Registration Dossier
Registration Dossier
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EC number: 926-540-5 | CAS number: 1174510-13-4
Eye irritation
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:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- ACIDE IOXITALAMIQUE 95
- IUPAC Name:
- ACIDE IOXITALAMIQUE 95
- 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".
Constituent 1
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.
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