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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 October 1988 - 02 March 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Levomenol
EC Number:
245-423-3
EC Name:
Levomenol
Cas Number:
23089-26-1
Molecular formula:
C15H26O
IUPAC Name:
6-methyl-2-(4-methylcyclohex-3-en-1-yl)hept-5-en-2-ol

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Animal Breeder: Gaukler; D-6050 Offenfach/ Main, FRG
- Weight at study initiation: male 2.84 kg, females 3.0 kg
- Housing: individually in stainless steel cages with wire mesh walk floors (floor area: 40 x 51 cm).
- Diet: Kilba 341, 4 MM (Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland); about 130 g/animal/day
- Water: tap water; about 250 mL/animal/day
- Acclimation period: at least 8 days before study start (same housing conditions as during the study).

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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Remarks:
no vehicle
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied. 0.5 mL (to test patches, 2.5 x 2.5 cm)
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 (2 females, 1 male)
Details on study design:
TEST SITE
- Area of exposure: upper third of the back or flanks
- Type of wrap: porous dressing (four layers of absorbent gauze + porous bandage)

REMOVAL OF TEST SUBSTANCE
- Washing: Removal of the test substance at the end of the exposure period with Lutrol and Lutrol/water (1:1).
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
30 - 60 minutes after removal of the test patch and 24 h, 48 h, 72 h and 7 d after beginning of application

SCORING SYSTEM
Evaluation of erythema (R) and edema (ED):
0 = none
1 = very slight
2 = well-defined
3 = moderate to severe
4= sevree to very severe
Calculation of the mean according to 83/467/EEC criteria of 29th 1983 (for calculation of the means of erythrema and eodema only the readings of 24, 48 and 72 hours are used).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: only one animal showed a slight edema after 24 h
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4

Any other information on results incl. tables

Table 1: Results

Readings Animal Erythema Edema Further findings
4h 1 1 0  
  2 1 0  
  3 1 0  
24h 1 2 0  
  2 1 0  
  3 2 1  
48h 1 1 0  
  2 0 0  
  3 2 0  
72h 1 0 0 scaling
  2 0 0  
  3 1 0 scaling
7d 1 0 0 scaling
  2 0 0 scaling
  3 0 0 scaling
Mean (24h-72h) 1 1,0 0,0  
  2 0,3 0,0  
  3 1,7 0,3  
Mean (24h-72h) all animals 1,0 0,1  

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions chosen, the test substance is considered not to be irritating to the skin.
Executive summary:

A study according to OECD guideline 404 was designed to assess the skin irritation potential of the test item following a single dermal application to rabbits. Three rabbits each were administered a single dermal dose of 0.5 mL of the test substance and observed for 7 days. Slight erythrema were observed, which were fully rerversible within 7 days. One animal showed a very slight edema which was fully reversible within 48 hours. The mean erythrema and oedema scores were below the threshold for classification. The test substance is considered not to be irritating to the skin.