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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Remarks:
only tested at a concentration of 10% (no rationale for dose selection), no positive control, no purity of the test substance given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: open epicutanoeous sensitisation test
- Short description of test conditions: Induction: 10 dermal applications of a 10% solution of the test substance every second day; Challenge: single dermal application of a 10% solution of the test substance 14 days after induction phase
- Parameters analysed / observed: erythema at challenge site according to an arbitrary scale ranging from 0 (no reaction) to 4 (beet red erythema) 24 and 48 h after challenge
GLP compliance:
not specified
Type of study:
open epicutaneous test

Test material

1
Chemical structure
Reference substance name:
2,4-difluoroaniline
EC Number:
206-687-5
EC Name:
2,4-difluoroaniline
Cas Number:
367-25-9
Molecular formula:
C6H5F2N
IUPAC Name:
2,4-difluoroaniline

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: MRC/DH
Sex:
female

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
arachis oil
Concentration / amount:
10%
Day(s)/duration:
22 days (10 applications every second day)
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, open
Vehicle:
arachis oil
Concentration / amount:
10%
Day(s)/duration:
single application 14 days after induction
Adequacy of challenge:
not specified
No. of animals per dose:
10 (treatment group) and 5 (control group)
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
Induction and Challenge: 10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
Induction and Challenge: 10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Induction: 0%; Challenge: 10%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Induction: 0%; Challenge: 10%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
In this skin sensitisation test, 10 guinea pigs were sensitized by open epicutaneous application method. After 10 dermal applications of a 10% solution of the test substance every second day (induction phase), animals were challenged by a single dermal application of a 10% solution of the test substance 14 days after induction phase. None of the animals showed indications for skin sensitisation 24 and 48 h after challenge. Since the test substance was only tested at 10% and no rationale for dose selection is given, this study cannot be used for classification purposes.