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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study. GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
July 17th, 1992
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Undecylenamidopropyl Betaine
- Physical state: solid
- Analytical purity: 84%


In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 360.2 ± 20.5 g (test group) and 340.3 ± 18.6 g (control group)
- Housing: 2 or 3 animals in Makrolon-cages No. IV
- Diet (e.g. ad libitum): type "3023" from Altromin International, Lage, Germany as pelleted diet, ad libitum
- Water (e.g. ad libitum): tap water from municipal source, ad libitum
- Acclimation period: 13 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: tap water, filter sterilized
Concentration / amount:
Intradermal induction: 0.5 % (w/w) in vehicle
Dermal induction: 35 % (w/w) in vehicle
Challenge: 5 % (w/w) in vehicle
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: tap water, filter sterilized
Concentration / amount:
Intradermal induction: 0.5 % (w/w) in vehicle
Dermal induction: 35 % (w/w) in vehicle
Challenge: 5 % (w/w) in vehicle
No. of animals per dose:
Number of animals in the test group: 10
Number of animals in the negative control group: 5
Number of animals in the dose range finding study: 3
Details on study design:
RANGE FINDING TESTS:
Intradermal: 0.1 mL of 5 %, 3.5 %, 2 % and 0.5 % (w/w) solution in vehicle.
Dermal: soaked patch with 50 %, 35 %, 20 % and 5 % (w/w) solution in vehicle.
Challenge: soaked patch with Duhring chamber with 20 % and 5 % (w/w) solution in vehicle.

MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal application (day 0)
- No. of exposures: 1
- Test groups:
(1) 0.1 mL FCA (1 + 1).
(2) 0.1 mL per side of the solution 0.5% test substance
(3) 0.1 mL per side of the solution 0.5% test substance experiment in FCA (1 + 1).
- Control group:
(1) 0.1 mL FCA (1 + 1).
(2) 0.1 mL per side of the solution of the vehicle
(3) 0.1 mL per side of the solution of the vehicle in FCA (1 + 1)
- Site: Ieft and right shoulder

Topical application (day 7)
- No. of exposures: 1
- Exposure period: 48 h
- Test groups: 35 % (w/w) in vehicle
- Control group: vehicle
- Site: same as for intradermal induction

As the applied test substance concentration was slightly irritating, no pretreatment to generate local irritation was required.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21
- Exposure period: 24 h
- Test groups: left flank: 5 % (w/w) in vehicle in Duhring chamber; right flank: vehicle in Duhring chamber
- Control group: left flank: 5 % (w/w) in vehicle in Duhring chamber; right flank: vehicle in Duhring chamber
- Evaluation (hr after challenge): 24 + 48 h
Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazole

Results and discussion

Positive control results:
Sensitisation rate of 90 % (9 of 10 animals positive) (experiment: 2008-02-25 to 2008-03-28)

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

Skin reactions after induction

 

 

Intradermal Induction

Epicutanous Induction

Group

Animal

Erythema

Edema

Erythema

Edema

Test group

1

0

0

0

0

2

0

0

0

0

3

1

0

0

0

4

0

0

0

0

5

1

0

1

0

6

1

1

1

0

7

0

0

0

0

8

0

0

0

0

9

1

0

0

0

10

1

0

1

0

Control group

1

0

0

0

0

2

0

0

0

0

3

0

0

0

0

4

0

0

0

0

5

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
In this study, Undecylenamidopropyl Betaine is not a dermal sensitiser.
Executive summary:

In a dermal sensitisation study according to OECD TG 406, 1992 with Undecylenamidopropyl Betaine (84% a.i.) in filter-sterilised tap water, female Dunkin-Hartley guinea pigs were tested using the Maximization test method. Positive control substance was 2-Mercaptobenzothiazole with a sensitisation rate of 90%.

In the main experiment ten animals were treated intradermally with a 0.5% (w/w) solution of the test substance in vehicle; for the dermal induction a 35% (w/w) concentration of the test substance in vehicle was used (= test group). Further five female animals were treated similarly - with the exception that they received only the vehicle instead of the test substance (= control group).

On day 21 of the application period the challenge application was performed on all control and test group animals. Duhring chambers with a 5% (w/w) solution of the test substance in vehicle were used. 

Besides slight crust formation at the injection sides after intradermal application with FCA no symptoms of systemic toxicity or other toxic reactions were observed at any time during the study. Body weight development of the animals was positive and within normal ranges.

In the challenge no visible changes (no erythema and no edema) were observed at any time point; i.e, there was no positive challenge result in the test and the control group animals. Thus, the sensitisation rate was 0%.

In this study, Undecylenamidopropyl Betaine is not a dermal sensitiser.