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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Non-sensitising

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
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:
Study undertaken prior to 2000
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 Adjuvant
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: 24.0. Group: test group. Dose level: 0.1ml. No with. + reactions: 0.0. Total no. in groups: 20.0.
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: 48.0. Group: test group. Dose level: 0.1ml. No with. + reactions: 0.0. Total no. in groups: 20.0.
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: 24.0. Group: negative control. Dose level: 0ml. No with. + reactions: 0.0. Total no. in groups: 10.0.
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: 48.0. Group: negative control. Dose level: 0ml. No with. + reactions: 0.0. Total no. in groups: 10.0.
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
In a study performed to OECD Guideline 406, Ferrocene was found to be non sensitising
Executive summary:

In a study performed to OECD Guideline 406, Ferrocene was found to be non sensitising with 0 /20 postitive reactions

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In a study performed to OECD Guideline 406, Ferrocene was found to be non-sensitising with 0/20 positive reactions

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No respiratory sensitising study is available, but given that the material is not sensitising for the skin it is unlikely to be a respiratory sensitiser


Justification for classification or non-classification

In a study performed to OECD Guideline 406, Ferrocene was found to be non-sensitising, and is therefore not classified for skin sensitisation.

No respiratory sensitising study is available, but given that the material is not sensitising for the skin it is unlikely to be a respiratory sensitiser