Dodecan-1-ol, ethoxylated

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 study 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 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

The objective of the study was to assess the dermal toxicity of the given test chemical after single dose application by dermal route in rats and an observation period of 14 days.

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

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:

not specified

Details on test material:

Identification: Dodecan-1-ol, ethoxylated
Appearance: Colourless clear liquid
AI Content : 99.28%
Sponsored by: Sustainability Support Services (Europe) AB
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:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: In-House Bred
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Healthy young adult animals were used for the study
- Weight at study initiation: Male:Minimum: 249 g and Maximum: 283 g
(Prior to Treatment)Female:Minimum: 234 g and Maximum: 246 g
- Housing:The animals were housed individually in polycarbonate cages.
- Bedding:All cages were provided with corn cobs
- 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 at least twice every week.
- Diet (e.g. ad libitum): All animals were provided conventional laboratory rodent diet, ad libitum.
- Water (e.g. ad libitum):Aqua guard filtered tap water was provided ad libitum via drinking bottles.
- Acclimation period:All animals were acclimatized to the test conditions for 7 days prior to administration of the test item.
- Identification:During Acclimatization, animals were temporarily marked by permanent marker, on their tails. After acclimatization, the animals were marked by toe pad micro tattooing and cage cards. Individual cage cards were labelled with study no., study type, test system, sex, animal number, experimental start and completion date.
- Randomization:Animals were selected manually. No computer generated randomization program was used.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 19.70 °C; Maximum: 23.30 °C
- Humidity (%): Minimum: Minimum: 51.80% ; Maximum: 64.30%
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12

IN-LIFE DATES: From:April 25, 2014 To: May 23, 2014

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: The test item was applied uniformly over clipped dorsal area of rat skin.
- % coverage: approximately 10%
- Type of wrap if used: Test item was held in contact with the skin with a porous gauze dressing and non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, residual test item was removed by using distilled water.
- Time after start of exposure: 24-hour.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

10 (Five per sex)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical Observation - After test item administration, individual animals were frequently observed at 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing). Subsequently, all animals were observed once a day during the 14 day observation period.
Mortality - Animals were observed twice daily for any mortality during the experimental period.
Body weight - All rats were weighed on days 0 (prior to dosing), 7 and 14.
Local Signs/Skin Reactions - All animals were observed once daily during days 1-14 (in common with clinical signs).
- Necropsy of survivors performed: yes, at the end of 14 day observation period, all the surviving rats were euthanised by overdose of CO2 and subjected to gross pathology examination, for external and internal observations.

Statistics:

No statistical analysis was performed since the study was terminated with limit test.

Results and discussion

Preliminary study:

Limit Test - Five male and five female wistar rats were treated with test item by a single dermal application at the dose level of 2000 mg/kg body weight. Since no test item related mortality was observed, the study was terminated with limit test only.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed at limit dose of 2000 mg/kg body weight of test item during the 14 day observation period.

Clinical signs:

other: All the animals were observed with normal clinical signs throughout the experimental period.

Gross pathology:

The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality.

Other findings:

not specified

Any other information on results incl. tables

Table 1: Individual Animal Body Weight (g) andBody Weight Change%

Dose:2000 mg/ kg bodyweight                                                                              Density:0.9137

Animal No.	Sex	Dose Volume* (ml)	Body Weight (gram)			Body Weight Change (%)
			Day 0	Day 7	Day 14	Day 0-7	Day 0-14
1	Male	0.60	273	295	308	8.06	12.82
2		0.56	258	279	304	8.14	17.83
3		0.62	283	305	312	7.77	10.25
4		0.55	249	264	272	6.02	9.24
5		0.56	256	268	276	4.69	7.81
6	Female	0.51	234	232	230	-0.85	-1.71
7		0.51	234	238	242	1.71	3.42
8		0.51	234	232	236	-0.85	0.85
9		0.54	246	243	244	-1.22	-0.81
10		0.52	236	236	239	0.00	1.27

Key:* = based on density and day 0 body weight

Table 2: Individual Animal Clinical Signs and Symptoms

Animal No.	Sex	Hour(s) - Day 0				Day
		1	2	3	4	1	2	3	4	5	6	7
1	Male	1	1	1	1	1	1	1	1	1	1	1
2		1	1	1	1	1	1	1	1	1	1	1
3		1	1	1	1	1	1	1	1	1	1	1
4		1	1	1	1	1	1	1	1	1	1	1
5		1	1	1	1	1	1	1	1	1	1	1
6	Female	1	1	1	1	1	1	1	1	1	1	1
7		1	1	1	1	1	1	1	1	1	1	1
8		1	1	1	1	1	1	1	1	1	1	1
9		1	1	1	1	1	1	1	1	1	1	1
10		1	1	1	1	1	1	1	1	1	1	1

 

Animal No.	Sex	Day
		8	9	10	11	12	13	14
1	Male	1	1	1	1	1	1	1
2		1	1	1	1	1	1	1
3		1	1	1	1	1	1	1
4		1	1	1	1	1	1	1
5		1	1	1	1	1	1	1
6	Female	1	1	1	1	1	1	1
7		1	1	1	1	1	1	1
8		1	1	1	1	1	1	1
9		1	1	1	1	1	1	1
10		1	1	1	1	1	1	1

Keys: 1 = Norma

Table 3: Individual Animal Mortality Record

 Dose:2000 mg/kg body weight

Animal No.	Sex	Days of Observation (0 to 14)
		Morning Observations	Evening Observations
1	Male	No mortality and morbidity	No mortality and morbidity
2		No mortality and morbidity	No mortality and morbidity
3		No mortality and morbidity	No mortality and morbidity
4		No mortality and morbidity	No mortality and morbidity
5		No mortality and morbidity	No mortality and morbidity
6	Female	No mortality and morbidity	No mortality and morbidity
7		No mortality and morbidity	No mortality and morbidity
8		No mortality and morbidity	No mortality and morbidity
9		No mortality and morbidity	No mortality and morbidity
10		No mortality and morbidity	No mortality and morbidity

Table 4:Summaryof Animal Body Weight (g) and Body Weight Changes (%)

Dose:2000 mg/kg body weight

Sex		Body Weight (gram)			Body Weight Changes (%)
		Day 0	Day 7	Day 14	Day 0-7	Day 0-14
Male	Mean	263.80	282.20	294.40	6.94	11.59
	SD	13.85	17.51	18.89	1.52	3.94
	n	5	5	5	5	5
Female	Mean	236.80	236.20	238.20	-0.24	0.60
	SD	5.22	4.60	5.50	1.18	1.99
	n	5	5	5	5	5

Keys:SD= Standard deviation, n = Number of animals

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

Under the conditions of this, acute dermal toxicity dose (LD50) value for given test chemical was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical does not exhibit acute dermal toxicity i.e it is acutely non toxic to animals.

Executive summary:

Acute dermal toxicity study was conducted for the given test chemical as per OECD No.402 in Wistar Rats.

Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Rats free from injury and irritation of skin were selected for the study. Twenty four hours prior to dermal application of test item, approximately 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight of test item based on the density (0.9137) and latest body weight was applied by single dermal application and observed for 14 days after treatment.

On test day 0, calculated amount of test item was applied directly on the intact skin of clipped area of rats; the porous gauze dressing was put on to the intact skin of clipped area. This porous gauze dressing was covered with a non-irritating tape. After the 24-hour application period, the dressings were removed and the skin was gently wiped with distilled water. The skin reactions were assessed.

The animals were observed daily for mortality and clinical signs, during the acclimatization period. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1‑14. Mortality was recorded after application on test day 0 and twice daily during days 1-14 (at least once on the day of sacrifice). Local signs / Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were re­corded on day 0 (prior to application) and on day 7 and 14. All animals were necropsied and examined macroscopically.

No mortality was observed in any animal till the end of the experimental period. All the animals were observed with normal clinical signs throughout the experimental period. In males, mean body weight was observed with increase on day 7 and 14, as compared to day 0. In females, mean body weight was observed with decrease on day 7 and increase on 14, as compared to day 0. The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality.

Under the conditions of this, acute dermal toxicity dose (LD50) value for given test chemical was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical does not exhibit acute dermal toxicity i.e it is acutely non toxic to animals.