Oxacycloheptadec-10-en-2-one

Endpoint summary

Description of key information

Skin Irritation:

The overall irritation score of the substance was determined to be 0 and no erythema and edema (skin irritation) were found at the end of 14 days observation period after patch removal. Hence, it was concluded that the test chemical was not irritating to the skin of Sprague Dawley rats under the experimental conditions tested and classified as “Category-Not Classified” as per CLP Classification.

Eye Irritation:

Day 1 readings showed scores of 1, 2, and 3 for redness and chemosis. Discharge was also noted in all three animals. These signs generally remained at day 2, subsided by day 3 and cleared by day 4. Cornea and iris were not involved and remained normal.

Hence, the test chemical can be considered to be not irritating to rabbit eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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 a study report.

Qualifier:

according to guideline

Guideline:

other: Acute Dermal toxicity (OECD 402 Guidelines)

Principles of method if other than guideline:

To determine the dermal reaction profile of the test chemical in Sprague Dawley rats

GLP compliance:

yes

Specific details on test material used for the study:

- Name of test material (as cited in study report): Ambrettolide
- Molecular formula : C16H28O2
- Molecular weight : 252.395 gram/mol
- Substance type: Organic
- Physical state: Liquid
- Laboratory Test Item Code : TAS/122/062
- Manufacturing Date : 13-01-2016
- Expiry Date : 13-12-2018
- Consistency : Liquid
- Activity (Clinical Indication) : Industrial chemical
- Batch Number : A6P/16/2500
- Storage Condition : Ambient Temperature
- Preparation of Test Item : The test item was used undiluted and as supplied by the Sponsor.

Species:

rat

Strain:

Sprague-Dawley

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: National Institute of Biosciences, Pune
- Age at study initiation: Young adult (8 to 10 weeks old)
- Sex: Female. Females were nulliparous and non-pregnant
- Weight at study initiation: weight range of approximately 225.2 to 238.2 grams at initiation of dosing.

Body weights at the start :
Female
Mean : 232.06 g (= 100 %)
Minimum : 225.2 g (- 2.96 %)
Maximum : 238.2 g (+ 2.65 %)
Total No. of animals : 5
- Housing: The rats were individually housed in polycarbonate cages with paddy husk as bedding.
- Identification: Each rat was individually identified by the cage number.
- Diet (e.g. ad libitum): Rodent feed supplied by the Nutrivet Life Sciences, Pune, was provided ad libitum
- Water (e.g. ad libitum): Water was provided ad libitum from individual bottles attached to the cages. All water was from a local source and passed through the reverse osmosis membrane before use.
- Acclimation period: All animals were acclimatized to laboratory conditions for minimum of 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.2 to 21.8 degree centigrade
- Humidity (%): 56.0% to 59.1%.
- Air changes (per hr): at least ten to fifteen air changes per hour of 100% fresh air that had been passed through the HEPA filters
- Photoperiod (hrs dark / hrs light):An artificial light and dark cycle of 12 hours each was provided to the room.

IN-LIFE DATES: :Experimental Starting Date : 31-10-2017
Experimental Completion Date : 24-11-2017

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

Dose Range Finding Study: 200, 1000, 2000 mg/kg bodyweight
Main study: 2000 mg/kg bodyweight

Duration of treatment / exposure:

24 hours

Observation period:

14 days

Number of animals:

5 females

Details on study design:

Details on study design
TEST SITE
- Area of exposure: Trunk (dorsal surface and sides from scapular to pelvic area)
- % coverage: Approximately 10% of the body surface area.
- Type of wrap if used: Porous gauze dressing and non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Distilled water was used to remove residual test item.
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : Dermal reaction was observed daily for study period of 14 days.
SCORING SYSTEM: Draize Method.

Other Observations:
Viability:
 
Twice daily.
 
Clinical Observations and General Appearance:
 
Animals were observed for clinical signs, mortality, until sacrifice.
Onset, duration and severity of any sign were recorded. The clinical signs and mortality observations were conducted at 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter for 14 day. Daily observation was done as far as possible at the same time.
 
The observations included general clinical signs, observations of eyes, mucous membranes, respiratory, circulatory system and behavior pattern.
 
Evaluation of Dermal Reaction:
 
Dermal reaction was observed daily for study period of 14 days.
 
Body weights:
 
Individual animal body weights were recorded pre-test (prior to administration of the test item), day 7 and at termination on day 14.
 
Gross Pathology:
 
Necropsy was performed on animals surviving at the end of the study. Macroscopic examination of all the orifices, cavities and tissues were made and the findings were recorded. All animals surviving the study period were sacrificed by the carbon dioxide asphyxiation technique (day 15).
 
Histopathology:
 
No gross abnormalities were observed in animals sacrificed terminally hence, no histopathology was performed


Preparation of Animals:
The animals were kept in their cages for at least 5 days prior to administration for acclimatization to the laboratory condition and after acclimatization period, animals were randomly selected.
 

Irritation parameter:

erythema score

Basis:

mean

Time point:

14 d

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

14 d

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Evaluation of Dermal Reaction
Sex : Female
Dose Range Finding Study:
Group I : Animal treated at the dose level of 200 mg/kg body weight did not result in any skin reaction during the study period of 14 days.
Group I : Animal treated at the dose level of 1000 mg/kg body weight did not result in any skin reaction during the study period of 14 days.
Group I : Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days.
Main Study:
Group II : Animals treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days.

Other effects:

Clinical Signs of Toxicity and Mortality
Sex : Female
Dose Range Finding Study:
Group I : Animal treated at the dose level of 200 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. The animal survived through the study period of 14 days.
Group I : Animal treated at the dose level of 1000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. The animal survived through the study period of 14 days.
Group I : Animal treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. The animal survived through the study period of 14 days.
Main Study:
Group II : Animals treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. All animals survived through the study period of 14 days.
Body Weight
Sex : Female
Dose Range Finding Study:
Group I (200 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 4.15% and 7.66% respectively.
Group I (1000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 6.75% and 13.23% respectively.
Group I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 5.21% and 10.91% respectively.
Main Study:
Group II (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 5.26% and 9.95% respectively.
Gross Pathological Findings
Gross pathological examination did not reveal any abnormalities in animals from 200 mg/kg, 1000 mg/kg and 2000 mg/kg dose groups from dose range finding study and main study sacrificed terminally

Summary of Evaluation of Dermal Reaction

 

Laboratory Test Item Code :TAS/122/062

Test System : Sprague Dawley Rat

Sex : Female

Finding Study:

Group  No.	Dose mg/kg	Dermal Reaction	Total Number of Animals	Animal Nos.	Period of signs in days  From - to
I	200	No dermal reaction observed	1	1	Day 0 - Day 14

 

Group  No.	Dose mg/kg	Dermal Reaction	Total Number of Animals	Animal Nos.	Period of signs in days  From - to
I	1000	No dermal reaction observed	1	2	Day 0 - Day 14

 

Group  No.	Dose mg/kg	Dermal Reaction	Total Number of Animals	Animal Nos.	Period of signs in days  From - to
I	2000	No dermal reaction observed	1	3	Day 0 - Day 14

 

Main Study:

Group  No.	Dose mg/kg	Dermal Reaction	Total Number of Animals	Animal Nos.	Period of signs in days  From - to
II	2000	No dermal reaction observed	2	4, 5	Day 0 - Day 14

 

 

Individual Animal - Evaluation of Dermal Reaction

 

Laboratory Test Item Code :TAS/122/062

Test System : Sprague Dawley Rat

Sex : Female  

Finding Study:

Group : I                                                                      Dose  : 200 mg/kg body weight

Animal	Dermal	D A Y S
No.	Reaction	0	1	2	3	4	5	6	7	8	9	10	11	12	13	14
1	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

 

Group : I                                                                    Dose  : 1000 mg/kg body weight

Animal	Dermal	D A Y S
No.	Reaction	0	1	2	3	4	5	6	7	8	9	10	11	12	13	14
2	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

 

Group : I                                                                    Dose  : 2000 mg/kg body weight

Animal	Dermal	D A Y S
No.	Reaction	0	1	2	3	4	5	6	7	8	9	10	11	12	13	14
3	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

 

Main Study:

Group : II                                                                   Dose  : 2000 mg/kg body weight

Animal	Dermal	D A Y S
No.	Reaction	0	1	2	3	4	5	6	7	8	9	10	11	12	13	14
4	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
5	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Individual Animal -Clinical Signs of Toxicity and Mortality

 

Laboratory Test Item Code :TAS/122/062

Test System : Sprague Dawley Rat

Sex : Female

Finding Study:

Group No.	Dose mg/kg	Observed Signs	Total Number of Animals	Animal Nos.	Period of signs in days From - to	Mortality
I	200	No clinical signs observed	1	1	Day 0 - Day 14	0

 

Group No.	Dose mg/kg	Observed Signs	Total Number of Animals	Animal Nos.	Period of signs in days From - to	Mortality
I	1000	No clinical signs observed	1	2	Day 0 - Day 14	0

 

Group No.	Dose mg/kg	Observed Signs	Total Number of Animals	Animal Nos.	Period of signs in days From - to	Mortality
I	2000	No clinical signs observed	1	3	Day 0 - Day 14	0

 

Main Study:

Group No.	Dose mg/kg	Observed Signs	Total Number of Animals	Animal Nos.	Period of signs in days From - to	Mortality
II	2000	No clinical signs observed	2	4	Day 0 - Day 14	0
				5	Day 0 - Day 14	0

Summary of Gross Pathological Findings

 

Laboratory Test Item Code :TAS/122/062

Test System : Sprague Dawley Rat

Sex : Female

Finding Study:

Group No.	Dose mg/kg	Animal Numbers	Animal Fate	Gross Pathological Findings
I	200	1	TS	No abnormality detected

 

Group No.	Dose mg/kg	Animal Numbers	Animal Fate	Gross Pathological Findings
I	1000	2	TS	No abnormality detected

 

Group No.	Dose mg/kg	Animal Numbers	Animal Fate	Gross Pathological Findings
I	2000	3	TS	No abnormality detected

 

                    Main Study:

Group No.	Dose mg/kg	Animal Numbers	Animal Fate	Gross Pathological Findings
II	2000	4, 5	TS	No abnormality detected

 

                     TS = Terminal Sacrifice

Mean Body Weight and Percent Body Weight Gain (g)

 

Laboratory Test Item Code :TAS/122/062

Test System : Sprague Dawley Rat

Sex : Female

Finding Study:

Group No.	Dose (mg/kg body weight)		Body weight Day 0	Body weight Day 7	% body weight gain day 0-7	Body weight Day 14	% body weight gain day 7- 14	% body weight gain day 0- 14
I	200	Mean	233.8	243.5	4.15	251.7	3.37	7.66
		± SD	-	-	-	-	-	-

 

Group No.	Dose (mg/kg body weight)		Body weight Day 0	Body weight Day 7	% body weight gain day 0-7	Body weight Day 14	% body weight gain day 7- 14	% body weight gain day 0- 14
I	1000	Mean	225.2	240.4	6.75	255.0	6.07	13.23
		± SD	-	-	-	-	-	-

 

Group No.	Dose (mg/kg body weight)		Body weight Day 0	Body weight Day 7	% body weight gain day 0-7	Body weight Day 14	% body weight gain day 7- 14	% body weight gain day 0- 14
I	2000	Mean	228.2	240.1	5.21	253.1	5.41	10.91
		± SD	-	-	-	-	-	-

 

Main Study:

Group No.	Dose (mg/kg body weight)		Body weight Day 0	Body weight Day 7	% body weight gain day 0-7	Body weight Day 14	% body weight gain day 7- 14	% body weight gain day 0- 14
II	2000	Mean	236.55	249.00	5.26	260.10	4.46	9.95
		± SD	2.33	3.39	0.40	3.96	0.17	0.59

 

Interpretation of results:

other: not irritating

Conclusions:

Based on all the observations and results, it was concluded that the test chemical was not irritating to the skin under the experimental conditions tested and is classified as a "non-irritant" to skin as per CLP classification.

Executive summary:

A study was designed and conducted to determine the dermal reaction profile of the test chemical in Sprague Dawley rats. The study was performed as per OECD Guidelines 402 and complying to the GLP procedures. 5 female young adult, non-pregnant rats were used for the study. The animals were kept in their cages for at least 5 days prior to administration for acclimatization to the laboratory condition and after acclimatization period, animals were randomly selected. Approximately 24 hours before application, the hair of each rat was closely clipped from the trunk (dorsal surface and sides from scapular to pelvic area) with an electric clipper, so as to expose at least 10% of the body surface area. The test item was applied directly onto the exposed skin of the animal, taking care to spread the test item evenly over the entire area of approximately 10% of the total body surface area or as much of the area as can reasonably be covered. The test item was held in contact with the skin using a porous gauze dressing and non-irritating tape around the animal to cover the exposure site for first 24 hours exposure period. Elizabethan collar was placed on each animal for first 24 hours after application of the test item. These collars prevent ingestion of test item. Following 24 hours of exposure, the wrapping was removed and the test site wiped free of excess test item. Distilled water was used to remove residual test item. A single dose of 200 mg/kg body weight of the test item was administered to 1 female animal. No death or clinical signs of toxicity was observed during first 48 hours, hence, additional 1 female animal was administered at the dose of 1000 mg/kg body weight. Administration of 1000 mg/kg body weight did not reveal any clinical signs of toxicity or death during first 48 hours, hence, additional 1 female animal was administered at the dose of 2000 mg/kg body weight. Administration of 2000 mg/kg body weight did not reveal any clinical signs of toxicity or death during first 48 hours. As the dose range finding study revealed no mortality or clinical signs at the maximum dose of 2000 mg/kg, the main study was initiated with two additional animals. The animals were administered with a dose of 2000 mg/kg body weight in sequential manner at 48 hours intervals. Animals from dose range finding study treated at the dose levels of 200 mg/kg, 1000 mg/kg and 2000 mg/kg and animals from main study treated at the dose level of 2000 mg/kg exhibited normal body weight gain and revealed no clinical signs of toxicity or mortality during the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. The overall irritation score of the substance was determined to be 0 and no erythema and edema (skin irritation) were found at the end of 14 days observation period after patch removal. Thus, based on all the observations and results, it was concluded that the test chemical was not irritating to the skin under the experimental conditions tested and is classified as a "non-irritant" to skin as per CLP classification.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed journal

Qualifier:

according to guideline

Guideline:

other: Draize test or modified Draize test in rabbits

Principles of method if other than guideline:

Eye irritation study was conducted on rabbits to evaluate the irritation potential of the test chemical

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Albino Rabbits were used

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

0.5%

Duration of treatment / exposure:

No data available

Observation period (in vivo):

4 days

Number of animals or in vitro replicates:

3

Details on study design:

TEST SITE
- Area of exposure: No data available
- % coverage: No data available
- Type of wrap if used: No data available

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data available
- Time after start of exposure: No data available

SCORING SYSTEM: redness ,chemosis and discharge from eye

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Reversibility:

fully reversible within: day 4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Day 1 readings showed scores of 1, 2, and 3 for redness and chemosis. Discharge was also noted in all three animals. These signs generally remained at day 2, subsided by day 3 and cleared by day 4. Cornea and iris were not involved and remained normal.

Other effects:

No data available

Interpretation of results:

other: not irritating

Conclusions:

Day 1 readings showed scores of 1, 2, and 3 for redness and chemosis respectively. Discharge was also noted in all three animals. These signs generally remained at day 2, subsided by day 3 and cleared by day 4. Cornea and iris were not involved and remained normal.
Hence, the test chemical can be considered to be not irritating to rabbit eyes.

Executive summary:

Draize test or modified Draize test in rabbits was performed to evaluate the toxic nature of the test chemical. The test compound was instilled into the rabbit eye at a concentration of 0.5%. Day 1 readings showed scores of 1, 2, and 3 for redness and chemosis respectively. Discharge was also noted in all three animals. These signs generally remained at day 2, subsided by day 3 and cleared by day 4. Cornea and iris were not involved and remained normal.

Hence, the test chemical can be considered to be not irritating to rabbit eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation:

Various studies have been summarized to determine the level of dermal irritation/corrosion caused by the test chemical in living organisms. The studies are based on in vivo experiments in rats, rabbits, humans along with in vitro data for test chemical.

Study 1:

A study was designed and conducted to determine the dermal reaction profile of the test chemical in Sprague Dawley rats. The study was performed as per OECD Guidelines 402 and complying to the GLP procedures. 5 female young adult, non-pregnant rats were used for the study. The animals were kept in their cages for at least 5 days prior to administration for acclimatization to the laboratory condition and after acclimatization period, animals were randomly selected.

Approximately 24 hours before application, the hair of each rat was closely clipped from the trunk (dorsal surface and sides from scapular to pelvic area) with an electric clipper, so as to expose at least 10% of the body surface area. The test item was applied directly onto the exposed skin of the animal, taking care to spread the test item evenly over the entire area of approximately 10% of the total body surface area or as much of the area as can reasonably be covered. The test item was held in contact with the skin using a porous gauze dressing and non irritating tape around the animal to cover the exposure site for first 24 hours exposure period. Elizabethan collar was placed on each animal for first 24 hours after application of the test item. These collars prevent ingestion of test item. Following 24 hours of exposure, the wrapping was removed and the test site wiped free of excess test item. Distilled water was used to remove residual test item. A single dose of 200 mg/kg body weight of the test item was administered to 1 female animal. No death or clinical signs of toxicity was observed during first 48 hours, hence, additional 1 female animal was administered at the dose of 1000 mg/kg body weight. Administration of 1000 mg/kg body weight did not reveal any clinical signs of toxicity or death during first 48 hours, hence, additional 1 female animal was administered at the dose of 2000 mg/kg body weight. Administration of 2000 mg/kg body weight did not reveal any clinical signs of toxicity or death during first 48 hours. As the dose range finding study revealed no mortality or clinical signs at the maximum dose of 2000 mg/kg, the main study was initiated with two additional animals. The animals were administered with a dose of 2000 mg/kg body weight in sequential manner at 48 hours intervals. Animals from dose range finding study treated at the dose levels of 200 mg/kg, 1000 mg/kg and 2000 mg/kg and animals from main study treated at the dose level of 2000 mg/kg exhibited normal body weight gain and revealed no clinical signs of toxicity or mortality during the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. The overall irritation score of the substance was determined to be 0 and no erythema and edema (skin irritation) were found at the end of 14 days observation period after patch removal. Hence, it was concluded that the test chemical was Non-Irritating to the skin of female Sprague Dawley rats under the experimental conditions tested and classified as “Category- Not Classified” as per CLP Classification.

Study 2:

This result is supported by an in-vitro dermal irritation study performed according to the OECD 439 In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method” to determine the irritation potential of the test chemical. The MatTek EpiDerm™ model was used to assess the potential dermal irritation of the test article by determining the viability of the tissues following exposure to the test article via MTT. The objective of this study was to assess the dermal irritation potential of test article Tissues were exposed to test article and controls for ~one hour, followed by a 42 hour post-exposure recovery period. The viability of each tissue was determined by MTT assay. The MTT data shows that the assay quality controls were met. The mean tissue viabilities for the Positive control, Methyl acetate were 6.5%, 10.7% respectively in the first and second run, whereas the tissue viabilities of the negative control, Tissue culture water remained at 100% in the both the runs. The Mean % tissue viability compared to negative control (n=3) of the test substance was determined to be 100.2%. Hence, under the experimental test conditions it was concluded that test substance was considered to be not irritating to the human skin and being classified as “Not Classified'' as per CLP Regulation.

Eye Irritation:

Various studies have been summarized to determine the extent of ocular damage caused by the test chemical in living organisms. The studies are based on in vivo experiments in rabbits along with in vitro data for test chemical.

Study 1:

Draize test or modified Draize test in rabbits was performed to evaluate the toxic nature of the test chemical. The test compound was instilled into the rabbit eye at a concentration of 0.5%. Day 1 readings showed scores of 1, 2, and 3 for redness and chemosis respectively. Discharge was also noted in all three animals. These signs generally remained at day 2, subsided by day 3 and cleared by day 4. Cornea and iris were not involved and remained normal.

Study 2:

This is supported by the results of an in vitro eye irritation study performed according to the OECD 492 test guideline to determine the irritation potential of the test chemical. The MatTek EpiOcular™ model was used to assess the potential ocular irritation of the test article by determining the viability of the tissues following exposure to the test article via MTT. The objective of this study was to assess the ocular irritation potential of test article. Tissues were exposed to test article and controls for ~6 hours, followed by a ~25 minute post-soak and approximately 18 hour recovery after the post-soak. The viability of each tissue was determined by MTT assay.  The mean OD570 of the negative control tissues was 1.665 and 1.589, which met the acceptance criteria of greater than 0.8 and less than 2.5. The mean relative viability of the positive control tissues was 45.2 and 36.5, which met the acceptance criterion of less than 50%. The differences in viability between identically treated tissues were 0.03 to 5.60, which met the acceptance criterion of less than 50%. All controls passed the acceptance criteria for a valid study. The mean % tissue viability of test chemical was determined to be 100.2%. Thus,the test chemical was considered to be not irritating to  MatTek EpiOcular Tisssue Model OCL-200 and being classified as “Not classified’’. Hence, the test chemical can be considered to be not irritating to rabbit eyes.

Available studies fortest chemicalindicate that it lacks the potential to cause any irritation to the eyes. Hence, it can be considered to be not irritating to eyes. Comparing the above annotations with the criteria of the CLP regulation, the test chemical can be classified under the category “Not Classified”.

Justification for classification or non-classification

All available studies for the test chemical indicate a strong possibility that it is not likely to cause any irritation or corrosion to the skin and eyes.Hence, the test chemical can be considered to be not irritating to skin and eyes and it can be classified under the category "Not Classified" as per CLP regulation.