Registration Dossier

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:
1984-09-04 to 1984-09-25
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
non-GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
OECD 1981
Deviations:
no
Principles of method if other than guideline:
NA
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
other: white Russian
Details on test animals or tissues and environmental conditions:
body weight: 2.4 - 2.75 kg
age: 6-7 months

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated left eye served as negative control.
Amount / concentration applied:
0.1 g test item was applied once in rabbit´s eye.
Duration of treatment / exposure:
The subsatnce was applied one to the rabbit's eye (without washing).
Observation period (in vivo):
Examinations: 1, 24, 48 and 72 hours after application and thereafter once per day.
The observation period was 21 days after application.
Number of animals or in vitro replicates:
3 ( female)
Details on study design:
NA

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
(extent of opacity area)
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Remarks:
(extent of opacity area)
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
cornea opacity score
Remarks:
(extent of opacity area)
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
(extent of opacity area)
Basis:
mean
Time point:
24/48/72 h
Score:
0.44
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
24/48/72 h
Score:
1.11
Max. score:
3
Reversibility:
fully reversible within: 3 days
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:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Not indicated.
Other effects:
No other effects.

Any other information on results incl. tables

Additional results:

irriation parameter                               Basis                  Time point       results       Max. scroce        Reversibility

conjunctivae score (secretion)          animal #1            24/48/72 h        0.33          3                         fully reversible within: 48 hours       

conjunctivae score (secretion)          animal #2            24/48/72 h        0                3                  

conjunctivae score (secretion)          animal #3            24/48/72 h        0                3                        

conjunctivae score (secretion)          mean                   24/48/72 h        0.11          3                         fully reversible within: 48 hours       

  

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance Sodium cyanate revealed only very weak irritating effects to rabbit´s eye (mean 24/48/72 h scores: cornea score 0.22, iris score 0.22, conjunctivae score 1.11, chemosis score 0) wich were reversible within at least 3 days.
Executive summary:

In a primary eye irritation study, 0.1 g of sodium cyanate (98 %) was instilled into the conjunctival sac of the right eye of 6-7 months old White Russian rabbits (3 females) for 72 h hours. Animals then were observed for 21 days. Irritation was scored by the method of Draize. The substance Sodium cyanate revealed only very weak irritating effects to rabbit´s eye (mean 24/48/72 h scores: cornea score 0.22, iris score 0.22, conjunctivae score 1.11, chemosis score 0) which were reversible within at least 3 days. None of the individual animals showed a mean score over 24/48/72 h treatment higher than the threshold values given in 67/548/EEC and Regulation (EC) No 1272/2008.