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Diss Factsheets

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:
2000
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
444-240-8
EC Name:
-
Cas Number:
302933-83-1
Molecular formula:
C55-n H95.5-2n N7 013 Na1.5 (n-0-6) molecular weight: 1097-l4n (n=0-6)
IUPAC Name:
Sodium surfactin
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL/eye = 44 mg/eye
Observation period (in vivo):
1/24/48/72/96 h and 5 days after administration
Duration of post- treatment incubation (in vitro):
The lid were held together for one second. Half a minute after the instillation, the treated eyes in the washed eye group were washed with approximately 60 mL of tepid water for injection for half a minute.
Number of animals or in vitro replicates:
6
Details on study design:
The test substance (44 mg Sodium surfactin) was instilled to the conjunctival sac of the left eye, while the right eye remained untreated to serve as a control. The lids were then held together for one second. Half a minute after the instillation, the treated eyes in the washed eye group were washed with approximately 60 mL of tepid water for injection for half a minute.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
24 h
Score:
>= 33 - <= 53.7
Max. score:
53.7
Reversibility:
fully reversible within: 5 days
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
72 h
Score:
ca. 2.7 - <= 19.3
Max. score:
19.3
Reversibility:
fully reversible within: 5 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
2
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
MMTS in the washed eye group was lower than in the non-washed group

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
It is concluded from the results that Sodium surfactin has severely irritative potential for the rabbit eye, and the irritation is reduced by washing the eye.
Executive summary:

Sodium surfactin was investigated for the eye-irritative potential by administration to the left eyes of rabbits with and without subsequent washing of the treated eyes. Corneal opacity, iridial congestion, conjunctival redness and chemosis and discharge were observed in both of the non-washed eye and washed eye groups, which disappeared by day 5 after administration.

It is concluded from the results that Sodium surfactin has severely irritative potential for the rabbit eye, and the irritation is reduced by washing the eye.