Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye 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 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.