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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(+)-trans-2-methoxycyclohexan-1-ol
Cas Number:
7429-40-5
Molecular formula:
C7H14O2
IUPAC Name:
(+)-trans-2-methoxycyclohexan-1-ol
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: 3.25 - 3.99 kg
- Housing: single housing (stainless steel wire mesh cage)
- Diet (e.g. ad libitum): about 250 ml tap water per animal per day
- Water (e.g. ad libitum): about 130 g per animal per day (Kliba-Labordiaet, Klingentalmuehle Ag, KaiserAugst, Switzerland)
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml



Duration of treatment / exposure:
4 h
Observation period:
15 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cn x 2.5 cm
- Type of wrap if used: Idealbinde (Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixmull (R) Stretch (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol (R) and Lutrol (R)/water (1:1)
- Time after start of exposure: 4h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: 15 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: 15 days

Any other information on results incl. tables

Readings

Animal

Erythema

Edema

Symptoms

1 h

1

2

0

 

2

2

0

 

3

2

0

 

24 h

1

0

0

 

2

2

0

15

3

2

0

15

48 h

1

0

0

 

2

2

0

15

3

2

0

15

72 h

1

0

0

 

2

2

0

S, 15, 17

3

2

0

S, 15, 17

8 d

1

0

0

 

2

1

0

 

3

1

0

 

15 d

1

0

0

 

2

1

0

 

3

1

0

 

Mean

1

0.0

0.0

 

2

2.0

0.0

 

3

2.0

0.0

 

Mean

 

1.3

0.0

 

S: scaling

15: erythema extending beyond the area of exposure

17: scaling extending beyond the area of exposure

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Under the test conditions chosen and considering the descriebed findings trans-2-methoxycyclohexanol (Rac.) gives indication of an irritant property at the skin.