Registration Dossier
Registration Dossier
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EC number: 700-345-3 | CAS number: 515851-08-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N4-[3-(1H-imidazol-1-yl)propyl]-2-methylbenzene-1,4-diamine trihydrochloride
- EC Number:
- 700-345-3
- Cas Number:
- 515851-08-8
- Molecular formula:
- C13H21Cl3N4
- IUPAC Name:
- N4-[3-(1H-imidazol-1-yl)propyl]-2-methylbenzene-1,4-diamine trihydrochloride
- Reference substance name:
- [TN]Kn 172[/TN][SPEC][/SPEC][AM]>99%[/AM]Active Matter
- IUPAC Name:
- [TN]Kn 172[/TN][SPEC][/SPEC][AM]>99%[/AM]Active Matter
- Details on test material:
- other: Kn 172
Batch No.: Kn-Gi 8634/1
Batch No.: Kn-Gi-8634/1
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 g - Duration of treatment / exposure:
- 24 hour(s)
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- Comment: rinsed after (see exposure time),
one animal test due to severe eye irritation
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: hours
- Score:
- 24 - 72
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: hours
- Score:
- 24 - 72
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1 and 2
- Time point:
- other: hours
- Score:
- 24 - 72
- Max. score:
- 0.33
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: hours
- Score:
- 24 - 72
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Redness
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: hours
- Score:
- 24 - 72
- Max. score:
- 0
Any other information on results incl. tables
A severe reaction was observed following ocular administration of KN 172 to a single rabbit.
The severity of the observed chemosis did not permit the evaluation of the Cornea and iris at the 24 and 48 hour examinations. The reaction observedup to the 7 day examination appeared to be completely reversible at the end of the observation period but of such severity to require classification of the test item as severely irritant for the eye.
European Directives concerning the classification, packaging and labelling of dangerous substances (671548EEC and subsequent revisions) wouldindicate the following:
Classification : Xi / R41- Risk of serious damage to eyes
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information
- Conclusions:
- Classification: risk of serious damage to eyes
- Executive summary:
The acute eye irritation of KN 172 was investigated in the rabbit.
A severe reaction was observed following ocular administration of KN 172 to a single rabbit.
The severity of the observed chemosis did not permit the evaluation of the Cornea and iris at
the 24 and 48 hour examinations. The reaction observed up to the 7 day examination appeared
to be completely reversible at the end of the observation period but of such severity to require
classification of the test item as severely irritant for the eye.
European Directives concerning the classification, packaging and labelling of dangerous
substances (671548EEC and subsequent revisions) would indicate the following:
Classification: Required
Symbol: Xi
R Phrase: R41- Risk of serious damage to eyes
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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