Registration Dossier
Registration Dossier
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EC number: 221-605-8 | CAS number: 3159-62-4
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- 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:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Reference Type:
- publication
- Title:
- Percutaneous absorption of some anionic surfactants
- Author:
- Howes D
- Year:
- 1 975
- 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:
- distribution
- excretion
- metabolism
- other: Storage
- Principles of method if other than guideline:
- - Method: 6 animals, 3 injected subcutaneously and 3 injected intraperitoneally, were exposed to aqueous samples of radiolabelled sodium stearate and the excretion, metabolism and absorption assessed.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium stearate
- EC Number:
- 212-490-5
- EC Name:
- Sodium stearate
- Cas Number:
- 822-16-2
- IUPAC Name:
- sodium stearate
- Test material form:
- other: Aqueous solution
- Details on test material:
- No data reported
Constituent 1
- 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:
- other: Injection: three subcutaneously and three intraperitoneally
- Vehicle:
- water
- Details on exposure:
- No data reported
- Duration and frequency of treatment / exposure:
- No data reported
Doses / concentrations
- Remarks:
- Doses / Concentrations:
- Doses: 0.1 or 0.5 mL aqueous samples
- Concentration: 0.18 mg 14C sodium stearate
- No. of animals per sex per dose / concentration:
- - Number of animals: 6 in total
- Number of animals injected subcutaneously: 3 animals
- Number of animals injected intraperitoneally: 3 animals - Control animals:
- not specified
- Positive control reference chemical:
- No data reported
- Details on study design:
- No data reported
- Details on dosing and sampling:
- No data reported
- Statistics:
- No data reported
Results and discussion
- Preliminary studies:
- No data reported
Main ADME resultsopen allclose all
- Type:
- excretion
- Results:
- Negligible amounts (0.1% of 0.18 mg dose) of the 14C appeared in the urine or faeces
- Type:
- metabolism
- Results:
- Expired CO2 contained 38 ± 9% of the 0.18 mg dose of the 14C
- Type:
- absorption
- Results:
- The carcass retained 56 ± 16 % of 0.18 mg dose of the 14 C
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Adsorption: The carcass retained 56 ± 16 % of 0.18 mg dose of the 14 C
- Details on distribution in tissues:
- No data reported
- Details on excretion:
- - Excretion: Negligible amounts (0.1% of 0.18 mg dose) of the 14C appeared in the urine or feces
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:
- The injection of rats subcutaneously or intraperitoneally with 0.18 mg 14C sodium stearate led to 0.1 % of the applied 14C dose being excreted, 38 ± 9 % being expired and 56 ± 16 % being retained in the carcass.
- Executive summary:
The injection of rats subcutaneously or intraperitoneally with 0.18 mg 14C sodium stearate led to 0.1 % of the applied 14C dose being excreted, 38 ± 9 % being expired and 56 ± 16 % being retained in the carcass. 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.
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