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EC number: 204-559-3 | CAS number: 122-63-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
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- Water solubility
- Solubility in organic solvents / fat solubility
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- Auto flammability
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- Stability in organic solvents and identity of relevant degradation products
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- Stability: thermal, sunlight, metals
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- Endpoint summary
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- 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
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- 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
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- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Skin irritation:
In a patch test conducted on Female New Zealand White rabbits, no erythema and oedema (skin irritation) were found at the end of 72 hour observation period after patch removal.
Eye irritation:
Eye irritation and reversibility of effects on eyes of rabbits was observed at 72 hours. Under the experimental test conditions, Benzyl propionate (CAS No. - 122-63-4) is “Non Irritant” to New Zealand White Male rabbit eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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 “Benzyl propionate (CAS No. - 122-63-4)” after dermal 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):Benzyl propionate
- Molecular formula :C10H12O2
- Molecular weight :164.20 g/mol
- Substance type:Organic
- Physical state:Colourless Liquid
- A.I Content:99.39 %
- Lot/batch No.:Lot 1/04
- Storage condition of test material:Tightly closed, in well-ventilated place. Keep away from source of ignition - no smoking.
- Other:
Handling and Disposal
Safety precautions : Take precautionary measures against static discharges. Keep away from source of ignition. When using do not eat or drink, Aprons, caps, mask, gloves and goggles were used to ensure the health and safety of the Personnel.
Disposal : The remaining unused test item (if any) was disposed as per internal SOPs of sa-FORD. - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: Female
- Source:Procured from RABBI ROOF, Hyderabad.
- Age at study initiation:4 to 5 Months (Approximately).
- Weight (Prior to Treatment):Minimum: 1.914 kg and Maximum: 2.358 kg
- Health Status :Healthy young adults and nulliparous and non-pregnant Rabbits were used for the study.
- 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 (Nutrivet Life Sciences, Pune) 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 5 days (Animal No.-1) and 10 days (Animal No.-2 and 3) prior to the application of the test item.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):Minimum: 19.30 °C and Maximum: 22.50 °C
- Humidity (%):Minimum: 43.80 % and Maximum: 68.40 %
- Air changes (per hr):More than 12 changes per hour
- Photoperiod (hrs dark / hrs light):12:12 - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 ml
- Concentration (if solution):N/A
VEHICLE
- Amount(s) applied (volume or weight with unit):N/A
- Concentration (if solution):N/A
- Lot/batch no. (if required):N/A
- Purity:N/A - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure:The dorsal lumbar region at contralateral sites.
- % coverage:Approximately 6 X 6 cm.
- Type of wrap if used:A porous gauze dressing and non-irritating tape (Micropore 3”).
REMOVAL OF TEST SUBSTANCE
- Washing (if done):The residual test item was removed by using cotton soaked in distilled water.
- Time after start of exposure:4 hour
SCORING SYSTEM:Draize Method - Irritation parameter:
- erythema score
- Basis:
- animal: #1 ,#2 and #3
- Time point:
- other: At 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- no data
- Remarks on result:
- other: not irritating
- Irritation parameter:
- edema score
- Basis:
- animal: #1 ,#2 and #3
- Time point:
- other: At 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- no data
- Remarks on result:
- other: not irritating
- Irritant / corrosive response data:
- The following were observed in treated rabbits.
The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours after patch removal, evaluated and graded as per draize method.
In Animals No.1, 2 and 3 after post patch removal, revealed no erythema and oedema at 24 and 48 and 72 hour during the observation period.
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 Observation
No systemic toxicity was observed at treated rabbits during the experimental period.
Mortality
No mortality was observed during the observation period. - 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.
Hence, it was concluded that “Benzyl propionate (CAS No. - 122-63-4)” was Non-Irritating to the skin of Female New Zealand White rabbits under the experimental conditions tested and being classified as “Category- Not Classified” as per CLP Regulation. - Executive summary:
Acute Dermal Irritation/corrosion Study of “Benzyl propionate(CAS No. -122-63-4)”in Rabbits, was performed in a OECD GLP laboratory (Sustainability Support Services (Europe) AB has the letter of access). This study was performed as per OECD guideline No. 404.
Three healthy young adult female rabbits were used for conducting acute dermal irritation study.Body weights were recorded on day 0 (prior to application) and at termination. Rabbits with good intact skin were selected for the study. The hairs of all the rabbits were clipped at contralateral sites, approximately 24 hours prior to treatment.A dose of0.5 ml of test item (as such) wasappliedto the skin,over an area of approximately 6 x 6 cm clippedof haironone side of rabbits.The other untreated side was kept as control area and 0.5 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, there was no erythema and oedema observed at 1, 24, 48 and 72 hours observation.Hence the confirmatory test was conducted on additional two rabbits (No. 2 and 3)to confirm the non irritant nature of the test item. In Animals No. 2 and 3 after post patch removal, revealed no erythema and oedema at 1, 24, 48 and 72 hours observation. The patch was removed after 4 hours and rabbits wereobservedfor erythema and oedemaat 1, 24, 48 and 72 hours after patch removal, evaluatedand graded as per Draize method. 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 “Benzyl propionate (CAS No. - 122 -63-4)” was Non-Irritating to the skin of Female New Zealand White rabbits under the experimental conditions tested and Classified as “Category- Not Classified” as per CLP Regulation.
Reference
Table 1
Skin Reaction
In Treated area Dose:0.5 ml of test item Sex:Female
Animal No. |
Test |
Treated area* |
Erythema score |
Oedema score |
||||||
1h |
24h |
48h |
72h |
1h |
24h |
48h |
72h |
|||
1 |
Initial |
Left |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
Confirmatory |
Right |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Right |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
In Control area Dose:0.5 ml of distilled water Sex:Female
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
Table 1 Continued…
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:Female
Animal No. |
Body Weight (kg) |
|
Prior to Dosing |
At termination |
|
1 |
1.914 |
2.032 |
2 |
2.350 |
2.370 |
3 |
2.358 |
2.364 |
Table 3
Individual AnimalClinicalSigns
Sex:Female
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 “Benzyl propionate (CAS No. - 122-63-4)” 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):Benzyl propionate
- Molecular formula :C10H12O2
- Molecular weight :164.20 g/mol
- Substance type:Organic
- Physical state:Colourless Liquid
- Batch number: Lot 1/04
- AI Content: 99.39 %
- Manufactured date: December, 2013
- Expiry Date : December, 2014
- Storage conditions: Tightly closed, in well-ventilated place. Keep away from ignition source
- Safety precautions: Take precautionary measures against static discharges. Kept away from source of ignition. Whenusing do not eat or drink, Aprons, caps, mask, gloves and goggles were used to ensure the health and safety of the Personnel.
- Disposal: The remaining unused test item was dispersed as per the internal SOPs - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: Male
- Source:Procured from RABBI ROOF Animal Facility, A. P., India.
- Age at study initiation:4.5 to 5 Months (Approximately)
- Weight at study initiation:Minimum: 1.924 kg and Maximum: 2.038 kg (Prior to Treatment)
- Health Status: Healthy young adult.
- 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 (Nutrivet Life Sciences, Pune) 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 9 days (Animal No. 2 and 3) prior to the application of the test item.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):Minimum: 19.50 °C and Maximum: 22.20 °C
- Humidity (%):Minimum: 41.20 % and Maximum: 59.20 %
- 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):0.1 ml
- Concentration (if solution):N/A
VEHICLE
- Amount(s) applied (volume or weight with unit):N/A
- Concentration (if solution):N/A
- Lot/batch no. (if required):N/A
- Purity:N/A - Duration of treatment / exposure:
- 24 hrs
- Observation period (in vivo):
- Animals were observed at 24 hours intervals for 72 hours.
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):The treated eye of rabbit was washed with normal saline.
- Time after start of exposure:24 hours
SCORING SYSTEM:N/A
TOOL USED TO ASSESS SCORE: Ophthalmoscope and fluorescent strips. - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: 24,48 and 72 hrs
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Untreated (Control Eye)
- Irritation parameter:
- iris score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: 24,48 and 72 hrs
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Untreated (Control Eye)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: 24,48 and 72 hrs
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Untreated (Control Eye)
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: 24,48 and 72 hrs
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Untreated (Control Eye)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: After 24, 48, 72 Hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: For treated eye
- Irritation parameter:
- iris score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: After 24, 48, 72 Hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: For treated eye
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: After 24 Hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: For treated eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: After 48 Hours
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: For treated eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: After 72 Hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: For treated eyes
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: After 24, 48, 72 Hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: For treated eyes
- 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) in all the animals; Chemosis: Some swelling above normal (includes nictating membranes) were observed in animal number 1 and 3 whereas animal number 2 was normal.
Observation at 24 hours after instillation of test item revealed: Cornea- No ulceration or opacity in all the 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 animal no. 2. Animal no. 1 and 3 recovered to normal; Chemosis: No swelling was observed in all the Animals.
At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 0 % damage in Animal Nos 1, 2 and 3, respectively.
Observation at 48 and 72 hours after instillation of test item revealed: Cornea- No ulceration or opacity in all the 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 animal no. 3 at 48 hours which was recovered to normal at 72 hours observation whereas blood vessels were normal in Animal Numbers 1 and 3 at 48 and 72 hours observation; Chemosis: No swelling was observed in all the animals.
The individual mean score for Animal Nos. 1, 2 and 3 at 24, 48, 72 hours for Corneal opacity, iris, conjunctiva, chemosis were found 0.00, 0.00, 0.00, 0.00 ; 0.00, 0.00, 0.67, 0.00 and 0.00, 0.00, 0.00, 0.00, respectively. - Other effects:
- Clinical Observation
No systemic toxicity was observed at treated rabbits during the experimental period.
Mortality
No mortality was observed during the observation period.
Body weight
All rabbits were weighed on test day 0 (prior to application) and at termination.
The body weights were marginally increased in all the animals when compared with pre-treatment body weight. - Interpretation of results:
- not irritating
- Conclusions:
- Under the experimental conditions tested, eye irritation and reversibility of effects on eyes of rabbits was observed at 72 hours.
Hence under the experimental test conditions, Benzyl propionate (CAS No. - 122-63-4) is “Non Irritant” to New Zealand White Male rabbit eyes and is being classified as “Not Classified” as per the CLP regulation. - Executive summary:
Acute Ocular Irritation/corrosion Study of “Benzyl propionate(CAS No. -122-63-4)”in Rabbits, was performed in an OECD GLP laboratory (Sustainability Support Services (Europe) AB has the letter of access). This study was performed as per OECD guideline No. 405.
.
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;0.1 ml of test item (as such)was instilled in the other (treated) eye of rabbits.The eye was observed at 1, 24, 48, 72 hours after test item instillation.Ophthalmoscope was used for scoring of eye lesions.
In the initial test,0.1 ml of test itemwas applied into the conjunctival sac of the right eye of Animal No.1. The left eye of the rabbit served as the control. Animal No. 1 presented ocular lesions at 1 hour observation period. Hence the confirmatory test was conducted on additional two rabbits (Animal No. 2 and 3);0.1 ml of test itemwas instilled into the conjunctival sac of right eye and left eye served as the control. Ocular lesions were observed at 1, 24 and 48 hour in Animal Number 2 whereas in Animal Number 3 ocular lesions presented only at 1 hour observation period. Untreated eye of the treated rabbits was normal throughout the experimental period of 72 hours.
The following grading scores were observed in treated eye of tested 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) in all the animals;Chemosis:Some swelling above normal (includes nictating membranes) were observed in animal number 1 and 3 whereas animal number 2 was normal. Observation at 24 hours after instillation of test item revealed: Cornea-No ulceration or opacity in all the 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 animal no. 2. Animal no. 1 and 3 recovered to normal;Chemosis:No swelling was observed in all the Animals. At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 0 % damage in Animal Nos 1, 2 and 3, respectively. Observation at 48 and 72 hours after instillation of test item revealed: Cornea-No ulceration or opacity in all the 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 animal no. 3 at 48 hours which was recovered to normal at 72 hours observation whereas blood vessels were normal in Animal Numbers 1 and 3 at 48 and 72 hours observation;Chemosis:No swelling was observed in all the animals.
The individual mean score for Animal Nos. 1, 2 and 3at 24, 48, 72 hoursfor Corneal opacity, iris, conjunctiva, chemosis were found 0.00, 0.00, 0.00, 0.00 ; 0.00, 0.00, 0.67, 0.00 and 0.00, 0.00, 0.00, 0.00, respectively. Under the experimental conditions tested, eye irritation and reversibility of effects on eyes of rabbits was observed at 72 hours.
Hence under the experimental test conditions,Benzyl propionate (CAS No. - 122-63-4) is “Non Irritant” to New Zealand White Male rabbit eyes and is being classified as “Not Classified” as per the CLP regulation.
Reference
Table 1 : Individual Animal Eye Irritation Scores
In Treated area Dose:0.1 ml of test item Sex:Male
Animal Numbers |
1 |
2 |
3 |
||||||||||||
Application Side |
Left |
Left |
Left |
||||||||||||
Eye Reactions |
At hour |
At hour |
At hour |
||||||||||||
* |
1 |
24 |
48 |
72 |
* |
1 |
24 |
48 |
72 |
* |
1 |
24 |
48 |
72 |
|
Corneal Opacity |
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 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctiva |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
Chemosis |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
Corneal Damage% |
0 |
0 |
0 |
Dose:Untreated (Control Eye) Sex:Male
Animal Numbers |
1 |
2 |
3 |
||||||||||||
Application Side |
Left |
Left |
Left |
||||||||||||
Eye Reactions |
At hour |
At hour |
At hour |
||||||||||||
* |
1 |
24 |
48 |
72 |
* |
1 |
24 |
48 |
72 |
* |
1 |
24 |
48 |
72 |
|
Corneal Opacity |
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 |
Iris |
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 |
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
Corneal Damage% |
0 |
0 |
0 |
Key:*= Pre-exposure eye examination,h = Hour.
Table 1 Continued…
Eye Irritation Scores - Mean Values after 24, 48, 72 Hours (Treated eye)
Animal No. Eye Reaction |
1 |
2 |
3 |
Corneal Opacity |
0.00 |
0.00 |
0.00 |
Iris |
0.00 |
0.00 |
0.00 |
Conjunctiva |
0.00 |
0.67 |
0.00 |
Chemosis |
0.00 |
0.00 |
0.00 |
Formula :
Mean Eye Irritation Score = Sum of the Individual Animal Score for eye reactionat 24, 48 and 72 hours
Number of the Observations (3)
Table 2 : Individual Animal Clinical Signs
Sex:Male
Animal No. |
Days (Post application observation) |
|||
0 |
1 |
2 |
3 |
|
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
3 |
1 |
1 |
1 |
1 |
Key:1 = Normal
Table 3: Individual Animal Body Weight
Sex :Male
Animal No. |
Animal Body Weight (kg) |
|
Prior to application |
At termination |
|
1 |
1.950 |
1.978 |
2 |
2.038 |
2.128 |
3 |
1.924 |
1.962 |
Key:kg = Kilogram
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation:
In a patch test conducted on Female New Zealand White rabbits, no erythema and oedema (skin irritation) were found at the end of 72 hour observation period after patch removal.
Hence, it was concluded that Benzyl propionate (CAS No. - 122-63-4) was non-irritating to the skin of under the experimental conditions tested.
The supporting studies also indicate that the substance is not a skin irritant.
Eye Irritation:
Under the experimental conditions tested, eye irritation and reversibility of effects on eyes of rabbits was observed at 72 hours. Hence under the experimental test conditions, Benzyl propionate (CAS No. - 122-63-4) is “non irritant” to New Zealand White Male rabbit eyes.
Justification for selection of skin irritation / corrosion endpoint:
No erythema and oedema (skin irritation) were found at the end of 72 hour observation period after patch removal.
Hence, it was concluded that “Benzyl propionate (CAS No. - 122-63-4)” was Non-Irritating to the skin of Female New Zealand White rabbits under the experimental conditions tested and being classified as “Category-Unclassified” as per CLP Regulation.
Justification for selection of eye irritation endpoint:
Under the experimental conditions tested, eye irritation and reversibility of effects on eyes of rabbits was observed at 72 hours.
Hence under the experimental test conditions, Benzyl propionate (CAS No. - 122-63-4) is “Non Irritant” to New Zealand White Male rabbit eyes and is being classified as “Unclassified” as per the CLP regulation.
Justification for classification or non-classification
The available studies indicate that the test substance, benzyl propionate is non irritating to skin and eye and hence is being classified as 'Non irritant' as per the CLP classification.
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