00, 2.00, 1.00; 0.67, 0.00, 2.00, 1.00 and 0.67, 0.00, 2.00, 1.00 respectively
- Other effects:
- Clinical ObservationNo systemic toxicity was observed in treated rabbits during the experimental periodMortalityNo mortality was observed during the observation periodBody weightAll rabbits were weighed on test day 0 (prior to application) and at termination
Referenceopen allclose all
Table 1 : Individual Animal Eye Irritation Scores
In Treated area Dose:100 mg (0.1gm) of test item
Sex:Female
Animal Numbers |
1 |
2 |
3 |
|||||||||||||||
Application Side |
Left |
Left |
Left |
|||||||||||||||
Eye Reactions |
At hour |
At hour |
At hour |
|||||||||||||||
* |
1 |
24 |
48 |
72 |
Day 7 |
* |
1 |
24 |
48 |
72 |
Day 7 |
* |
1 |
24 |
48 |
72 |
Day 7 |
|
Corneal Opacity |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
Area of Opacity |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctiva |
0 |
1 |
2 |
2 |
2 |
0 |
0 |
1 |
2 |
2 |
2 |
0 |
0 |
1 |
2 |
2 |
2 |
0 |
Chemosis |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
Corneal Damage% |
40 |
20 |
20 |
Dose:Untreated (Control Eye) Sex:Female
Animal Numbers |
1 |
2 |
3 |
|||||||||||||||
Application Side |
Left |
Left |
Left |
|||||||||||||||
Eye Reactions |
At hour |
At hour |
At hour |
|||||||||||||||
* |
1 |
24 |
48 |
72 |
Day 7 |
* |
1 |
24 |
48 |
72 |
Day 7 |
* |
1 |
24 |
48 |
72 |
Day 7 |
|
Corneal Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctiva |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Corneal Damage% |
0 |
0 |
0 |
Key:*= Pre-exposure eye examination.
Eye Irritation Scores - Mean Values after 24, 48, 72 Hours (Treated eye)
Animal No. Eye Reaction |
1 |
2 |
3 |
Cornea |
1.00 |
0.67 |
0.67 |
Iris |
0.00 |
0.00 |
0.00 |
Conjunctiva |
2.00 |
2.00 |
2.00 |
Chemosis |
1.00 |
1.00 |
1.00 |
Formula :
Mean Irritation Score= Sum of the Individual Animal Score for eye reactions at 24, 48 and 72 hours
Number of the Observations (3)
Table 2 : Individual Animal Clinical Signs
Sex:Female
Animal No. |
Days (Post application observation) |
|||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
|
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Key:1 = Norma
Individual Animal Body Weight
Sex :Female
Animal No. |
Animal Body Weight (kg) |
|
Prior to application |
At termination |
|
1 |
2.448 |
2.612 |
2 |
2.120 |
2.156 |
3 |
2.236 |
2.402 |
Key:kg = Kilogram
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Acute Dermal Irritation/corrosion Study of Sodium Salicylate, a structurally similar substance to Potassium salicylate, was performed in an OECD GLP laboratory as per OECD guideline No. 404. According to results, it was concluded that Sodium salicylate was Non-Irritating to the skin of male New Zealand White rabbits under the experimental conditions tested and classified as "Not Classified" as per CLP criteria. Consequently, also potassium salicylate can be regarded as non-irritating to skin.
Acute Eye Irritation/Corrosion Study of Sodium Salicylate in Rabbits, was performed in a OECD GLP laboratory.The study was performed according to OECD 405 Guidelines. 3 female young adult rabbits were used for the study. Under the experimental conditions tested, eye irritation and reversibility of effects on eyes of rabbits was observed within day 7. Hence, “Sodium salicylate (CAS No. – 54-21-7) is “Mildly Irritating to eyes” of New Zealand White female rabbit eyes and is being classified "Category 2"as per the CLP regulation. Consequently, also potassium salicylate can be classified as a Category 2 Eye irritant.
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