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Diss Factsheets

Administrative data

Description of key information

In a Study performed to OECD Guideline 404, Ferrocene is non-irritating on the skin of male rabbits.


In a Study performed to OECD Guideline 405, Ferrocene is non-irritating for the eye and ocular mucosa of a rabbit.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified
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:
0.5g
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:
other: 72 hours
Score:
0.5
Max. score:
1
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.56
Max. score:
2
Reversibility:
fully reversible within: 6 days
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Interpretation of results:
GHS criteria not met
Conclusions:
In a Study performed 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
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
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
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
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:
24/48/72 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
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified

Conjunctiva effects are probably due to physical powder irritation. These effects are reversible within 24 hours

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
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In a Study performed to OECD Guideline 404, Ferrocene is non-irritating on the skin of male rabbits. This is based on the irritation index value of 0.5

In a Study performed to OECD Guideline 405, Ferrocene is non-irritating for the eye and ocular mucosa of a rabbit. This is based on the overall score of 0.02


Justification for selection of skin irritation / corrosion endpoint:
Only study available. Study is reliable, Klimisch score 2

Justification for selection of eye irritation endpoint:
Only study available. Study is reliable, Klimisch score 2

Justification for classification or non-classification

In a Study performed to OECD Guideline 404, Ferrocene on the skin of male rabbits is a non-irritant and in a Study performed to OECD Guideline 405, Ferrocene non-irritating for the eye and ocular mucosa. of a rabbit.

Therefore according to EU classifiation and labelling legislation ferrocene is not classfied as an irritant for the eye or skin