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Toxicological information

Skin irritation / corrosion

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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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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.

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"-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.