Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

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)

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 406 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
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.

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 vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
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
Challenge
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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
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 group
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

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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"-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 was found to be not sensitising to skin. The GHS criteria were not met.