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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
before 1980, comparable to OECD 405
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
sec-butylamine
EC Number:
237-732-7
EC Name:
sec-butylamine
Cas Number:
13952-84-6
Molecular formula:
C4H11N
IUPAC Name:
butan-2-amine

Test animals / tissue source

Species:
rabbit
Strain:
other: albino

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
one tenth ML
Duration of treatment / exposure:
1 minutes
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
One tenth animal was placed in the conjunctival sas of both eyes of three albino rabbits. One eye of each animal was washed with flowing water initiated fifteen seconds after instillation and continued for a period of one minute; the contraleral eye remained unwashed. The irritant reactions were scored periodically for seven days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 10 min/1h/2h/4h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: not reversible within 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 10 mn/1hr/2hr/4hr
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks:
after 7 days
Remarks on result:
other: not reversible within 7 days
Irritation parameter:
conjunctivae score
Remarks:
chemosis
Basis:
other: mean
Remarks:
3 rabbits
Time point:
other: 10 mn/1hr/2hr/4hr
Score:
1
Max. score:
1
Reversibility:
not reversible
Remarks:
after 7 days
Remarks on result:
other: not reversible within 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: not reversible within 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: not reversible within 7 days
Irritation parameter:
conjunctivae score
Remarks:
chemosis
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not reversible
Remarks on result:
other: not reversible within 7 days
Irritant / corrosive response data:
Reactions in washed and unwashed eyes were identical. The cornea began to opacify immediately and opacification was virtually complete within 10 minutes (the iris and ppil were not discernible. Severe conjuntival inflammation also developed promptly. In addition, tissue necrosis appeared within minutes in portions of the conjunctivae and along the borders of the eyelids; the latter solidified within a day or two. The reaction persisted through the seventh day without change and appeared to be irreversible.

Applicant's summary and conclusion

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

One tenth animal was placed in the conjunctival sas of both eyes of three albino rabbits. One eye of each animal was washed with flowing water initiated fifteen seconds after instillation and continued for a period of one minute; the contraleral eye remained unwashed. The irritant reactions were scored periodically for seven days. Reactions in washed and unwashed eyes were identical. The cornea began to opacify immediately and opacification was virtually complete within 10 minutes (the iris and pupil were not discernible. Severe conjunctival inflammation also developped promptly. In addition, tissue necrosis appeared within minutes in portions of the conjunctivae and along the borders of the eyelids; the latter solidified within a day or two. The reaction persisted through the seventh day without change and appeared to be irreversible.