[3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1992-08-24 to 1992-09-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP study conducted according to the original OECD Guideline 404 (1981).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(Adopted 12th May 1981)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan

EC Number:

229-861-2

EC Name:

[3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan

Cas Number:

6790-58-5

Molecular formula:

C16H28O

IUPAC Name:

(3aR,5aS,9aS,9bR)-3a,6,6,9a-tetramethyl-dodecahydronaphtho[2,1-b]furan

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): 8α,-11-Oxido-13,14,15,16-tetranorlabdan / Ambroxan
- Physical state: white solid
- Stability under test conditions: stable for at least 2 years
- Storage condition of test material: cool and dark

Test animals

Species:

rabbit

Strain:

other: Kleinrussen, Chbb:HM

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Thomae GmbH, Biberach-D
- Age at study initiation: approximately 19 months
- Weight at study initiation: approximately 2460 g
- Housing: individual accommodation
- Diet (e.g. ad libitum): Ssniff rabbit diet K4, Ssniff GmbH, Soest-D (Batch 550792/01) ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 20-25°C
- Humidity (%): approximately 45-70%
- Air changes (per hr): at least eight per hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: August 24, 1992 To: September 07, 1992

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

moistened

Controls:

other: untreated skin areas serve as the control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, 72 hours and 7 days after exposure

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: right flank
- % coverage: ca. 6 cm²
- Type of wrap if used: adhesive air- and vapour permeable gauze-patch fixed by a hypo-allergenic adhesive gauze-bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, but no detail
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scale, as described in OECD Guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

probability of weak irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

probability of weak irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

probability of weak irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

Scratching was observed at 24-48-72 hours

Irritant / corrosive response data:

Slight to weak erythema and slight oedema of the first, slight erythema of the second, and no reaction of the third experimental animals were observed during the first 72 hours after exposure. One week later the first and second experimental animals were without irritation effects.

Other effects:

None

Any other information on results incl. tables

Table 7.3.1/1: Mean irritant/corrosive response data for each animal at each observation time up to removal of animals from the test

 

Score at time point / Reversibility	Erythema Max. score 4	Oedema Max. score 4
1 h	1 / 1 / 0	1 / 0 / 0sc
24 h	2 / 1 / 0	1 / 0 / 0sc
48 h	1 / 1 / 0	0 / 0 / 0sc
72 h	1 / 1 / 0	0 / 0 / 0sc
Average 24h, 48h, 72h	1.3 / 1.0 / 0.0	0.3 / 0.0 / 0.0
Reversibility*)	c.	c.
Average time for reversion	7 days	48 hours

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

sc = scratch

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the test material induces a slight to weak irritation being reversible within 7 days. Therefore the test material is not classified as irritant to the skin according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).

Executive summary:

In a dermal irritation study performed according to the OECD guideline No. 404, and in compliance with GLP, 0.5 g of undiluted test material was moistened and applied on the shaved skin of the dorsal flank area of 3 Kleinrussen, Chbb:HM rabbits.Test sites were covered with a semi-occlusive dressing for 4 hours. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48, 72 hours and 7 days after the removal of the patch.

 

Slight to weak erythema and slight oedema of the first, slight erythema of the second, and no reaction of the third experimental animal were observed during the first 72 hours after exposure. One week later the first and the second experimental animal were without irritation effects.

The individual scores for each animal within 3 scoring times (24, 48 and 72 hours) were 1.33 / 1.00 / 0.00 for erythema and 0.33 / 0.00 / 0.00 for oedema.

 

Therefore the test material is not classified as irritant to the skin according to the Annex I of the Regulation (EC) No. 1272/2008 (CLP).

This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.