Registration Dossier
Registration Dossier
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EC number: 235-719-0 | CAS number: 12609-95-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Remarks:
- Ex NONS.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 2004 to June 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
Constituent 1
- Specific details on test material used for the study:
- Read across data is presented from the structurally related substance, 1,1'-Bis(ferrocenyl)octane, CAS Number 501410-94-2, EC Number 479-710-1. This substance bears a close similarity to 1,1''-isopropylidenediferrocene, CAS Number 12609-95-9, EC Number 235-719-0, the distinction being that the alkyl bridging functionality between the two ferrocene moieties is an octyl derivative as opposed to an isopropyl derivative.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml
- 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)
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 3 days.
- Other effects:
- No effects on mean body weight and body weight development were noted. During the study the behaviour and general state of animals were normal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD 405, 1,1'-Bis(ferrocenyl)octan is slightly irritating to the eyes. It is not classified for eye irritation. GHS criteria are not met.
- Executive summary:
The eye irritation potential of1,1'-Bis(ferrocenyl)octane, CAS Number 501410-94-2, EC Number 479-710-1was investigated in accordance with the standardised guideline OECD 405.
An OECD 405 study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results was performed on 1,1'-Bis(ferrocenyl)octane, CAS Number 501410-94-2, EC Number 479-710-1.
The study was assigned a reliability score of 1 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).
This substance is considered to be sufficiently close in structural integrity to 1,1''-isopropylidenediferrocene, CAS Number 12609-95-9, EC Number 235-719-0 so as to justify valid read across.
Under the conditions of the study 1,1'-Bis(ferrocenyl)octane is not irritating to eyes. It is not classifed for eye irritation according to GHS criteria.
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