Registration Dossier
Registration Dossier
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EC number: 211-889-1 | CAS number: 705-86-2
Endpoint summary
Administrative data
Description of key information
Skin Irritation:
A study was designed and conducted to determine the dermal irritation/corrosion potential of the test chemical, Decan-5-Olide (CAS:705 -86 -2) in Newzealand white rabbits. The study was performed as per OECD Guideline 404. The total mean score of skin reaction was 0 at 1, 24, 48, 72 hours respectively post removal of the test patch. There were no clinical signs and no pre-terminal deaths in any of the rabbits. No abnormalities were detected at necropsy.
Hence, it was concluded that the test chemical was Non-Irritating to the skin of Newzealand white rabbits under the experimental conditions tested and classified as “Category- Not Classified” as per CLP Classification.
Eye Irritation:
The acute eye irritation / corrosion study in New Zealand White rabbits was conducted to evaluate the eye irritation / corrosion potential of Decan-5-Olide (CAS:705 -86 -2) in New Zealand White Rabbits" when a single dose of the test item was instilled into the conjunctival sac of the rabbit’s eye according to OECD 405 guideline. The eyes of each rabbit were examined at 1, 24, 48 and 72 hours post-instillation and scored. The individual mean score for animal nos. 1, 2 and 3 at 24, 48, 72 hours (at treated site)for corneal opacity, iris, conjunctiva and chemosis were found 0 respectively. There were no clinical signs of toxicity and pre-terminal death, and no abnormality was detected at necropsy.
Thus, it was concluded that the test chemical was not observed to be an ocular irritant and thus under the experimental conditions tested and classified as “Category- Not Classified” as per CLP Classification.
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 study report.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted: 28th July 2015
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Name : Decan-5-olide
Chemical Name (IUPAC) : Decan-5-olide
Molecular Formula : C10-H18-O2
Molecular Weight : 170.25
Origin : Organic
Physical state : Colourless liquid
Purity as per Certificate of Analysis : 97.2 %
Batch No. : P586
InChI: InChI=1S/C10H18O2/c1-2-3-4-6-9-7-5-8-10(11)12-9/h9H,2-8H2,1H3
Smiles : CCCCCC1CCCC(=O)O1 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Eurofins Advinus limited, Bengaluru 560058
- Age at study initiation: 6 months
- Weight at study initiation: 2.6342 to 2.6772 kg
- Housing: The rabbits were housed individually in rabbit cages (approx. size: Length 65 x Breadth 65 x Height 45 cm) with noryl shallow cage body and facil ities for pelleted food (Stainless steel feed hopper) and drinking water (750 Markrolon® bottle fitted with sipper tube) and noryl perforated raised shelf for en richment.
- Diet (e.g. ad libitum): ad libitum The animals were offered rabbit feed manufactured Krishna Valley Agro-tech LLP, MIDC Kupwad block, Sangli, Maharashtra.
- Water (e.g. ad libitum): The animals were provided deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on -line water filter-cum-purifier manufactured by Eureka Forbes Ltd., Mumbai 400 001, India
- Acclimation period: After physical examination good healthy animals were selected for the experiment. One rabbit (RBb947) was acclimatized for six days while the other two (RBb948 and RBb949) rabbits were acclimatized for seven days under laboratory conditions after physical examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 23°C
- Humidity (%): 65 to 66%
- Air changes (per hr): 13.3 to 14.3 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hour light, 12 hour dark cycle
IN-LIFE DATES: From:15 December 2021 To: 25 December 2021 - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- 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:
- Three male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: Left side of the dorsolateral trunk surface
- % coverage: 6 cm X 6 cm
- Type of wrap if used: The cotton gauze of size approximately 6 cm2 (2 x 3 cm of 6 ply). Patches were secured to the body of the animal by an adhesive ta pe, and a crepe bandage was wrapped around the torso of the animal, which was anchored using safety pins.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The applied area was washed with de-ionized water to remove the residual test item.
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS : The reactions were assessed at 1, 24, 48, 72 hours, post removal of test patches.
SCORING SYSTEM: Draize method - Irritation parameter:
- erythema score
- Remarks:
- For Test item Treated area
- Basis:
- animal:
- Remarks:
- #1, #2 and #3
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- For Test item Treated area
- Basis:
- animal:
- Remarks:
- #1, #2 and #3
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- For Control area
- Basis:
- animal:
- Remarks:
- #1, #2 and #3
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- For Control area
- Basis:
- animal:
- Remarks:
- #1, #2 and #3
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Skin reaction were assessed at 1, 24, 48, 72 hours, post removal of the test patch.
Single animal: The test patches with the respective contact periods of 3 minutes, 1 hour and 4-hour were removed and flushed with de-ionized water and skin reaction was assessed immediately after washing of the respective control and treatment patches. The reactions were assessed at 1, 24, 48, 72 hours, post removal of test patches.
Additional two animals: Four hours after application, treated and control patches on the skin was removed and skin flushed with de-ionized water and skin reaction was assessed at 1, 24, 48, 72 hours, post removal of test patches.
Additional two animals: Four hours after application, treated and control patches on the skin was removed and skin flushed with de-ionized water and skin reaction was assessed at 1, 24, 48, 72 hours, post removal of test patches.
There were no skin reactions at 1, 24, 48, 72 hours, post removal of the test patch. The total mean score of skin reaction was 0 at 1, 24, 48, 72 hours respectively post removal of the test patch. - Other effects:
- Clinical Signs and Pre-Terminal Deaths: There were no clinical signs and no pre-terminal deaths during the course of the experiment.
Body weights: The body weights of all the rabbits increased throughout the observation period.
Necropsy: There were no abnormalities at necropsy - Interpretation of results:
- other: Non-irritating
- Conclusions:
- Based on the present study results, the test item, DECAN-5-OLIDE (CAS: 725-86-2) is “Non-irritant” to the skin when tested in New Zealand White rabbits according to OECD 404 guideline.
- Executive summary:
The acute skin irritation / corrosion study in New Zealand White Rabbits was conducted to evaluate the skin irritation potential of Decan-5-Olide according to OECD 404 guidline. Three healthy young adult male rabbits were used for the study. Body weights were recorded on day of treatment (prior to application) and at termination. Rabbits with good intact skin were selected for the study. The fur on the left side of the dorsolateral trunk surface [about 19 x 14 cm] was clipped with an electric clipper, approximately 24 hours prior to treatment. A volume of 0.5 mL of the undiluted test item was applied in between the prepared area of the skin and the cotton gauze of size approximately 6 cm2 (2 x 3 cm of 6 ply). A control patch (bare cotton gauze) was applied 3 – 4 cm anterior to the 4-hour test patch. All the patches were secured to the body of the animal by an adhesive tape, and a crepe bandage (except for 3 minutes patch) was wrapped around the torso of the animal. After 4 hours contact period, the treated area was washed with de-ionized water. The study was conducted in a stepwise manner (i.e., one rabbit for the initial test and two rabbits for the confirmatory test). The degree of irritation was evaluated at 1, 4, 24, 48 and 72 hours post removal of the test patch. The total mean score of skin reaction was 0 at 1, 24, 48, 72 hours respectively post removal of the test patch. There were no clinical signs and no pre-terminal deaths in any of the rabbits. No abnormalities were detected at necropsy.Based on the present study results,the test item,Decan-5-Olideis considered as“Non-irritant”to the skin of New Zealand White rabbits.
Reference
IndividualBody Weights, Body Weight Change, Clinical Signs, Pre-terminal Deaths and Necropsy Findings
Rabbit No. |
Sex |
Body weights (kg) |
Clinical signs*
|
Pre-terminal deaths |
Necropsy findings |
||
At Treatment
|
At Termination
|
Body weight change# |
|
||||
RBb947 |
M |
2.6342 |
2.6839 |
0.0497 |
N |
Nil |
NAD |
RBb948 |
M |
2.6716 |
2.6994 |
0.0278 |
N |
NAD |
|
RBb949 |
M |
2.6772 |
2.7219 |
0.0447 |
N |
NAD |
|
M: Male N: Normal NAD: No Abnormality Detected N: Normal
*: Observation of clinical signs is applicable for throughout the experimental period.
#: [At Termination - At Treatment]
Individual Skin Reaction Scores:
Rabbit No. |
Score |
Application |
Observations (post removal of the 4-hour test patch) |
|||
1 hour |
24 hours |
48 hours |
72 hours |
|||
RBb947* |
Erythema |
Control |
0 |
0 |
0 |
0 |
Treatment |
0 |
0 |
0 |
0 |
||
Edema |
Control |
0 |
0 |
0 |
0 |
|
Treatment |
0 |
0 |
0 |
0 |
||
RBb948 |
Erythema |
Control |
0 |
0 |
0 |
0 |
Treatment |
0 |
0 |
0 |
0 |
||
Edema |
Control |
0 |
0 |
0 |
0 |
|
Treatment |
0 |
0 |
0 |
0 |
||
RBb949 |
Erythema |
Control |
0 |
0 |
0 |
0 |
Treatment |
0 |
0 |
0 |
0 |
||
Edema |
Control |
0 |
0 |
0 |
0 |
|
Treatment |
0 |
0 |
0 |
0 |
||
0: No Erythema / No Edema
*: The responses (skin reactions) were assessed immediately after the removal of the test patches at 3 minutes, 1 hour and 4thhour after application the score of erythema and edema was “0” and it indicated that the test item was not severely irritating or corrosive
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 study report.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 9th October 2017, Corrected 14 June 2021
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Name : Decan-5-olide
Chemical Name (IUPAC) : Decan-5-olide
Molecular Formula : C10-H18-O2
Molecular Weight : 170.25
Origin : Organic
Physical state : Colourless liquid
Purity as per Certificate of Analysis : 97.2 %
Batch No. : P586
InChI: InChI=1S/C10H18O2/c1-2-3-4-6-9-7-5-8-10(11)12-9/h9H,2-8H2,1H3
Smiles : CCCCCC1CCCC(=O)O1 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Livian Biolabs Pvt Ltd. Tumkur, Karnataka
- Age at study initiation: 4 - 5 months
- Weight at study initiation: 2.6010 to 2.7128 kg
- Housing: The rabbits were housed individually in rabbit cages (approx. size: L 65 x B 65 x H 45 cm) with noryl shallow cage body and facilities for pelleted f ood (Stainless steel feed hopper) and drinking water (750 mL Markrolon® bottle fitted with sipper tube). The perforated noryl raised shelf for enrichment wa s provided
- Diet (e.g. ad libitum): ad libitum, The animals were offered rabbit feed manufactured by Krishna Valley Agrotech LLP, MIDC Kupwad block, Sangli, Maharasht ra.
- Water (e.g. ad libitum): ad libitum, Deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-c um-purifier manufactured by Eureka Forbes Ltd., Mumbai 400 001, India, was provided to animals in Markrolon® bottles with stainless steel sipper tubes
- Acclimation period: One rabbit (RBb950 was acclimatized for Six days while the other two rabbits (RBb951 and RBb952 were acclimatized for Seven days under laboratory conditions after physical examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 23°C
- Humidity (%): 65 to 67 %
- Air changes (per hr): 14.3 air changes/hour
- Photoperiod (hrs dark / hrs light): 12-hour light and 12 hour dark cycle
IN-LIFE DATES: From: 05 January 2022 To: 15 January 2022 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- 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 hours
- Observation period (in vivo):
- The rabbit used for the single animal test was observed for a period of 5 days and the additional two rabbits were observed for a period of 4 days post-instillation. The eyes of each rabbit were examined for ocular reaction at 1, 24, 48 and 72 hours post-instillation and scored.
- Number of animals or in vitro replicates:
- Three female rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye irrigated with normal saline for one minute to remove the residual test item.
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize method
- Irritation parameter:
- cornea opacity score
- Basis:
- animal:
- Remarks:
- #1, #2 and #3
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- Untreated (control eye)
- Irritation parameter:
- iris score
- Basis:
- animal:
- Remarks:
- #1, #2 and #3
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- Untreated (control eye)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal:
- Remarks:
- #1, #2 and #3
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- Untreated (control eye)
- Irritation parameter:
- chemosis score
- Basis:
- animal:
- Remarks:
- #1, #2 and #3
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- UNtreated (control eye)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal:
- Remarks:
- #1, #2 and #3
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- Treated eye
- Irritation parameter:
- iris score
- Basis:
- animal:
- Remarks:
- #1, #2 and #3
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- Treated eye
- Irritation parameter:
- conjunctivae score
- Basis:
- animal:
- Remarks:
- #1, #2 and #3
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- Treated eye
- Irritation parameter:
- chemosis score
- Basis:
- animal:
- Remarks:
- #1, #2 and #3
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- Treated eye
- Irritant / corrosive response data:
- The rabbit used for the single animal test was observed for a period of 5 days and the additional two rabbits were observed for a period of 4 days post-instillation. The eyes of each rabbit were examined for ocular reaction at 1, 24, 48 and 72 hours post-instillation and scored.
The eyes of each rabbit were examined by using an ophthalmoscope at 1, 24, 48, 72 hours post-instillation and scored.
In addition, all the treated eyes were examined using ophthalmic fluorescein sodium at 24 hours post-instillation for all the three rabbits.
The individual mean score for animal nos. 1, 2 and 3 at 24, 48, 72 hours (at treated site)for corneal opacity, iris, conjunctiva and chemosis were found 0 respectively. - Other effects:
- Clinical signs and pre-terminal deaths : There were no clinical signs of toxicity and pre-terminal deaths.
Body Weights : The body weights of all rabbits increased during the observation period.
Necropsy : There was no abnormality detected in any of the animals at necropsy - Interpretation of results:
- other: Non-irritating
- Conclusions:
- Based on the present study results the test item Decan-5-Olide (CAS:705-86-2) is “Non - irritant to Eyes” of the eye when tested in New Zealand white rabbits according to OECD 405 guideline.
- Executive summary:
The acute eye irritation / corrosion study in New Zealand White rabbits was conducted to evaluate the eye irritation / corrosion potential of Decan-5-Olide (CAS:705 -86 -2): Acute Eye Irritation / Corrosion study in New Zealand White Rabbits" when a single dose of the test item was instilled into the conjunctival sac of the rabbit’s eye according to OECD 405 guideline. On test day one (treatment day), a volume of 0.1 mL of undiluted test item was instilled into the conjunctival sac of the left eye of the animal after gently pulling the lower lid away from the eyeball. The lids were then held together gently for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. All the rabbits were treated in a similar manner. The rabbit used for the single animal test was observed for a period of 5 days and the additional two rabbits were observed for a period of 4 days post-instillation. The eyes of each rabbit were examined examined by using an ophthalmoscope at 1, 24, 48 and 72 hours post-instillation and scored. The rabbits were observed for clinical signs and pre-terminal deaths twice daily with a minimum of 6 hours gap between observations on days 2 to 5/4. Body individual weights were recorded at the start of acclimatization, day 1 of treatment (prior to test item instillation) and at the termination of the observation period. The individual mean score for animal nos. 1, 2 and 3 at 24, 48, 72 hours (at treated site)for corneal opacity, iris, conjunctiva and chemosis were found 0 respectively. There were no clinical signs of toxicity and pre-terminal death, body weights of all rabbits increased during the observation periodand no abnormality was detected at necropsy.Based on the present study results the test itemDecan-5-Olideis“Non - irritant to Eyes”ofthe eye of New Zealand white rabbits.
Reference
Individual Body Weight, Clinical Signs and Necropsy Findings:
Animal No. |
Body weight (kg) |
|
Necropsy findings |
|
||||||||||||
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
|
|||||||||||
Sex |
At Start of Acclimatization |
At Treatment |
At Termination |
AM
|
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
|||
RBb950 |
F |
2..5681 |
2.6010 |
2.6840 |
N |
N
|
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
|
RBb951 |
F |
2.5937 |
2.6739 |
2.7486 |
N |
N |
N |
N |
N |
N |
N |
N |
- |
- |
NAD |
|
RBb952 |
F |
2.6385 |
2.7128 |
2.7912 |
N |
N |
N |
N |
N |
N |
N |
N |
- |
- |
NAD |
|
NAD: No Abnormality Detected F: Female AM: Ante Meridian PM: Post Meridian h: hour N: Normal
Note: There are no pre-terminal deaths
Individual Animals Eye Irritation Scores (Treated Eyes):
Rabbit Number |
RBb950 |
RBb951 |
RBb952 |
|||||||||
Eye Reactions |
Hour |
Hour |
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 |
Area of Opacity |
NA |
NA |
NA |
NA |
NA |
NA |
NA |
NA |
NA |
NA |
NA |
NA |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctival Redness |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctival Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
NA: Not applicable
Eye Irritation Scores - Mean Values of all Animals (Treated Eye):
Eye reaction |
Hours |
|||
1 |
24 |
48 |
72 |
|
Corneal Opacity |
0 |
0 |
0 |
0 |
Area of Opacity |
NA |
NA |
NA |
NA |
Iris |
0 |
0 |
0 |
0 |
Conjunctival redness |
0 |
0 |
0 |
0 |
Conjunctival chemosis |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation:
The available data from the skin irritation study is as follows:
The acute skin irritation / corrosion study in New Zealand White Rabbits was conducted to evaluate the skin irritation potential of Decan-5-Olide according to OECD 404 guidline. Three healthy young adult male rabbits were used for the study. Body weights were recorded on day of treatment (prior to application) and at termination. Rabbits with good intact skin were selected for the study. The fur on the left side of the dorsolateral trunk surface [about 19 x 14 cm] was clipped with an electric clipper, approximately 24 hours prior to treatment. A volume of 0.5 mL of the undiluted test item was applied in between the prepared area of the skin and the cotton gauze of size approximately 6 cm2 (2 x 3 cm of 6 ply). A control patch (bare cotton gauze) was applied 3 – 4 cm anterior to the 4-hour test patch. All the patches were secured to the body of the animal by an adhesive tape, and a crepe bandage (except for 3 minutes patch) was wrapped around the torso of the animal. After 4 hours contact period, the treated area was washed with de-ionized water. The study was conducted in a stepwise manner (i.e., one rabbit for the initial test and two rabbits for the confirmatory test). The degree of irritation was evaluated at 1, 4, 24, 48 and 72 hours post removal of the test patch. The total mean score of skin reaction was 0 at 1, 24, 48, 72 hours respectively post removal of the test patch. There were no clinical signs and no pre-terminal deaths in any of the rabbits. No abnormalities were detected at necropsy.Based on the present study results,the test item,Decan-5-Olideis considered as“Non-irritant”to the skin of New Zealand White rabbits andis classified as follows: The test item does not meet theclassification criteriaas per as per Globally Harmonized System of Classification and Labelling of Chemicals (GHS), 2021, as there were no skin reactions in any of the rabbits.
Eye Irritation Study:
The available data from the eye irritation study is as follows:
The acute eye irritation / corrosion study in New Zealand White rabbits was conducted to evaluate the eye irritation / corrosion potential of Decan-5-Olide (CAS:705 -86 -2): Acute Eye Irritation / Corrosion study in New Zealand White Rabbits" when a single dose of the test item was instilled into the conjunctival sac of the rabbit’s eye according to OECD 405 guideline. On test day one (treatment day), a volume of 0.1 mL of undiluted test item was instilled into the conjunctival sac of the left eye of the animal after gently pulling the lower lid away from the eyeball. The lids were then held together gently for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. All the rabbits were treated in a similar manner. The rabbit used for the single animal test was observed for a period of 5 days and the additional two rabbits were observed for a period of 4 days post-instillation. The eyes of each rabbit were examined examined by using an ophthalmoscope at 1, 24, 48 and 72 hours post-instillation and scored. The rabbits were observed for clinical signs and pre-terminal deaths twice daily with a minimum of 6 hours gap between observations on days 2 to 5/4. Body individual weights were recorded at the start of acclimatization, day 1 of treatment (prior to test item instillation) and at the termination of the observation period. The individual mean score for animal nos. 1, 2 and 3 at 24, 48, 72 hours (at treated site)for corneal opacity, iris, conjunctiva and chemosis were found 0 respectively. There were no clinical signs of toxicity and pre-terminal death, body weights of all rabbits increased during the observation periodand no abnormality was detected at necropsy.Based on the present study results the test itemDecan-5-Olideis“Non - irritant to Eyes”ofthe eye of New Zealand white rabbits.
Justification for classification or non-classification
Based on the available results the test chemical, Decan-5-Olide (CAS:705 -86 -2) does not have a potential for the skin and eye irritation. Thus the test chemical can be considered to be not irritating to skin and eyes. Hence, the test chemical can be classified under the category "Not Classified" as per CLP Regulation.
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