Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Standard test protocol conducted under GCP (good clinical practices)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Guideline:
other: ICH: Repeated Insult Patch Test
Principles of method if other than guideline:
Human subjects participated in the study over a 6-week period involving 3 phases: (1) Induction - 24 hour dermal exposure 3 times a week, (2) Rest for 2 weeks, and (3) Challenge - during 6th week of study, subjects had patches (identical to those used for induction) applied to a different site4 hours. Sites were graded 24, 48, and/or 72 hours following exposure.
GLP compliance:
no
Remarks:
Good Clinical Practices followed

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Ethical approval:
confirmed, but no further information available
Subjects:
- Number of subjects exposed: 112 (100 finished study)
- Sex: 30 M, 82 F
- Age: 18-44 (32 subjects); 45 - 66 (71 subjects), over 65 (9 subjects)
- Race: Asian (3), Black (12), caucasian (82), hispanic (15)
Controls:
no
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: repeated insult patch test


ADMINISTRATION
- Type of application: Hill top chamber
- Concentrations: neat
- Volume applied: 0.3 ml
- Testing/scoring schedule: 24 hours
- Removal of test substance: 24 hours after administratioin

EXAMINATIONS
- Grading/Scoring system: skin irritation

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: none observed


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

Applicant's summary and conclusion

Conclusions:
HFO-1234ze is not a skin sensitizer in humans under the conditions of the study.