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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 (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The LLNA method was adopted in 2002, four years after the date of this study.
Since an in vivo study is available, a LLNA-Test can be waived.

Test material

Constituent 1
Chemical structure
Reference substance name:
2,6-difluorobenzaldehyde
EC Number:
610-142-0
Cas Number:
437-81-0
Molecular formula:
C7 H4 F2 O
IUPAC Name:
2,6-difluorobenzaldehyde

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100% / 0.5 ml
Route:
intradermal
Vehicle:
other: Sesame Oil
Concentration / amount:
1% / 2x0.1 ml
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: Sesame Oil
Concentration / amount:
20% / 0.5 ml
Day(s)/duration:
24 h
No. of animals per dose:
10
Challenge controls:
5 female, vehicle only
Positive control substance(s):
no

Results and discussion

Positive control results:
Positive Control Group not required, because the substance itself has been found to be a skin sensitizer.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Group:
positive control
Dose level:
0
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
None
Remarks on result:
not measured/tested
Reading:
2nd reading
Group:
positive control
Dose level:
0
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
None
Remarks on result:
not measured/tested
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1
No. with + reactions:
9
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1
No. with + reactions:
9
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1
No. with + reactions:
0
Total no. in group:
5

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
Testing for sensitizing properties of 2,6-Difluorbenzaldehyd was performed in female guinea pigs according to the method of MAGNUSSON & KLIGMAN.
Intradermal induction was performed using 1 % 2,6-DifIuorbenzaIdehyd in sesame Oil DAB10. Dermal induction treatment were carried out with 100 % 2,6-DifIuorbenzaIdehyd and challenge treatment with 20 % 2,6-Difluorbenzaldehyd sesame oil DAB10.
The validity of the test system is confirmed by the periodically conducted positive control test using benzocain for the maximization test report number 98.0490, dated June 30, 1998; Hoechst Marion Roussei, Preclinical Development Germany, Drug Safety).
Based on the results of this study 2,6-Difluorbenzaldehyd may cause sensitization oy skin contact.