Registration Dossier

Toxicological information

Dermal absorption

Currently viewing:

Administrative data

Endpoint:
dermal absorption in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to an equivalent of OECD guideline 428, but not under GLP conditions. Report is concise but clear.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 428 (Skin Absorption: In Vitro Method)
Deviations:
yes
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ethylhexyl Methoxycinnamate
- Physical state: Liquid (cream)
- Composition of test material, percentage of components: 2% Ethylhexyl Methoxycinnamate alone or combination of 7.5% Ethylhexyl Methoxycinnamate 1789 and 2% Ethylhexyl Methoxycinnamate in cream (3 vehicles)
- Specific activity (if radiolabelling): 100-120 uCi/g vehicle
Radiolabelling:
yes
Remarks:
14C

Test animals

Species:
other: mini pig
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
other: Closed system
Vehicle:
other: O/W lotion, O/W cream and W/O cream
Duration of exposure:
6 hours
Doses:
- Nominal doses:
In three vehicles (1 lotion, 2 creams):
7.5% Ethylhexyl Methoxycinnamate
2% Ethylhexyl Methoxycinnamate 1789 + 7.5% Ethylhexyl Methoxycinnamate (14C)
- Actual doses:
Ethylhexyl Methoxycinnamate in O/W lotion: 67.35 ug/cm2
Ethylhexyl Methoxycinnamate in O/W cream: 58.9 ug/cm2
Ethylhexyl Methoxycinnamate in W/O cream: 58.9 ug/cm2
- Rationale for dose selection: Based on studies of consumer's application habits (Doskoczil et al)
No. of animals per group:
Not relevant
Control animals:
no
Remarks:
not relevant

Results and discussion

Percutaneous absorptionopen allclose all
Dose:
7.5% Ethylhexyl Methoxycinnamate (14C) in O/W lotion
Parameter:
percentage
Absorption:
2.8 %
Remarks on result:
other: 6 hrs
Remarks:
Based on amount of test material in stripped skin and chamber liquid
Dose:
2% Ethylhexyl Methoxycinnamate 1789 and 7.5% Ethylhexyl Methoxycinnamate (14C) in O/W lotion
Parameter:
percentage
Absorption:
2.8 %
Remarks on result:
other: 6 hrs
Remarks:
Based on amount of test material in stripped skin and chamber liquid
Dose:
7.5% Ethylhexyl Methoxycinnamate (14C) in O/W cream
Parameter:
percentage
Absorption:
3.5 %
Remarks on result:
other: 6 hrs
Remarks:
Based on amount of test material in stripped skin and chamber liquid
Dose:
2% Ethylhexyl Methoxycinnamate 1789 and 7.5% Ethylhexyl Methoxycinnamate (14C) in O/W cream
Parameter:
percentage
Absorption:
3.1 %
Remarks on result:
other: 6 hrs
Remarks:
Based on amount of test material in stripped skin and chamber liquid
Dose:
7.5% Ethylhexyl Methoxycinnamate (14C) in W/O cream
Parameter:
percentage
Absorption:
3.9 %
Remarks on result:
other: 6 hrs
Remarks:
Based on amount of test material in stripped skin and chamber liquid
Dose:
2% Ethylhexyl Methoxycinnamate 1789 and 7.5% Ethylhexyl Methoxycinnamate (14C) in W/O cream
Parameter:
percentage
Absorption:
3.5 %
Remarks on result:
other: 6 hrs
Remarks:
Based on amount of test material in stripped skin and chamber liquid
Conversion factor human vs. animal skin:
Not relevant

Any other information on results incl. tables

After an exposure time of 6 hours to the intact surface of the mini pig skin the majority of the applied dose per cm2 of Ethylhexyl Methoxycinnamate in all three vehicles was recovered as rest material (remains onto skin).

The penetration rate of Ethylhexyl Methoxycinnamate from all 3 vehicles is less than 4% of the applied dose.

No alteration of the penetrating capability of Ethylhexyl Methoxycinnamate 1789 and Ethylhexyl Methoxycinnamate was noted when samples containing both UV-filters are used for penetration studies, as compared to a previous study.

Applicant's summary and conclusion

Conclusions:
There were no significant differences between the penetration rate values of Ethylhexyl Methoxycinnamate applied in different vehicles. No more than 4% of Ethylhexyl Methoxycinnamate was found to be absorbed in mini pig skin when applied in a concentration of 7.5% under the study conditions.
Executive summary:

The effect of 3 cosmetic vehicles (1 lotion, 2 creams) on the penetration rate of the chemical UV-filter Ethylhexyl Methoxycinnamate through the excised skin of mini pigs was investigated in this study.

The data presented here indicate that the penetration rate of Ethylhexyl Methoxycinnamate can be classified as low (less than 4% after 6 hours). The authors used this data to calculate the approximate penetration rate of Ethylhexyl Methoxycinnamate in these 3 vehicle types into and through the human skin. Based on consumer habits (Doskoczil et al.), it can be assumed that at maximum 0.8 mg/kg of Ethylhexyl Methoxycinnamate will be resorbed after application to the intact skin surface.