2-(4-methylphenoxy)-N-(1H-pyrazol-3-yl)-N-[(thiophen-2-yl)methyl]acetamide

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

From April 14 through May 23, 2014

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Semi-occlusive repeated insult patch study in humans

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-(4-methylphenoxy)-N-(1H-pyrazol-3-yl)-N-[(thiophen-2-yl)methyl]acetamide

EC Number:

815-961-9

Cas Number:

1374760-95-8

Molecular formula:

C17H17N3O2S

IUPAC Name:

2-(4-methylphenoxy)-N-(1H-pyrazol-3-yl)-N-[(thiophen-2-yl)methyl]acetamide

Test material form:

liquid

Details on test material:

- Physical state: Clear liquid

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 110 subjects completed the study (118 were enrolled)
- Sex: 37 males and 73 females
- Age: 21-70 years
- Race: no data

Clinical history:

No subject was used if he or she exhibited any dermatological or other medical or physical condition that would preclude topical application of the test material. Upon enrollment, no subject reported using any medication that would interfere with the sensitization results. No kown pregnant nor nursing women were used on this RIPT. No minor subjects were used on this RIPT.

Controls:

None

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: Patch test

ADMINISTRATION
- Type of application: Semi-occlusive
- Description of patch: a webril/adhesive patch was used.
- Vehicle / solvent: None
- Concentrations: 0,01 %
- Volume applied: 0.2 mg
- Testing/scoring schedule: Subjects participated over a 6-week period involving 3 phases: (1) Induction, (2) Rest, and (3) Challenge.
Induction phase: 9 consecutive applications over a period of approximately 3 weeks.
Rest period: Approximately two weeks.
Challenge phase: after two weeks.
- Removal of patches: Approximately 24 h after each application
- Other: Patches were applied to the back, either to the right (challenge) or left (induction) of the midline.

EXAMINATIONS
During induction, sites were evaluated at 48 h intervals (72 h if weekend). After challenge, evaluations were done at 24, 48, 72 and 96 h after application.

Grading/Scoring system:
0 = No visible reaction
+/- = Faint erythema
1 = Erythema
2 = Intense erythema, induration
3 = Intense erythema, induration, vesicles
4 = Severe reaction with erythema, induration, vesicles, pustules (may be weeping)
E = Edema.
DR = Dryness
P = Peeling
S = Staining
^ = Hyperpigmentation/Hypopigmentation
TR = Tape Reaction
C = Change of test site
N9R = No 9th reading
- = No reading
X = Discontinued

Statistical analysis: None

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: None

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 110
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Any other information on results incl. tables

110 subjects between the ages of 21 and 70 were enrolled and twelve subjects completed the study.

During the Induction Phase, one subject exhibited a low-level (+/-) reaction. During the challenge, no subject exhibited any reaction

Applicant's summary and conclusion

Conclusions:

Under the condition of the study, the test material is not a skin sensitizer at 100 ppm (0,01%)

Executive summary:

A panel of 118 male and female human volunteers participated in a repeat insult patch test in which a 0,01 % solution of test material applied to the back of the subjects under semi-occlusive patches. 110 subjects completed the study. During the induction phase nine patches were applied, separated by a 48 h interval. The patches were removed 24 h after application. Following a 2 -weeks rest period, a challenge patch was applied and the sites scored 24, 48, 72 and 96 h after application.

During the Induction Phase, one subject exhibited a low-level (+/-) reaction. During the challenge, no other subject exhibited any reaction.

Under the conditions employed in this study, there was no evidence of sensitisation to the test material at 0,01 %.