Registration Dossier
Registration Dossier
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EC number: 235-719-0 | CAS number: 12609-95-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vivo study available, ex NONS; OECD 404
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 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 404 (Acute Dermal 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.
In vitro test system
- Source species:
- rabbit
- Source strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent no treatment
- Amount/concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hours
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated skin
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 h, 24 h, 48 h, 72 h, 7 d, 14 d
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.66
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 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 404, 1,1'-Bis(ferrocenyl)octane is slightly irritating to skin. It is not classifed for skin irritant according to GHS criteria.
- Executive summary:
The skin irritation/corrosion potential of 1,1'-Bis(ferrocenyl)octane, CAS Number 501410-94-2, EC Number 479-710-1was investigated in accordance with the standardised guideline OECD 404.
An OECD 404 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 slightly irritating to skin. It is not classifed for skin irritant according to GHS criteria.
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