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Diss Factsheets

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
Study period:
1999-03-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted July 17, 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
July 30, 1996
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was conducted in 1999 when the LLNA was not yet an established method.

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N-dibutyloleamide and oleic acid, sulphated, sodium salts
EC Number:
915-926-9
Molecular formula:
C18H34Na2O6S + C26H52NNaO5S
IUPAC Name:
N,N-dibutyloleamide and oleic acid, sulphated, sodium salts
Test material form:
liquid
Details on test material:
The water content of the actual test item was 57.6% (w/w); the water content of the REACH registration substance was analytically determined to be 3.8% (w/w).

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright-White ; HsdPoc:DH
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HARLAN WINKELMANN, Gartenstr. 27, D-33178 Borchen SPF breeding colony
- Females nulliparous and non-pregnant: yes
- Weight at study initiation: 278 g (349 – 415 g)
- Housing: macrolon cages
- Die: ad libidum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%):50 ± 20
- Photoperiod: 12 hours light /12 hours dark

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
intradermal injection: 0.2 %
epidermal injection: 4.0 %
epidermal injection: 1 %
Challenge
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
intradermal injection: 0.2 %
epidermal induction: 4 %
epidermal challenge: 1 %
No. of animals per dose:
10
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epidermal)
- Exposure period: 9 days
- Test groups: 1
- Control group: 1
- Site: dorsal neck
- Frequency of applications: 3 applications (2 injections & 1 epidermal)
- Duration: epidermal application sites were occluded for 48 hours
- Concentrations: intradermal: 0.1 %; epidermal: 4 %

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: challenge was performed on days 22 and 29
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Site: flank
- Concentrations: 1 %
- Evaluation (hr after challenge): 24 & 48 hours
Positive control substance(s):
yes
Remarks:
alpha-hexyl cinnamic aldehyde, in a separate study

Results and discussion

Positive control results:
The positive control group was conducted in a separate study in the beginning of the same year. The animals showed skin sensitisation after dermal induction using 50 % alpha-hexyl cinnamic aldehyde and challenge treatment with 25 % of the same substance.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Reading:
other: all readings
Group:
negative control
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
25 %
No. with + reactions:
6
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
25 %
No. with + reactions:
8
Total no. in group:
20

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item did not elicit hypersensitivity reactions in any of the challenged animals.
Executive summary:

Testing for sensitizing properties of the test item was performed in female guinea pigs according to the method of OECD TG 406. Intradermal induction was performed using 0.2 % of the test item in deionized water. Dermal induction was done by application of 4 % of the test item in water for 24 hours. Challenge treatment was carried out with 1 % of the test item in deionized water.

The validity of the test system was confirmed by the periodically conducted positive control tests using alpha-hexyl cinnamic aldehyde in a previously validated study. Based on the results of this study, the test item showed no evidence for sensitizing properties.