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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1 October 1999 - 14 March 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The Buehler test is a standard method to asses the skin sensitisation characteristics of a chemical according to OECD TG 406.

Test material

Constituent 1
Chemical structure
Reference substance name:
Alcohols, C12-14 (even numbered), propoxylated, aminated
EC Number:
946-944-5
Molecular formula:
C12H27N (C3H6O)n n=1-5, C14H31N (C3H6O)n n=1-4
IUPAC Name:
Alcohols, C12-14 (even numbered), propoxylated, aminated
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: test material was provided by the sponsor

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elm Hill Breeding Laboratories
- Age at study initiation: 5 weeks (assay), 7 weeks (naives)
- Weight at study initiation: 290- 347g (dose range finding); 302- 418g (assay); 482- 572g (naives)
- Housing: individual housing
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
- Indication of any skin lesions: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 25 October 1999 To: 1 December 1999

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.3ml of 3% solution of test item
Day(s)/duration:
three 6h applications seven days between each application
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.3ml of 1% solution of test item
Day(s)/duration:
6h application 14 days after the last induction exposure
Adequacy of challenge:
highest non-irritant concentration
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.3ml of 0.5% solution of test item
Day(s)/duration:
6h application, 7 days after challenge
No. of animals per dose:
dose range finding study: 8 animals
main study: vehicle control 10 animals, test item 20 animals, postive control 6 animals, 4 naive animals in re-challenge phase
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6h
- Test groups: 20 animals (10 males and 10 females)
- Control group: 10 animals (5 males and 5 females)
- Site: left flank
- Frequency of applications: test item was applied 3 times, seven days between applications
- Concentrations: 3%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after the last induction application
- Exposure period: 6h
- Test groups: 20 animals (10 males and 10 females)
- Control group: 10 animals (5 males and 5 females)
- Site: left or right flank
- Concentrations: 1%
- Evaluation (hr after challenge): 24h

OTHER:
RE- CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 6h
- Test groups: 20 animals (10 males and 10 females)
- Control group: 4 naive animals (2 males and 2 females)
- Site: left or right flank
- Concentrations: 0.5%
- Evaluation (hr after challenge): 24h
Challenge controls:
The control group was challenged with the vehicle on one site and with the test item on another site
Positive control substance(s):
yes
Remarks:
DNCB 0.3%

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
vehicle
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
other: vehicle control challenged with test item
Dose level:
1%
No. with + reactions:
3
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
other: vehicle control challenged with test item
Dose level:
1%
No. with + reactions:
4
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1%
No. with + reactions:
1
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1%
No. with + reactions:
1
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.02%
No. with + reactions:
1
Total no. in group:
6
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.02%
No. with + reactions:
2
Total no. in group:
6
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.2%
No. with + reactions:
6
Total no. in group:
6
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.2%
No. with + reactions:
6
Total no. in group:
6
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
other: naive control (not induced) challenged with test item
Dose level:
0.5%
No. with + reactions:
0
Total no. in group:
4
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
other: naive control (not induced) challenged with test item
Dose level:
0.5%
No. with + reactions:
1
Total no. in group:
4
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5%
No. with + reactions:
3
Total no. in group:
20
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5%
No. with + reactions:
5
Total no. in group:
20

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the study the induction with the test item at 3% did not elicit a delayed contact hypersensitivity response in guinea pigs when challenged with the test article at 1% or when rechallenged at 0.5%.
Executive summary:

The purpose of the study was to determine the potential of the test material to elicit a delayed dermal contact hypersensitivity in guinea pigs by measurement of skin reactivity. The irritation potential of the test article was first determined by a dose ranging study. Based on the results of the dose range finding study 3% was chosen for the induction phase of this study as it produced mild irritation. For the challenge phase the test article was dosed at 1%, the highest non irrtating concentration and at re-challenge at 0.5%.

For the induction phase 10 guinea pigs (5/sex) in the vehicle control group were induced with three 6h occluded dermal application of distilled water, with 7 days between applications. A test item group of 20 animals (10/sex) was induced in the same manner with the test item at 3%. A positive control group of 6 animals (3/sex) was induced with a known dermal sensitiser DNCB 0.3% in ethanol. All animals were observed for dermal irritation and scored 24 and 48h after each application.

Fourteen days after the last induction all animals were challenged with occluded application on naive test sites. All animals in the vehicle control group were challenged with the vehicle (distilled water) and the test item at 1% on separate sites. All animals in the test group were challenged with the test item at 1%. All animals in the postive control group were challenged with DNCB (in acetone) at 0.02% and 0.2%. 24h after the challenge the animals were depilated and scored for dermal irritation. The scoring was repeated at 48h.

The re-challenge with the test item at 0.5% was repeated 7 days after the primary challenge.

Under the conditions of the study the induction with the test item at 3% did not elicit a delayed contact hypersensitivity response in guinea pigs when challenged with the test article at 1% or when rechallenged at 0.5%.