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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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
Chemical structure
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
Chemical structure
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
Chemical structure
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

Resultsopen allclose all
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
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
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.

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