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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1997

Materials and methods

Principles of method if other than guideline:
Method: Wahlberg, J. E., Boman, A., Guinea Pig Maxirnization Test, in: K. E. Andersen, H. I. Maibach (eds.), Contact Allergy Predictive Tests in Guinea Pig, p. 59-106. S. Karger, Basel (1985)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
This study was conducted due to non-REACH regulatory requirements. With the existing data from this study this study precludes the need for an additional LLNA study. In addition, a supplementary LLNA study would violate the ECHA objectives with regards to animal welfare.

Test material

Constituent 1
Chemical structure
Reference substance name:
5-bromo-5-nitro-1,3-dioxane
EC Number:
250-001-7
EC Name:
5-bromo-5-nitro-1,3-dioxane
Cas Number:
30007-47-7
Molecular formula:
C4H6BrNO4
IUPAC Name:
5-bromo-5-nitro-1,3-dioxane
Specific details on test material used for the study:
10% in w/v Propylenglycol

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: 300 - 400 g

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Intradermal: propylene glycol; Topical: ethanol
Concentration / amount:
0.25%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Intradermal: propylene glycol; Topical: ethanol
Concentration / amount:
0.25%
No. of animals per dose:
24
Details on study design:
RANGE FINDING TESTS: The topical irritancy of the substances used for induction and challenge was studied by means of a 48-h closed patch test in 4-8 animals. On each animal the compound was applied on three patches on the flank: one near the back, one near the abdomen, and one in the middle.

MAIN STUDY
A. INDUCTION EXPOSURE (Intradermal and Epicutaneous)

- Exposure period: The testing was performed one week after pretreatment with Freund's complete adjuvant
- Test groups: 24 animals
- Control group: 12 animals
- Concentrations: For intradermal sensitization the test substance was diluted with propylene glycol at 0.25 % w/v a. i. For topical sensitization, 200 μL in ethanol 99.5 % at 0.50 % w/v a. i. was used.

B. CHALLENGE EXPOSURE

- Concentrations: Test substance was tested in ethanol 99.5 % at 0.25 % w/v a. i.
- Evaluation (hr after challenge): 24 h after removal of the patches with unknown criteria and grading

C. Rechallenge
Animals were rechallenged ethanol solutions of equimolar concentrations (0.012 mol/L) of test substance at 0.25 % w/v a. i.
On each patch 30 μL of the test solution was applied.
Challenge controls:
Control group: Control animals only exposed to the suspected sensitizer at challenge.
Vehicle group: Test animals receiving the suspected sensitizer during sensitization but the vehicle alone at challenge.
Positive control substance(s):
yes
Remarks:
2-methylol phenol

Results and discussion

Positive control results:
Positive control animals sensitized to and challenged with the known sensitizer 2-methylol phenol showed the expected results.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Group:
other: control group
Dose level:
0.25%
No. with + reactions:
0
Total no. in group:
12
Key result
Reading:
1st reading
Group:
test chemical
Dose level:
0.25%
No. with + reactions:
19
Total no. in group:
24
Key result
Reading:
1st reading
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
12
Key result
Reading:
1st reading
Group:
positive control
Dose level:
0.25%
No. with + reactions:
4
Total no. in group:
6
Key result
Reading:
rechallenge
Group:
test chemical
Dose level:
0.25%
No. with + reactions:
18
Total no. in group:
24
Key result
Reading:
rechallenge
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
12

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification

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