Dodecan-1-ol, ethoxylated

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 experimental reports

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

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 irritation/corrosive potential of the test chemical after dermal application on the intact skin of New Zealand White rabbits

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dodecan-1-ol, ethoxylated

EC Number:

500-002-6

EC Name:

Dodecan-1-ol, ethoxylated

Cas Number:

9002-92-0

Molecular formula:

C58H118024

IUPAC Name:

Dodecan-1-ol, ethoxylated

Test material form:

liquid

Details on test material:

Identification: Dodecan-1-ol, ethoxylated
Appearance: Colourless clear liquid
AI Content: 99.28%
Manufactured date: December, 2012
Expiry Date: December, 2014
Storage conditions: Room temperature (20 - 30 °C)
Safety precautions: Aprons, masks, caps, gloves and goggles were used to ensure the health and safety of the Personnel.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: LIVEON BIOLABS PVT. LTD
- Sex: Male
- Age at study initiation: 3-3.5 MONTHS
- Weight at study initiation: Minimum: 1.854 kg and Maximum: 2.568 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
- Acclimatisation: Rabbits were acclimatised to the test conditions for a period of 6 days (Animal No.-1) and 8 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 study no., study type, test system, sex, dose, experiment start date and experiment completion date.
- 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.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 20.50 °C Maximum: 22.30 °C
- Humidity (%): Minimum: 52.80 % Maximum: 67.40 %
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

Preparation of Application Site
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.

Test Item Application Procedure
The 0.5 ml of test item (as such) was applied uniformly over clipped area (approximately 6 X 6 cm) of the trunk of each rabbit skin (treated site) and 0.5 ml distilled water was applied at control site. Test item was held in contact with the skin with a porous gauze dressing and non-irritating tape (Micropore 3”) throughout a 4-hour exposure period, to prevent access by the rabbits to the patch and resultant ingestion of the test item. At the end of the exposure period, residual test item was removed by using cotton soaked in distilled water.
A single rabbit (Animal No. 1) was used for initial testing. The patch was removed after 4 h and the responses graded, no erythema and oedema was observed at 1 hour, 24 hour, 48 hour and 72 hour in animal no. 1. Hence the confirmatory test was conducted on additional two rabbits (No. 2 and 3) after 24 hour to confirm the non irritant nature of the test item.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

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.
SCORING SYSTEM: Draize Method

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

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:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Evaluation of Skin Irritation:
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, revealed no erythema and no oedema at 1, 24, 48 and 72 hour observation post patch removal.
Animal No. 2 and 3, revealed no erythema and no oedema at 1, 24, 48 and 72 hour observation post patch removal.
The individual mean score at 24, 48 and 72 hours for animal nos. 1, 2 and 3 were 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively.

Other effects:

Clinical Observation:
No systemic toxicity was observed at treated rabbits during the experimental period.
Mortality:
No mortality was observed during the observation period.

Any other information on results incl. tables

Skin Reaction

 

In Treated area Dose:0.5 ml of test item                                                                          Sex:Male

 

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 area  Dose:0.5 ml of distilled water                                                            Sex:Male

 

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

Mean Individual Animal Score at 24, 48 and 72 hours

 

Animal Number                   Observations	1	2	3
Erythema	0.00	0.00	0.00
Oedema	0.00	0.00	0.00

 

Table 2

Individual Animal BodyWeight

Sex:Male

Animal No.	Body Weight (kg)
	Prior to Dosing	At termination
1	2.568	2.610
2	1.854	1.922
3	1.926	1.980

Key: kg = kilogram

Table 3

Individual AnimalClinicalSigns

Sex:Male

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 individual mean score at 24, 48 and 72 hours for animal nos. 1, 2 and 3 were 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively. 
Hence, it was concluded that the test chemical was Non-Irritating to the skin of male New Zealand White rabbits under the experimental conditions tested and Classified as “Category- Not Classified” as per GHS Classification.

Executive summary:

Acute Dermal Irritation/corrosion Study of the test chemical in Rabbits, was performed as per OECD guideline No. 404. Three healthy young adult male rabbits were used for conducting acute dermal irritation study.Body weights were recorded on day 0 (prior to application) and at termination.Rabbits with good intact skin were selected for the study. The hairs of all the rabbits were clipped at contralateral sites, approximately 24 hours prior to treatment.A dose of 0.5 ml of test item (as such) was applied to the skin,over an area of approximately 6 x 6 cm clippedof 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 in animal no. 1, no erythema and no oedema observed at 1 hour of observation. At 24, 48 and 72 hours observation no erythema and oedema was observed in animal no 1.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 item. Animal No. 2 and 3, revealed no erythema and no oedema at 1, 24, 48 and 72 hour observation post patch removal. The patch was removed after 4 hours and rabbits wereobservedfor erythema and oedemaat 1, 24, 48 and 72 hours after patch removal, evaluated and graded as per Draize method. Animal No.1, 2 and 3 at 1, 24, 48 and 72 hour observation post patch removal, revealed no erythema and no oedema. The individual mean score at 24, 48 and 72 hours for animal nos. 1, 2 and 3 were 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively.  Hence, it was concluded that the test chemical was Non-Irritating to the skin of male New Zealand White rabbits under the experimental conditions tested and Classified as “Category- Not Classified” as per GHS Classification.