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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an U.S.E.P.A. O.T.S. Testing Guideline with GLP compliance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OTS 798.4100 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
Buehler test
Justification for non-LLNA method:
Pre existing study

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
As per IUCLID5 Sections 1.1. - 1.4.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
Young Adult Male Hartley guinea pigs were acquired from Sasco, Inc., Omaha, Nebraska and weighted 300 - 500 grams at time of dosing. The animals were individually housed in stainless steel, wire mesh bottom cages. The animal room was individually ventilated at no less than 10 air changes per hour. The temperaturewas maintained at 64 - 79°F and relative humidity was 40 - 70%. Room light was a 12/12 hour light/dark cycle. Fresh Agway Certified Guinea Pig Feed was provided ad libitum. Water was provided ad libitum via an automatic watering system.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
0.5 ml of neat vinyl neononanoate for the induction phase and 0.5 ml of a 1/10 dilution in corn oil for the challange phase.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
0.5 ml of neat vinyl neononanoate for the induction phase and 0.5 ml of a 1/10 dilution in corn oil for the challange phase.
No. of animals per dose:
44 total
Details on study design:
Before exposure to test article, positive control or vehicle article, a strip of hair along one side of the dorsal midline was removed by clipping and shaving. Animals were clipped and shaved throughout the study as needed. For exposures test articles were applied to gauze pads and placed on the shaved area. The gauze pads were stabilized with a strip of hypoallergenic tape. An occlusive barrier consisting of a rubber patch was applied to the test site and secured with 2 inch Blenderm around the back and abdomen. After six hours, all wrappings were removed. Approximately 24 and 48-hours post treatment, the skin was scored using the Draize scoring method.

For each induction phase, 0.5 ml of neat vinyl neononanoate or 0.5 ml of 0.3% DNCB positive control was applied to one site as described previously. Each subsequent application of test or positive control article was applied on the same site. The animals were exposed for six hours once a week, for a period of three weeks.

Thirteen days after the last induction dose was applied, the guinea pigs from the negative challenge control, positive control and test groups were clipped on a naive site as previously described. This site was located on the opposite side of the dorsal midline from the induction test site. The following day (Day 14 post induction applications), 0.5 ml of a 1:10 v/v dilution of vinyl neononanoate prepared in corn oil was applied to a naive site on each guinea pig in the test article group and the corresponding challenge control group. A volume of 0.5 ml of corn oil was applied as described previously on each guinea pig in the vehicle challenge control group. A volume of 0.5 ml of the positive control article (0.2% DNCB prepared in 80% ethanol) was applied in a similar manner to each guinea pig in the positive control group and the corresponding challenge control group.




Challenge controls:
Yes
Positive control substance(s):
yes
Remarks:
0.2% DNCB prepared in 80% ethanol)

Results and discussion

Positive control results:
For the positive control DNCB, Challenge response grades ranged from 4 - 5 with a Severity Index of 4.5 & 4.2 at 24 and 48 hr observation times respectively in all the animals.

In vivo (non-LLNA)

Results
Reading:
other: Both 24 and 48 hr scorings.
Hours after challenge:
24
Group:
test group
Dose level:
0.5 ml neat.
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No data
Remarks on result:
other: Reading:

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The results of the challenge indicate that under the conditions of this test, the positive control DNCB is a delayed contact sensitizer and vinyl neononanoate is not a delayed contact sensitize.r
Executive summary:

When tested for skin sensitization potential by an U.S.E.P.A. O.T.S. 798.4100 Skin Sensitization Testing Guideling applying the Buehler guinea pig methodology, vinyl neononanoate was found not to be a dermal sensitizer under the conditions of this GLP study.