Potassium salicylate

Endpoint summary

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

Reference

Reference 1

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

Reference 2

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

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

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

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.

Reference 2

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

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

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.