Registration Dossier

Diss Factsheets

Toxicological information

Basic toxicokinetics

Currently viewing:

Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: GLP-status not known, guideline not known, information from a peer-reviewed, published review article. Notable limitations in design and/or reporting, reliability not known.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Final report of the safety assessment of lithium stearate, aluminum distearate, aluminum stearate, aluminum tristearate, ammonium stearate, calcium stearate, magnesium stearate, potassium stearate, sodium stearate and zinc stearate
Author:
Cosmetics Ingredients Review
Year:
1982
Bibliographic source:
Journal of the American college of toxicologists, vol. 1, issue 12, pp. 143-177
Reference Type:
publication
Title:
Percutaneous absorption of some anionic surfactants
Author:
Howes D
Year:
1975
Bibliographic source:
Journal of the Society of Cosmetic Chemistry, vol. 26, issue 1, pp. 47-63 cited in CIR (1982)

Materials and methods

Objective of study:
absorption
Principles of method if other than guideline:
- Method: 7.5 cm2 clipped rat skin was exposed for 15 minutes to 0.1 mL aqueous solution containing 184 µg/mL 14C sodium stearate. The treated skin was excised after 6 hours and monitored for 14C.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium stearate
EC Number:
212-490-5
EC Name:
Sodium stearate
Cas Number:
822-16-2
Molecular formula:
C18H36O2.Na
IUPAC Name:
sodium stearate
Test material form:
other: Aqueous solution
Details on test material:
No data reported
Radiolabelling:
yes
Remarks:
14C

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data reported

Administration / exposure

Route of administration:
dermal
Vehicle:
water
Details on exposure:
- Absorption medium: Clipped rat skin
- Absorption area: 7.5 cm2
Duration and frequency of treatment / exposure:
- Exposure period: 15 minutes
Doses / concentrations
Remarks:
Doses / Concentrations:
- Doses: 0.1 mL aqueous samples
- Concentration: 184 µg 14C sodium stearate
No. of animals per sex per dose / concentration:
No data reported
Control animals:
not specified
Positive control reference chemical:
No data reported
Details on study design:
- Method: 7.5 cm2 clipped rat skin was exposed for 15 minutes to 0.1 mL aqueous solution containing 184 µg/mL 14C sodium stearate. The treated skin was excised after 6 hours and monitored for 14C.
Details on dosing and sampling:
No data reported
Statistics:
No data reported

Results and discussion

Preliminary studies:
No data reported
Main ADME results
Type:
absorption
Results:
The expired CO2, urine, faeces and carcass recovered 0.53 ± 0.14 µg 14C

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Adsorption: The expired CO2, urine, feces and carcass recovered 0.53 ± 0.14 µg 14C
Details on distribution in tissues:
No data reported
Details on excretion:
No data reported

Metabolite characterisation studies

Metabolites identified:
not specified
Details on metabolites:
No data reported

Bioaccessibility (or Bioavailability)

Bioaccessibility (or Bioavailability) testing results:
No data reported

Applicant's summary and conclusion

Conclusions:
0.1 mL aqueous solution containing 184 µg radiolabelled 14C sodium stearate was applied for 15 minutes over 7.5 cm2 of intact rat skin and the expired CO2, urine, feces and carcass recovered 0.53 ± 0.14 µg 14C.
Executive summary:

0.1 mL aqueous solution containing 184 µg radiolabelled 14C sodium stearate was applied for 15 minutes over 7.5 cm2 of intact rat skin and the expired CO2, urine, feces and carcass recovered 0.53 ± 0.14 µg 14C. No information on the test methods used is available in the publication (CIR 1982). However, this information is taken from a peer reviewed article and can be considered adequate for use for this endpoint.