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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

In vivo test system

Test animals

Species:
mouse

Study design: in vivo (LLNA)

Vehicle:
other: acetone
Concentration:
3, 10 or 30% w/v
Details on study design:
The results are expressed as counts per minute (cpm) values per lymph node for each group. The activity of each test group is then divided by the activity of the vehicle control group to give the ratio for each concentration in comparison with the vehicle control. The criterion for a positive response is that at least one concentration of the test substance should elicit a 3-fold or greater increase in isotope incorporation relative to the vehicle control group, in which case the substance would be considered as a skin sensitiser.

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
other: Test:control group CPM/lymph node ratio
Value:
2.03
Test group / Remarks:
30% w/v
Parameter:
other: Test:control group CPM/lymph node ratio
Value:
1.19
Test group / Remarks:
10% w/v
Parameter:
other: Test:control group CPM/lymph node ratio
Value:
0.98
Test group / Remarks:
3% w/v

Any other information on results incl. tables

The counts per minute (CPM)/Lymph node value in the vehicle control group was 59. The corresponding CPM value for the test concentration of 3% w/v was 58, for the test concentration of 10% w/v it was 70 and for the test concentration of 30% w/v it was 120. The ratios of test group to control group were 0.98, 1.19 and 2.03.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is unlikely to be a moderate or strong skin sensitiser.
Executive summary:

The skin sensitisation potential of the test substance was under GLP in a local lymph node assay conducted to principles similar to those of the OECD TG 429. The substance was dissolved in acetone and applied to the dorsum of the ear of mice, which is the common test species for the LLNA. Three test concentrations of 3%, 10% and 30% w/v in acetone were tested in addition to the vehicle control (acetone). The results were expressed as a counts per minute (cpm) value per lymph node for each group. The measured activity was then divided by the activity of the vehicle control group to give a test:control ratio for each concentration. The criterion for a positive response is that one or more concentrations of the test substance should elicit a 3-fold or greater increase in isotope incorporation relative to the vehicle control group. Since the test:control ratio was less than 3 in all three test groups, the substance was considered unlikely to be a moderate or strong skin sensitiser.