Registration Dossier
Registration Dossier
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EC number: 471-480-0 | CAS number: 1645-83-6
Sensitisation data (human)
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:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Remarks:
- Standard test protocol conducted under GCP (good clinical practices)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- according to 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 site 4 hours. Sites were graded 24, 48, and/or 72 hours following exposure.
- GLP compliance:
- no
- Remarks:
- Good Clinical Practices followed
Test material
- Reference substance name:
- -
- EC Number:
- 471-480-0
- EC Name:
- -
- Cas Number:
- 1645-83-6
- Molecular formula:
- Hill formula: C3H2F4 CAS formula: C3H2F4
- IUPAC Name:
- (1E)-1,3,3,3-tetrafluoroprop-1-ene
Constituent 1
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 administration
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 sensitiser in humans under the conditions of the study.
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