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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
A Guinea Pig Maximization Test according Magnusson and Kligman was performed on male guinea pigs to determine whether the test substance exhibits skin-sensitizing properties.
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The LLNA method was not available.

Test material

Constituent 1
Chemical structure
Reference substance name:
p-(trifluoromethoxy)phenyl isocyanate
EC Number:
252-328-0
EC Name:
p-(trifluoromethoxy)phenyl isocyanate
Cas Number:
35037-73-1
Molecular formula:
C8H4F3NO2
IUPAC Name:
1-isocyanato-4-(trifluoromethoxy)benzene
Details on test material:
technical pure (99 %)

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright white W 58
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: acetone/oil
Concentration / amount:
Intradermal induction: 1.0 %
Topical induction: 12 %
Challenge: 6 %


Topical induction: 5% (=25 mg test substance/ animal)
Challenge: 3% (=15 mg test substance/ animal)
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: acetone/oil
Concentration / amount:
Intradermal induction: 1.0 %
Topical induction: 12 %
Challenge: 6 %


Topical induction: 5% (=25 mg test substance/ animal)
Challenge: 3% (=15 mg test substance/ animal)
No. of animals per dose:
15 animals (test and control group)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
6 %
No. with + reactions:
15
Total no. in group:
15
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
6 %
No. with + reactions:
15
Total no. in group:
15
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
15
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
15

Any other information on results incl. tables

A clear evidence for a sentitising effect of 4-trifluoromethoxyphenyl isocyanate was found in the GPMT

Applicant's summary and conclusion

Interpretation of results:
Category 1A (indication of significant skin sensitising potential) based on GHS criteria
Remarks:
Based on EU GHS criteria
Conclusions:
4-Trifluoromethoxyphenyl isocyanate showed sensitising results.
Executive summary:

The Guinea Pig Maximization test was performed similarly to OECD Guideline 406 on male guinea pigs. 4-Trifluoromethoxyphenyl isocyanate showed sensitising results.