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Toxicological information

Skin sensitisation

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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:
1989
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.