Registration Dossier

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:
1975
Reference Type:
secondary source
Title:
Unnamed
Year:
2000

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
Name:
Unnamed
Type:
Constituent
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

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In an unpublished study, Chlorowax 500C (a C12 chlorinated paraffin; 59% chlorinated) was applied to the skin of 200 male and female subjects.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.