Reaction mass of (3aR*,5aS*,9aS*,9bR*)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan and (3aR*,5aS*,9aS*,9bS*)-3a,6,6,9a-Tetramethyldodecahydronaphtho[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 1990-02-28 to 1990-03-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study performed according to OECD test guideline No. 404 (1981) and in compliance with GLP. 4. Initial and final body weights were not reported. However this was not considered to affect the reliability of this study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

body weights not reported

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-Tetramethyldodecahydronaphtho[2,1-b]furan

Constituent 2

Reference substance name:

(3aS,5aR,9aR,9bS)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan

Cas Number:

234431-64-2

Molecular formula:

C16H28O

IUPAC Name:

(3aS,5aR,9aR,9bS)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan

Constituent 3

Reference substance name:

(3aR,5aS,9aS,9bS)-3a,6,6,9a-tetramethyldodecahydronaphtho[2,1-b]furan

Cas Number:

68365-89-9

Molecular formula:

C16H28O

IUPAC Name:

(3aR,5aS,9aS,9bS)-3a,6,6,9a-tetramethyldodecahydronaphtho[2,1-b]furan

Constituent 4

Reference substance name:

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

Cas Number:

2006270-65-9

Molecular formula:

C16H28O

IUPAC Name:

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

Test material form:

other: cream

Details on test material:

- Physical state: white cream
- Storage condition of test material: in the dark under ambient condition. On receipt the test material container was noted to be damaged and some test material had leaked in transit.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
- Source: Cheshire Rabbit Farms Limited, Duddon Lodge, Tarpoley, Cheshire
- Age at study initiation: young adult
- Weight at study initiation: no data
- Housing: individually in aluminium cages with grid floors beneath which were peat moss filled trays
- Diet (e.g. ad libitum): Standard Rabbit Diet ad libitum (supplied by Special Diets Services, Witham, Essex)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18 °C
- Humidity (%): mean 42 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1990-02-22 To: 1990-03-03

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after patch removal

Number of animals:

2 males and 1 female

Details on study design:

TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: no data
- Type of wrap if used: the patch was covered with Micropore tape and the trunk was loosely bound with Elastoplast Elsatic Bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was wiped with water dampened tissues
- Time after start of exposure: 4 hours

SCORING SYSTEM: OECD recommended scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1 and #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

probability of weak irritation

Results 3

Irritation parameter:

edema score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Very slight erythema and very slight oedema were noted 1 h after patch removal in one rabbit. Erythema (score 1) persisted until 24 h with dryness noted after 48 h. One rabbit showed very slight erythema 1 h after patch removal but this was quickly reversible by 24 h. No skin reactions were noted in the third rabbit.

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	0/1/1	0/0/1
24 h	0/0/1	0/0/0
48 h	0/0/0^$	0/0/0
72 h	0/0/0	0/0/0
Average 24h, 48h, 72h	0.0/0.0/0.33	0.0/0.0/0.0
Reversibility*)	c	-
Average time (day) for reversion**	48 h

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

**): correspond to the last day for which skin irritation signs in the last animal were observed

^$= Dryness

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the test material induced a slight irritation being reversible within 48 h.
Therefore the test material does not require a classification as irritant to the skin according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

Executive summary:

In a dermal irritation study performed according to the OECD guideline No. 404, and in compliance with GLP, 0.5 mL of undiluted test material was dermally applied on the clipped skin of the dorsal surface of the trunk of 3 New Zealand White 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 and 72 hrs after the removal of the patch.

The mean scores calculated for each animal tested within 3 scoring times (24, 48 and 72 hrs) were 0.0/0.0/0.33 for erythema and 0.0/0.0/0.0 for oedema.

Very slight erythema and very slight oedema were noted 1 h after patch removal in one rabbit. Erythema (score 1) persisted until 24 h with dryness noted after 48 h. One rabbit showed very slight erythema 1 h after patch removal but this was quickly reversible by 24 h. No skin reactions were noted in the third rabbit.

Therefore the test material does not require a classification as irritant to the skin according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

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