Registration Dossier
Registration Dossier
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EC number: 287-476-5 | CAS number: 85535-84-8
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- no data
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Limited reporting in expert reviews; no information on concentrations applied or frequency of exposure.
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 975
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Application of Chlorowax 500C to the skin of 200 male and female subjects [no further details given in expert review]
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Alkanes, C10-13, chloro
- EC Number:
- 287-476-5
- EC Name:
- Alkanes, C10-13, chloro
- Cas Number:
- 85535-84-8
- IUPAC Name:
- Alkanes, C10-C13, Chloro
- Details on test material:
- Name of test material (as cited in study report): Chlorowax 500C
- Substance type: technical product
- Physical state: liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: C12 chlorinated paraffin (59% chlorinated)
- Stability under test conditions: no data
- Storage condition of test material: no data
- Other: average molecular weight - 415
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- 200 male and female subjects
- Clinical history:
- no data
- Controls:
- no data
- Route of administration:
- dermal
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: none
- Number of subjects with negative reactions: 200
- Number of subjects with equivocal reactions; none
- Number of subjects with irritating reactions: none
Applicant's summary and conclusion
- Conclusions:
- Application of an unspecified amount of Chlorowax 500C (a C12 chlorinated paraffin; 59% chlorinated) to the skin of 200 male and female subjects evidently showed no skin sensitising potential.
- Executive summary:
In an unpublished study, Chlorowax 500C (a C12 chlorinated paraffin; 59% chlorinated) was applied to the skin of 200 male and female subjects. No data is available as to the frequency or duration of exposure or the amount of test material applied. No local skin sensitisation reactions were reported in the 200 volunteers.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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