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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A pre-testing guideline study not conducted under the GLP regulations and without positive control data.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Existing study available.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
As per Vinyl Neodeconate IUCLID Data Set 2007

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
No data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
50 % in corn oil
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
corn oil
Concentration / amount:
50 % in corn oil
No. of animals per dose:
20
Details on study design:
Preliminary test: Groups of guinea-pigs (two male and two female per group) were used to determine the concentration of vinyl neodecanoate that were used at a later time for the intradermal induction, topical induction and topical challenge.

Definitive test: One group of animals (ten females and ten males per group), and an additional group (five females and five males) used as controls were tested for sensitization. No positive control for determining response to a reference substance was included. The test was carried out in two phases. The induction phase of the test was achieved in two segments:

1. Intradermal injection: Three pairs of intradermal injections were given on each side of the midline of the shorn shoulder region. Test animals received three injections as follows:

Injection 1: 2 x 0.1 ml Freund's complete adjuvant
Injection 2: 2 x 0.1 ml test substance in solvent
Injection 3: 2 x 0.1 ml test substance in 50:50 FCA/solvent
Control animals were given the 2 x 0.1 of FCA, solvent and 50:50 FCA/solvent

2. Topical application: Seven days after the intradermal injection, same area of skin was clipped free from hair. A Whatman patch (4 x 4 cm) was soaked with the test material and placed over the previously injected sites and then covered by plastic adhesive tape. All patches were firmly secured to the animal body with elastic adhesive bandage. Test materials were kept in contact with skin for 48 hr.

Challenge phase: The challenge phase was conducted 2 weeks after the topical application of the test material. A Whatman filter paper soaked with test material was applied to a 3 x 3 cm shorn skin on the flank and kept in contact for 24 hours by a semiocclusive dressing. This was covered by overlapping adhesive tape which was secured by an elastic adhesive bandage. The site was examined immediately, at 24 and 48 hr after removal of the test material. Based on the findings from the initial test, the following concentrations were used in the test: Intradermal induction (0.1% w/v in corn oil), topical induction (undiluted test substance), and topical challenge (50% w/v in corn oil). Sign of sensitization was scored by level of erythema seen immediately, 24, and 48 hour after removal of the challenge patches. Erythema was scored on a four point scale.
Challenge controls:
Five animals of each sex were treated with corn oil only to serve as irritation controls.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50% Vinyl Neodeconoate
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% Vinyl Neodeconoate. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No data.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50% Vinyl Neodeconoate
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% Vinyl Neodeconoate. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No data.

Any other information on results incl. tables

The degree of erythema intensity and its persistence was extremely low or not present in all animals treated with the test substance. Therefore, none of the findings resented a positive response.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Vinyl Neodeconoate was not a dermal sensitizer on guinea pigs and does not require Classification and Labelling as a Skin Sensitizer.
Executive summary:

In a Guinea pig dermal sensitization Maximization study Vinyl Neodecanoate did not induce any evidence of allergic dermal reactions. Therefore, Vinyl Neodecanoate is not a skin sensitizer under the extreme conditions of this study.