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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Summary report signed by the study director of the original GLP study, plus one internal reviewer. The toxicological information contained in the report is derived from studies which fulfil the requirements of good laboratory practice. The report format does not give all informations required by the guideline: Some experimental details, body weights, and individual data are not provided. Doses are spaced by a factor of 3, instead of 2 as required in the guideline.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
Not explicitly stated in report
Deviations:
not specified
GLP compliance:
yes
Remarks:
Confirmed by study director
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Reference substance name:
Benzeneacetic acid, 2-[(6-chloro-4-pyrimidinyl)oxy]-α-(methoxymethylene)-, methyl ester, (αE)-
IUPAC Name:
Benzeneacetic acid, 2-[(6-chloro-4-pyrimidinyl)oxy]-α-(methoxymethylene)-, methyl ester, (αE)-
Constituent 2
Chemical structure
Reference substance name:
603-525-9
EC Number:
603-525-9
Cas Number:
131860-97-4
Molecular formula:
C15H13ClN2O4
IUPAC Name:
603-525-9

In vivo test system

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified

Study design: in vivo (LLNA)

Vehicle:
dimethylformamide
Concentration:
1%, 3%, 10% w/v
No. of animals per dose:
no data
Positive control substance(s):
not specified
Statistics:
no data

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
10.78
Test group / Remarks:
10% w/v
Parameter:
SI
Value:
2.87
Test group / Remarks:
3% w/v
Parameter:
SI
Value:
0.81
Test group / Remarks:
1% w/v
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Vehicle only (DMF): 63 CPM / lymph node 1% w/v: 51 CPM / lymph node 3% w/v: 181 CPM / lymph node 10% w/v: 679 CPM / lymph node

Applicant's summary and conclusion

Interpretation of results:
sensitising
Conclusions:
The available study (CTL, Robinson) was conducted under GLP. While the full study report is not available, the results are sufficiently detailed and unambiguous as to be suitable for classification and labeling.