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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1 - 30 Apr 2009
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
OECD 429
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
sukls28108/2009
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of acetic acid and acetylferrocene and butan-1-ol and 2-methylpropan-1-ol and propan-1-ol and propan-2-ol
EC Number:
700-283-7
Molecular formula:
Exact molecular formula is not known as it is a reaction mass. Empiric formula: C5H5FeC5H4COCmHn
IUPAC Name:
Reaction products of acetic acid and acetylferrocene and butan-1-ol and 2-methylpropan-1-ol and propan-1-ol and propan-2-ol
Details on test material:
According to INQ-C-0000036278-61-01, INQ-C-0000036386-62-01, and INQ_RESULT_INQ-C-0000036417-65-01 from ECHA, identification of a substance has been changed to UVCB substance. Name of the substance on the study results is the old name (reaction mass of butan-1-ol and propan-2-ol, ReduxCo), however these reports should be regarded valid as all studies were performed on the substance that is being registered - ReduxCo.

In vivo test system

Test animals

Species:
mouse
Strain:
Balb/c
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
other: DAE 433 - mixture of 40% dimethylacetamide, 30% acetone and 30% ethanol
Concentration:
Positive control DNCB: 0,5 (w/v)
ReduxCo: 30%, 3%, 0.3% (v/v) in DAE 433
No. of animals per dose:
Total 36:
- 3 females - pilot experiment
- 18 females (6 animals in 3 groups)
- 6 females - positive control group
- 6 females - negative control group
- 3 females - reserve group
Positive control substance(s):
other: DNCB (dinitrochlorobenzene)

Results and discussion

Positive control results:
The positive control substance DNCB elicited a reaction pattern with statistically significant increase in ear weight and LN hyperplasia, which was in congruence with the expected mode of action of a contact allergen.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Ear weight index: 1.05 LN weight: 1.2 LN cell count: 1.3
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: not known

Any other information on results incl. tables

Comparison of values between treated groups and control grpups revealed that the test substance, ReduxCo, did not cause statistically significant increase in LN cell count and LN weight. Also index of LN cell count and LN weigh were not exceeded in any dose level,.

The animals exposed to test substance at all concentrations showed no skin reactions or negative clinical symptoms of intoxication throughout the experiment.

According to criteria given, the results were considered as negative.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the given test conditions, the test substance, ReduxCo, elicited negative response in LLNA test.
Executive summary:

Based on LLNA results the test substance, ReduxCo, does not have to be classified as the substance, which may cause sensitisation by skin contact.