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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:
10th Dec 1998 - 24th Dec 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: done under GLP and OECD method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Directive 92/69/EEC, Method B5;OECD Guideline No.405
GLP compliance:
yes

Test material

Constituent 1
Details on test material:
Nature of substance: Administered as supplied

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Amount / concentration applied:
30 mg
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.7
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 hour
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 hrs
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 hour
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 72 hr
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.3
Max. score:
2
Reversibility:
not fully reversible within: 72 hour
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days
Other effects:
A single application of the test material to the non-irrigated eye of three rabbits produced translucent iridial inflammation in two treated eyes at the one hour observation. These had resolved by the 24 hour observation.
Moderate to mild redness of the conjunctivae was apparent up to 72 hours in two rabbits which had resolved by 7 days. Moderate to mild chemosis of the conjunctivae was also
present but resolved in all rabbits by 7 days. No corneal alterations were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Mild, transient irritation may be possible but severity is not sufficient for classification under EC criteria.
Executive summary:

Potential of the substance BMS 217947-01 for causing eye damage or irritation was tested according to EU Test Method B5, Directive 92/69/EEC and OECD Guideline 405. The test substance was applied to 3 New Zealand White rabbits. Mild, transient irritation was observed. Iridial inflammation in two treated eyes was observed at the one hour observation, but it was resolved by the 24 hour observation. Moderate to mild redness and mild chemosis of the conjunctivae were observed, but the effects were fully reversible in all cases within 7 days. No corneal alterations were observed. As a result, the substance is not classified for causing eye irritiaion or eye damage.