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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:
key study
Study period:
August 24 - September 17, 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted version 1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was performed in 1994. The Test guideline (TG) for the determination of skin sensitization in the mouse, the LLNA (TG 429) was adopted in 2002.

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(4-fluorophenyl)-2-hydroxy-N-(propan-2-yl)acetamide
EC Number:
611-084-9
Cas Number:
54041-17-7
Molecular formula:
C11H14FN
IUPAC Name:
N-(4-fluorophenyl)-2-hydroxy-N-(propan-2-yl)acetamide
Specific details on test material used for the study:
The stability and homogeneity of the test substance in the application formulations were confirmed analytically.

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hsd/Win:DH
Sex:
male

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: Cremophor EL in saline solution (2% v/v)
Concentration / amount:
intradermal induction: 5% (20 mg test substance/animal)
topical induction: 50% (250 mg test substance/animal)
Challenge: 50% (250 mg test substance/animal) and 25% (125 mg test substance/animal)
Day(s)/duration:
2d (48h)
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Challenge
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
other: Cremophor EL in saline solution (2% v/v)
Concentration / amount:
intradermal induction: 5% (20 mg test substance/animal)
topical induction: 50% (250 mg test substance/animal)
Challenge: 50% (250 mg test substance/animal) and 25% (125 mg test substance/animal)
Day(s)/duration:
1d (24h)
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
test group: 20 animals
control group: 10 animals
Positive control substance(s):
yes
Remarks:
2-mercaptobenzothiazole formulated with physiological NaCl

Results and discussion

Positive control results:
Reliability of the Method:
The reliability of the method of the maximization test was checked on male guinea pigs using 2-mercaptobenzothiazole formulated with physiological NaCl at the following concentrations: A 2.5% test substance concentration was used for intradermal induction, and a 40% concentration for topical induction.
After the first challenge with 40% and 12% test substance sample, respectively, 80% and 55% of the animals of the test substance group exhibited skin reactions. After the second challenge with 3% and 1% test substance sample, respectively, skin reactions were recorded for 15% of the animals of the test substance group, in each case. No skin redness occurred in the control groups after either challenge.
In a more recent study involving 2-mercaptobenzothiazole and at the same induction concentrations, 80% and 65% of the animals of the test substance group reacted to the first challenge with 40% and 25% test substance sample, respectively; 80% and 75% of the animals of the test substance group exhibited a reaction after the second challenge with 12% and 6% test substance sample, respectively; no skin redness was observed in the control groups.
Both studies thus confirm the sensitivity and reliability of the method of the maximization test.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
After the second induction, a few animals of the test substance group exhibited incrustations or skin flaking in the treated areas.
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
After the second induction, a few animals of the test substance group exhibited incrustations or skin flaking in the treated areas.
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0.5 mL Cremophor EL in sterile physiological saline solution (2% v/v)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
After the second induction, open wounds followed by incrustations or skin flaking in the treated
areas were observed on a few animals of the control group.
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5 mL Cremophor EL in sterile physiological saline solution (2% v/v)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
After the second induction, open wounds followed by incrustations or skin flaking in the treated
areas were observed on a few animals of the control group.
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
After the second induction, a few animals of the test substance group exhibited incrustations or skin flaking in the treated areas.
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
After the second induction, a few animals of the test substance group exhibited incrustations or skin flaking in the treated areas.
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FOE 5043-hydroxy does not have a skin sensitization potential under the test conditions of the maximization test.
Executive summary:

Using the maximization test of MAGNUSSON and KLIGMAN, the test substance was tested on male guinea pigs to determine whether it has skin sensitizing properties.


The following test substance concentrations were used in the test: Intradermal induction: 5%; Topical induction: 50%; Challenge: 50% and 25%.


The test substance was formulated as a suspension with Cremophor EL in sterile physiological saline solution (2% v/v). After the challenge with the 50% and 25% test substance concentration, neither the control animals nor the animals of the test substance group exhibited any redness of the skin or formation of edema. Thus, the test substance does not have a skin sensitization potential under the test conditions of the maximization test.