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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A well reported study conducted to scientifically acceptable standards.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975
Reference Type:
secondary source
Title:
Unnamed
Year:
2000

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Dermal irritation potential of Cereclor 50 LV and 63 L assessed in humans following 48 h occluded application to the skin of the upper arm of 26 volunteers
GLP compliance:
no
Remarks:
Study conducted prior to introduction of GLP.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Cereclor 50 LV and Cereclor 63 L
- Substance type: technical product
- Physical state: liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: C10-13 chlorinated paraffins, 50 and 63% chlorination
- Stability under test conditions: no data
- Storage condition of test material: no data

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 26
- Sex: no data
- Age: 18-65 years old
- Race: white
- Demographic information: no data
- Known diseases: no data
- Other: The intake of aspirin was forbidden during the period of the trial due to possible anti-erythema effects.
Route of exposure:
dermal
Reason of exposure:
intentional
Exposure assessment:
measured

Results and discussion

Clinical signs:
The mean numerical scores for Cereclor 50 LV (total of assessments at 24 and 48 h) and by two independant assessors, were 1.69 and 0.81 for erythema (on a 12 point scale) and 0.38 and 0.65 for dryness (on a 4 point scale), with the total score (i.e. erythema plus dryness) being 2.07 and 1.46. Those for Cereclor 63 L were 1.62 and 1.38 for erythema, 0.42 and 0.73 for dryness, with a total score of 2.04 and 2.11. The number of severe reactions (moderate redness, oedema or vesiculation), as adjudged by either or both assessors at the 48 h assessment, were 1 and 0 for Cereclor 50 LV and Cereclor 63 L, respectively. No glazing, wrinkling, translucency or scaling of the skin was reported. The liquid paraffin control was assigned comparable or higher values than either of the chlorinated paraffins.

Applicant's summary and conclusion

Conclusions:
In a well reported human occluded patch test study, Cereclor 50 LV and Cereclor 63 L (C10-13 chlorinated paraffins; 50 and 63% chlorination, respectively) were considered as only mildly irritant following application to the skin of the upper arm of 26 healthy volunteers for 48 h.
Executive summary:

In a well reported human occluded patch test study, Cereclor 50 LV and Cereclor 63 L (C10-13 chlorinated paraffins; 50 and 63% chlorination, respectively) were applied to the skin of the upper arm of 26 healthy volunteers (at 20 µl) for 48 h, with patch test renewal after the first 24 h. The degree of severity of erythema and dryness reactions were determined by two independent assessors, 1 h after removal of the patches and residues at each of the two time points (24 and 48 h).

 

The mean numerical scores for Cereclor 50 LV (totalled over the two assessment times) for the two assessors were 1.69 and 0.81 for erythema (on a 12 point scale) and 0.38 and 0.65 for dryness (on a 4 point scale), with the total score (i.e. erythema plus dryness) being 2.07 and 1.46. Those for Cereclor 63 L were 1.62 and 1.38 for erythema, 0.42 and 0.73 for dryness, with a total score of 2.04 and 2.11. The number of severe reactions (moderate redness, oedema or vesiculation), as adjudged by either or both assessors at the 48 h assessment, were 1 and 0 for Cereclor 50 LV and Cereclor 63 L, respectively. No glazing, wrinkling, translucency or scaling of the skin was reported. The liquid paraffin control was assigned comparable or higher values than either of the chlorinated paraffins.

 

Overall, Cereclor 50 LV and Cereclor 63 L were considered as only mildly irritant under these test conditions.