Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
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
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

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
72 hrs
Observation period (in vivo):
1, 24, 48 and 72 hrs
Number of animals or in vitro replicates:
3
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 hr
Score:
ca. 6.67
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
24 h
Score:
ca. 5.33
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
48 h
Score:
ca. 0.67
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
72 h
Score:
ca. 0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
2

Results :

Table 1 : Individual score of ocular reactions

Animal n° Time (hrs) Score of ocular reactions 
Cornea Iris Conjuntivae
Opacity Area Redness Chemosis Discharge
1 1 0 0 0 2 0 2
24 0 0 0 2 0 1
48 0 0 0 0 0 0
72 0 0 0 0 0 0
2 1 0 0 0 2 0 1
24 0 0 0 1 0 0
48 0 0 0 0 0 0
72 0 0 0 0 0 0
3 1 0 0 0 2 0 1
24 0 0 0 2 0 2
48 0 0 0 1 0 0
72 0 0 0 0 0 0

Mean total scores :

- 1hr : 6.67

- 24hrs : 5.33

- 48hrs : 0.67

- 72hrs : 0

Classification according to EEC criteria

  Animal 1 Animal 2 Animal 3 EEC Index
24 hrs 48 hrs 72 hrs 24 hrs 48 hrs 72 hrs 24 hrs 48 hrs 72 hrs
Cornea opacity 0 0 0 0 0 0 0 0 0 0
Iris lesions 0 0 0 0 0 0 0 0 0 0
Conjunctival redness 2 0 0 1 0 0 2 1 0 2
Conjunctival chemosis 0 0 0 0 0 0 0 0 0 0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to OPPTS, ocular administration of squalan is not an ocular irritant.
According to EEC, squalane does not require a risk phrase.
Executive summary:

The aim of the study is to determine the irritant and/or corrosive effects if any, of a test article when instilled ibnto the rabbit eye. This study was designed to comply with the standards set forth in EPA Health Effects testing Guidelines, OPPTS Series 870.2400, final guideline, august 2008.

Three healthy New Zealand White rabbits, free from evidence of ocular irritation and corneal abnormalities, were dosed with squalane. The test article (0.1 ml) was placed into the conjunctival sac of one eye of each rabbit. The contralateral eye served as a control. The eyes were examined and scored by the Draize technique at 1, 24, 48 and 72hrs. Sodium fluoresecein dye procedures were used at 24hrs observation interval. The control eyes were observed at the same time periods. Observations for mortality, toxicity and pharmacological effects were recorded at each ocular observation period. Body weights were recorded pretest. The mean total scores were calculated by adding the total score for each time period and dividing by the number of animals.

There was no corneal opacity or iritis noted in any observation period. Conjunctival irritation, noted in 3/3 eyes, cleared within 72hrs.

The control eyes appeared normal at all periods.

There were no abnormal physical signs noted during the observation period.

According to OPPTS, ocular administration of squalane is not an ocular irritant.

According to EEC, squalane does not require risk phrases.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation : In vivo irritant and corrosive effects of squalan were determined using EPA OPPTS 870.2500 guideline. In this study, the squalan is considered non-irritant.

Eyes irritation : the irritant and corrosive effects were determined using EPA OPPTS Series 870.2400 guideline. According to OPPTS and EEC, ocular administration of squalane is not an ocular irritant

Justification for selection of skin irritation / corrosion endpoint:

Recent study according OECD guideline and reliable without restriction

Justification for selection of eye irritation endpoint:

Recent study according OECD guideline and reliable without restriction

Justification for classification or non-classification

Skin irritation :In vivo irritant effects of squalan were determined using EPA OPPTS 870.2500 guideline. In this study, the squalan is considered non-irritant.

Eyes irritation :the irritant effects were determined using EPAOPPTS Series 870.2400 guideline.According to OPPTS and EEC, ocular administration of squalane is not an ocular irritant