Alcohols, C16-18 and C18-unsatd., ethoxylated

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

02 - 24 Dec 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 1992

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 2015

Deviations:

yes

Remarks:

no stepwise testing performed, age of the animals not reported, scoring according to Draize was reported until reading time point 72 h only although effects were observed up to the 14 day reading

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

adopted in 1992

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C16-18 and C18-unsatd., ethoxylated

EC Number:

500-236-9

EC Name:

Alcohols, C16-18 and C18-unsatd., ethoxylated

Cas Number:

68920-66-1

Molecular formula:

not applicable, UVCB

IUPAC Name:

Alcohols, C16-18(even numbered) and C18 unsaturated, ethoxylated < 2.5 EO

Test animals

Species:

rabbit

Strain:

other: Mol:Russian

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Møllegaard Breeding and Research Centre, Ejby, Lille Skensved, Denmark
- Weight at study initiation: 2.2 – 2.5 kg
- Housing: Individually, in PPO cages (floor area 2576 cm^2) with perflorated floor
- Diet: Altromin 2123 (Altromin, Lage, Germany), ad libitum
- Water: Drinking water acidified with hydrochloric acid (to pH 2.5), ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

21 days
Reading time points: 1, 24, 48 and 72 h and 7, 14 and 21 days

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: A clipped area on the back of the animals of 10 x 10 cm. The clipped area was divided into four fields, the two posterior fields were used for testing. The test item was applied on two 2.5 x 2.5 cm 16-layer gauze patches and placed on the test site.
- Type of wrap if used: The gauze patches were secured with 2.5 cm wide adhesive tape and fixed with Micropore tape, 5cm width, loosely wound round the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated skin was cleaned with mild soap and lukewarm water.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS : 1, 24, 48 and 72 h and 7, 14 and 21 days

SCORING SYSTEM: Draize scoring

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 2

Irritation parameter:

edema score

Basis:

animal: #1 and #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 3

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 21 days

Irritant / corrosive response data:

Skin reactions were observed from the 24-hour reading onwards in all animals. At the 24 h reading, all animals showed slight erythema (score 1) and 1/3 animals showed slight edema (score 1). At the 48 and 72 h readings, 3/3 animals showed moderate to severe erythema (score 3) and slight edema (score 2). 7 days after application of the test article, all animals showed massive scab formation on the test areas. On study Day 14, 2/3 animals showed larger residues of scales on both test areas, 1/3 animals showed slight redness and residues of scales on both test areas and in 2/3 animals shiny skin was observed. 21 days after administration, all animals were free of lesions and showed complete hair and intact skin.

Any other information on results incl. tables

Table 1: Results on skin irritation for individual animals: erythema scores

Rabbit	Test field	Erythema
		1 h	24 h	48 h	72 h	Mean 24/48/72 h
1	left	0	1	3	3	2.33
	right	0	1	3	3
2	left	0	1	3	3	2.33
	right	0	1	3	3
3	left	0	1	3	3	2.33
	right	0	1	3	3

Table 2: Results on skin irritation for individual animals: edema scores

Rabbit	Edema
		1 h	24 h	48 h	72 h	Mean 24/48/72 h
1	left	0	0	2	2	1.33
	right	0	0	2	2
2	left	0	1	2	2	1.67
	right	0	1	2	2
3	left	0	0	2	2	1.33
	right	0	0	2	2

Applicant's summary and conclusion

Interpretation of results:

other: Skin irrit. 2, H315. Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).