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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:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 1981
Deviations:
no
GLP compliance:
no
Remarks:
study performed prior to implementation of GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
4-tert-butylcyclohexanol
EC Number:
202-676-4
EC Name:
4-tert-butylcyclohexanol
Cas Number:
98-52-2
Molecular formula:
C10H20O
IUPAC Name:
4-tert-butylcyclohexan-1-ol

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.2-2.5 kg
- Housing: individually
- Diet: K4 Alleindiaet fuer Kaninchen (Ssniff Versuchstier-Diaeten GmbH, Soest, Germany); ad libitum
- Water: tap water; ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 07 Dec 1982 To: 15 Dec 1982

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: paraffin
Controls:
other: not required, untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 550 mg
A thick paste was prepared by mixing the test material with a few drops of paraffin.

Duration of treatment / exposure:
4 hours
Observation period:
8 days
Reading time points: 1, 24, 48 and 72 hours, 6 and 8 days
Number of animals:
6 (3 males, 3 females)
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm² (shaved area: 10 cm x 10 cm)
- Type of wrap if used: The test site was covered with a gauze patch. The patch was held in contact with the skin by means of a polyethylene foil for the duration of the exposure period. Finally the animals were wrapped in flexible bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was carefully removed with distilled water.

SCORING SYSTEM: Draize Scoring System

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: eschar formation at day 6
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: score = 1 at 1 h-reading; eschar formation at day 6
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: eschar formation at day 6
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: score = 1 at 1 h-reading
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: score = 2 at 1 h-reading
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: score = 2 at 1 h-reading
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: score = 1 at 1 h-reading

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Under the conditions of this skin irritation study in the rabbit, the test substance is not considered skin irritating.