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EC number: 203-965-8 | CAS number: 112-38-9
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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP in vivo study equivalent to OECD guideline/EU method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report Date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A Magnusson and Kligman was performed for this undecylenic acid as it is known that this substance may induce false positive in the LLNA test.
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Type:
- Constituent
- Details on test material:
- -33.2% Sodium Undecylenate in water
- Physical state: solution
- Stability under test conditions: at RT
- Name of test material (as cited in study report): Undecylenate de Sodium
- Molecular formula (if other than submission substance): C11H19O2Na
- Lot No. 3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Shamrock Bioservice, Gambais, France
- Weight at study initiation: 352 g (males) 346 g (females)
- Housing: in sterilized carbonate cages on sifted and dusted sawdust
- Diet / Water (e.g. ad libitum): ad lib.
- Acclimation period:>=7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/-3
- Humidity (%): 50+/-20
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1%
- No. of animals per dose:
- 10 control (5 males+5 females), 20 treated (10 males+10 females)
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
day 1: three intradermal injections/animal (0.1 ml each)
-Freud`s Adjuvant : phys.saline 1:1
-0.1% test substance in phy. saline
-Freud`s: 0.1% test substance in vehicle 1:1 (control: Freund`s : phys saline 1:1)
-day 8: irritation with 0.5 ml 10% Sodium Lauryl Sulfate in vaseline
-day9: 0.5 ml epicutaneously (0.05% test substance in vehicle) 48 h
B. CHALLENGE EXPOSURE
on day 26: 0.5 ml on 4scm; left flank: vehicle; right flank: 0.05% test substance in vehicle (occlusive dressing)
(check for reactions 24 and 48h after removal of dressing) - Challenge controls:
- Freund's complete adjuvant
- Positive control substance(s):
- yes
- Remarks:
- 2,4-DINITRO CHLOROBENZENE (DNCB)
Results and discussion
- Positive control results:
- Under the given experimental conditions and according to the Magnusson and Kligman method, the test substance 2,4-DINITRO CHLOROBENZENE at a concentration of 0.5% (w/w) induced positive skin sensitization reactions in 50% of the guinea-pigs.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test group
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test group
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- According to GHS criteria, no classification of undecylenic acid sodium salt is required.
- Executive summary:
The sensitization potential of the test substance SODIUM UNDECYLATE (in a 33.2% aqueous solution) was evaluated in the Guinea-pig according to the maximization procedure by Magnusson and Kligman. 20 Dunkin-Hartley guinea pigs (10 males and 10 females) were treated in the test group. The test substance was applied by intradermal injection at a concentration of 0.1% in physiological saline, after 9 days(and irritation by sodium lauryl sulfate in vaseline) epicutanously at a concentration of 0,05%, and again for challenge at the latter concentration and route on a different section of the skin.No symptoms, mortality or cutaneaous reactions due to any sensitization process by treatment with the test substance, SODIUM UNDECYLATE (in a 33.2% aqueous solution), were observed in guinea pigs.
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