Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Not a GLP or O.E.C.D. Testing Guideline study with few details on experimental dosing and results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Male and female rabbits were dosed with 0.5 ml of test material under an occluded patch for 4 hours on intact skin. Excess sample is removed and the rabbits are observed for 14 days. Irritation is scored by the Draize method.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml undilute
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3 male and 3 female

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Remarks:
mean score
Time point:
other: 5 hours
Score:
2.9
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
A 4 hour application of 0.5 ml o vinyl 2-ethylhexanoate to occluded rabbit skin resulted in minor to moderate erythema and edema on 6 of 6 rabbits. By 3 days only minor irritation persisted on 2 rabbits. The skin of all 6 rabbits had a normal appearance after 7 days.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Conclusions:
Minor to moderate erythema and edema on 6 of 6 rabbits, which subsided completely after 7 days.
Executive summary:

An Acute Dermal Irritation/Corrosion study was conducted with undiluted Vinyl 2 -ethylhexanoate in six rabbits. The exposure conditions were 6 -hr under occlusion. Based on results from this test, vinyl 2 -ethylhexanoate can be classified as a Catagory 3 mild irritant to rabbit skin under conditions of the test. The results from this study are appropriate and reliable for predicting the skin irritation potential of Vinyl 2 -ethylhexanoate