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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:
2003-07-21 to 2003-08-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
α-methylcyclohexanepropanol
EC Number:
234-091-5
EC Name:
α-methylcyclohexanepropanol
Cas Number:
10528-67-3
Molecular formula:
C10H20O
IUPAC Name:
4-cyclohexylbutan-2-ol

Test animals

Species:
rabbit
Strain:
other: Chbb:HM(SPF) - Littlerussian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 17 to 20 months
- Weight at study initiation: 2.7 — 3.1 kg b. w.
- Housing: individually in PPO cages (floor area: 2576 sq. cm) with perforated floor
- Diet: ad libitum, Altromin 2123" from Altromin, D-32791 Lage, Lippe
- Water: ad libitum, domestic quality drinking water acidified with hydrochloric acid to pH 2.5
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: undiluted (100 %)
Duration of treatment / exposure:
3 min, 1 (for 1 animal) and 4 h (for all 3 animals)
Observation period:
immediately and after 1, 24, 48, 72 h and 7, 14, 21 days
Number of animals:
1 animal (3min, 1 and 4 h), 2 animals (4 h)
Details on study design:
TEST SITE
- Area of exposure: back skin, 2.5 x 2.5 cm
- Type of wrap if used: 16-layer gauze patch secured with adhesive Gothaplast tape and Gothaplast tape wound around the trunk of the animal

REMOVAL OF TEST SUBSTANCE
- Washing: mild soap and lukewarm water
- Time after start of exposure: after exporsure time was over test field was marked and directly washed

SCORING SYSTEM:
- Erythema and Eschar Formation: 1-4
- Oedema Formation: 1-4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.9
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: exposure time 4 h
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: exposure time 4 h
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: exposure time 4 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: exposure time 4 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: exposure time 4 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: exposure time 4 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: exposure time 4 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: exposure time 4 h

Any other information on results incl. tables

Results of Animal 1 after 3 min and 1 h exposure:

Exposure time  Timepoint of observation [h] Erythema score (of max. 4) Edema score (of max. 4)
3 min 0 2 0
1 1 0
24 2 0
48 1 0
72 0 0
1 h 0 2 0
1 1 0
24 2 2
48 2 2
72 2 2

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The test substance was determined to cause skin irritation in rabbits.
Executive summary:

The skin irritant effect of the test substance was investigated according to OECD Guideline 404. During an initial test using one female albino rabbit a sequential application (exposure time 3 min, 1 h and 4 h) of the test substance was carried out on one site of the left back area. The skin was examined for signs of irritation directly after application as well as 1 h, 24 h, 48 h and 72 h after the termination of exposure as well as on day 7, 14 and 21. Since the animal did show very well defined but reversible signs of skin irritation within the observation period of 21 days it was decided to carry out a confirmatory test with two additional animals in order to allow a categorization of the test item based on the classification criteria. Two female albino rabbits were exposed to the test item at one skin site on the backs during the confirmatory test. After 4 hour exposure time the test item was removed and the skin was examined 1 h, 24 h, 48 h and 72 h after the termination of exposure as well as on day 7, 14 and 21. Very well defined skin reactions were observed in these animals, too. All effects were fully reversible within 21 days. Under the experimental conditions described, the mean score (24/48/72h) for erythema was 2.9 and for edema 2.3. For individual animals the erythema score for 24/48/72h was 3 for animals 1 and 2 and 2.67 for animal 3. The edema score for individual animals at 24/48/72h was 3 for animal 1 and 2 for animals 2 and 3. Considering these results the test substance was determined to be irritating to the skin.