Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
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 based on the O.E.C.D. Testing Guideline with GLP compliance and test substance characterizating including stability determination.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
As per Vinyl Neodeconoate IUCLID 4 Data Set

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Rabbits of 3 - 6 months of age were allowed to acclimate for a period of 14 days before being placed on-study. The animals were singly housed in hanging, stainless—steel cages. Food was provided ad libitum by means of a top—loading food hopper and water by means of an automatic valve— regulated drinking line. The rabbit food (Standard Rabbit Diet, S.Q.C., Special Diet Services Ltd., Essex) was replenished weekly, and the water (filtered but untreated water from the public supply) was automatically replenished. The temperature in the rabbit rooms was maintained in the range 16—19°C.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml undiluted
Duration of treatment / exposure:
4 hr
Observation period:
7 days
Number of animals:
6
Details on study design:
Three male and three female rabbits were used in this test. The dorsal hair between the shoulder and hindquarter was shorn with fine electrical clippers. Square 2 x 2 cm lint patches soaked with 0.5 ml of undiluted vinyl neodecanoate were placed on the test sites. The patches and the surrounding skin were covered with a layer of gauze and held in place by an elastic adhesive for 4 hour. After removal of the patch, sites were examined for erythema and edema on a graded scale of 0 to 4. Development of erythema and edema was observed at 30 minutes and at 24, 48 and 72 hours and 7 days after the application of the test material. Mean score at each time point of individual and group were calculated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4 h
Score:
0.2
Max. score:
0.5
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24
Score:
0.5
Max. score:
1
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
0.3
Max. score:
1
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 7 d
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 7 d
Score:
0
Max. score:
0
Irritant / corrosive response data:
Semi-occlusive application of 0.5 ml undiluted vinyl neodecanoate for 4 hour to the back of rabbits resulted in a very slight irritation (average edema score of 0; average erythema score of 0.3) in four of six rabbits at 24 hour post exposure. On day 7, all signs of irritation were cleared out.

Any other information on results incl. tables

Primary irritation scores of semi-occluded rabbit skin after a single application of vinyl neodecanoate (4 h exposure)

Rabbit
No. & Sex
             Response             4 h          24 h       48 h        72 h        7 days
----------------------------------------------------------------------
85 M
                      Erythema              0             0.5          0             0             0
                               Edema                   0             0             0             0             0
86 M
                      Erythema              0             0             0             0             0
                               Edema                   0             0             0             0             0
91 M
                      Erythema              0             0.5          0             0             0
                               Edema                   0             0             0             0             0
263 F
                      Erythema              0             0             0             0             0
                               Edema                   0             0             0             0             0
264 F
                      Erythema              0.5          1             1             0.5          0
                               Edema                   0             0             0             0             0
112 F
                      Erythema              0.5          1             0.5          0.5          0
                               Edema                   0             0             0             0             0
-----------------------------------------------------------------------
Mean erythema score
                         0.2          0.5          0.3          0.2          0
Mean edema score
                              0             0             0             0             0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Vinyl Neodeconoate is not a skin irritant under the conditions of this O.E.C.D. 404 Testing Guideline study.
Executive summary:

An O.E.C.D. 404 "Acute Dermal Irritation/Corrosion" Testing Guideline study was conducted with undiluted Vinyl Neodecanoate in six rabbits. The exposure conditions were 4 -hr under semi-occlusion. Based on results from this test, vinyl neodecanoate can be classified as non-irritating to rabbit skin under conditions of the test. The results from this study are most appropriate and reliable for predicting the skin irritation potential of Vinyl Neodecanoate