Registration Dossier
Registration Dossier
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EC number: 202-805-4 | CAS number: 99-97-8
Endpoint summary
Administrative data
Description of key information
Skin Irritation
Acute Dermal Irritation/corrosion Study of the test chemical was performed as per OECD guideline No. 404. Three healthy young adult female New Zealand White rabbits were used.The individual mean score at 24, 48 and 72 hours for animal nos. 1, 2 and 3 were 0.33, 1.00, 0.33 and 0.00, 0.33, 0.00, for erythema and oedema formation, respectively. Hence, under the experimental conditions tested it was concluded that the test chemical was Non-Irritating to the skin of female New Zealand White rabbits and Classified as “Category- Not Classified as Skin Irritant" as per CLP criteria.
Eye Irritation
Acute Eye Irritation/Corrosion Study of the test chemical was performed as per OECD guideline no. 405. 3 female New Zealand White Rabbits free from injury of eye were selected for the study. 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 0.00, 0.00, 0.67, 0.00; 0.00, 0.00, 0.67, 0.33 and 0.00, 0.00, 0.67, 0.00 respectively.Hence, under the experimental conditions, it was concluded that the test chemical was “Non Irritant” to New Zealand White female rabbit eyes and was being classified as Category “Not Classified as an Eye Irritant” as per CLP criteria.
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 the test chemical after dermal application on the intact skin in rabbits.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Procured from GENTOX Bio services., Hyderabad, India
- Age at study initiation: 3 to 4 Months (Approximately)
- Weight at study initiation: Minimum: 1.796 kg and Maximum: 1.998 kg (Prior to Treatment)
- Housing: The animals were housed individually in stainless steel cages.
- 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: 5 days (Animal No.-1) and 7 days (Animal No.-2 and 3)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 19.60 °C, Maximum: 22.30 °C
- Humidity (%): Minimum: 51.10 % , Maximum: 67.40 %
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12
IN-LIFE DATES: From: To: - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - 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: Approximately 24 h prior to treatment, the fur coat of each rabbit was removed from dorsal lumbar region approximately 6 X 6 cm at contralateral sites on each rabbit using clipper, one as control and other site as treatment. Rabbits with healthy intact skin were selected for the study
- % coverage: 6 X 6 cm
- Type of wrap if used: porous gauze dressing and non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton soaked in distilled water
- Time after start of exposure: 4-hour exposure period
SCORING SYSTEM:
Gradation as per draize method - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- > 0 - <= 1
- 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:
- 0.33
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- 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.
Animal No. 1, very slight erythema (barely perceptible) and very slight oedema (barely perceptible) observed at 1 hour of observation. At 24 hour very slight erythema (barely perceptible) and no oedema was observed. At 48 and 72 hours observation no erythema and no oedema was observed in animal no 1.
Animal No. 2, revealed very slight erythema (barely perceptible) and very slight oedema (barely perceptible) observed at 1 hour of observation post patch removal. At 24 hour well defined erythema and very slight oedema (barely perceptible) was observed. At 48 hour very slight erythema (barely perceptible) and no oedema was observed. At 72 hour no erythema and no oedema was observed. Animal No. 3, revealed very slight erythema (barely perceptible) and very slight oedema (barely perceptible) observed at 1 hour of observation post patch removal. At 24 hour slight erythema (barely perceptible) and no oedema was observed. At 48 and 72 hour no erythema and no oedema was observed.
The individual mean score at 24, 48 and 72 hours for animal nos. 1, 2 and 3 were 0.33, 1.00, 0.33 and 0.00, 0.33, 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.
Body Weights
Body weights were increased as compared to day 0 in all the three animals at terminal sacrifice - Interpretation of results:
- other: not irritating
- Conclusions:
- The individual mean score at 24, 48 and 72 hours for animal nos. 1, 2 and 3 were 0.33, 1.00, 0.33 and 0.00, 0.33, 0.00, for erythema and oedema formation, respectively. Hence, under the experimental conditions tested it was concluded that the test chemical was Non-Irritating to the skin of female New Zealand White rabbits and Classified as “Category- Not Classified as Skin Irritant" as per CLP criteria
- Executive summary:
Acute Dermal Irritation/corrosion Study of the test chemical was performed as per OECD guideline No. 404. Three healthy young adult female New Zealand White rabbits were used. 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 chemical (as such) 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 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 chemical application site was wiped with water without altering the integrity of the epidermis. Initially, the test chemical was applied to the clipped area of skin of one rabbit. The test site was covered with gauze patch. At 1 hour of observation, very slight erythema (barely perceptible) and very slight oedema (barely perceptible) was observed in animal no. 1. At 24 hour very slight erythema (barely perceptible) and no oedema was observed. Hence the confirmatory test was conducted after 24 hours on additional two rabbits (No. 2 and 3) to confirm the non irritant nature of the test chemical. At 48 and72 hours observation no erythema and no oedema was observed in animal no 1.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.At 48 and 72 hours observation no erythema and no oedema was observed in animal no 1. Animal No. 2, revealed very slight erythema (barely perceptible) and very slight oedema (barely perceptible) observed at 1 hour of observationpost patch removal. At 24 hour well defined erythema and very slight oedema (barely perceptible) was observed. At 48 hour very slight erythema (barely perceptible) and no oedema was observed. At 72 hour no erythema and no oedema was observed. Animal No. 3, revealed very slight erythema (barely perceptible) and very slight oedema (barely perceptible) observed at 1 hour of observation post patch removal. At 24 hour very slight erythema (barely perceptible)andno oedema was observed. At 48 and 72 hour no erythema and no oedema was observed.The individual mean score at 24, 48 and 72 hours for animal nos. 1, 2 and 3 were 0.33, 1.00, 0.33 and 0.00, 0.33, 0.00, for erythema and oedema formation, respectively. Hence, under the experimental conditions tested it was concluded that the test chemical was Non-Irritating to the skin of female New Zealand White rabbits and Classified as “Category- Not Classified as Skin Irritant" as per CLP criteria.
Reference
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 |
Right |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
2 |
Confirmatory |
Right |
1 |
2 |
1 |
0 |
1 |
1 |
0 |
0 |
3 |
Right |
1 |
1 |
0 |
0 |
1 |
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 |
Left |
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) 1 = Very slight oedema(barely perceptible)
2 = Well defined erythema
Mean Individual Animal Score at 24, 48 and 72 hours
Animal Number Observations |
1 |
2 |
3 |
Erythema |
0.33 |
1.00 |
0.33 |
Oedema |
0.00 |
0.33 |
0.00 |
Individual Animal BodyWeight
Sex:Female
Animal No. |
Body Weight (kg) |
|
Prior to Dosing |
At termination |
|
1 |
1.796 |
1.856 |
2 |
1.940 |
1.992 |
3 |
1.998 |
2.110 |
Key: kg = kilogram
Individual Animal Clinical Signs
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 the test chemical on eye, when exposed by the ocular route in rabbits
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Procured from LIVEON BOLABS PVT. LTD,
- Age at study initiation: 2.0 to 3.5 Months (Approximately)
- Weight at study initiation: Minimum: 1.644 kg and Maximum: 1.674 kg (Prior to Treatment)
- Housing: The animals were housed individually in stainless steel cages
- 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: 6 days (Animal No.-1) and 9 days (Animal No. 2 and 3)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 19.50 °C and Maximum: 21.30 °C
- Humidity (%): Minimum: 47.90 % and Maximum: 59.70 %
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12
IN-LIFE DATES: From: To: - 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 - Duration of treatment / exposure:
- 1 hrs
- Observation period (in vivo):
- All the three treated animals were observed at 1, 24, 48 and 72 hours after instillation of test item
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing was done with normal saline
- Time after start of exposure:N/A
SCORING SYSTEM:
Grading of irritation lesions was carried out as per draize method
TOOL USED TO ASSESS SCORE: ophthalmoscope - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: within 72 hrs
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: within 72 hrs
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: within 72 hrs
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: within 72 hrs
- Remarks on result:
- no indication of 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 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 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- 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 all the animals; Chemosis: Some swelling above normal (includes nictitating membranes) was observed in animal no. 2 whereas no swelling (normal) in animal no. 1 and 3.
At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 0% damage in all the animals.
Observation at 48 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 all the animals; Chemosis: No swelling (normal)was observed in all the animals.
Observation at 72 hour 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 - Blood vessels normal in all the animals; Chemosis: No swelling (normal) 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 and chemosis were found 0.00, 0.00, 0.67, 0.00; 0.00, 0.00, 0.67, 0.33 and 0.00, 0.00, 0.67, 0.00 respectively. - Other effects:
- Clinical Observation
No systemic toxicity was observed in treated rabbits during the experimental period.
Mortality
No mortality was observed during the observation period.
Body weight
All rabbits were increased in body weight at termination when compared to day 0. - Interpretation of results:
- other: not irritating
- 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 0.00, 0.00, 0.67, 0.00; 0.00, 0.00, 0.67, 0.33 and 0.00, 0.00, 0.67, 0.00 respectively.Hence, under the experimental conditions, it was concluded that the test chemical was “Non Irritant” to New Zealand White female rabbit eyes and was being classified as Category “Not Classified as an Eye Irritant” as per CLP criteria.
- Executive summary:
Acute Eye Irritation/Corrosion Study of the test chemical was performed as per OECD guideline no. 405.3 female New Zealand White 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 (as such, undiluted) of test chemical was instilled in the other (treated) eye of each rabbit. The eye was observed at 1, 24, 48 and 72 hours after test chemical instillation. Ophthalmoscope was used for scoring of eye lesions. In the initial test, 0.1 ml of test chemical was applied 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); 0.1 ml of test chemical was instilled into the conjunctival sac of right eye of both the rabbits and left eye served as the control. Untreated eye of all the three rabbits was normal throughout the experimental period of 72 hours. All the three treated animals were observed at 1, 24, 48 and 72 hours after instillation of test chemical. Grading of irritation lesions was carried out as per Draize method. Observation at 1 hour after instillation of test chemical 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 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 chemical 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 all the animals; Chemosis: Some swelling above normal (includes nictitating membranes) was observed in animal no. 2 whereas no swelling (normal) in animal no. 1 and 3. At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 0% damage in all the animals. Observation at 48 hours after instillation of test chemical 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 all the animals; Chemosis: No swelling (normal)was observed in all the animals. Observation at 72 hours after instillation of test chemical 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 - Blood vessels normal in all the animals; Chemosis: No swelling (normal) 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 and chemosis were found 0.00, 0.00, 0.67, 0.00; 0.00, 0.00, 0.67, 0.33 and 0.00, 0.00, 0.67, 0.00 respectively. Hence, under the experimental conditions, it was concluded that the test chemical was “Non Irritant” to New Zealand White female rabbit eyes and was being classified as Category “Not Classified as an Eye Irritant” as per CLP criteria.
Reference
Individual Animal Eye Irritation Scores
In Treated area Dose:0.1 ml of test item (as such, undiluted) Sex:Female
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 |
1 |
1 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
1 |
1 |
1 |
0 |
Chemosis |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
11 |
0 |
0 |
0 |
Corneal Damage% |
0 |
0 |
0 |
||||||||||||
Key:*= Pre-exposure eye examination.
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 |
* |
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 |
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 |
Corneal Opacity |
0.00 |
0.00 |
0.00 |
Iris |
0.00 |
0.00 |
0.00 |
Conjunctiva |
0.67 |
0.67 |
0.67 |
Chemosis |
0.00 |
0.33 |
0.00 |
Formula :
Mean Eye Irritation Score =
Sum of the Individual Animal Score for eye reactionat24, 48 and 72 hours
Number of the Observations (3)
Individual Animal ClinicalSigns
Sex:Female
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
Individual Animal Body Weight
Sex :Female
Animal No. |
Animal Body Weight (kg) |
|
Prior to application |
At termination |
|
1 |
1.674 |
1.750 |
2 |
1.644 |
1.690 |
3 |
1.658 |
1.706 |
Key:kg = Kilogram
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation
Acute Dermal Irritation/corrosion Study of the test chemical was performed as per OECD guideline No. 404. Three healthy young adult female New Zealand White rabbits were used. 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 of 0.5 ml of test chemical (as such) 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 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 chemical application site was wiped with water without altering the integrity of the epidermis. Initially, the test chemical was applied to the clipped area of skin of one rabbit. The test site was covered with gauze patch. At 1 hour of observation, very slight erythema (barely perceptible) and very slight oedema (barely perceptible) was observed in animal no. 1. At 24 hour very slight erythema (barely perceptible) and no oedema was observed. Hence the confirmatory test was conducted after 24 hours on additional two rabbits (No. 2 and 3) to confirm the non irritant nature of the test chemical. At 48 and72 hours observation no erythema and no oedema was observed in animal no 1.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.At 48 and 72 hours observation no erythema and no oedema was observed in animal no 1. Animal No. 2, revealed very slight erythema (barely perceptible) and very slight oedema (barely perceptible) observed at 1 hour of observationpost patch removal. At 24 hour well defined erythema and very slight oedema (barely perceptible) was observed. At 48 hour very slight erythema (barely perceptible) and no oedema was observed. At 72 hour no erythema and no oedema was observed. Animal No. 3, revealed very slight erythema (barely perceptible) and very slight oedema (barely perceptible) observed at 1 hour of observation post patch removal. At 24 hour very slight erythema (barely perceptible)andno oedema was observed. At 48 and 72 hour no erythema and no oedema was observed.The individual mean score at 24, 48 and 72 hours for animal nos. 1, 2 and 3 were 0.33, 1.00, 0.33 and 0.00, 0.33, 0.00, for erythema and oedema formation, respectively. Hence, under the experimental conditions tested it was concluded that the test chemical was Non-Irritating to the skin of female New Zealand White rabbits and Classified as “Category- Not Classified as Skin Irritant" as per CLP criteria.
Eye Irritation
Acute Eye Irritation/Corrosion Study of the test chemical was performed as per OECD guideline no. 405.3 female New Zealand White 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 (as such, undiluted) of test chemical was instilled in the other (treated) eye of each rabbit. The eye was observed at 1, 24, 48 and 72 hours after test chemical instillation. Ophthalmoscope was used for scoring of eye lesions. In the initial test, 0.1 ml of test chemical was applied 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); 0.1 ml of test chemical was instilled into the conjunctival sac of right eye of both the rabbits and left eye served as the control. Untreated eye of all the three rabbits was normal throughout the experimental period of 72 hours. All the three treated animals were observed at 1, 24, 48 and 72 hours after instillation of test chemical. Grading of irritation lesions was carried out as per Draize method. Observation at 1 hour after instillation of test chemical 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 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 chemical 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 all the animals; Chemosis: Some swelling above normal (includes nictitating membranes) was observed in animal no. 2 whereas no swelling (normal) in animal no. 1 and 3. At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 0% damage in all the animals. Observation at 48 hours after instillation of test chemical 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 all the animals; Chemosis: No swelling (normal)was observed in all the animals. Observation at 72 hours after instillation of test chemical 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 - Blood vessels normal in all the animals; Chemosis: No swelling (normal) 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 and chemosis were found 0.00, 0.00, 0.67, 0.00; 0.00, 0.00, 0.67, 0.33 and 0.00, 0.00, 0.67, 0.00 respectively. Hence, under the experimental conditions, it was concluded that the test chemical was “Non Irritant” to New Zealand White female rabbit eyes and was being classified as Category “Not Classified as an Eye Irritant” as per CLP criteria.
Justification for classification or non-classification
Available data for the test chemical suggests that it is not likely to cause any irritation to eyes and skin. The test chemical can be considered to be not irritating to eyes and skin and can be classified under the category “Not Classified” as per CLP regulation.
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