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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
Study period:
1998/06/30- 1998/09/21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
(1992)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
(1992)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
Currently no LLNA study is available for assessment. The Buehler test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, C16-18 and C18-unsatd., epoxidized, Me esters, oligomeric reaction products with trimethylolpropane
Molecular formula:
Not applicable (UVCB substance)
IUPAC Name:
Fatty acids, C16-18 and C18-unsatd., epoxidized, Me esters, oligomeric reaction products with trimethylolpropane
Specific details on test material used for the study:
- Physical state: clear, colourless, viscous liquid
- Analytical purity: 90 %
- Lot/batch No.: 18009
- Expiration date of the lot/batch: Jan 1999
- Storage condition of test material: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Postfach 11 61, 33178 Borchen, Germany
- Weight at study initiation: male: 380 - 500 g; female: 324 - 438 g
- Housing: The guinea pigs were kept in collective housing up to a maximum of 10 animals per cage in a battery of cages, equipped with a paper disposal system.
- Diet: "Harlan Teklad FD2 Guinea Pig Diet" (pelleted diet) produced by Harlan Teklad, Shaw's farm, Blackthorn Bicester, Oxon, OX6 OTP, England
- Water: community tap water
- Acclimation period: >15 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3°C
- Humidity: 30 - 70 %
- Air changes: 16/ hour
- Photoperiod: Artificiallight was set to give a cycle of 12 hours light and 12 hours dark with light on at 7.00 a.m.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Remarks:
PEG400
Concentration / amount:
100%
Day(s)/duration:
3 exposures/ once a week/ for 6 hours
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Remarks:
PEG400
Concentration / amount:
25%
Day(s)/duration:
Day 14 after last induction/ for 6 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
- total animals: 30
- control animals: 10 (5 males, 5 females)
- test animals: 20 (10 males, 10 females)
Details on study design:
RANGE FINDING TESTS:
A preliminary test was performed in order to select the concentrations of the test article for the main study. 3 males and 3 females were used in the induction and challenge exposures. The liquid test article was applied undiluted or in concentrations of 75 %, 50 %, 25 % and 10 %, dissolved in PEG, to the clipped skin on the back of each animal using Hill-Top-Chambers (Hill Top, Cincinnati, USA) secured with rubberdental dam (4D Rubber Co., Ltd., UK). In each case, the volume applied was 0.3 mL. The animals were then immobilised in metal restrainers for 6 h, after which time the patches were removed and the animals returned to their cages. Skin reactions were recorded 24 and 48 h after patch removal according to the classification scheme stipulated in the OECD 406.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours until patch removal
- Site: area of clipped skin in the left anterior quadrant of the back of each test animal. Test item exposure occurred always on the same test site.
- Frequency of applications: once a week
- Duration: skin reaction was observed after 24 hours
- Concentrations: undiluted (100 %)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: day 14 after last induction exposure
- Exposure period: 6 hours until patch removal
- Site: area of clipped skin in the right anterior quadrant of the back of each test animal.
- Concentrations: 25 % formulation in PEG400
- Evaluation: 21 hours after patch removal
Positive control substance(s):
yes
Remarks:
alpha-hexyl cinnamic aldehyde

Results and discussion

Positive control results:
The sensitivity of the test system and the reliability of the experimental technique is assessed at least every six months by use of "alpha-hexyl cinnamic aldehyde" which is known to induce skin sensitisation in guinea pigs. This test was conducted as a Buehler test according to the OECD 406. The historical control data confirmed the vailidity of the test system and study performance.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
50%
No. with + reactions:
6
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
50%
No. with + reactions:
6
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
25%
No. with + reactions:
2
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10

Any other information on results incl. tables

No skin reactions were observed after the challenge exposure in test and in control animals at 24 and 48 h after the end of the exposure. Therefore, the sensitisation rate determined at 24 and 48 h was 0 % in each case.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met