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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 April 1990 - 5 June 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of dipotassium 3,3'-sulphonylbis(benzenesulphonate) and potassium 3-(phenylsulphonyl)benzenesulphonate
EC Number:
915-932-1
Molecular formula:
Reaction mass of C12H8O8S3.2K and C12H9O5S2.K
IUPAC Name:
Reaction mass of dipotassium 3,3'-sulphonylbis(benzenesulphonate) and potassium 3-(phenylsulphonyl)benzenesulphonate
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Test substance: Additive VP KU 1-1909
Lot#: DZA-UER -8919598-A
Manufacturer: Bayer AG, Leverkusen
Purity: 86.5% (see annex, appendix.3)
Identity/Stability: guaranteed for the study period
Storage: room temp, darkness
CAS #: 63316-43-8
Molecular weight: 336 g/mol

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino HC:NZW
Details on test animals or tissues and environmental conditions:
Prior to the study, rabbits were individually housed in stainless steel cages with perforated bases, uder standardized conventional coditions. Excrement trays beneath the cages contained low-dust (wood) bedding. Bedding was regularly spot checked for contaminants at the instance of the Department of Laboratory Animal Services, and changed at leased twice weekly.

Room temp: 20 +/- 3 Celsius
Humidity: 50%
Light/Dark cycle: 12h, artificial illumination
Air exchange rate: ~10 times per hour

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
ca. 70 mg
Duration of treatment / exposure:
eyelids were gently held shut for aprox. one second and were not rinsed for 24 hours
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
6 rabbits used
Details on study design:
Eye irritation was scored and recorded at the 1 hr, 24 hrs, 48 hrs, 72 hrs, 8 days, 14 days, and 21 days after administation. The signs of cornea (opacity and area affected), iris (hyperaemia, reaction to light), conjunctivae (erythema, chemosis) and discharge were recorded as described by DRAIZE, and the aqueous humour as described by MCDONALD and SHADDUCK. In addition any serious lesions or toxic effects other than ocular ones were recorded. The examinations of cornea, iris, and aqueous humur were facilitated using optical insturments. To define epithelial damage, one drop of a 1% fluoresceom solution was applied to the corneal surface 24 hours after administration of the test substance; where positibe effects were recorded this was repeated at the later observation times. The eye was then rinsed with saline to remove excess and nonabsorbed fluorescein. Evaluation was performed by means of ultraviolet illumination in a darkened room and diffuse white illumination, according to MCDONALD and SHADDUCK.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal: 2 thru 6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not Applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: 2 thru 6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: Not Applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: 1 thru 3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 14 days
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: 4 thru 6
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: 1 thru 6
Time point:
24/48/72 h
Score:
<= 1
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Only mild signs of eye irritation, which were fully reversible withing 14 days, were observed.
Other effects:
None reported.

Any other information on results incl. tables

Only mild signs of eye irritation, which were fully reversible withing 14 days, were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was determined to be slightly to moderately irritating the the eye.
Executive summary:

In a GLP guidline study conducated according to OECD guideline 405, six rabbits were tested for irritation to the eye. One animal showed a transient moderate opacity exlusively located at the inferior section of the cornea. In this rabbit the iris was temporatily affected. The signes proved to be fully reversable thus considered to be slightly to moderately irritating to the eye. All other animals showed only mild signs of eye irriations. Based on these results, the substance does not meet the GHS criteria for classification as causing serious eye damage (Category 1), a serious eye irritant (Category 2A), or mild eye irritant (Category 2B).