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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:
2010
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
synthetic squalane

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
4h exposure
Observation period:
After removal of wrappings : observation at 30min, 24h, 48h and 72h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.22
Max. score:
0.33
Reversibility:
fully reversible
Remarks:
no effect after 72h
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
ca. 0.33
Max. score:
1
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
ca. 0.33
Max. score:
1
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0

Any other information on results incl. tables

Detail on results :

Rabbit

H3711

H3712

H3713

MEAN SCORES

Sex

M

M

M

 

Pretest body weight (kg)

2.6

2.6

2.8

 

Terminal body weight (kg)

2.7

2.7

2.8

 

Time after patch removal

Erythema & Eschar formation

60min

1

1

1

 

24h

0

0

1

0.33

48h

0

0

1

0.33

72h

0

0

0

0

Time after patch removal

Edema

60min

1

0

0

 

24h

0

0

0

0

48h

0

0

0

0

72h

0

0

0

0

 

 

 

 

 

Sum of mean scores

 

 

 

0.66

Primary Irritation Index (PII) (=Sum of mean scores/3)

 

 

 

0.22

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to EEC, squalane is not considered irritating to the skin.
Executive summary:

In vivo irritant or corrosive effects of squalan were determined using EPA OPPTS 870.2500 guideline. The test item was applied on rabbit skin during 4h. The test sites were scored for dermal irritation at 60min after removal of wrappings and scored again at 24, 48 and 72h. The modified Primary Irritating Index is 0.22.

In conclusion, in this study, the squalan is considered non-irritant.