Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1996
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
No toxicology data are available on the substance "95SA", also called "ioxitalamic acid, ammonium salt". However, data are available on the substance "95" (also called "ioxitalamic acid") and, therefore, the Applicant proposes to rely on these data. The chemical structure of both substances is the same, but "95SA" is an ammonium salt of "95". The quality (purity) of both substances is also comparable as "95SA" has a slightly higher total impurity content than "95" (total impurities < 2% in "95SA", while < 1% in "95"). It is not believed that these 2 minor differences may alter dramatically the toxicity profile established for "95". It is also of importance to know that "95" is a well-characterized pharmaceutical active substance, authorised in drug product called Telebrix.
Therefore, the data on "95" are considered fully relevant to assess the toxicity profile of "95SA".

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye not treated
Amount / concentration applied:
0.1g
Duration of treatment / exposure:
1s
Observation period (in vivo):
1h, 24h, 48h, 72 h
Number of animals or in vitro replicates:
3 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1h
Score:
ca. 0.67
Max. score:
1
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48h
Score:
ca. 0
Max. score:
0
Remarks on result:
other: No other effect observed for 72h
Irritation parameter:
conjunctivae score
Remarks:
pruritus
Basis:
mean
Time point:
other: 1h
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 24h
Irritation parameter:
conjunctivae score
Remarks:
pruritus
Basis:
mean
Time point:
other: 24h
Score:
ca. 0
Max. score:
0
Remarks on result:
other: No other effect observed for 72h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 1h
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24h
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 48h
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 72h
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1h
Score:
ca. 0
Max. score:
0
Remarks on result:
other: No other effect observed for 72h
Irritation parameter:
cornea opacity score
Remarks:
opacity and opacity surface
Basis:
mean
Time point:
other: 1h
Score:
ca. 0
Max. score:
0
Remarks on result:
other: No other effect observed for 72h

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Upon directive 67/548, substance acide ioxitalamique is a not eye irritating substance.