3,7,11-trimethyldodeca-1,6,10-trien-3-ol,mixed isomers

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Remarks:

Test substance represents a main component (stereoisomer) of the registered substance.

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study; non-GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

(E)-3,7,11-trimethyldodeca-1,6,10-trien-3-ol

EC Number:

255-053-4

EC Name:

(E)-3,7,11-trimethyldodeca-1,6,10-trien-3-ol

Cas Number:

40716-66-3

Molecular formula:

C15H26O

IUPAC Name:

(E)-3,7,11-trimethyldodeca-1,6,10-trien-3-ol

Details on test material:

- Name of test material (as cited in study report): trans-nerolidol
- Analytical purity: no data given

Specific details on test material used for the study:

Test substance represents a main component (stereoisomer) of the registered substance.

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Weight at study initiation: males 2.63 kg; female 2.54 kg
- Housing: individually in a stainless steel cage with wire mesh walk floor (40 cm x 51 cm)
- Diet: Kliba 341, 4 mm (Klingentalmuehle AG, Kaiseraugst, Switzerland), ca. 130 g per animal per day
- Water: ca. 250 ml tap water per animal per day
- Acclimation period: at least 8 days
- Clipping of the fur: at least 15 h before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature: 20-24 °C
- Humidity: 30-70 %
- Housing in fully air-conditioned rooms
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: undiluted substance

Controls:

other: the untreated sited of the same animal served as control.

Amount / concentration applied:

undiluted

Duration of treatment / exposure:

4 hours

Observation period:

8 days

Number of animals:

3 (2 males and 1 female)

Details on study design:

An test patch of 2.5 cm x 2.5 cm was wetted with ca. 0.5 ml of the the undiluted test substance and was applied on the upper third of the back or flanks of the animal under semiocclusive conditions. After the application time of 4h the sites were wiped with Lutrol and Lutrol/water (1:1). The animals were observed for 8 days on working days.
Skin changes were recorded at 30-60min after removal of the test patches, and after 24h, 48h, 72h and 8days after the beginning of the application.
For calculation of the means of erythema and edema only the readings of 24, 48 and 72 h were used. The calculation of the mean scores was conducted according to 83/467/EEC criteria of Jul 29th, 1983.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24-48-72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: scaling was seen after 8 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24-48-72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24-48-72 h

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: scaling was seen after 8 days

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Very slight to moderate effects were observed for erythema in all three rabbits. The effects were fully reversible within 8 days in all 3 animals. Scale was seen in 2/3 animals on day 8. No effects were seen for edema.

Any other information on results incl. tables

Table 1: Summary of dermal effects in rabbits after dorsal application of the test material for 4 h under semiocclusive conditions

	Animal No.	Erythema score	Edema score	Further effects
4h	1	0	0
	2	0	0
	3	0	0
24 h	1	1	0
	2	1	0
	3	2	0
48 h	1	2	0
	2	1	0
	3	3	0
72 h	1	1	0	scale
	2	1	0
	3	3	0
8 days	1	0	0	scale
	2	0	0
	3	0	0	scale