Registration Dossier
Registration Dossier
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EC number: 235-719-0 | CAS number: 12609-95-9
Endpoint summary
Administrative data
Description of key information
Two studies on skin sensitisation potential are presented on structurally related substances as valid read across candidates: 1,1'-Bis(ferrocenyl)octane, CAS Number 501410-94-2, EC Number 479-710-1 (OECD 406) and Iron(2+) dicyclopenta-2,4-dienide (Ferrocene), CAS Number 102-54-5, EC Number 203-039-3 (comparable to OECD 406).
In an OECD 406 study, 1,1'-Bis(ferrocenyl)octane was found to be not sensitising to skin, the GHS criteria were not met.
In the case of iron (2 +) dicyclopenta-2,4 -dienide (ferrocene), CAS Number 102 -54 -5, EC Number 203 -039 -3, the skin sensitisation potential was investigated in a study which was comparable to to guideline OECD 406. Iron (2 +) dicyclopenta-2,4 -dienide (ferrocene) was found to be not sensitising to skin, the GHS criteria were not met.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 2004 to May 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A guinea pig sensitisation study was conducted to evaluate the sensitisation potential of the test item 1,l' - Bis(ferrocenyl)octane. The study was performed according to Magnusson and Kligman.
- 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.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Route:
- intradermal and epicutaneous
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) Intradermal induction exposure:
Test group: 5 % test item in NaCl 0,9 %,
Control group: NaCl 0,9 % b) Dermal induction exposure:
Test group: 100 % test item
Control group: oleum helianthi
Concentration of test material and vehicle used for each challenge:
Test group: 100 % test item
Control group: 100 % test item - Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) Intradermal induction exposure:
Test group: 5 % test item in NaCl 0,9 %,
Control group: NaCl 0,9 % b) Dermal induction exposure:
Test group: 100 % test item
Control group: oleum helianthi
Concentration of test material and vehicle used for each challenge:
Test group: 100 % test item
Control group: 100 % test item - No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading : 1st Reading; Hours afetr challenge: 24h; Group: Test group; Dose level: 100%; No with + reactions: 0; Total in group: 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading; Hours after challenge: 48h; Group: Test group; Dose level: 100%; No with + reactions: 0; Total in group: 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading; Hors after challenge: 24h; Group: Negative control; Dose level: 0%; Bo. with + reactions: 0; Total in group: 5.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading; Hours after challenge: 48h; Group: Negative control; Dose level: 0%; No. with + reactions: 0; Total in group: 5.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- positive control group not reported
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- other: positive control group not reported
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- positive control group not reported
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- other: positive control group not reported
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a study conducted according to OECD guideline 406, 1,1'-Bis(ferrocenyl)octane was found to be not sensitising to the skin.
- Executive summary:
The skin sensitisation 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 406.
An OECD 406 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 was found to be not sensitising to skin. The GHS criteria were not met.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A guinea pig sensitisation study was conducted to evaluate the sensitisation potential of the test item, iron(2+) dicyclopenta-2,4-dienide (ferrocene), CAS Number 102-54-5, EC Number 203-039-31. The study was performed according to Magnusson and Kligman. (OECD 406).
- Specific details on test material used for the study:
- Read across data is presented from the structurally related substance, iron(2+) dicyclopenta-2,4-dienide (ferrocene), CAS Number 102-54-5, EC Number 203-039-3. This substance bears a close similarity to 1,1''-isopropylidenediferrocene, CAS Number 12609-95-9, EC Number 235-719-0. Therefore, it is considered that read-across is valid.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: F. winkelmann, 4799 Borchen
- Sex: female
- Weight at study initiation: 308.7g
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 4-8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):20-+1
- Humidity (%): 60+-5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 5% intracutalous and 100% epidermal
- Route:
- epicutaneous, open
- Vehicle:
- corn oil
- Concentration / amount:
- 5% intracutalous and 100% epidermal
- No. of animals per dose:
- 10
- Positive control substance(s):
- yes
- Remarks:
- Freunds Complete Ajuvant
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1ml
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading; Hours after challenge: 24h; Group: Test group; Dose level: 0.1ml; No. with + reactions: 0; Total no. in group: 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1ml
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading; Hours after challenge: 48h; Group: Test group; Dose level: 0.1ml; No. with + reactions: 0; Total no. in group: 20.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0ml
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading; Hours after challenge: 24h; Group: Negative control; Dose level: 0ml; No. with + reactions: 0; Total no. in group: 10.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0ml
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading; Hours after challenge: 48h; Group: Negative control; Dose level: 0ml; No. with + reactions: 0; Total no. in group: 10.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- positive control group not reported
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- other: positive control group not reported
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- positive control group not reported
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- other: positive control group not reported
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a study performed to OECD Guideline 406, Ferrocene was found to be non sensitising
- Executive summary:
The skin sensitisation potential of iron(2+) dicyclopenta-2,4-dienide (ferrocene), CAS Number 102-54-5, EC Number 203-039-3 was investigated in a study which was comparable to guideline OECD 406.
The study was assigned a reliability score of 2 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 this study, Ferrocene was found to be non sensitising with 0 /20 postitive reactions. The GHS criteria are not met.
Referenceopen allclose all
Maximum concentration not causing irritating effects in preliminary test: 100 %.
Signs of irritation during induction:
No reaction on the skin of guinea pigs was observed.
Evidence of sensitisation of each challenge concentration:
After the challenge with test item 1,1'-Bis(ferrocenyl)octane
in undiluted form a positive response was not observed in
the animals of the test group.
Other observations:
No effects on mean body weight and body weight development were noted.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
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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