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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:
14 April 2005 and 18 May 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
β,4-dimethylcyclohex-3-ene-1-propan-1-al
EC Number:
229-846-0
EC Name:
β,4-dimethylcyclohex-3-ene-1-propan-1-al
Cas Number:
6784-13-0
Molecular formula:
C11H18O
IUPAC Name:
3-(4-methylcyclohex-3-en-1-yl)butanal
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK.
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: The animals were individually housed in suspended cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
3 minutes, 1 hour and 4 hours
Observation period:
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later
Number of animals:
3
Details on study design:
TEST SITE: One rabbit was initially treated. Three suitable sites were selected on the back of the rabbit. At each test site a quantity of 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. Each patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset and the animal was returned to its cage for the duration of the exposure period. One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours after application. After consideration of the skin reactions produced in the first animal, two additional animals were treated with 0.5 ml of test material. One patch was applied to the back of each rabbit, and was allowed to remain in contact with the skin for a period of four hours.

REMOVAL OF TEST SUBSTANCE: Any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.

OBSERVATION TIME POINTS AND SCORING: Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: At day 14 only some desquamation is seen
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: At day 14 only some desquamation is seen.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: At day 14 only some desquamation is seen.
Other effects:
Other skin reactions were a light brown discoloration of the epidermis, desquamation and loss of skin elasticity. One treated skin site appeared normal at the 14-day observation. Desquamation is seen at day 7 with erythema in 2/3 animals. At day 14 only some desquamation is seen, without inflammation.

Any other information on results incl. tables

Individual Skin Reactions Following 4-Hour Exposure:





























































































































































     
   Individual Scores - Rabbit Number and Sex 
Skin ReactionObservationTime   Total
   15 Male62 Male63 Male 
 1 Hour122 (5)
 24 Hours1225
Erythema/Eschar48 Hours12 Br2(5)
Formation72 Hours1 Le2BrLe2Br5
 7 DaysODlDlD(2)
 14 DaysOD*OD*OD*0
 1 Hour0 -I1(2)
 24 Hours0112
 48 Hours011(2)
Oedema Formation
 72 Hours0112
 7 Days0000
 14 Days0000
Sum of24 and 72-hour Readings (S) 14  
Primary Irritation Index (S/6) 14/6 = 2.3  
Classification MODERATE IRRITANT  

Individual Skin Reactions Following 1-Hour and 3-Minute Exposures:





























































































  Individual Scores - Rabbit Number and Sex
  15 Male
Skin ReactionObservation Time1-Hour Exposure3-Minute Exposure
 1 Hour10
 24 Hours10
Erythema/Eschar48 Hours10
Formation72 Hours1 Le0
 7 DaysOD0
 14 DaysOD*0
 1 Hour00
 24 Hours00
 48 Hours00
Oedema Formation72 Hours00
 7 Days00
 14 Days00

 () = Total values not used for calculation of primary irritation index


Br= Light brown discolouration of the epidermis


Le = Loss of skin elasticity


D = Moderate desquamation


D* = Slight desquamation

Applicant's summary and conclusion

Interpretation of results:
other: Not a skin irritant in accordance with EU CLP (EC no 1272/2008 and its amendments)
Conclusions:
The test substance is not classified to be a skin irritant under the conditions of the study.
Executive summary:

The study was performed to assess the irritancy potential of Limoxal following single, 3-minute, 1 and 4-hour, semi-occluded applications to the intact rabbit skin according to the OECD Guideline 404 in compliance with GLP.
No corrosive effects noted after the 3-minute and 1-hour semi-occluded applications of test material to intact skin of one rabbit. A single 4 hour semi-occluded application of test material to the intact skin of 3 rabbits resulted in well-defined erythema and very slight to slight edema. The mean erythema and oedema scores over 24, 48 and 72 hours were 1 and 0 for one rabbit and 2 and 1 for other two rabbits. In all cases, erythema was reversible within 14 days and oedema was reversible in 7 days in all the animals. Other skin reactions were a light brown discoloration of the epidermis, desquamation and loss of skin elasticity. One treated skin site appeared normal at the 14-day observation. Desquamation is seen at day 7 with erythema in 2/3 animals. At day 14 only some desquamation is seen, without inflammation. Therefore the substance does not need to be classified for skin irritation.