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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:
MAR - AUG 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
12 MAY 1981
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
19 SEP 1984
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Thymol
EC Number:
201-944-8
EC Name:
Thymol
Cas Number:
89-83-8
Molecular formula:
C10H14O
IUPAC Name:
5-methyl-2-(propan-2-yl)phenol
Test material form:
solid: crystalline

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK ltd.
- Weight at study initiation: 3 - 3.4 kg
- Housing: single caged (type III cage)
- Diet (e.g. ad libitum): ad libitum (ssniff K 4, Versuchstierdiäten GmbH, Soest/Westfalen)
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: 14 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 (+/- 2)
- Humidity (%): 45 - 65
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent negative control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg, moistened with water

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): moistened patch
Duration of treatment / exposure:
4 hour(s)
Observation period:
14 days
Number of animals:
6 (4 males + 2 females)
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: patch 'Hypoallergen' (Beiersdorf No. 2342), wrap 'Fixomull-Strech Klebevlies' (Beiersdorf No. 2039)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): exposed areas were washed with water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
24 h , 48 h, 72 h, 7 d, 14 d

SCORING SYSTEM:
- Method of calculation: Draize score

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.1
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.1
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
F85
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
F85
Time point:
24/48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
F85
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
G88
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
G88
Time point:
24/48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
G88
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
E91
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
E91
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
E91
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
E91
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
E91
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
E91
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
J3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
edema score
Basis:
animal #4
Remarks:
J3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
J4
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
J4
Time point:
48 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
J4
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
edema score
Basis:
animal #5
Remarks:
J4
Time point:
24/48 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
edema score
Basis:
animal #5
Remarks:
J4
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
J5
Time point:
24/48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
J5
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
edema score
Basis:
animal #6
Remarks:
J5
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritant / corrosive response data:
In rabbit E91 the application site was necrotic from the 1st day of observation and in rabbits F85 and G88 from the 2nd day of observation. In rabbit J3 there was a necrotic application site at the 1 h assessment time point; in rabbits J4 and J5 the application site was hardened at the 1 h assessment time point. In rabbits F85, G88, E91, J3, J4 and J5, these skin changes persisted until the end of the observation period.
Based on these results the test item is assessed as 'skin corrossive'.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Remarks:
EU GHS
Conclusions:
Based on the results of this study the test item is assessed as 'skin corrossive'.
Executive summary:

The test item was tested ina study according to OECD TG 404. 500 mg of the test substance were applied for 4 h on the skin of six rabbits. The post observation time was 14 days. Erythrema and edema were observed in all animals. The findings were not reversible within 14 days. As a result, the test item was classified as corrosive.