Isotridecan-1-ol

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted April 24, 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted Dec. 29, 1992

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

August 1998

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan IVIAFF Testing Guideline of 12 Nosan No. 8147

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

EC Number:

607-896-8

Details on test material:

- Name of test material (as cited in study report): Tridecanol H
- Physical state: Liquid / colorless - clear
- pH-value: about 5 - 6
- Analytical purity: >99 w%
- Lot/batch No.: EVD 55712
- Test substance No.: 03/0197-1
- Stability: The stability under storage conditions was confirmed by reanalysis.
- Storage condition of test material: Room temperature, exclusion of oxygen (storage under nitrogen)
- Homogeneity: The test substance was homogeneous by visual inspection.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: About 7 - 8 months
- Weight at study initiation: 3.89 - 4.18 kg
- Housing: Single housing
- Diet: Kliba-Labordiaet, Provimi Kliba SA, Kaiseraugst, Switzerland (about 130 g/animal per day )
- Water: Tap water ad libitum
- Acclimation period: At least 5 days before the beginning of the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr):
- 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:

undiluted
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution):

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:

Duration of treatment / exposure:

4 hour(s)

Observation period:

14 days

Number of animals:

3 (2 female and 1 male animal)

Details on study design:

TEST SITE
- Area of exposure:flank (the test patch (2.5 cm x 2.5 cm) was moistened with a dose of 0.5 ml of the undiluted liquid test substance)
- % coverage:
- Type of wrap if used: The test substance was covered with a test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull stretch (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed at the end of the exposure period with Lutrol E 400 (Polyethylenglycol) and Lutrol/water (1 : 1)
- Time after start of exposure: 4 h

SCORING SYSTEM: according to Draize / OECD 404

EVALUATION OF RESULTS:
For evaluation, the calculation of the mean values of erythema and edema for readings 24, 48 and 72 hours were quoted. Additionally, the reversibility of the observed findings was taken into account. The evaluation is based on the criteria of Annex VI of the Commission Directive 67/548/EEC that were in place on the date of report signature.

ILLUMINATION USED FOR READING: Daylight tubes "Lumilux" (L 58W/860 PLUS ECO 25X1, Osram, Germany)

CHECK FOR DEAD OR MORIBUND ANIMALS: Twice each workday (beginning and end) and once on Saturdays, Sundays and on public holidays.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(animal 1-3)

Time point:

other: 24 - 48 - 72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within:

Remarks:

(within the observation period of 14 days)

Remarks on result:

other: Scaling at the end of the observation period in 3 animals (see table below for details).

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

(animal 1-3)

Time point:

other: 24 - 48 - 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible

Remarks:

in 2 animals after 24 h, in 1 animal after 14 days

Remarks on result:

other: Scaling at the end of the observation period in 3 animals (see table below for details).

Irritant / corrosive response data:

Moderate erythema (grade 2), observed in all animals immediately and 1 hour after removal of the patch, increased to marked (grade 3) after 24 hours and persisted up to 72 hours in all animals and up to day 7 in one animal. Marked erythema decreased to moderate in two animals on day 7 and to slight (grade 1) in all animals after 14 days (study termination). Slight or moderate edema (grade 1 or 2) was noted in all animals immediately and 1 hour after removal of the patch. Slight edema persisted in 1 animal up to day 7. Additionally erythema and edema were partly extended beyond the area of exposure.

Moreover scaling, partly extending beyond the area of exposure, severe scaling as well as petechiae, both extending beyond the area of exposure and thickening of the skin in the region of the application area were noted during the observation period.

The cutaneous reactions (such as slight erythema) were not reversible in all animals within study termination on day 14.

Any other information on results incl. tables

Exposition:	4 h (semiocclusive)
Animal	Reading	Erythema	Edema	Comments
1	0 h	2	1	Erythema/Edema extending beyond the area of exposure
2	0 h	2	1	Erythema/Edema extending beyond the area of exposure
3	0 h	2	1	Erythema/Edema extending beyond the area of exposure
1	1 h	2	1	Erythema/Edema extending beyond the area of exposure
2	1 h	2	2	Erythema/Edema extending beyond the area of exposure
3	1 h	2	1	Erythema/Edema extending beyond the area of exposure
1	24 h	3	0	Erythema extending beyond the area of exposure
2	24 h	3	1	Erythema/Edema extending beyond the area of exposure
3	24 h	3	0	Erythema extending beyond the area of exposure
1	48 h	3	0	Erythema extending beyond the area of exposure
2	48 h	3	1	Erythema/Edema extending beyond the area of exposure
3	48 h	3	0	Erythema extending beyond the area of exposure
1	72 h	3	0	Erythema extending beyond the area of exposure
2	72 h	3	1	Erythema/Edema/Petechiae extending beyond the area of exposure
3	72 h	3	0	Erythema extending beyond the area of exposure
1	7 days	2	0	Scaling
2	7 days	3	1	Erythema/Edema/Severe Scaling extending beyond the area of exposure
3	7 days	2	0	Erythema/Scaling extending beyond the area of exposure
1	14 days	1	0	Scaling
2	14 days	1	0	Erythema/Scaling extending beyond the area of exposure, Thickening of the skin in the region of the application area
3	14 days	1	0	Erythema/Scaling extending beyond the area of exposure
mean (animal 1)	24 - 72 h	3	0
mean (animal 2)	24 - 72 h	3	1
mean (animal 3)	24 - 72 h	3	0
mean (animal 1-3)	24 - 72 h	3.00	0.33

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria