Dodecan-5-olide

Skin irritation / corrosion

Administrative data

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 report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

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 test chemical after dermal application on the intact skin of rabbits.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dodecan-5-olide

EC Number:

211-932-4

EC Name:

Dodecan-5-olide

Cas Number:

713-95-1

Molecular formula:

C12H22O2

IUPAC Name:

6-heptyloxan-2-one

Test material form:

liquid

Details on test material:

- Name of the test material : Dodecan 5- olide
- Molecular formula : C12H22O2
- Molecular weight : 198.31 g/mol
- Substance type : Organic
- Physical state : Liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Species :Rabbits (Oryctolagus cuniculus)
Strain :New Zealand White
Age :3 to 3.5 Months (Approximately)
Sex :Female
Number of Animals: Three
Supplier/Source: Procured from LIVEON BIOLABS PVT. LTD. (CPCSEA Reg. No. 1610/RO/bc12/CPCSEA).
Health Status: Healthy young adults rabbits were used for the study. Females were nulliparous and non pregnant.
Body weight of animals: Minimum: 1.624 kg and Maximum: 2.376 kg (Prior to Treatment)

Acclimatisation: Rabbits were acclimatised to the test conditions for a period of 8 days (Animal No.-1) and 10 days (Animal No.-2 and 3) prior to the application of the test item.

Identification: During acclimatization marking was done with non toxic marker pen in the inside of left ear of rabbits and after acclimatization, animals were marked with permanent number in the inner side of right ear of rabbits. Permanent marker and cage card was used for identification. The individual cage cards were labelled with at least project No., species, strain, group, sex, animal number, experiment start and end date.

Husbandry Conditions
Diet : All animals were provided conventional laboratory rabbit diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No.: 200004.
Water : Aqua guard filtered tap water was provided ad libitum.
Husbandry : 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.

Experimental Room Condition
Temperature : Minimum: 19.90 °C, Maximum: 22.30 °C
Relative humidity: Minimum: 52.80 %, Maximum: 67.40 %
Light-dark-rhythm: 12:12
Air Changes: More than 12 changes per hour

Test system

Type of coverage:

semiocclusive

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): No data available

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml distilled water
- Concentration (if solution): No data available
- Lot/batch no. (if required): No data available- Purity: No data available

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 6 X 6 cm at contralateral sites
- Type of wrap if used: porous gauze dressing and non-irritating tape (Micropore 3”)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed by using cotton soaked in distilled water
- Time after start of exposure: 4hr

Control site: 0.5 ml distilled water was applied at control site.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 24, 48 and 72 hours after patch removal, evaluated and graded as per Draize method. The individual mean score at 24, 48 and 72 hours for Animal Nos. 1, 2 and 3 were 0.33, 0.33, 0.33 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively.

Fully reversible erythema and No edema (skin irritation) were observed at the end of 72 hour observation period after patch removal.

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.

Any other information on results incl. tables

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	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

 

 

 

 

 

In Control areaDose: 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	Right	0	0	0	0	0	0	0	0
3		Right	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	0.33	0.33	0.33
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	1.624	1.690
2	2.198	2.234
3	2.376	2.396

Table 3

Individual AnimalClinical 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.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 24, 48 and 72 hours after patch removal, evaluated and graded as per Draize method. The individual mean score at 24, 48 and 72 hours for Animal Nos. 1, 2 and 3 were 0.33, 0.33, 0.33 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively.

Fully reversible erythema and No edema (skin irritation) were observed at the end of 72 hour observation period after patch removal.
Hence, it was concluded that the test chemical was Non-Irritating to the skin of female New Zealand White rabbits under the experimental conditions tested and Classified as “Category- Not Classified as Skin Irritant” as per CLP Classification.

Executive summary:

Acute Dermal Irritation/corrosion Study of test chemical was performed as per OECD guideline No. 404 using three healthy young adult female. 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 item (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 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, animal no. 1 revealed very slight erythema (barely perceptible) and edema at 1, 24, 48 and 72 hours observation. Hence the confirmatory test was conducted on additional two animals (no. 2 and 3) to confirm the non-irritant nature of the test item.

After 4 hours of exposure, animal no. 2 and 3 revealed very slight erythema (barely perceptible) and no edema at 1, 24, 48 and 72 hours observation.

The patch was removed after 4 hours and animals were observed for erythema and oedema at 1, 24, 48 and 72 hours after patch removal, evaluated and graded as per DSraize method.

The individual mean score at 24, 48 and 72 hours for Animal Nos. 1, 2 and 3 were 0.33, 0.33, 0.33 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively

Hence, it was concluded that the test chemical was Non-Irritating to the skin of female New Zealand White rabbits under the experimental conditions tested and Classified as “Category- Not Classified as Skin Irritant” as per CLP Classification.