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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
At the time of the present study (1998) the LLNA method was not established as standard method for the skin sensitization examination.

Test material

Constituent 1
Chemical structure
Reference substance name:
Bromacil
EC Number:
206-245-1
EC Name:
Bromacil
Cas Number:
314-40-9
Molecular formula:
C9H13BrN2O2
IUPAC Name:
5-bromo-3-sec-butyl-6-methylpyrimidine-2,4(1H,3H)-dione
Specific details on test material used for the study:
Purity: 98.07%

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
Housing: Animals were housed (1 animal/cage) in elevated stainless steel cages with wire mesh flooring.
The temperature ranged from 20°C - 23°C (68°F - 73°F) and the relative humidity ranged from 21 - 70%.
Food: Purina Certified Guinea Pig Diet #5026 was provided ad libitum.
Water: Supplied ad libitum.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
0.5 g
Day(s)/duration:
0d/7d/14d/6h
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
0.5 g
Day(s)/duration:
29d/6h
No. of animals per dose:
20
Details on study design:
A 0.5 g portion of bromacil moistened with 0.5 mL of propylene glycol was applied to a 25-mm Hill Top Chamber™, placed on the test site, and covered with a piece of dental dam (approximately 2 inches x 2 inches). After positioning the chamber and the occlusive dental dam on the prepared skin site, plastic wrap was
wrapped snugly around the trunk of the animal and overwrapped with Elastikon ™. Approximately 6 hours after application, the entire wrapping was removed, and the test sites were wiped with propylene glycol and then deionized water. This procedure was performed at 7-day intervals for three consecutive weeks.
Positive control substance(s):
yes
Remarks:
A positive control is periodically tested at White Eagle Labs in order to document the effect of a weak sensitizer in this test system. As sensitizer alpha-hexylcinnamaldehyde, technical grade, 85% was used.

Results and discussion

Positive control results:
The test article, alpha-Hexylcinnamaldehyde, technical, 85% (HCA) when induced at a 2.0% w/v concentration and challenged at 1.5% w/v concentration at a dose level of 0.5 mL, is a dermal sensitizer in albino guinea pigs.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
1
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
2
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
3
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
7
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
8
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
9
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
11
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
12
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
13
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
14
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
15
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
16
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
17
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
18
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
19
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
1
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
2
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
3
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
7
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
8
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
9
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
11
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
12
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
13
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
14
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
15
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
16
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
17
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
18
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
19
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 g bromacil and 0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
21
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
22
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
23
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
24
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
25
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
26
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
27
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
28
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
29
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
30
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
21
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
22
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
23
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
24
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
25
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
26
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
27
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
28
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
29
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5 mL propylene glycol
No. with + reactions:
0
Total no. in group:
30
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
lt was concluded that repeated administration of bromacil did not produce delayed contact hypersensitivity in guinea pigs under the study conditions utilized.
Executive summary:

The test article bromacil when induced and challenged at a dose level of 0.5 g of test article moistened with 0.5 mL of propylene glycol (considered 100%), is not a dermal sensitizer in albino guinea pigs.