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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Similar to guideline. Non-GLP. Only short summary available. However, sufficient for robust study summary.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Principles of method if other than guideline:
No use of radiolabelled material.
GLP compliance:
no
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-Methoxy-6-methylbenzoic acid
EC Number:
612-182-4
Cas Number:
6161-65-5
Molecular formula:
C9H10O3
IUPAC Name:
2-Methoxy-6-methylbenzoic acid
Details on test material:
- test substance number: BAS 560 F - (Benzoe-)Säure
- batch number: 30529/6
- project number: 45H0246/012060
- substance number: 01/0246-1
- CAS number: 6161-65-5

In vivo test system

Test animals

Species:
mouse

Study design: in vivo (LLNA)

Vehicle:
other: acetone
Concentration:
0; 3; 10 and 30% in acetone.
Statistics:
The statistical evaluations were perforrned using the WILCOXON-test ( # for p =< 0.05; ##f or p =<0.01).

Results and discussion

Any other information on results incl. tables

The test substance did not induce a statistically significant and/or biologically relevant proliferation of the auricular lymph nodes when applied as 3%, 10% or 30% preparations in acetone to the ear of the mice. The ear-weight indicated a significant irritant property of the test substance when applied as a 30% preparation only. No signs of systemic toxicity were noticed.

Based on the results of the study it was concluded that under the test conditions chosen the test substance does not have a sensitizing effect in the Murine Local Lymph Node Assay.

Lymph Node weights:

Mean Index
untreated 4.1 0.92
vehicle acetone 4.5 1.00
3% in acetone 4.6 1.03
10% in acetone 4.6 1.01
30% in acetone 4.6 1.02

Cell Counts:

Mean Index
untreated 1184278 0.92
vehicle acetone 1293000 1.00
3% in acetone 1233306 0.95
10% in acetone 1220333 0.94
30% in acetone 1117700 0.86

Ear weights:

Mean Index
untreated 20.7 0.99
vehicle acetone 20.9 1.00
3% in acetone 21.4 1.02
10% in acetone 21.6 1.03
30% in acetone 23.7 1.13*

* Statistical Significancy compared to Vehicle Control

Body weight change:

Mean Index
untreated 1.3 1.21
vehicle acetone 1.1 1.00
3% in acetone 0.4 0.35
10% in acetone 0.7 0.61
30% in acetone 0.8 0.74

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Based on the results of this study, the test substance does not need to be classified as skin sensitizer, according to Regulation (EU) No. 1272/2008 and Directive 67/548/EEC, respectively.