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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
16 - 31 May 1988
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:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 1981
Deviations:
yes
Remarks:
occlusive dressing
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 2015
Deviations:
yes
Remarks:
no sequential testing approach; occlusive dressing
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Dodecan-1-ol
EC Number:
203-982-0
EC Name:
Dodecan-1-ol
Cas Number:
112-53-8
Molecular formula:
C12H26O
IUPAC Name:
Dodecan-1-ol
Constituent 2
Chemical structure
Reference substance name:
2-(dodecyloxy)ethanol
EC Number:
224-886-5
EC Name:
2-(dodecyloxy)ethanol
Cas Number:
4536-30-5
Molecular formula:
C14H30O2
IUPAC Name:
2-(dodecyloxy)ethanol
Constituent 3
Chemical structure
Reference substance name:
2-[2-(dodecyloxy)ethoxy]ethanol
EC Number:
221-279-7
EC Name:
2-[2-(dodecyloxy)ethoxy]ethanol
Cas Number:
3055-93-4
Molecular formula:
C16H34O3
IUPAC Name:
2-[2-(dodecyloxy)ethoxy]ethanol
Constituent 4
Chemical structure
Reference substance name:
2-[2-[2-(dodecyloxy)ethoxy]ethoxy]ethanol
EC Number:
221-280-2
EC Name:
2-[2-[2-(dodecyloxy)ethoxy]ethoxy]ethanol
Cas Number:
3055-94-5
Molecular formula:
C18H38O4
IUPAC Name:
2-{2-[2-(dodecyloxy)ethoxy]ethoxy}ethanol
Constituent 5
Chemical structure
Reference substance name:
3,6,9,12-tetraoxatetracosan-1-ol
EC Number:
226-097-1
EC Name:
3,6,9,12-tetraoxatetracosan-1-ol
Cas Number:
5274-68-0
Molecular formula:
C20H42O5
IUPAC Name:
3,6,9,12-tetraoxatetracosan-1-ol
Constituent 6
Chemical structure
Reference substance name:
3,6,9,12,15-pentaoxaheptacosan-1-ol
EC Number:
221-281-8
EC Name:
3,6,9,12,15-pentaoxaheptacosan-1-ol
Cas Number:
3055-95-6
Molecular formula:
C22H46O6
IUPAC Name:
2-[2-[2-[2-(2-dodecoxyethoxy)ethoxy]ethoxy]ethoxy]ethanol
Constituent 7
Chemical structure
Reference substance name:
3,6,9,12,15,18-hexaoxatriacontan-1-ol
EC Number:
221-282-3
EC Name:
3,6,9,12,15,18-hexaoxatriacontan-1-ol
Cas Number:
3055-96-7
Molecular formula:
C24H50O7
IUPAC Name:
2-[2-[2-[2-[2-(2-dodecoxyethoxy)ethoxy]ethoxy]ethoxy]ethoxy]ethanol
Constituent 8
Chemical structure
Reference substance name:
3,6,9,12,15,18,21-heptaoxatritriacontanol
EC Number:
221-283-9
EC Name:
3,6,9,12,15,18,21-heptaoxatritriacontanol
Cas Number:
3055-97-8
Molecular formula:
C26H54O8
IUPAC Name:
2-[2-[2-[2-[2-[2-(2-dodecoxyethoxy)ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethanol
Constituent 9
Chemical structure
Reference substance name:
Tetradecanol
EC Number:
204-000-3
EC Name:
Tetradecanol
Cas Number:
112-72-1
Molecular formula:
C14H30O
IUPAC Name:
tetradecan-1-ol
Constituent 10
Chemical structure
Reference substance name:
2-(tetradecyloxy)ethanol
EC Number:
218-371-4
EC Name:
2-(tetradecyloxy)ethanol
Cas Number:
2136-70-1
Molecular formula:
C16H34O2
IUPAC Name:
2-(tetradecyloxy)ethanol
Constituent 11
Chemical structure
Reference substance name:
2-(2-Tetradecyloxyethoxy)ethanol
EC Number:
611-348-3
Cas Number:
56049-79-7
Molecular formula:
C18H38O3
IUPAC Name:
2-(2-Tetradecyloxyethoxy)ethanol
Constituent 12
Chemical structure
Reference substance name:
2-[2-[2-(tetradecyloxy)ethoxy]ethoxy]ethanol
EC Number:
248-016-9
EC Name:
2-[2-[2-(tetradecyloxy)ethoxy]ethoxy]ethanol
Cas Number:
26826-30-2
Molecular formula:
C20H42O4
IUPAC Name:
2-{2-[2-(tetradecyloxy)ethoxy]ethoxy}ethanol
Constituent 13
Chemical structure
Reference substance name:
2-[2-[2-(2-tetradecoxyethoxy)ethoxy]ethoxy]ethanol
Cas Number:
39034-24-7
Molecular formula:
C22H46O5
IUPAC Name:
2-[2-[2-(2-tetradecoxyethoxy)ethoxy]ethoxy]ethanol
Constituent 14
Chemical structure
Reference substance name:
2-[2-[2-[2-(2-tetradecoxyethoxy)ethoxy]ethoxy]ethoxy]ethanol
Cas Number:
92669-01-7
Molecular formula:
C24H50O6
IUPAC Name:
2-[2-[2-[2-(2-tetradecoxyethoxy)ethoxy]ethoxy]ethoxy]ethanol
Constituent 15
Chemical structure
Reference substance name:
Hexadecan-1-ol
EC Number:
253-149-0
EC Name:
Hexadecan-1-ol
Cas Number:
36653-82-4
Molecular formula:
C16H34O1
IUPAC Name:
Hexadecan-1-ol
Constituent 16
Chemical structure
Reference substance name:
2-(hexadecyloxy)ethanol
EC Number:
218-373-5
EC Name:
2-(hexadecyloxy)ethanol
Cas Number:
2136-71-2
Molecular formula:
C18H38O2
IUPAC Name:
2-(hexadecyloxy)ethanol
Constituent 17
Reference substance name:
Unknown constituents
IUPAC Name:
Unknown constituents
Test material form:
liquid
Details on test material:
Density: ca. 0.9 mg/cm³

Test animals

Species:
rabbit
Strain:
Himalayan
Remarks:
Chbb-SPF
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.2 kg
- Housing: Individual housing in stainless steel cages
- Diet: K4 Alleindiät für Kaninchen, Ssniff Speziafutter GmbH, Soest, Germany, 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:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
14 days
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: The test item was applied to a test area of approx. 6 cm² on the dorso lateral part of the trunk, covered with a gauze patch (2.5 x 2.5 cm) and covered with a piece of polyethylene foil.
- Type of wrap if used: The patch was hold in place with an elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Remaining test substance was gently rinsed with lukewarm water.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS: 1, 24, 48, 72 h and 6, 8, 10, 14 days

SCORING SYSTEM: Draize scoring scheme

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1 and #3
Time point:
24/48/72 h
Score:
3.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal: #2 and #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
One hour after administration, 2/3 animals showed moderate to severe erythema (score 3) and 1/3 rabbits showed well-defined erythema (score 2). In addition, slight edema (2/3 rabbits) and very slight edema (1/3 rabbits) was observed. At the 24 h reading, moderate to severe erythema (score 3) was noted in 2/3 animals and severe erythema to slight eschar formation (score 4) was noted in 1/3 animals. In addition, severe edema were observed in 2/3 rabbits (score 4) and moderate edema (score 3) was noted in 1/3 rabbits. The findings became more severe in time, as all 3 rabbits showed severe erythema to slight eschar formation (score 4) and severe edema (score 4) at the 48 and 72 h reading. Erythema and edema were no longer observed in the animals on Day 6, however, scales were observed in all 3 animals, which persisted in 2/3 animals until Day 10 and in 1/3 animals until study termination on Day 14.

Any other information on results incl. tables

Table 1: Erythema findings observed during the 14 day observation period

Animal 1 h 24 h 48 h 72 h 6 days 8 days 10 days 14 days Mean 24/48/72 h
1 3 3 4 4 - - - - 3.67
2 3 4 4 4 - - - - 4.00
3 2 3 4 4 - - - - 3.67

Table 2: Edema findings observed during the 14 day observation period.

Animal 1 h 24 h 48 h 72 h 6 days 8 days 10 days 14 days Mean 24/48/72 h
1 2 3 4 4 - - - - 3.67
2 1 4 4 4 - - - - 4.00
3 2 4 4 4 - - - - 4.00

Table 3: Skin irritation findings

Animal 1 h 24 h 48 h 72 h 6 days 8 days 10 days 14 days
1 x x x d x d scp scp det sc det -
2 - x x d cr x d cr scp cr scp det sc det ns sc det
3 - x x d cr x d cr scp cr scp det ns - -
x: yellow stained skin in the test area; d: dry skin; cr: cracked skin; scp: scabs; sc: scales; det: detaching, ns: new skin

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Executive summary:

The classification of the test material is based on a very rigorous treatment of the animals with the test material. Exposure to the test material under occlusive conditions is significantly higher than under the current OECD 404 prescribed exposure under semi-occluded conditions. Higher exposures will likely result in more severe effects. Hence, the results from this study overpredict the irritation potential when assessed against new OECD 404 guidance criteria.