Registration Dossier
Registration Dossier
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EC number: 310-202-3 | CAS number: 37206-42-1
Endpoint summary
Administrative data
Description of key information
Two studies on skin irritation 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 404) and Iron(2+) dicyclopenta-2,4-dienide (Ferrocene), CAS Number 102-54-5, EC Number 203-039-3 (comparable to OECD 404).
In an OECD 404 study, 1,1'-Bis(ferrocenyl)octane was found to be not irritating 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 irritation potential was investigated in a study which was comparable to to guideline OECD 404. Iron (2 +) dicyclopenta-2,4 -dienide (ferrocene) was found to be not irritating to skin, the GHS criteria were not met.
As regards eye irritation two studies on skin irritation 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 404) and Iron(2+) dicyclopenta-2,4-dienide (Ferrocene), CAS Number 102-54-5, EC Number 203-039-3 (comparable to OECD 404).
In an OECD 405 study, 1,1'-Bis(ferrocenyl)octane was found not to be irritating to eyes, 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 eye irritation potential was investigated in a study which was comparable to to guideline OECD 404. Iron (2 +) dicyclopenta-2,4 -dienide (ferrocene) was found to be not irritating to eyes, the GHS criteria were not met.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- 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 structural similarity to 1,1"-isopropylidenebis(ethylferrocene), CAS Number 37206 -42 -1, EC Number 310 -202 -3, the distinction being that the alkyl bridging functionality between the two ferrocene moieties is an octyl derivative as opposed to an isopropyl derivative and that two cyclopentadienyl moieties in the target substance bear ethyl substituents.
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- 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
- 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.
- 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"-isopropylidenebis(ethylferrocene), CAS Number 37206 -42 -1, EC Number 310 -202 -3 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.
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- OECD 404
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- 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"-isopropylidenebis(ethylferrocene), CAS Number 37206 -42 -1, EC Number 310 -202 -3. Therefore, it is considered that read-across is valid.
- Species:
- rabbit
- Strain:
- other: White Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: dr. Karl.Thomae GmbH, Biberach
- Weight at study initiation: 2.1-2.8kg
- Diet:ad libitum
- Water: ad libitum
- Acclimation period: 14days
- Sex: male
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-1
- Humidity (%): 60+-5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours then patch removed.
- Observation period:
- 3 days
- Number of animals:
- 3
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.56
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a Study performed comparable to OECD Guideline 404, Ferrocene on the skin of male rabbits is a non-irritant. This is based on the primary dermal irritation index value of 0.5. GHS criteria are not met.
- Executive summary:
The skin irritation 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 404.
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"-isopropylidenebis(ethylferrocene), CAS Number 37206 -42 -1, EC Number 310 -202 -3 so as to justify valid read across.
In this study, ferrocene on the skin of male rabbits is a non-irritant. This is based on the primary dermal irritation index value of 0.5. GHS criteria are not met.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- 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 structural similarity to 1,1"-isopropylidenebis(ethylferrocene), CAS Number 37206 -42 -1, EC Number 310 -202 -3, the distinction being that the alkyl bridging functionality between the two ferrocene moieties is an octyl derivative as opposed to an isopropyl derivative and that two cyclopentadienyl moieties in the target substance bear ethyl substituents..
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml
- Number of animals or in vitro replicates:
- 3
- 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: 3 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 3 days
- 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: 3 days
- 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: 3 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (mean score)
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 3 days
- 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
- Remarks:
- (mean score)
- 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.
- 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"-isopropylidenebis(ethylferrocene), CAS Number 37206 -42 -1, EC Number 310 -202 -3 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.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
- 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"-isopropylidenebis(ethylferrocene), CAS Number 37206 -42 -1, EC Number 310 -202 -3. Therefore, it is considered that read-across is valid.
- Species:
- rabbit
- Strain:
- other: White Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr Karl Thomae, GmbH, Biberach
- Weight at study initiation: 2.2-2.4kg
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-1
- Humidity (%): 60+-5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1g
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 6 days
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a Study performed to OECD Guideline 405, Ferrocene was non-irritating for the eye and ocular mucosa. of a rabbit. This is based on the overall score of (2.5/100) = 0.02. GHS criteria are not met.
- Executive summary:
The eye irritation 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 405.
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"-isopropylidenebis(ethylferrocene), CAS Number 37206 -42 -1, EC Number 310 -202 -3 so as to justify valid read across.
In this study, ferrocene in the eye of male rabbits is a non-irritant. This is based on the overall score of (2.5/110) = 0.02. GHS criteria are not met.
Referenceopen allclose all
Conjunctiva effects are probably due to physical powder irritation. These effects are reversible within 24 hours.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
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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