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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to EU / OECD guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
[(2-chlorophenyl)methyl]dimethylamine
EC Number:
688-329-1
Cas Number:
10175-31-2
Molecular formula:
C9H12ClN
IUPAC Name:
[(2-chlorophenyl)methyl]dimethylamine

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
10,25, 50% (w/v)
No. of animals per dose:
5 animals/group
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
1.5
Test group / Remarks:
10% (w/v)
Remarks on result:
other: Negative Control: 1.0 Positive Control: 7.6
Parameter:
SI
Value:
0.9
Test group / Remarks:
25% (w/v)
Remarks on result:
other: Negative Control: 1.0 Positive Control: 7.6
Parameter:
SI
Value:
1.5
Test group / Remarks:
50% (w/v)
Remarks on result:
other: Negative Control: 1.0 Positive Control: 7.6
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: 50 % (w/v) : 490.2 25 % (w/v) : 292.4 10 % (w/v) : 480.8 Negative Control: 323.2 Positive Control: 2444

Any other information on results incl. tables

No mortality or signs of systemic toxicity were observed during the study. There were no indications of any irritancy at the site of application. No treatment related effects were observed on animal body weights.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In conclusion, under the conditions of the present assay test item was shown to have no sensitization potential (non-sensitizer) in the
Local Lymph Node Assay.