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Diss Factsheets

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:
1980-10-31
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-guideline, available as unpublished report, predates implementation of GLP and/or development of study guidelines but otherwise acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A 0.1 ml sample of dimethylsulfide borane was placed in one eye each of six rabbits. Ocular reaction were followed for seven days.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethyl sulphide-borane
EC Number:
236-313-6
EC Name:
Dimethyl sulphide-borane
Cas Number:
13292-87-0
Molecular formula:
C2 H9 B S
IUPAC Name:
Dimethylsulfide -- borane
Details on test material:
- Name of the test substance used in the study report: Dimethylsulfide borane
- Lot No.: #B-156889
- Physical state: yellow liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: from stock colony
- Housing: Individual cages

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
The eyes of the rabbits were judged free of irritation by examining under UV-light after instillation of 2% fluorescein stain. Prior to treatment, the rabbits were placed in a restrainer in a chemical fume hood. A 0.1 mL sample was instilled into the lover conjuctival sac of one eye of each rabbit. The opposite eye of each rabbit remained untreated and served as the control. Rabbits were left in the fume hood for 24 hours and then the treated eyes were irrigated with copious amounts of distilled water. Animals were then returned to their individual cages.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hours
Score:
0.8
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 hours
Score:
1
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 and 48 hours
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 hours
Score:
0.8
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
1.8
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hours
Score:
1.5
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours
Score:
1.7
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hours
Score:
1.8
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 hours
Score:
2
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 hours
Score:
1.7
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.93
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.93
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.7
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
1.83
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
All rabbits exhibited a positive response characterized by diffuse areas of corneal opacity, injected iris, slight conjuctival redness and swelling. Scores improved slightly by the seventh day. One rabbit of six exhibited significant corneal opacity. A "foamy" reaction occured immediately after compound instillation. All rabbits showed excessive discharge and evidence of necrosis in the conjunctival tissue of the lower eye lids.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria