Registration Dossier
Registration Dossier
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EC number: 203-366-1 | CAS number: 106-14-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- Not reported
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary literature source (documentation insufficient for assessment).
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Final report on safety assessment of oleic acid, lauric acid, palmitic acid, myristic acid and stearic acid.
- Author:
- Cosmetic Ingredient Review (CIR) panel
- Year:
- 1 987
- Bibliographic source:
- J. Am. Coll. Tox. 6(3):321- 401
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Magnusson B and Kligman AM, 1969. The guinea pig maximization test
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Stearic acid
- EC Number:
- 200-313-4
- EC Name:
- Stearic acid
- Cas Number:
- 57-11-4
- Molecular formula:
- C18H36O2
- IUPAC Name:
- Octadecanoic Acid
- Details on test material:
- - Name of test material (as cited in study report): Stearic acid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- female
- Details on test animals and environmental conditions:
- Not reported
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- 50% formulation containing 3.5% stearic acid
100% formulation containing 3.5% stearic acid
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 50% formulation containing 3.5% stearic acid
100% formulation containing 3.5% stearic acid
- No. of animals per dose:
- 10
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three
- Exposure period: 3 wk
- Test groups: One
- Control group: Received following injections:
Site 1: 50% aqueous Freund complete adjuvant
Site 2: Propylene glycol
Site 3: A 1:1 preparation of propylene glycol and 50% Freund complete adjuvant
- Site: Upper back
- Frequency of applications: One injection at start of the induction periodfollowed 1 wk later by a topical booster
- Concentrations:
Site 1: 50% aqueous Freund complete adjuvant
Site 2: 50% formulation containing 3.5% stearic acid, in propylene glycol
Site 3: 50% formulation containing 3.5% stearic acid, in 50% aqueous Freund adjuvant
Topical booster: Slight irritating concentration of the formulation in petrolatum
B. CHALLENGE EXPOSURE
- No. of exposures: Three
- Test groups: One
- Control group: One
- Concentrations: The test group and the control group were treated with 50% or 100% of the formulation (3.5% stearic acid)
- Evaluation (hr after challenge): Sites were scored 48h and 72h after start of the challenge
OTHER: A topical application of 10% sodium lauryl sulfate in petrolatum was made 24h before the topical booster if the formulation was not sufficiently irritating.
The challenge patches were applied occlusively. - Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Concentration:
- Not applicable
- No. of animals per dose:
- Not applicable
- Details on study design:
- Not applicable
- Statistics:
- Not applicable
Results and discussion
- Positive control results:
- Two control guinea pigs died and 4 of the remaining 8 sites challenged with the 100% formulation patch had minimal faint erythema and desquamation was observed at another site after 72h.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- Minimal faint erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: Minimal faint erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Mild erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Mild erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- Faint erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: Faint erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- Desquamation
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: Desquamation.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Faint erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Faint erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Visible erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Visible erythema.
- Reading:
- other: No data
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- Died
- Remarks on result:
- other: Reading: other: No data. . Hours after challenge: 24.0. Group: positive control. Dose level: 100%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: Died.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- Minimal faint erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 100%. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: Minimal faint erythema.
Any other information on results incl. tables
Five of 10 treatment sites had minimal erythema, and 1 of 10 sites had mild erythema 48h after challenge with the 100% concentration. There were 3 sites with minimal erythema after 72h, 2 of which had signs of desquamation. Other treatment sites had no signs of sensitization.
Challenge of the treatment sites with 50% formulation resulted in minimal erythema at 1 of 10 sites after 48h, which was visible after 72h. All other treatment sites challenged with 50% concentration had no signs of sensitisation.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the study, and taking into account the limited amount of information available, it appears that the test substance was not sensitizing to skin.
- Executive summary:
A maximization study was conducted in guinea pig according to Magnusson-Kligman (1969) to evaluate the allergic contact sensitization potential of stearic acid.
A cosmetic product containing 3.5% stearic acid was tested at the concentrations 50% and 100% on 10 female guinea pigs.
Induction exposure:
Intradermal injections was made on 3 sites, along the upper backs, as follows:
Site 1: 50% aqueous Freund complete adjuvant
Site 2: 50% formulation containing 3.5% stearic acid, in propylene glycol
Site 3: 50% formulation containing 3.5% stearic acid, in 50% aqueous Freund adjuvant
A topical booster with slight irritating concentration of the formulation in petrolatum was applied 1 wk after start of the induction.
A group of guinea pigs served as a control and received following injections:
Site 1: 50% aqueous Freund complete adjuvant
Site 2: Propylene glycol
Site 3: A 1:1 preparation of propylene glycol and 50% Freund complete adjuvant
Challenge:
Two weeks after the topical booster, the test group and the control was treated with 50% or 100% of the formulation.
Sites were scored 48h and 72h later.
Under the conditions of the study, and taking into account the limited amount of information available, it appears that the test substance was not sensitizing to skin.
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