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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-03-18 to 2008-04-01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP guideline study reliable without restrictions Deviation from guideline without an effect on the results - according to the guideline, systemic effects should be recorded. This was missing in the study report. - according to the guideline, the individual bodyweight of the rabbits at the conclusion of the study should be stated. This was missing in the study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
, adopted 2002-04-24
Deviations:
yes
Remarks:
, see "Rationale for reliability incl. deficiencies" above
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
signed 2007-10-15

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Chemical name: 5-Cyclohexyl-2-methyl-pentan-1-ol
- Empirical formula: C12H24O
- Molecular weight: 184.3 g/mol
- Physical state: liquid, clear colourless to pale yellow

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan France SARL, 03800 Gannat, France
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: animals were individually housed in suspended cages.
- Diet (ad libitum): Certified Rabbit Diet
- Water (ad libitum): mains drinking water
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 23 °C
- Relative humidity: 30 to 70 %
- Air exchanges: at least fifteen changes per hour
- 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(s) applied (volume or weight with unit): 0.5 mL of the test material
Duration of treatment / exposure:
4 hours
Observation period:
approximately one hour following the removal of the patches, and 24, 48 and 72 hours later and on Days 7 and 14.
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: dorsal/flank area
- Type of wrap if used: 2.5 cm x 2.5 cm cotton gauze patch, which was secured in position with a strip of surgical adhesive tape. The trunk of each rabbit was wrapped in an elasticated corset.

REMOVAL OF TEST SUBSTANCE
- Washing: any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: four hours after application

SCORING SYSTEM: according to the Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Also observed: loss of skin elasticity (at 48 and 72 h), light brown discolouration of the epidermis (at 72 h), loss of skin flexibility (at 72 h) and moderate desquamation (at Day 7).
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Also observed: light brown discolouration of the epidermis (at 72 h) and moderate desquamation (at Day 7).
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Also observed: light brown discolouration of the epidermis (at 72 h), loss of skin elasticity (at 72 h) and crust formation (at Day7).
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Very slight erythema was noted at all treated skin sites one hour after patch removal. Well-defined erythema and very slight to slight oedema were noted at all treated skin sites at the 24, 48 and 72 hour observations. Very slight erythema was noted at one treated skin site at the 7-day observation.


Loss of skin elasticity was noted at one treated skin site at the 48-hour observation and at two treated skin sites at the 72-hour observation. Loss of skin flexibility was noted at one treated skin site at the 72-hour observation. Light brown discolouration of the epidermis was noted at all treated skin sites at the 72-hour observation. Moderate desquamation was noted at two treated skin sites with crust formation noted at the remaining treated skin site at the 7-day observation.

All treated skin sites appeared normal at the 14-day observation.

No corrosive effect were noted.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test substance is not a skin irritant

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