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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:
21 March to 07 April 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP study conducted according to OECD Guideline 404 with deviations: age at study initiation, feeding conditions not reported. These deviations do not affect the quality of the study and are not considered to be relevant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
age at study initiation, feeding conditions not reported
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)
Remarks:
13 December 2005

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Source and lot/batch No.of test material: MANE FILS SA / 713060- Physical state: Colourless liquid- Date received: 13 March 2006- Expiration date of the lot/batch: February 2007- Purity test date: February 2006- Test item was considered at 100% for the study.- Name of test material (as cited in study report): Figolide A45240- Storage condition of test material: Room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Elevage de Gérome, Quartier Labaste – F40260 Linxe- Weight at study initiation: 2.48-2.86 kg- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.- Diet: No data- Water: No data- Acclimation period: 5 daysENVIRONMENTAL CONDITIONS- Temperature: 19-23 °C- Humidity: 30-59 %IN-LIFE DATES: 21 March to 07 April 2006

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: On the left flank an untreated area was served as the control
Amount / concentration applied:
TEST MATERIAL - Amount(s) applied (volume or weight with unit): 0.5 mL - Concentration (if solution): Undiluted
Duration of treatment / exposure:
4 h
Observation period:
Skin reactions were appreciated 1 hour and then 24, 48, 72 hours and Days 4 to 10 after removal of the patch.
Number of animals:
3 males
Details on study design:
Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated.TEST SITE - Area of exposure: The test item was applied, as supplied, at a dose of 0.5 mL, on an undamaged skin area of the right flank of each animal. - Type of wrap if used: The patch was secured in position with a strip of surgical adhesive tape. REMOVAL OF TEST SUBSTANCE - Time after start of exposure: 4 hOBSERVATION TIME POINTS- Skin reactions were appreciated 1 hour and then 24, 48, 72 hours and Days 4 to 10 after removal of the patch.SCORING SYSTEM: According to OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 days
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 4 days
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
24 hours after the test item application, it was noted a well definite erythema, associated with a very slight oedema. The oedematous reactions were totally reversible between the 3rd and the 4th day of the test and the erythematous reactions were totally reversible between the 4th and the 7th day of the test.On the cutaneous aspect, the skin recovered a normal aspect, between the 5th and the 11th day of the test.
Other effects:
None

Any other information on results incl. tables

Table 7.3.1/1: Individual and average scores after 4 h exposure

Observations

Score

Skin

reactions

Observation

time

Animal no.A7286

Animal no.A7303

Animal no.A7304

Erythema

and eschar

1 h

2

2

2

24 h

2

2

2

48 h

1

2

2

72 h

0

1

2

Day 4

0

0

2

Day 5

-

0

1

Day 6

-

0

0

Day 7

-

0

0

Day 8

-

0

0

Day 9

-

0

0

Day 10

-

0

0

Mean (24, 48 and 72 h)

1.0

1.7

2.0

Oedema

formation

1 h

1

1

1

24 h

1

1

1

48 h

0

1

0

72 h

0

0

0

Day 4

0

0

0

Day 5

-

0

0

Day 6

-

0

0

Day 7

-

0

0

Day 8

-

0

0

Day 9

-

0

0

Day 10

-

0

0

Mean (24, 48 and 72 h)

0.3

0.7

0.3

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, test substance is not classified as irritating to skin according to the criteria of the Annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
Executive summary:

In a dermal irritation study performed according to the OECD Guideline No. 404, and in compliance with GLP, undiluted test substance was applied at the dose of 0.5 mL, under semiocclusive dressing during 4 hours on an undamaged skin area of 3 rabbits. On the opposite flank an untreated area was served as the control. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48, 72 h and Days 4 to 10 after the removal of the patch. Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated.

 

24 hours after the test item application, it was noted a well definite erythema, associated with a very slight oedema. The oedematous reactions were totally reversible between the 3rd and the 4th day of the test and the erythematous reactions were totally reversible between the 4th and the 7th day of the test. On the cutaneous aspect, the skin recovered a normal aspect, between the 5th and the 11th day of the test.The individual scores for each animal within 3 scoring times (24, 48 and 72 h) were 1.0 / 1.7 / 2.0 for erythema and 0.3 / 0.7 / 0.3 for oedema. 

 

Under the test conditions, the test substance is not classified according to the criteria of the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.