Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch# 13037

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
Amount applied: 0.1 ml
Number of animals or in vitro replicates:
9

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hour
Score:
20.333
Max. score:
27
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
50.333
Max. score:
57
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
50.333
Max. score:
57
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
39.333
Max. score:
47
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day 7
Score:
15.333
Max. score:
36
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day 14
Score:
6.666
Max. score:
10
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day 21
Score:
6.666
Max. score:
10

Any other information on results incl. tables

Unwashed eyes:  Corneal opacity, noted in 6/6 eyes,
persisted to Day 21 in 3/6 eyes.  Iritis, noted in 6/6 eyes,
cleared by Day 7.  Conjunctival irritation, noted in 6/6
eyes, cleared by Day 14.

Washed eyes:  Corneal opacity, noted in 3/3 eyes, cleared by
Day 14.  Iritis, noted in 3/3 eyes, cleared by Day 7. 
Conjunctival irritation, noted in 3/3 eyes, cleared by Day
14.

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information
Conclusions:
Classification: irritating
Surfynol 104 Surfactant is an ocular irritant and possibly corrosive.
Executive summary:

Nine healthy New Zealand White rabbits, free from evidence
of ocular irritation and corneal abnormalities, were dosed. 
Surfynol 104 (0.1 ml) was placed into the conjunctival sac
of one eye of each rabbit.  Six eyes remained unwashed. 
Three eyes were washed with lukewarm water for one minute,
30 seconds postdose.  The eyes were examined and scored by
the Draize technique at one hour and at 24, 48, and 72 hours
postdose.  In order to determine reversibility, the eyes
were examined again on Days 7, 14, and 21.  Sodium
fluorescein was used to determine corneal effects following
the 24-hour scoring interval. There were no abnormal systemic signs noted during the observation period.

Surfvnol 104 Surfactant is an ocular irritant and possiblv corrosive.