Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD 429: Local Lymp Node Assay (LLNA)
GLP compliance:
yes

In vivo test system

Test animals

Species:
other: Mouse, CBA/JHsd

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
5 groups of 5 females, dosed for 3 days with 0, 1, 5, 25 or
50% solutions of the test substance in DMSO.


HCA in acetone used as positive control.
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
5 groups of 5 females, dosed for 3 days with 0, 1, 5, 25 or
50% solutions of the test substance in DMSO.


HCA in acetone used as positive control.
No. of animals per dose:
Number of animals in test group: 5
Number of animals in negative control group: 5

Results and discussion

Any other information on results incl. tables

Evidence of sensitisation of each challenge concentration:
Significant increases in cell proliferation measurements
compared to the vehicle control group were observed at the
two highest dose levels. However, stimulation indexes of
less than 3 were observed at all test concentrations.

Applicant's summary and conclusion

Interpretation of results:
other: not classified