Isotridecanol, ethoxylated

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 1981

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isotridecanol, ethoxylated

EC Number:

500-241-6

EC Name:

Isotridecanol, ethoxylated

Cas Number:

69011-36-5

Molecular formula:

not available, isomeric structures

IUPAC Name:

Isotridecanol, ethoxylated

Test animals

Species:

rabbit

Strain:

other: kleine weiße Russen, Chbb-SPF

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.2 - 2.3 kg
- Housing: individually
- Diet: K4 monodiet for rabbits, Ssniff Spezialfutter GmbH, 4770 Soest, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

1, 24, 48, 72 h and 6, 8, 10 and 14 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approx. 6 cm²

REMOVAL OF TEST SUBSTANCE
- Washing: with warm tap water
- Time after start of exposure: 4 h

SCORING SYSTEM:
Erythema and Eschar Formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

edema Formation
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of 3 animals

Time point:

24/48/72 h

Score:

3.22

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3.33

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks:

Eschar was still seen at the 14 day reading time point.

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3.33

Max. score:

4

Reversibility:

not reversible

Remarks:

Eschar was still seen at the 14 day reading time point.

Results 5

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of 3 animals

Time point:

24/48/72 h

Score:

3.89

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 6

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 7

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks:

Eschar was still seen at the 14 day reading time point.

Results 8

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3.67

Max. score:

4

Reversibility:

not reversible

Remarks:

Eschar was still seen at the 14 day reading time point.

Irritant / corrosive response data:

Slight to moderate erythema and edema were observed as early as 1 h after removal of the patch. Erythema and edema scores increased until the 72 h reading. At the 48 h reading time point dry skin was seen in 2/3 rabbits. Eschar formation was observed in all animals beginning 6 days after exposure. Beginning scale off of eschar was observed 8 days after exposure. No scoring was performed 8, 10 and 14 days (3/3, 3/3 and 2/3 animals) after exposure. After 14 days no eschar and no erythema and edema were seen in 1/3 rabbits. Findings of the other rabbits comprised of eschar which was not completely scaled off.

Any other information on results incl. tables

Table 1: Results of skin irritation study 

Observation time	Rabbit no.
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	Sy 2	1	2	1	Sy 2	1
24 h	Sy 3	4	Sy 3	4	Sy 3	3
48 h	Y 3	4	Sy 3	4	Sy 3	4
72 h	Yb 4	4	Y 3	4	Y 4	4
6 d	-	-	-	-	-	-
8 d	-	-	-	-	-	-
10 d	-	-	-	-	-	-
14 d	0	0	-	-	-	-
Mean value 24 + 48 + 72 h	3.33	4.0	3.00	4.00	3.33	3.67
Mean value 24 + 48 + 72 h all animals	3.22	3.89

Sy: Slight yellowish discoloration, Y: Yellowish discoloration, Yb: Yellow-brownish discoloration

Applicant's summary and conclusion

Interpretation of results:

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